Patient Profile Navigator
Patient Profile Navigator
For all your HR+, HER2-, N0 and N1, early-stage breast cancer patients
Moving from assumed to proven chemotherapy benefit:
The clarity your patients deserve

In your clinical practice you need to make important decisions and need to consider complex questions daily for your patients:

Will my patient really benefit from chemotherapy? What is the outcome for my patient in the next 5-9 years? Should I order an Oncotype DX Breast Recurrence Score® test to better understand the underlying tumour biology of my patient’s cancer and thus be able to make a tailored chemotherapy treatment decision?

The Oncotype DX Breast Recurrence Score® test is clinically validated for
HR+, HER2-, N0/N1, early-stage breast cancer patients

The Patient Profile Navigator will provide you with N0 and N1 clinical data to help you decide whether an Oncotype DX® test would aid in making these important decisions.

 

With some clicks you can:

  • Choose your clinical pathological parameter/s of interest
  • Browse through clinical data
  • Get in contact with an Exact Sciences representative
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Select your patient profile (1/2)
Choose from the nodal status selection below:
Nodal status
N0
N1
(1-3 nodes)
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Select your patient profile (2/2)
Choose from the parameters below:
Age
Age less than equal to 50
≤50 years
Age more than 50
>50 years
Tumour Size
Tumour Size less than equal to 1
<1 cm
Icon Tumor Size 1-2
1.1-2.0 cm
Tumour Size 2-3 cm
2.1-3.0 cm
Tumour Size larger or equal to 3.1cm
≥3.1 cm
Tumour Grade
Tumour Grade 1
Grade 1
Tumour Grade 2
Grade 2
Icon Tumor Grade 3
Grade 3
Ki-67
Ki-67 less than 10%
<10%
Ki-67 10-20%
10-20%
Ki-67 20-40%
20-40%
Ki-67 larger than 40%
>40%
CREATE YOUR SELECTED PATIENT PROFILE
Select your patient profile (2/2)
Choose from the parameters below:
Menopausal status
Pre-menopausal
Post-menopausal
Tumour Grade
Icon Tumor Grade 1
Grade 1
Icon Tumor Grade 2
Grade 2
Icon Tumor Grade 3
Grade 3
Tumour Size
Icon Tumour Size T1
T1
Icon Tumour Size T2
T2
Icon Tumour Size T3
T3
Micromets
0.2-2.0mm
Ki-67
Ki-67 less than 10%
<10%
Ki-67 10-20%
10-20%
Ki-67 20-40%
20-40%
Ki-67 larger than 40%
>40%
Tumour Grade
Icon Tumor Grade 1
Grade 1
Icon Tumor Grade 2
Grade 2
Icon Tumor Grade 3
Grade 3
Tumour Size
Icon Tumour Size T1
T1
Icon Tumour Size T2
T2
Icon Tumour Size T3
T3
Micromets
0.2-2.0mm
Ki-67
Ki-67 less than 10%
<10%
Ki-67 10-20%
10-20%
Ki-67 20-40%
20-40%
Ki-67 larger than 40%
>40%
CREATE YOUR SELECTED PATIENT PROFILE
Your patient profile
Age less than equal to 50
Age
≤50 years
  • The Recurrence Score® (RS) result distribution does not vary with age.1
  • In the absence of Oncotype DX® testing, the high chemotherapy baseline treatment rate in patients <50 years, may lead to potential overtreatment.6
  • The Oncotype DX® test provides detailed estimates of chemotherapy benefit for patients ≤50 years based on the TAILORx and the NSABP-B20 trials1-5:
    • RS® result: 0-15: no significant CT benefit1-4
    • RS® result: 16-20: 0.6% (±2.1) CT benefit1-4
    • RS® result: 21-25: 7.8% (±3.4) CT benefit1-4
    • RS® result: 26-100: substantial CT benefit4-5

1. Sparano et al. N Engl J Med. 2018; 2. Sparano et al. N Engl J Med. 2019; 3. Sparano et al. Abstract GS1-05, General Session #1, SABCS 2022; 4. Geyer et al. npj Breast Cancer. 2018; 5. Paik et al. J Clin Oncol. 2006; 6. Griggs J Clin Oncol. 2012.

Age more than 50
Age
>50 years
  • The Recurrence Score® (RS) result distribution does not vary with age.1
  • In the absence of Oncotype DX® testing, the low chemotherapy baseline treatment rate in patients >70 years, may lead to potential undertreatment.6
  • The Oncotype DX® test provides chemotherapy benefit estimates for HR+, HER2-, N0, early breast cancer patients >50 years based on the TAILORx and the NSABP-B20 trials1-5:
    • RS® result: 0-25: no significant CT benefit1-5
    • RS® result: 26-100: substantial CT benefit4-5

 


1. Sparano et al. N Engl J Med. 2018; 2. Sparano et al. N Engl J Med. 2019; 3. Sparano et al. Abstract GS1-05, General Session #1, SABCS 2022; 4. Geyer et al. npj Breast Cancer. 2018; 5. Paik et al. J Clin Oncol. 2006; 6. Griggs. J Clin Oncol. 2012.
Tumour Size less than equal to 1
Tumour Size
<1 cm
  • Tumour size does not correlate with Recurrence Score® results and was not shown to predict chemotherapy benefit.1-3
  • TAILORx showed that a consistent proportion of patients with small tumours ≤1 cm were present across all Recurrence Score® result groups. In addition, about 14% of patients with Recurrence Score® results 26-100 and small tumours less than ≤1 cm may benefit from adjuvant chemotherapy.1-3
  • A real-world registry demonstrated that a significant portion of patients with ≤1 cm tumours had Recurrence Score® results 26-100.4


1. Sparano et al. N Engl J Med. 2018; 2. Geyer et al. npj Breast Cancer. 2018; 3. Paik et al. J Clin Oncol. 2006; 4. Adapted from Stemmer et al. npj Breast Cancer. 2017.
Icon Tumor Size 1-2
Tumour Size
1.1-2.0 cm
  • Tumour size is not associated with Recurrence Score® results and was not shown to predict chemotherapy benefit.1-3
  • TAILORx showed that patients with tumour size 1.1–2.0 cm are distributed across all Recurrence Score® result groups (0–25 and 26–100). About 53% of patients with RS® results 26-100 have tumours 1.1 to 2 cm and may benefit from adjuvant chemotherapy.1-3
  • Real-world registries confirmed a wide distribution in both Recurrence Score® result groups 0-25 and 26-100, and demonstrated that a significant proportion of patients with tumours ≤2.0 cm had RS® results 26-100.4,5


1. Sparano et al. N Engl J Med. 2018; 2. Geyer et al. npj Breast Cancer. 2018; 3. Paik et al. J Clin Oncol. 2006; 4. Adapted from Stemmer et al. npj Breast Cancer. 2017; 5. Walter et al. Geburtshilfe Frauenheilkd. 2020.
Tumour Size 2-3 cm
Tumour Size
2.1-3.0 cm
  • Tumour size does not correlate with Recurrence Score® results and was not shown to predict chemotherapy benefit.1-3
  • TAILORx showed that a consistent portion of patients with tumour size 2.1 – 3.0 cm were present across all Recurrence Score® result groups (0–25 and 26–100).1
  • Real-world registries demonstrated that a significant proportion of patients with a tumour size >2 cm had Recurrence Score® results 0-25 and may not benefit from chemotherapy.1-5


1. Sparano et al. N Engl J Med. 2018; 2. Geyer et al. npj Breast Cancer. 2018; 3. Paik et al. J Clin Oncol. 2006; 4. Stemmer et al. EBCC 2015. Poster 163; 5. Walter et al. Geburtshilfe Frauenheilkd. 2020.
Tumour Size larger or equal to 3.1cm
Tumour Size
≥3.1 cm
  • Tumour size is not associated with Recurrence Score®results and was not shown to predict chemotherapy benefit.1-3
  • TAILORx showed that a consistent proportion of patients with tumour size ≥3.1 cm were present across all Recurrence Score® result groups (0–25 and 26–100).1


1. Sparano et al. N Engl J Med. 2018; 2. Geyer et al. npj Breast Cancer. 2018; 3. Paik et al. J Clin Oncol. 2006.
Tumour Grade 1
Tumour Grade
Grade 1
  • Tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • TAILORx demonstrated that 7% of patients with Recurrence Score® results 26-100 had grade 1 tumours and may benefit from adjuvant chemotherapy.1
  • Real-world evidence confirmed that about 6% of grade 1 patients have Recurrence Score® results 26-100 and may benefit from chemotherapy.1-4

1. Sparano et al. N Engl J Med. 2018; 2. Geyer et al. npj Breast Cancer. 2018; 3. Paik et al. J Clin Oncol. 2006; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020.
Tumour Grade 2
Tumour Grade
Grade 2
  • Tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • TAILORx showed that patients with tumour grade 2 are similarly distributed across all Recurrence Score® result groups.1
  • Real-world evidence reported that about 15% of grade 2 patients have Recurrence Score® results of 26-100 and may benefit from chemotherapy.1-4
  • A decision-impact study demonstrated that the Oncotype DX® test led to a treatment change of 41% for patients with grade 2 tumours in routine clinical practice and to an overall reduction of 60% in chemotherapy recommendations.5


1. Sparano et al. N Engl J Med. 2018; 2. Geyer et al. npj Breast Cancer. 2018; 3. Paik et al. J Clin Oncol. 2006; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Curtit E. et al, SFPM conference. 2019.
Icon Tumor Grade 3
Tumour Grade
Grade 3
  • Tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • TAILORx and a real-world registry demonstrated that on average, 58% of grade 3 patients have Recurrence Score® results 0-25 and thus may not benefit from chemotherapy.1-4
  • A decision-impact study demonstrated that the Oncotype DX® test led to treatment recommendation change of 36% in routine clinical practice and to an overall reduction of 34% in chemotherapy recommendations.5


1. Sparano et al. N Engl J Med. 2018; 2. Geyer et al. npj Breast Cancer. 2018; 3. Paik et al. J Clin Oncol. 2006; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Curtit E. et al, SFPM conference. 2019.
Ki-67 less than 10%
Ki-67
<10%
  • Ki-67 does not correlate with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown in independent trials.2
  • Prospective data demonstrated that about 1 in 10 patients with Ki-67 values of <10% had a Recurrence Score® result 26-100 and may benefit from chemotherapy.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score®result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 10-20%
Ki-67
10-20%
  • Ki-67 does not correlate with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data demonstrated that more than 10% of patients with Ki-67 values 10-19% had a Recurrence Score® result 26-100 and may benefit from adjuvant chemotherapy.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score® result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 20-40%
Ki-67
20-40%
  • Ki-67 does only weakly correlate with Recurrence Score® results (R=0.3437) and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data show Ki-67 values 20-39% do not give a clear indication whether there is an adjuvant chemotherapy benefit or not.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score® result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 larger than 40%
Ki-67
>40%
  • Ki-67 does only weakly correlate with Recurrence Score® results (R=0.3437) and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data demonstrated that about 1 out 10 of patients with Ki-67 values of >39% have Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.3
  • An overall high discordance of 45% between Ki-67 and the RS® result, was reported in real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St. Gallen. 2013.
Conclusion
Conclusion
previous slide

In the absence of Oncotype DX® testing, the high chemotherapy baseline treatment rate in patients <50 years may lead to potential overtreatment1

The data from the SEER registry shows that1:

  • Patients <50 years of age with early HR+, HER2- breast cancers tend to receive more chemotherapy.
  • Therefore, the risk of chemotherapy overtreatment could increase with decreasing patient age.2

1. Griggs J Clin Oncol. 2012; 2. Sparano et al. N Engl J Med. 2018.

In TAILORx, distribution of Recurrence Score® results is consistent across age groups1

The results from the TAILORx study show that1:

  • The distribution of Recurrence Score® results does not vary with age, suggesting the tumour biology is not correlated with age.
  • Given the high chemotherapy treatment rate in patients ≤50 years,2 there is a possible risk of chemotherapy overtreatment in younger patients, if not tested.

1. Sparano et al. N Engl J Med. 2018; 2. Griggs J Clin Oncol. 2012.

The Oncotype DX® test is the only test predictive of chemotherapy, and it provides precise chemotherapy benefit estimates for patients ≤50 years2-5

The results from TAILORx and NSAPB-20 suggest that2-5:

  • A large proportion of patients ≤50 years of age do not benefit from chemotherapy.3
  • The Oncotype DX® test provides estimates of benefit from chemotherapy for patients younger ≤50 years old.4,5
  • TAILORx 12-year data observed a chemotherapy benefit in women ≤50 years with Recurrence Score® (RS) results 16-20 and high clinical risk or RS® results 21-25 regardless of clinical risk.5
  • More precisely, for this age group studies determined:
    • RS® result: 0-15: no significant CT benefit1-5
    • RS® result: 16-20: 0.6% (±2.1) CT benefit3-5
    • RS® result: 21-25: 7.8% (±3.4) CT benefit3-5
    • RS® result: 26-100: substantial CT benefit1-2

1. Paik et al. J Clin Oncol. 2006; 2. Geyer et al. npj Breast Cancer. 2018; 3. Sparano et al. N Engl J Med. 2018; 4. Sparano et al. N Engl J Med. 2019; 5. Sparano et al. Abstract GS1-05, General Session #1, SABCS 2022.

In the absence of Oncotype DX® testing, the low chemotherapy baseline treatment rate in patients >70 years may lead to potential undertreatment1

The data from the SEER registry show that1:

  • Older patients with early HR+, HER2- breast cancer tend to receive less chemotherapy.
  • Therefore, the potential of chemotherapy undertreatment may increase with patient age.

1. Griggs J Clin Oncol. 2012.

In TAILORx, distribution of Recurrence Score® results is consistent across age groups1:

The results from the TAILORx study show that1:

  • The distribution of Recurrence Score® results does not vary with age, suggesting the tumour biology is not correlated with age.
  • About 15% of patients aged >50 years have Recurrence Score® results 26-100 and may benefit from chemotherapy.

1. Sparano et al. N Engl J Med. 2018.

The Oncotype DX® test is the only test predictive of chemotherapy benefit, and it provides chemotherapy benefit estimates for patients1-5

The results from TAILORx and NSABP-20 suggest that1-5:

  • A large proportion of patients >50 years of age do not benefit from chemotherapy.3
  • The Oncotype DX® test provides estimates of benefit from chemotherapy by age and clinical risk groups.1-5
  • For this age group studies demonstrated:
    • RS® result: 0-25: no significant CT benefit1-5
    • RS® result: 26-100: substantial CT benefit1,2

1. Paik et al. J Clin Oncol. 2006; 2. Geyer et al. npj Breast Cancer. 2018; 3. Sparano et al. N Engl J Med. 2018; 4. Sparano et al. N Engl J Med. 2019. 5. Sparano et al. Abstract GS1-05, General Session #1, SABCS 2022.

Tumour size does not predict the Recurrence Score® result1

The TAILORx study shows that1:

  • Tumour size is not associated with Recurrence Score® results.
  • A consistent proportion of patients with small tumours ≤1 cm were present across all Recurrence Score® result groups.
  • 14% of patients with Recurrence Score® results 26-100 had a tumour size ≤1 cm and may benefit from adjuvant chemotherapy.

1. Sparano et al. N Engl J Med. 2018.

No significant chemotherapy treatment interaction was found with tumour size in TAILORx1

The TAILORx results show that1:

  • No statistically significant interaction between chemotherapy treatment and tumour size was found for patients with Recurrence Score® results 11-25.

1. Sparano et al. N Engl J Med. 2018.

Real-world registry shows a wide distribution of Recurrence Score® results within each tumour size group, including small tumours <1cm1

The real-world CLALIT registry demonstrates that:1

  • Tumour size is not associated with Recurrence Score® results,1 consistent with TAILORx.2
  • Tumour size has not been shown to predict the Recurrence Score® result.1,2
  • A significant proportion of patients with tumour sizes ≤1 cm have Recurrence Score® results 26-1001 and may benefit from chemotherapy.2

1. Adapted from Stemmer et al. npj Breast Cancer. 2017; 2. Sparano et al. N Engl J Med. 2018.

Clinical pathologic features alone do not predict Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour size does not predict Recurrence Score® results.1
  • A consistent proportion of patients have Recurrence Score® results 26-100 irrespective of tumour size.1
  • A significant number of patients with small tumour sizes have Recurrence Score® results 26-1001 and may benefit from chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Tumour size does not predict the Recurrence Score® result1

The TAILORx study shows that1:

  • Tumour size is not associated with Recurrence Score® results.
  • A consistent proportion of patients with tumour sizes 1.1 – 2.0 cm were present across all Recurrence Score® result groups.
  • 53% of patients with Recurrence Score® results 26-100 have a tumour size 1.1 – 2.0 cm and may benefit from adjuvant chemotherapy.

1. Sparano et al. N Engl J Med. 2018.

No significant chemotherapy interaction was found with tumour size in TAILORx1:

The TAILORx results show that1:

  • No statistically significant interaction between chemotherapy treatment and tumour size was found for patients with Recurrence Score® results 11-25.

1. Sparano et al. N Engl J Med. 2018.

Real-world registry shows a wide distribution of Recurrence Score® results within each tumour size group1

The real-world CLALIT registry demonstrates that1:

  • Tumour size is not associated with Recurrence Score® result,1 consistent with TAILORx.2
  • Tumour size has not been shown to predict the Recurrence Score® result.1,2
  • A significant proportion of patients with tumour sizes >1 to ≤2 cm are distributed in both Recurrence Score® result groups 0-25 and 26-100.

1. Adapted from Stemmer et al. npj Breast Cancer. 2017; 2. Sparano et al. N Engl J Med. 2018.

Clinical pathologic features alone do not predict Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour size does not predict Recurrence Score® results.1
  • A significant proportion of patients with tumours ≤2 cm have Recurrence Score® results 26-1001 and may benefit from chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Tumour size does not predict the Recurrence Score® result1

The TAILORx study showed that1:

  • The distribution of Recurrence Score® results was not affected by tumour size.
  • A consistent proportion of patients with tumour size 2.1 – 3.0 cm were present across all Recurrence Score® result groups.

1. Sparano et al. N Engl J Med. 2018.

No significant chemotherapy interaction was found with tumour size in TAILORx1:

The TAILORx results show that1:

  • No statistically significant interaction between chemotherapy treatment and tumour size was found for patients with Recurrence Score® results 11-25.

1. Sparano et al. N Engl J Med. 2018

Real-world registry confirms a wide distribution of Recurrence Score® results within each tumour size group1

The real-world CLALIT registry demonstrates that1:

  • Tumour size is not associated with Recurrence Score® results,1 consistent with TAILORx.2
  • A significant proportion of patients with a tumour size >2 cm have Recurrence Score® results 0-251 and may not benefit from chemotherapy.2

1. Adapted from Stemmer et al. npj Breast Cancer. 2017; 2. Sparano et al. N Engl J Med. 2018.

Clinical pathologic features alone do not predict Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour size does not predict Recurrence Score® results.1-2
  • A significant proportion of patients with tumour size 2-5 cm have Recurrence Score® results 0-251 and may not benefit from chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006.

Tumour size does not predict the Recurrence Score® result1

The TAILORx study showed that1:

  • A consistent proportion of patients with larger tumours ≥3.1 cm were present across all Recurrence Score® result groups.

1. Sparano et al. N Engl J Med. 2018.

Real-world registry confirms a wide distribution of Recurrence Score® results within each tumour size group1

The real-world CLALIT registry demonstrates that1:

  • Tumour size is not associated with Recurrence Score® results,1 consistent with TAILORx.2
  • Tumour size has not been shown to predict the Recurrence Score® result.1,2
  • A significant proportion of patients with a tumour size >2 cm have Recurrence Score® results 0-251 and may not benefit from chemotherapy.2

1. Adapted from Stemmer et al. npj Breast Cancer. 2017; 2. Sparano et al. N Engl J Med. 2018.

Clinical pathologic features alone do not predict Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour size does not predict Recurrence Score® results.1,2
  • A significant proportion of patients with large tumour sizes >5 cm have Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006.

Tumour grade does not predict the Recurrence Score® result1

The TAILORx study showed that1:

  • 7% of patients with Recurrence Score® results 26-100 have grade 1 tumours and may benefit from adjuvant chemotherapy.

1. Sparano et al. N Engl J Med. 2018.

Tumour grade does not predict chemotherapy benefit1

The TAILORx results show that1:

  • No statistically significant interaction between chemotherapy treatment and tumour grade was found for patients with Recurrence Score® results 11-25.

1. Sparano et al. N Engl J Med. 2018.

Clinical pathologic features alone do not predict Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour grade does not predict the Recurrence Score® result.1
  • While there are fewer patients with grade 1 tumours and Recurrence Score® results 26-100, about 6% of patients with grade 1 tumours have Recurrence Score® results 26-100 and may benefit from chemotherapy.3-4

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018; 3. Paik et al. J Clin Oncol. 2006; 4. Geyer et al. npj Breast Cancer. 2018.

Tumour grade does not predict the Recurrence Score® result1

The TAILORx study showed that1:

  • Grade 2 patients are almost equally distributed across all Recurrence Score® result groups.
  • Tumour grade 2 alone cannot predict the Recurrence Score® result and therefore predict chemotherapy benefit.

1. Sparano et al. N Engl J Med. 2018.

Tumour grade does not predict chemotherapy benefit1

The TAILORx results show that1:

  • No statistically significant interaction between chemotherapy treatment and tumour grade was found for patients with Recurrence Score® results 11-25.

1. Sparano et al. N Engl J Med. 2018.

Clinical pathologic features alone do not predict Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany confirmed:1

  • Tumour grade does not predict the Recurrence Score® result.1
  • The Recurrence Score® results help classify grade 2 patients and potentially spare chemotherapy in the majority.1,2
  • About 15% of grade 2 patients have Recurrence Score® results 26-1001 and may benefit from chemotherapy.3-4

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018; 3. Paik et al. J Clin Oncol. 2006; 4. Geyer et al. npj Breast Cancer. 2018.

Treatment change pre- and post-Oncotype DX® testing in routine clinical practicea,1

A sub-analysis of grade 2 patients tested in a French decision impact study demonstrated that1:

  • Oncotype DX® test use for grade 2 patients in clinical practice led to an overall reduction in chemotherapy recommendation of 60%.
  • Among the 40% of grade 2 patients who had an initial recommendation of HT, 13% (19 pts) had an escalation to CT-HT after receiving the Recurrence Score® results.
  • Among the 60% of the patients with grade 2 who were initially recommended CT-HT, 69% (156 pts) had a de-escalation to HT alone after receiving the Recurrence Score® results.

 

PONDx France sub-analysis of patients with grade 2 tumours:
(n=432) ER+/HER2- patients across 49 institutions in France before the publication of TAILORx results.a,1

View next slide to see characteristics of patient subgroup


1. Curtit E. et al, SFPM conference. 2019.

Characteristics of patient subgroup with Grade 2 tumours1
n %
Age <35
35-50
50-70
>70
5
124
261
42
1
29
60
10
Sex Female
Male
431
1
100
0
Size <1cm
1-2 cm
2.1-5 cm
>5 cm
0
288
144
0
0
67
33
0
Grade G1
G2
G3
0
432
0
0
100
0
RS® results 0-25
26-100
ND
369
59
4
85.4
13.7
0.9

1. Curtit E. et al, The Breast. 2019.

 

Tumour grade does not predict the Recurrence Score® result1

The TAILORx study showed that1:

  • Grade 3 patients are distributed across all Recurrence Score® result groups.
  • A significant proportion of patients with grade 3 tumours have Recurrence Score® results 0-25 and may not benefit of chemotherapy.

1. Sparano et al. N Engl J Med. 2018.

A large proportion of patients with grade 3 tumours have low Recurrence Score® results and may not benefit from chemotherapy1,2

Data from the TAILORx study1 and the CLALIT real-world registry2 show that:

  • Of the 1,676 (17%) of TAILORx patients with grade 3 tumours, 59% had Recurrence Score® results 0-25.1
  • In the CLALIT real-world registry, 57% of patients with grade 3 tumours had Recurrence Score® results 0-25.2

1. Sparano et al. N Engl J Med. 2018; 2. Stemmer S et al. npj Breast Cancer. 2019.

Clinical pathologic features alone do not predict Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany confirmed that1:

  • Real-world evidence confirms that tumour grade cannot predict the Recurrence Score® results.1
  • A majority of patients with grade 3 tumours have Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.2
  •  

    a Low clinical risk:
    N0, T ≤3 cm and Grade 1; N0, T ≤2 cm and Grade 2; N0, T ≤1 cm and Grade 3
    N1, T ≤2 cm and Grade 1
    High clinical risk: all other cases

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018.

The Oncotype DX Recurrence Score® assay informs chemotherapy recommendations in patients with Grade 3 tumoursa,1

A sub-analysis of grade 3 patients tested in a French decision impact study demonstrated that1:

  • Before receiving Recurrence Score® results, clinicians recommended chemotherapy to the vast majority (87%) of patients with grade 3 tumours.
  • With Recurrence Score® results they reduced chemotherapy recommendations overall by 34%.
  • There was a very significant de-escalation (38%) of CT-HT to HT alone.
  • There was an escalation (30%) to CT-HT for 6 patients that were initially recommended HT alone.

 

PONDx France sub-analysis of patients with grade 3 tumours:
(n=157) ER+/HER2- patients across 49 institutions in France before the publication of TAILORx results.a,1

View next slide to see characteristics of patient subgroup


1. Curtit et al., The Breast. 2019.

Characteristics of patient subgroup with Grade 3 tumours1
n %
Age <35
35-50
50-70
>70
1
27
98
31
1
17
62
20
Sex Female
Male
157
0
100
0
Size <1cm
1-2cm
2.1-5cm
>5cm
14
92
50
2
9
59
32
1
Grade G1
G2
G3
0
0
157
0
0
100
RS® results <18
18-30
>30
46
69
42
29
44
27

1. Curtit E. et al, The Breast. 2019.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1

Two independent studies from the IBCSG study group showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671

In the German prospective trial WSG plan B, Ki-67 expression was assessed centrally1:

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • About 1 in 10 patients with Ki-67 values of <10% had a Recurrence Score® result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant proportion of patients with a Ki-67 value of ≤10% result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1

Two independent studies from the IBCSG study group showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671

In the German prospective trial WSG plan B, Ki-67 expression was assessed centrally.1

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • More than 10% of patients with Ki-67 values 10-19% had a Recurrence Score® result 26-1001 and may benefit from adjuvant chemotherapy.

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant proportion of patients with a Ki-67 value of 10%-20% result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1

Two independent studies from the IBCSG study group showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671

In the German prospective trial WSG plan B, Ki-67 expression was assessed centrally1:

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • Ki-67 values 20-39% do not give a clear indication whether there is an adjuvant chemotherapy benefit or not.2-3

1. Adapted from Gluz et al. J Clin Oncol. 2016.

Relationship between Recurrence Score® results and Ki-671

The CLALIT real-world registry suggests that1:

  • There is weak to moderate correlation between Ki-67 values and the Recurrence Score® results.
  • A significant proportion of patients with Ki-67 values between 20-40% have Recurrence Score® results 0-25.

1. Ben-Baruch et al. St.Gallen. 2013.

Ki-67 does not predict Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany confirmed that1:

  • Ki-67 values have a weak to moderate correlation with the Recurrence Score® results.
  • A high proportion of patients with a Ki-67 value of ≥20% had a Recurrence Score® result of 0-251 and may not benefit of adjuvant chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1

Two independent studies from the IBCSG study group showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671

In the German prospective trial WSG plan B, Ki-67 expression was assessed centrally.1:

The results show that:

  • Ki-67 values centrally assessed had a weak to moderate correlation with the Recurrence Score® results.1
  • About 1 out 10 of patients with Ki-67 value of >39% have Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.2

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Sparano et al. N Engl J Med. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1

A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant number of patients with a Ki-67 value of >40% had Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.2
1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018.
next slide
Your patient profile
Menopausal status
Pre-menopausal
  • RxPONDER results add to findings of SWOG-8814 for node-positive disease and delivers insights for premenopausal patients in regards of chemotherapy benefit.1-3
  • Data from the RxPONDER trial have shown that N1 premenopausal patients with Recurrence Score® results 0–25 derived a modest 2.4% benefit from chemotherapy in terms of distant recurrence-free interval (DRFI) at 5 years.1,3
    • It is not known whether the benefit observed with chemotherapy is due to chemotherapy alone, ovarian function suppression, or a combination of the two.1,3
    • Absence of menstrual periods was associated with improved IDFS for premenopausal patients.4
  • The Oncotype DX® test provides detailed estimates of chemotherapy benefit for premenopausal women based on the RxPONDER trials:
    • RS® result 0-13: ~2.3% CT benefit1,3
    • RS® result 14-25: ~ 2.8% CT benefit1,3
    • RS® results 26-100: Substantial CT benefit*
  • Updated NCCN and ASCO guidelines suggest that the Oncotype DX® test for premenopausal pN1mi and N1 patients with HR+, HER2- breast cancer can be considered to assess prognosis and used in shared patient-physician treatment decision-making.5,6

  • * Benefit of chemotherapy for premenopausal N1 patients with Recurrence Score® results 26-100 has not been formally assessed in a randomised study. The benefit derived from chemotherapy was modest for RS® results 0-13 and 14-25 in the RxPONDER study, and it is inferred to be substantial for patients with RS® results 26-100.


    1. Kalinsky et al. N Engl J Med. 2021.; 2. Albain et al. Lancet Oncol. 2010.; 3. Kalinsky et al. SABCS 2021. ; 4. Kalinsky et al. SABCS 2021 GS2-07 5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V4.2023. 6. Andre et al JCO 2022;
Icon Tumor Grade 1
Tumour Grade
Grade 1
  • Overall, tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • The RxPONDER study showed that premenopausal patients with grade 1 tumours and Recurrence Score® results 0-25 received a modest benefit from chemotherapy.4

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 3. Albain et al Lancet Oncology 2010; 4. Kalinisky et al NEJM 2021
Icon Tumor Grade 2
Tumour Grade
Grade 2
  • Overall, tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1, 2
  • The RxPONDER study showed that premenopausal patients with grade 2 tumours and Recurrence Score® results 0-25 received a modest benefit from chemotherapy.2
  • A real-world registry confirmed that a significant proportion of node positive patients with grade 2 tumours had low Recurrence Score® results.3
  • A decision-impact study, conducted before publication of RxPONDER results, including patients with grade 2 tumours, demonstrated that the Oncotype DX® test led to a treatment change of 50.2% in routine clinical practice and to an overall reduction of 60.4% in chemotherapy recommendations.4


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Kalinisky et al NEJM 2021; 3. Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c.; 4 Battisti et al, St Gallen International conference 2019, P007
Icon Tumor Grade 3
Tumour Grade
Grade 3
  • Overall, tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-5
  • The RxPONDER study showed that premenopausal patients with grade 3 tumours and Recurrence Score® results 0-25 received a modest benefit from chemotherapy.2
  • Real-world registries confirmed that a significant proportion of node-positive patients with grade 3 tumours had low Recurrence Score® results.1,3-5


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Kalinisky et al NEJM 2021; 3. Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 4. Petkov et al SABCS 2016.; 5. Iorgulescu et al. JCO Precis Oncol 2019
Icon Tumour Size T1
Tumour Size
T1
  • Overall, tumour size is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • The RxPONDER study showed that premenopausal patients with T1 tumours and Recurrence Score® results 0-25 may derive a modest benefit from chemotherapy.2
  • The SEER real-world registry confirmed that a significant proportion of N1 patients with tumours ≤2 cm and grade 3 disease had low Recurrence Score® results.3


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 3. Kalinisky et al NEJM 2021 4. Petkov et al Poster SABCS 2016;
Icon Tumour Size T2
Tumour Size
T2
  • Overall, tumour size is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1,2
  • The RxPONDER study showed that premenopausal patients with T2/T3 tumours and Recurrence Score® results 0-25 received a modest benefit from chemotherapy.2
  • Real-world registries confirmed that a significant proportion of node-positive patients with tumours >2 cm had low Recurrence Score® results.3,4
  • A decision-impact study, conducted before publication of RxPONDER results, including patients with T2/T3 tumours, demonstrated that the Oncotype DX® test led to a treatment recommendation change of 50.2% in routine clinical practice and to an overall reduction of 60.4% in chemotherapy recommendations.5


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Kalinisky et al NEJM 2021 3. Petkov et al SABCS 2016 4. Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c 5. Battisti et al, St Gallen International conference 2019, P007
Icon Tumour Size T3
Tumour Size
T3
  • Overall, tumour size is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1,2
  • The RxPONDER study showed that premenopausal patients with T2/T3 tumours and Recurrence Score® results 0-25 received a modest benefit from chemotherapy.2
  • Real-world registries confirmed that a significant proportion of node-positive patients with tumours >2 cm had low Recurrence Score® results.3,4
  • A decision-impact study, conducted before publication of RxPONDER results, including patients with T2/T3 tumours, demonstrated that the Oncotype DX® test led to a treatment recommendation change of 50.2% in routine clinical practice and to an overall reduction of 60.4% in chemotherapy recommendations.5


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Kalinisky et al NEJM 2021 3. Petkov et al SABCS 2016 4. Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c 5. Battisti et al, St Gallen International conference 2019, P007
Micromets
0.2-2.0mm
  • pN1mi lymph-node status has not been shown to predict tumour biology1
  • The RxPONDER study post hoc analysis showed that premenopausal patients with micromets and Recurrence Score® results 0-25 benefitted from the addition of chemotherapy to endocrine therapy although there were a limited number of events in the analysis (n=22)2
  • A real-world registry confirmed that a significant proportion of node-positive patients with N1mi disease have low Recurrence Score® results.3
  • The NCCN Guidelines suggest that the assay can be considered to assess prognosis in premenopausal pN1mi and N1 patients with HR+, HER2- breast cancer.4


1. Bello et al Ann. Surgical Oncol. 2018 2. Kalinisky et al NEJM 2021 3. Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023.
Ki-67 less than 10%
Ki-67
<10%
  • Ki-67 does not correlate with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown in independent trials.2
  • Prospective data demonstrated that about 1 in 10 patients with Ki-67 values of <10% had a Recurrence Score® result 26-100 and may benefit from chemotherapy.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score®result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 10-20%
Ki-67
10-20%
  • Ki-67 does not correlate with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data demonstrated that more than 10% of patients with Ki-67 values 10-19% had a Recurrence Score® result 26-100 and may benefit from adjuvant chemotherapy.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score® result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 20-40%
Ki-67
20-40%
  • Ki-67 correlates only weakly with Recurrence Score® results (R=0.3437) and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data show Ki-67 values 20-39% do not give a clear indication whether there is an adjuvant chemotherapy benefit or not.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score® result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 larger than 40%
Ki-67
>40%
  • Ki-67 correlates only weakly with Recurrence Score® results (R=0.3437) and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data demonstrated that about 1 out 10 patients with Ki-67 values of >39% have Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.3
  • An overall high discordance of 45% between Ki-67 and the RS® result, was reported in real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St. Gallen. 2013.
Menopausal status
Post-menopausal
  • RxPONDER results add to findings of SWOG-8814, the study that established the Oncotype DX® test as predictive of chemotherapy benefit in N1 patients.1-3
  • Both studies have demonstrated that a substantial proportion of postmenopausal HR+, HER2-, N1 early-stage breast cancer patients can be spared chemotherapy when decisions are guided by the Oncotype DX® test.1-3
  • RxPONDER results confirmed that postmenopausal women with 1-3 positive nodes and Recurrence Score results 0-25 can forgo adjuvant chemotherapy, regardless of clinical pathological parameters.1,3
  • Updated ASCO and NCCN guidelines position the Oncotype DX® test as the “preferred” assay for postmenopausal pN1mi and N1 patients with HR+, HER2-, early-stage breast cancer.4,5

1. Kalinsky et al. N Engl J Med. 2021.; 2. Albain et al. Lancet Oncol. 2010.; 3. Kalinsky et al. SABCS 2021. 4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V4.2023. 5.Andre et al JCO 2022
Icon Tumor Grade 1
Tumour Grade
Grade 1
  • Tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • The RxPONDER study showed that postmenopausal patients with grade 1 tumours and Recurrence Score® results 0-25 did not benefit from chemotherapy.3
  • Real-world evidence has shown that around 6% of patients with grade 1 tumours have Recurrence Score results 26-1001 and may benefit from chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021;
Icon Tumor Grade 2
Tumour Grade
Grade 2
  • Tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • The RxPONDER study showed that postmenopausal patients with grade 2 tumours and Recurrence Score® results 0-25 did not benefit from chemotherapy.3
  • A real-world registry confirmed that a significant proportion of node positive patients with grade 2 tumours had low Recurrence Score® results.4
  • A decision-impact study, including patients with T2/T3 tumours, demonstrated that the Oncotype DX® test led to a treatment recommendation change of 50.2% in routine clinical practice and to an overall reduction of 60.4% in chemotherapy recommendations.5


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021 4. Stemmer et al npj Breast 2017.; 5. Battisti et al, St Gallen International conference 2019, P007
Icon Tumor Grade 3
Tumour Grade
Grade 3
  • Tumour grade is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • The RxPONDER study showed that postmenopausal patients with grade 3 tumours and Recurrence Score® results 0-25 did not benefit from chemotherapy.3
  • Real-world registries confirmed that a significant proportion of node-positive patients with grade 3 tumours had Recurrence Score® results 0-18.4-6


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021 4. Stemmer et al npj Breast 2017 5. Petkov et al SABCS 2016.; 6. Iorgulescu et al. JCO Precis Oncol 2019
Icon Tumour Size T1
Tumour Size
T1
  • Tumour size is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • The RxPONDER study showed that postmenopausal patients with T1 tumours and Recurrence Score® results 0-25 did not benefit from chemotherapy.3
  • Real-world evidence has shown that around 15% of T1 tumour patients have Recurrence Score results 26-1001 and may benefit from chemotherapy.2
  • The SEER real-world registry confirmed that a significant proportion of N1 patients with tumours ≤2 cm and grade 3 disease had low Recurrence Score® results and excellent outcomes.4


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021 4. Petkov et al Poster SABCS 2016;
Icon Tumour Size T2
Tumour Size
T2
  • Tumour size is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • The RxPONDER study showed that postmenopausal patients with T2/T3 tumours and Recurrence Score® results 0-25 did not benefit from chemotherapy.3
  • Real-world registries confirmed that a significant proportion of node-positive patients with tumours >2 cm had low Recurrence Score® results4,5 and would not benefit from chemotherapy.2,3
  • A decision-impact study, including patients with T2/T3 tumours, demonstrated that the Oncotype DX® test led to a treatment recommendation change of 50.2% in routine clinical practice and to an overall reduction of 60.4% in chemotherapy recommendations.6


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021 4. Petkov et al SABCS 2016 5. Stemmer et al npj Breast 2017 6. Battisti et al, St Gallen International conference 2019, P007
Icon Tumour Size T3
Tumour Size
T3
  • Tumour size is not associated with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-3
  • The RxPONDER study showed that postmenopausal patients with T2/T3 tumours and Recurrence Score® results 0-25 did not benefit from chemotherapy.3
  • Real-world registries confirmed that a significant proportion of node-positive patients with tumours >2 cm had low Recurrence Score® results4,5 and would not benefit from chemotherapy.2,3
  • A decision-impact study, including patients with T2/T3 tumours, demonstrated that the Oncotype DX® test led to a treatment recommendation change of 50.2% in routine clinical practice and to an overall reduction of 60.4% in chemotherapy recommendations.6


1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021 4. Petkov et al SABCS 2016 5. Stemmer et al npj Breast 2017 6. Battisti et al, St Gallen International conference 2019, P007
Micromets
0.2-2.0mm
  • pN1mi lymph node status does not predict tumor biology1
  • The RxPONDER study showed that for postmenopausal patients with Recurrence Score® results 0-25, the number of positive nodes including micromets did not correlate with benefit from chemotherapy.2
  • A real-world registry confirmed that a significant proportion of node positive patients with N1mi disease have low Recurrence Score® results3 and may not benefit from chemotherapy.2
  • The Oncotype DX® test is the only assay recognized by the NCCN Guidelines® to predict adjuvant chemotherapy benefit and the only assay classified as the “preferred” test in postmenopausal pN1mi and N1 patients with HR+, HER2– breast cancer.4


1. Bello et al Ann. Surgical Oncol. 2018 2. Kalinisky et al NEJM 2021 3. Stemmer et al npj Breast 2017 4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023.
Ki-67 less than 10%
Ki-67
<10%
  • Ki-67 does not correlate with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown in independent trials.2
  • Prospective data demonstrated that about 1 in 10 patients with Ki-67 values of <10% had a Recurrence Score® result 26-100 and may benefit from chemotherapy.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score®result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 10-20%
Ki-67
10-20%
  • Ki-67 does not correlate with Recurrence Score® results and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data demonstrated that more than 10% of patients with Ki-67 values 10-19% had a Recurrence Score® result 26-100 and may benefit from adjuvant chemotherapy.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score® result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 20-40%
Ki-67
20-40%
  • Ki-67 correlates only weakly with Recurrence Score® results (R=0.3437) and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data show Ki-67 values 20-39% do not give a clear indication whether there is an adjuvant chemotherapy benefit or not.2-3
  • An overall high discordance of 45% between Ki-67 and the Recurrence Score® result was reported by real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St.Gallen. 2013.
Ki-67 larger than 40%
Ki-67
>40%
  • Ki-67 correlates only weakly with Recurrence Score® results (R=0.3437) and has not been shown to predict chemotherapy benefit.1-5
  • Relative adjuvant chemotherapy treatment effect is independent of Ki-67, as shown by independent trials.2
  • Prospective data demonstrated that about 1 out 10 patients with Ki-67 values of >39% have Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.3
  • An overall high discordance of 45% between Ki-67 and the RS® result, was reported in real-world evidence.4


1. Geyer et al. npj Breast Cancer. 2018; 2. Viale et al. J Natl Cancer Inst. 2008; 3. Gluz et al. J Clin Oncol. 2016; 4. Walter et al. Geburtshilfe Frauenheilkd. 2020; 5. Ben-Baruch et al. St. Gallen. 2013.
Conclusion
Conclusion
previous slide

In the absence of genomic testing, the vast majority of HR+, HER2-, node-positive, early-stage breast cancer patients receive chemotherapy1,2


The two registries show that:1,2

  • Around 70% of N+ patients across the US and European countries are treated with adjuvant chemotherapy.1,2
  • However, the majority of patients with early-stage breast cancer don’t benefit from adjuvant chemotherapy treatment.3
  • Therefore, the high chemotherapy baseline treatment rate in N+ patients suggests that it may lead to potential overtreatment.

1. Allemani et al. Int J Cancer 2013; 2. Zhang et al. Breast Can Res Treat 2020; 3. Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, et al. Lancet. 2012;379(9814):432-44

The Oncotype DX® test provides chemotherapy benefit estimates for premenopausal N1 patients1–3


SWOG-8814 and RxPONDER suggested that:

  • The Oncotype DX® test provides estimates of chemotherapy benefit for premenopausal patients and can help guide treatment decisions.1-3
  • N1 premenopausal patients with Recurrence Score® results 0–25, derived a 2.4% benefit from chemotherapy based on distant recurrence-free interval (DRFI) at 5 years.1-3
    • RS® result 0-13: ~2.3% CT benefit1,2
    • RS® result 14-25: ~2.8% CT benefit1,2
    • RS® results 26-100: Substantial CT benefit*

1. Kalinsky et al. New Engl J Med. 2021. 2. Kalinsky et al. SABCS 2021. GS2-07; 3. Albain et al. Lancet Oncol. 2010

RxPONDER was conducted to further refine chemotherapy benefit estimates in HR+, HER2-, N1, early-stage breast cancer patients1


The primary objective of the RxPONDER study was to:1

  • Determine the effect of chemotherapy, if any, in invasive disease-free survival in women with N1 disease and Recurrence Score® results 0-25, with adjustment for menopausal status.
  • The trial included 1,665 premenopausal patients.*

*Women were considered premenopausal if they were less than 6 months since last menstrual period and no prior bilateral oophorectomy and not on estrogen replacement


1. Kalinsky et al, N Engl J Med. 2021.

Premenopausal women with Recurrence Score® results 0–25 showed a modest benefit from chemotherapy1



RxPONDER demonstrated that:1

  • Based on DRFI, premenopausal women with Recurrence Score result of 0-25 had a 2.4% benefit from the addition of chemotherapy to endocrine therapy.
  • Based on IDFS, a consistent 4.9% benefit from chemotherapy at five years was observed.
  • It is not known whether the benefit observed with chemotherapy is due to chemotherapy alone, ovarian function suppression or a combination of the two.

1. Kalinsky et al. SABCS 2021 GS2-07

Chemotherapy benefit observed in most groups of N1, premenopausal patients with Recurrence Score® Results 0–251


The IDFS analysis in the RxPONDER study has shown that:

  • Chemotherapy benefit was observed in most age groups of premenopausal patients
  • 509 women were ≥50 years and premenopausal.
    • The IDFS forest plot suggests these women may not have benefited from the addition of chemotherapy.

1. Kalinsky et al, N Engl J Med 2021

Post-hoc analysis in premenopausal women suggests absence of regular menstrual periods might be associated with improved IDFS, regardless of treatment arm1



A post-hoc analysis of premenopausal women in the RxPONDER trial suggests:

  • That there is an improved IDFS for women in both treatment arms who no longer have regular menstrual periods** in the first 24 months.

1. Kalinsky et al. SABCS 2021 GS2-07

Prognosis and Absolute Chemotherapy Benefit in Premenopausal Patients1


In the RxPONDER study:

  • Premenopausal women with Recurrence Score® result of 0-25 had a significant benefit in IDFS from the addition of CT to ET.
  • Absolute chemotherapy benefit increased with increasing Recurrence Score® results.
  • The Breast Recurrence Score® test provides prognostic information for premenopausal patients:
    • IDFS event rates increased with increasing Recurrence Score® results.

1. Kalinsky et al, N Engl J Med 2021

Inclusion of the Oncotype DX Breast Recurrence Score® test in the NCCN* guidelines for premenopausal N1, pT1-3, HR+, HER2-, early-stage invasive breast cancer patients**1


The NCCN updated clinical practice guidelines for breast cancer concluded that:**1

  • In premenopausal patients with pN1mi or N1 disease, a gene expression assay can be considered to assess prognosis.

*National Comprehensive Cancer Network® (NCCN®) are registered trademarks of NCCN.

** Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023. © 2023 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. NCCN does not endorse any product or therapy. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

1. NCCN Guidelines Insights: Breast Cancer, version 4.2023. https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

ASCO 2022 guidelines position the Oncotype DX® test as the preferred test1


ASCO 2022 Guidelines strongly recommend the Oncotype DX® test based on RxPONDER study results:1

  • In N1 premenopausal patients, the Oncotype DX® test is prognostic and may be used for shared patient-physician decision making.

1. Andre et al. J Clin Oncol. 2022.

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour grade has not been shown to predict Recurrence Score® results.2,3
  • Around 6% of patients with grade 1 tumours had Recurrence Score® results 26-100.1

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021;

A majority of patients have low Recurrence Score® results regardless of tumour grade1


The real-world CLALIT registry demonstrates that1:

  • Tumour grade has not been shown to predict Recurrence Score® results.1,2
  • A significant proportion of node positive patients with grade 1 tumours have low Recurrence Score® results.1

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2.. Kalinsky et al NEJM 2021;

Nearly all subgroups of N1 premenopausal patients with Recurrence Score® results 0–25 derived a chemotherapy benefit


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • Overall, 357 premenopausal patients had grade 1 tumours. These women received a modest benefit from chemotherapy.

2.. 1. Kalinsky et al, N Engl J Med 2021

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour grade has not been shown to predict Recurrence Score® results.2-3
  • About 85% of grade 2 patients have Recurrence Score® results 0-25 and 15% of grade 2 patients have Recurrence Score results 26-100.1

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Kalinisky et al NEJM 2021; 3. Albain et al Lancet Oncology 2010

A majority of patients have low Recurrence Score® results regardless of tumour grade1


The real-world CLALIT registry demonstrates that1:

  • Tumour grade has not been shown to predict Recurrence Score® results.1,2
  • A significant proportion of node-positive patients with grade 2 tumours have low Recurrence Score® results1

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2.. Kalinsky et al NEJM 2021;

Nearly all subgroups of N1 premenopausal with patients with Recurrence Score® results 0–25 derived a chemotherapy benefit1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • Overall, 1,280 premenopausal patients had intermediate or high-grade tumours. These women received a modest benefit from chemotherapy.

1. Kalinsky et al, N Engl J Med 2021

The Oncotype DX Breast Recurrence Score® test informs treatment decisions in node–positive patients with grade 2 tumours1


A UK decision impact-study demonstrated that1:

  • 398 (68%) patients had grade 2 tumours and 188 (32%) were peri- and premenopausal.
  • Oncotype DX® test use for N1 patients in clinical practice led to an overall reduction in chemotherapy recommendations of 60.4%.
  • Among 30.1% of the patients who had an initial recommendation of ET, 13.1% (n=23) had an escalation to a recommendation of CT+ET after receiving the Recurrence Score® result.
  • Among the 69.9% of the patients who were initially recommended CT-ET, 66.1% (n=269) had a recommended de-escalation to ET alone after receiving the Recurrence Score® results.
  • Overall, 50.2% (n=292) change in recommended treatment in routine clinical practice, based on Recurrence Score® results.

 

*Please note this decision-impact study was conducted before the publication of the RxPONDER study results and that the decision-impact may vary as a result of this study.

PONDx UK decision impact-study:
(n=582)/ER+/HER2-/N1/early-breast patients across 30 institutions in UK between October 2017 and December 2018.

View next slide to see characteristics of patient subgroup


1. Battisti et al, St Gallen International conference 2019, P007



PONDx UK decision impact-study:
N=582/ER+/HER2-/N1/early-breast patients across 30 institutions in UK
between October 2017 and December 2018.

n

Nodal
involvement
 1 node 405
 2 nodes 130
3 nodes 47


Tumor
size
 <1 cm 20
 1 to <2 cm 201
 2 to <5 cm  324
≥5 cm 37


Grade
G1 77
G2 398
G3 107
Pre
menopausal
119
Peri
menopausal
69
Post
menopausal
388

1. Battisti et al, St Gallen International conference 2019, P007

 

Node-positive patients with low Recurrence Score® results and high-grade disease have excellent outcomes1


The real-world SEER registry demonstrates that1*:

  • Tumour grade has not been shown to predict Recurrence Score® results.
  • A significant proportion of node-positive patients with high grade disease have low Recurrence Score® results.1

*SEER registry includes post- and premenopausal patients.


1. Petkov et al. SABCS 2016

A majority of patients have low Recurrence Score® results regardless of tumour grade1


The real-world CLALIT registry demonstrates that1:

  • Tumour grade has not been shown to predict Recurrence Score® results.1,2
  • A significant proportion of node positive patients with grade 3 tumours have low Recurrence Score® results.1

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Kalinsky et al NEJM 2021

Nearly all subgroups of N1 premenopausal patients with Recurrence Score results 0–25 derived a chemotherapy benefit1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • Overall, 1,280 premenopausal patients had intermediate or high-grade tumours. These women received a modest benefit from chemotherapy.

1 . Kalinsky et al, N Engl J Med 2021

Tumour grade has not been shown to predict Recurrence Score® results2,3


The real-world National Cancer Database registry demonstrates that1*:

  • Tumour grade has not been shown to predict Recurrence Score® results.2-3
  • The Oncotype DX® test consistently identified patients with low Recurrence Score® results, despite grade 3 lesions or nodal involvement.1
  • Patients with Recurrence Score® results <18 and 1-3 positive nodes have similar 5-year overall survival outcomes with or without chemotherapy1

*The NCDB registry includes post- and premenopausal patients.


1.Iorgulescu et al. JCO Precis Oncol. 2019.; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed:1

  • Clinical and pathologic factors are prognostic but not predictive of chemotherapy benefit.
  • Tumour size has not been shown to predict Recurrence Score® results.2,3
  • Around 15% of patients with tumours ≤2 cm have Recurrence Score® results 26-1001 and may benefit from chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd 2020.; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021;

N1 patients with T1, grade 3 tumours and Recurrence Score® results 0-25 have excellent outcomes1


The real-world SEER registry demonstrates that1 :

  • Tumour size has not not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node positive patients with tumours ≤2 cm and high-grade disease have low Recurrence Score ® results and excellent outcomes at 5-year BCSS.1

1. Petkov et al. Poster SABCS 2016.; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021

Nearly all subgroups of N1 premenopausal patients with Recurrence Score1® results 0–25 derived chemotherapy benefit1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • For premenopausal patients with Recurrence Score® results 0-25, tumour size was not associated with benefit from chemotherapy.
  • Overall, 925 premenopausal patients had T1 tumours and received a modest benefit from chemotherapy.

1. Kalinsky et al, N Engl J Med 2021

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour size has not been shown to predict Recurrence Score® results.2-3
  • A significant proportion of patients with tumours ≥2 cm have Recurrence Score® results 0-25.1

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021

Most node-positive patients have Recurrence Score® results 0-25, regardless of tumour size1


The real-world CLALIT registry demonstrates that1:

  • Tumour size has not been shown to predict Recurrence Score® results.1,2
  • A significant proportion of node positive patients with tumours >2 cm  have low Recurrence Score® results 0-25.1

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Kalinsky et al NEJM 2021;

Nearly all subgroups of N1 premenopausal patients with Recurrence Score® results 0–25 derived chemotherapy benefit1

Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • For premenopausal patients with Recurrence Score® results 0-25, tumour size was not associated with benefit from chemotherapy.
  • Overall, 728 premenopausal patients had T2/3 tumours and received a modest benefit from chemotherapy.

1. Kalinsky et al, N Engl J Med 2021

The Oncotype DX Breast Recurrence Score® test informs treatment decisions in node–positive patients with T2/T3 tumours1


A UK decision-impact study demonstrated that1:

  • 361 (62%) patients had tumours ≥ 2cm and 188 (32%) were peri- and premenopausal.
  • Oncotype DX® test use for N1 patients in clinical practice led to an overall reduction in chemotherapy recommendation of 60.4%.
  • Among 30.1% of the patients who had an initial recommendation of ET, 13.1% (n=23) had an escalation to a CT+ET recommendation after receiving the Recurrence Score® result.
  • Among the 69.9% of the patients who were initially recommended CT+ET, 66.1% (n=269) had a de-escalation recommendation to ET alone after receiving the Recurrence Score® results.
  • Overall, 50.2% (n=292) treatment recommendation change in routine clinical practice, based on Recurrence Score® results.

 

*Please note this decision-impact study was conducted before the publication of the RxPONDER study results and that the decision-impact may vary as a result of this study.

PONDx UK decision impact-study:
(n=582)/ER+/HER2-/N1/early-breast patients across 30 institutions in UK between October 2017 and December 2018.

View next slide to see characteristics of patient subgroup


1. Battisti et al, St Gallen International conference 2019, P007



PONDx UK decision impact-study:
N=582/ER+/HER2-/N1/early-breast patients across 30 institutions in UK
between October 2017 and December 2018.

n

Nodal
involvement
 1 node 405
 2 nodes 130
3 nodes 47


Tumor
size
 <1 cm 20
 1 to <2 cm 201
 2 to <5 cm  324
≥5 cm 37


Grade
G1 77
G2 398
G3 107
Pre
menopausal
119
Peri
menopausal
69
Post
menopausal
388

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour size has not been shown to predict Recurrence Score® results.2-3
  • A significant proportion of patients with tumours ≥2 cm have Recurrence Score® results 0-25.1

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021

Most node-positive patients have Recurrence Score® results 0-25, regardless of tumour size1


The real-world CLALIT registry demonstrates that1:

  • Tumour size has not been shown to predict Recurrence Score® results.1,2
  • A significant proportion of node positive patients with tumours >2 cm  have low Recurrence Score® results 0-25.1

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Kalinsky et al NEJM 2021;

Nearly all subgroups of N1 premenopausal patients with Recurrence Score® results 0–25 derived chemotherapy benefit1

Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • For premenopausal patients with Recurrence Score® results 0-25, tumour size was not associated with benefit from chemotherapy.
  • Overall, 728 premenopausal patients had T2/3 tumours and received a modest benefit from chemotherapy.

1. Kalinsky et al, N Engl J Med 2021

The Oncotype DX Breast Recurrence Score® test informs treatment decisions in node–positive patients with T2/T3 tumours1


A UK decision-impact study demonstrated that1:

  • 361 (62%) patients had tumours ≥ 2cm and 188 (32%) were peri- and premenopausal.
  • Oncotype DX® test use for N1 patients in clinical practice led to an overall reduction in chemotherapy recommendation of 60.4%.
  • Among 30.1% of the patients who had an initial recommendation of ET, 13.1% (n=23) had an escalation to a CT+ET recommendation after receiving the Recurrence Score® result.
  • Among the 69.9% of the patients who were initially recommended CT+ET, 66.1% (n=269) had a de-escalation recommendation to ET alone after receiving the Recurrence Score® results.
  • Overall, 50.2% (n=292) treatment recommendation change in routine clinical practice, based on Recurrence Score® results.

 

*Please note this decision-impact study was conducted before the publication of the RxPONDER study results and that the decision-impact may vary as a result of this study.

PONDx UK decision impact-study:
(n=582)/ER+/HER2-/N1/early-breast patients across 30 institutions in UK between October 2017 and December 2018.

View next slide to see characteristics of patient subgroup


1. Battisti et al, St Gallen International conference 2019, P007



PONDx UK decision impact-study:
N=582/ER+/HER2-/N1/early-breast patients across 30 institutions in UK
between October 2017 and December 2018.

n

Nodal
involvement
 1 node 405
 2 nodes 130
3 nodes 47


Tumor
size
 <1 cm 20
 1 to <2 cm 201
 2 to <5 cm  324
≥5 cm 37


Grade
G1 77
G2 398
G3 107
Pre
menopausal
119
Peri
menopausal
69
Post
menopausal
388

Lymph-node status has not been shown to predict tumour biology1


Analysis of data concerning 610,350 specimens from the Exact Sciences (then Genomic Health) Clinical Laboratory demonstrates1:

  • Micrometastic nodal status has not been shown to predict Recurrence Score® results.
  • N0, N1mi, and N1 breast cancer patients have similar Recurrence Score® result distributions.

1. Bello et al. Ann Surg Oncol. 2018

Many patients have low Recurrence Score® results, regardless of nodal involvement1


The real-world CLALIT registry demonstrates that1:

  • Micrometastatic nodal status has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node positive patients with N1mi disease have low Recurrence Score® results 1

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021;

Premenopausal women with micrometastasis and Recurrence Score® results 0–25 derived a benefit from chemotherapy1


The RxPONDER study shows that1:

  • Based on IDFS a post hoc analysis in premenopausal women with micrometastasis found that absolute chemotherapy benefit at 5 years was 7.3%, although there were a limited number of events in the analysis (n=22).

1. Kalinsky et al. SABCS 2021 GS2-07

Inclusion of the Oncotype DX Breast Recurrence Score® test in the NCCN* guidelines for premenopausal pN1mi, pT1-3, HR+, HER2-, early-stage invasive breast cancer patients**1


The National Comprehensive Cancer Network® (NCCN) updated their guidelines for breast cancer based on the RxPONDER study results:1

  • In premenopausal patients with pN1mi or N1 disease, a gene expression assay can be considered to assess prognosis.

* National Comprehensive Cancer Network® (NCCN®) are registered trademarks of NCCN.

** Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023. © 2023 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. NCCN does not endorse any product or therapy. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023., https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

Ki-67 status is not predictive of adjuvant chemotherapy benefit1


Two independent studies from the IBCSG showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671


In the German prospective WSG PlanB trial, Ki-67 expression was assessed centrally1:

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • About 1 in 10 patients with Ki-67 values of <10% had a Recurrence Score® result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant proportion of patients with a Ki-67 value of ≤10% result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1


Two independent studies from the IBCSG showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671


In the German prospective WSG PlanB, Ki-67 expression was assessed centrally.1

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • More than 10% of patients with Ki-67 values 10-19% had a Recurrence Score® result 26-1001 and may benefit from adjuvant chemotherapy.

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant proportion of patients with a Ki-67 value of 10%-20% result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1


Two independent studies from the IBCSG showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671


In the German prospective WSG PlanB, Ki-67 expression was assessed centrally1:

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • Ki-67 values 20-39% do not give a clear indication whether there is an adjuvant chemotherapy benefit or not.2-3

1. Adapted from Gluz et al. J Clin Oncol. 2016.

Relationship between Recurrence Score® results and Ki-671


The CLALIT real-world registry suggests that1:

  • There is weak to moderate correlation between Ki-67 values and the Recurrence Score® results.
  • A significant proportion of patients with Ki-67 values between 20-40% have Recurrence Score® results 0-25.

1. Ben-Baruch et al. St.Gallen. 2013.

Ki-67 does not predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed that1:

  • Ki-67 values have a weak to moderate correlation with the Recurrence Score® results.
  • A high proportion of patients with a Ki-67 value of ≥20% had a Recurrence Score® result of 0-251 and may not benefit from adjuvant chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1


Two independent studies from the IBCSG showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671


In the German prospective WSG PlanB, Ki-67 expression was assessed centrally.1:

The results show that:

  • Ki-67 values centrally assessed had a weak to moderate correlation with the Recurrence Score® results.1
  • About 1 out 10 of patients with Ki-67 value of >39% have Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.2

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Sparano et al. N Engl J Med. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant number of patients with a Ki-67 value of >40% had Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.2
1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018.

In the absence of genomic testing, the vast majority of HR+, HER2-, node-positive, early-stage breast cancer patients receive chemotherapy1,2


The two registries show that:1,2

  • Around 70% of N+ patients across the US and European countries will be treated with adjuvant chemotherapy.1,2
  • However, the majority of patients with early-stage breast cancer don’t benefit from adjuvant treatment.3
  • Therefore, the high chemotherapy baseline treatment rate in N1 patients suggests that it may lead to potential overtreatment.

1. Allemani et al. Int J Cancer 2013; 2. Zhang et al. Breast Can Res Treat 2020; 3. Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, et al. Lancet. 2012;379(9814):432-44

The Oncotype DX Breast Recurrence Score® test can help guide treatment decisions for N1 postmenopausal patients1-3


SWOG-8814 and RxPONDER demonstrated that:1-3

  • The Oncotype DX Breast Recurrence Score® result is predictive of chemotherapy benefit in postmenopausal patients with HR+, HER2-, node-positive (1-3 positive nodes), early-stage, invasive breast cancer.
  • A substantial proportion of postmenopausal patients can be spared chemotherapy.

1. Kalinsky et al. New Engl J Med. 2021. 2. Kalinsky et al. SABCS 2021. GS2-07; 3. Albain et al. Lancet Oncol. 2010

SWOG-8814 established that Recurrence Score® results are predictive of chemotherapy benefit in HR+, HER2-, N+ postmenopausal patients1


The SWOG-8814 study shows that:1

  • The Recurrence Score® result predicts chemotherapy benefit for disease-free survival (P interaction = 0.029) in the first 5 years.
  • Postmenopausal women with Recurrence Score results of >30 had an overall 19% group benefit from the addition of chemotherapy to endocrine therapy.
  • In contrast, postmenopausal women with Recurrence Scores results 0-30 did not significantly benefit from the addition of chemotherapy to tamoxifen.

1. Albain et al. Lancet Oncol. 2010; 11: 55–65

RxPONDER was conducted to further refine chemotherapy benefit estimates in HR+, HER2-, N1 early-stage breast cancer patients1


The primary objective of the RxPONDER study was to1:

  • Determine the effect of chemotherapy, if any, in invasive disease-free survival in women with N1 disease and Recurrence Score® results 0-25, with adjustment for menopausal status.
  • The trial included 3,353 postmenopausal patients.*

*Women were considered postmenopausal if they had received prior bilateral oophorectomy or gone more than 12 months since last menstrual period with no prior hysterectomy.


1. Kalinsky et al, N Engl J Med 2021.

Postmenopausal patients with Recurrence Score® results 0-25 do not benefit from chemotherapy1


The RxPONDER study shows that1:

  • Postmenopausal women with Recurrence Score® results 0-25 do not benefit from chemotherapy in addition to endocrine therapy for either 5-year IDFS or DRFI endpoints.
  • Therefore, there is a potential risk of chemotherapy overtreatment in the absence of Oncotype DX® testing.

1. Kalinsky et al. SABCS 2021.

Patient age did not correlate with chemotherapy benefit for postmenopausal patients in RxPONDER1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • There was no chemotherapy benefit for postmenopausal women in any age range with 1-3 positive nodes and with Recurrence Score® results 0-25.

1. Kalinsky et al, N Engl J Med 2021

The Oncotype DX® test is the “preferred” assay for postmenopausal patients in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)* for breast cancer**1


The NCCN updated clinical practice guidelines for breast cancer concluded that:**1

  • The Oncotype DX® test is the only multigene assay validated to predict response to chemotherapy.
  • The Oncotype DX Breast Recurrence Score® test is the “preferred” multigene assay for postmenopausal N1 and pN1mic patients with HR+, HER2 – breast cancer.
  • Clinicians should strongly consider using the test to guide adjuvant chemotherapy decisions.
  • The assay obtains National Comprehensive Cancer Network® (NCCN®) category 1 based on evidence and consensus.

*National Comprehensive Cancer Network® (NCCN®) are registered trademarks of NCCN.

** Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023. © 2023 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. NCCN does not endorse any product or therapy. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

1. NCCN Guidelines Insights: Breast Cancer, version 4.2023. https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

ASCO 2022 guidelines position the Oncotype DX® test as the preferred test1


Based on RxPONDER study results the ASCO guidelines 2022 indicate that:1

  • The Oncotype DX® test is the only test strongly recommended for all postmenopausal N1 patients.
  • The recommendation is broad and independent of any clinical risk classification.
  • The recommendation level is strong and with high evidence quality based on ASCO recommendation framework.

1. Andre et al. J Clin Oncol. 2022.

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour grade has not been shown to predict Recurrence Score® results.2,3
  • While there are fewer patients with grade 1 tumours and Recurrence Score® results 26-100, around 6% of patients may benefit from chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021;

Tumour grade did not correlate with chemotherapy benefit in the RxPONDER study1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • No statistically significant interaction between chemotherapy benefit and tumour grade was found for patients with Recurrence Score® results 0-25.
  • Overall, 850 postmenopausal patients had Recurrence Score results 0-25 and grade 1 tumours and no chemotherapy benefit was observed for these women.

1. Kalinsky et al, N Engl J Med 2021

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour grade has not been shown to predict Recurrence Score® results.2-3
  • The Recurrence Score® results help identify the percentage of grade 2 patients with results that indicate no benefit from chemotherapy.1,2
  • About 15% of grade 2 patients have Recurrence Score® results 26-1001 and may benefit from chemotherapy.

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021

Many patients have Recurrence Score® results 0-25 regardless of tumour grade1


The real-world CLALIT registry demonstrates that1:

  • Tumour grade has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node-positive patients with grade 2 tumours have low Recurrence Score® results1 and may not benefit from chemotherapy.3

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021;

Tumour grade did not correlate with chemotherapy benefit in the RxPONDER study1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • No statistically significant interaction between chemotherapy benefit and tumour grade was found for patients with Recurrence Score® results 0-25.
  • Overall, 2,433 postmenopausal patients had Recurrence Score results 0-25 and grade 2/3 tumours and there was no chemotherapy benefit observed in these women.

1. Kalinsky et al, N Engl J Med 2021

The Oncotype DX Breast Recurrence Score® test informs treatment decisions in node–positive patients with grade 2 tumours1


A UK decision impact-study demonstrated that1:

  • 398 (68%) patients had grade 2 tumours.
  • Oncotype DX® test use for N1 patients in clinical practice led to an overall reduction in chemotherapy recommendation of 60.4%.
  • Among 30.1% of the patients who had an initial recommendation of ET, 13.1% (n=23) had an escalation to a recommendation of CT+ET after receiving the Recurrence Score® result.
  • Among the 69.9% of the patients who were initially recommended CT+ET, 66.1% (n=269) had a recommended de-escalation to ET alone after receiving the Recurrence Score® results.
  • Overall, 50.2% (n=292) change in recommended treatment in routine clinical practice, based on Recurrence Score® results.

 

PONDx UK decision impact-study:
(n=582)/ER+/HER2-/N1/early-breast patients across 30 institutions in UK between October 2017 and December 2018.

View next slide to see characteristics of patient subgroup


1. Battisti et al, St Gallen International conference 2019, P007



PONDx UK decision impact-study:
N=582/ER+/HER2-/N1/early-breast patients across 30 institutions in UK
between October 2017 and December 2018.

n

Nodal
involvement
 1 node 405
 2 nodes 130
3 nodes 47


Tumor
size
 <1 cm 20
 1 to <2 cm 201
 2 to <5 cm  324
≥5 cm 37


Grade
G1 77
G2 398
G3 107
Pre
menopausal
119
Peri
menopausal
69
Post
menopausal
388

1. Battisti et al, St Gallen International conference 2019, P007

 

Node-positive patients with low Recurrence Score® results and high-grade disease have excellent outcomes1


The real-world SEER registry demonstrates that1:

  • Tumour grade has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node-positive patients with high-grade disease have low Recurrence Score® results 0-18 and excellent outcomes at 5 years in terms of BCSS.1

1. Petkov et al. Poster SABCS 2016.; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021

Many patients have Recurrence Score® results 0-25 regardless of tumour grade1


The real-world CLALIT registry demonstrates that1:

  • Tumour grade has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node- positive patients with grade 3 tumours have low Recurrence Score® results1 and may not benefit from chemotherapy.3

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021

Tumour grade did not correlate with chemotherapy benefit in the RxPONDER study1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • No statistically significant interaction between chemotherapy benefit and tumour grade was found for patients with Recurrence Score® results 0-25.
  • Overall, 2,433 postmenopausal patients with Recurrence Score results 0-25 had grade 2/3 tumours. There was no observed chemotherapy benefit in these women.

1 . Kalinsky et al, N Engl J Med 2021

Tumour grade has not been shown to predict Recurrence Score® results2,3


The real-world National Cancer Database registry demonstrates that1:

  • Tumour grade has not been shown not predict Recurrence Score® results.2,3
  • The Oncotype DX® test consistently identified patients with low Recurrence Score® results, despite grade 3 lesions or nodal involvement.
  • Patients with Recurrence Score results <18 and 1-3 positive nodes had similar 5-year overall survival outcomes with or without chemotherapy.

1.Iorgulescu et al. JCO Precis Oncol. 2019.; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021

Clinical pathologic features have not shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed:1

  • Clinical and pathologic factors are prognostic but not predictive of chemotherapy benefit.
  • Tumour size has not been shown to predict Recurrence Score® results.2,3
  • Around 15% of patients with tumours ≤2 cm have Recurrence Score® results 26-1001 and may benefit from chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd 2020.; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021;

N1 patients with T1, grade 3 tumours and Recurrence Score® results 0-25 have excellent outcomes1


The real-world SEER registry demonstrates that1 :

  • Tumour size has not not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node positive patients with tumours ≤2 cm and high-grade disease have low Recurrence Score ® results and excellent outcomes at 5-year BCSS.1

1. Petkov et al. Poster SABCS 2016.; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021

Tumour size did not correlate with chemotherapy benefit in the RxPONDER study1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • No statistically significant interaction between chemotherapy benefit and tumour size was found for postmenopausal patients with Recurrence Score® results 0-25.
  • Overall, 1,966 postmenopausal patients had Recurrence Score results 0-25 and T1 tumours and there was no observed chemotherapy benefit for these women.

1. Kalinsky et al, N Engl J Med 2021

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour size has not been shown to predict Recurrence Score® results.1
  • A significant proportion of patients with tumours ≥2 cm have Recurrence Score® results 0-251 and may not benefit from chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021

The Oncotype DX® test consistently identifies low-risk patients despite tumour size, high grade, or nodal involvement1:


The real-world registry SEER demonstrates that1:

  • Tumour size has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node positive patients with tumours >2 cm and high-grade disease have low Recurrence Score® results and may not benefit from chemotherapy.3

1. Petkov et al. Poster SABCS 2016.; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021

Most node-positive patients have Recurrence Score® results 0-25, regardless of tumour size1


The real-world CLALIT registry demonstrates that1:

  • Tumour size has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node positive patients with tumours >2 cm  have low Recurrence Score® results1 and may not benefit from chemotherapy.3

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021;

Tumour size did not correlate with chemotherapy benefit in the RxPONDER study1


Invasive disease-free survival CET vs. ET
(Median follow up 5.3 years)

The RxPONDER study shows that1:

  • No statistically significant interaction between chemotherapy benefit and tumour size was found for postmenopausal patients with Recurrence Score® results 0-25.
  • Overall, 1,360 postmenopausal patients had Recurrence Score results 0-25 and T2/3 tumours and there was no observed chemotherapy benefit for these women.

1. Kalinsky et al, N Engl J Med 2021

The Oncotype DX Breast Recurrence Score® test informs treatment decisions in node–positive patients with T2/T3 tumours1


A UK decision-impact study demonstrated that1:

  • 361 (62%) patients had tumours ≥ 2cm.
  • Oncotype DX® test use for N1 patients in clinical practice led to an overall reduction in chemotherapy recommendation of 60.4%.
  • Among 30.1% of the patients who had an initial recommendation of ET, 13.1% (n=23) had an escalation to a CT+ET recommendation after receiving the Recurrence Score® result.
  • Among the 69.9% of the patients who were initially recommended CT+ET, 66.1% (n=269) had a de-escalation recommendation to ET alone after receiving the Recurrence Score® results.
  • Overall, 50.2% (n=292) treatment recommendation change in routine clinical practice, based on Recurrence Score® results.

 

PONDx UK decision impact-study:
(n=582)/ER+/HER2-/N1/early-breast patients across 30 institutions in UK between October 2017 and December 2018.

View next slide to see characteristics of patient subgroup


1. Battisti et al, St Gallen International conference 2019, P007



PONDx UK decision impact-study:
N=582/ER+/HER2-/N1/early-breast patients across 30 institutions in UK
between October 2017 and December 2018.

n

Nodal
involvement
 1 node 405
 2 nodes 130
3 nodes 47


Tumor
size
 <1 cm 20
 1 to <2 cm 201
 2 to <5 cm  324
≥5 cm 37


Grade
G1 77
G2 398
G3 107
Pre
menopausal
119
Peri
menopausal
69
Post
menopausal
388

Clinical pathologic features have not been shown to predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed1:

  • Tumour size has not been shown to predict Recurrence Score® results.1
  • A significant proportion of patients with tumours ≥2 cm have Recurrence Score® results 0-251 and may not benefit from chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Albain et al Lancet Oncology 2010; 3. Kalinisky et al NEJM 2021

The Oncotype DX® test consistently identifies low-risk patients despite tumour size, high grade, or nodal involvement1:


The real-world registry SEER demonstrates that1:

  • Tumour size has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node positive patients with tumours >2 cm and high-grade disease have low Recurrence Score® results and may not benefit from chemotherapy.3

1. Petkov et al. Poster SABCS 2016.; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021

Most node-positive patients have Recurrence Score® results 0-25, regardless of tumour size1


The real-world CLALIT registry demonstrates that1:

  • Tumour size has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node positive patients with tumours >2 cm  have low Recurrence Score® results1 and may not benefit from chemotherapy.3

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021;

Tumour size did not correlate with chemotherapy benefit in the RxPONDER study1


The RxPONDER study shows that1:

  • No statistically significant interaction between chemotherapy benefit and tumour size was found for postmenopausal patients with Recurrence Score® results 0-25.
  • Overall, 1,360 postmenopausal patients had Recurrence Score results 0-25 and T2/3 tumours and there was no observed chemotherapy benefit for these women.

1. Kalinsky et al, N Engl J Med 2021

The Oncotype DX Breast Recurrence Score® test informs treatment decisions in node–positive patients with T2/T3 tumours1


A UK decision-impact study demonstrated that1:

  • 361 (62%) patients had tumours ≥ 2cm.
  • Oncotype DX® test use for N1 patients in clinical practice led to an overall reduction in chemotherapy recommendation of 60.4%.
  • Among 30.1% of the patients who had an initial recommendation of ET, 13.1% (n=23) had an escalation to a CT+ET recommendation after receiving the Recurrence Score® result.
  • Among the 69.9% of the patients who were initially recommended CT+ET, 66.1% (n=269) had a de-escalation recommendation to ET alone after receiving the Recurrence Score® results.
  • Overall, 50.2% (n=292) treatment recommendation change in routine clinical practice, based on Recurrence Score® results.

 

PONDx UK decision impact-study:
(n=582)/ER+/HER2-/N1/early-breast patients across 30 institutions in UK between October 2017 and December 2018.

View next slide to see characteristics of patient subgroup


1. Battisti et al, St Gallen International conference 2019, P007



PONDx UK decision impact-study:
N=582/ER+/HER2-/N1/early-breast patients across 30 institutions in UK
between October 2017 and December 2018.

n

Nodal
involvement
 1 node 405
 2 nodes 130
3 nodes 47


Tumor
size
 <1 cm 20
 1 to <2 cm 201
 2 to <5 cm  324
≥5 cm 37


Grade
G1 77
G2 398
G3 107
Pre
menopausal
119
Peri
menopausal
69
Post
menopausal
388

Lymph node status does not predict tumour biology1


Analysis of data concerning 610,350 specimens from the Exact Sciences (then Genomic Health) Clinical Laboratory demonstrates1:

  • Micrometastic nodal status does not predict Recurrence Score® results.
  • N0, N1mi, and N1 breast cancer patients have similar Recurrence Score® result distributions.

1. Bello et al. Ann Surg Oncol. 2018

Many patients have Recurrence Score® results 0-25, regardless of nodal involvement1


The real-world CLALIT registry demonstrates that1:

  • Micrometastatic nodal status has not been shown to predict Recurrence Score® results.2,3
  • A significant proportion of node positive patients with N1mi disease have Recurrence Score® results 0-181 and may not benefit from chemotherapy.2,3

1. Adapted from: Stemmer et al NPJ Breast Cancer 2017, Supplementary Fig. S2.c; 2. Albain et al Lancet Oncology 2010; 3. Kalinsky et al NEJM 2021;

Postmenopausal patients received no benefit from chemotherapy benefit regardless of the number of positive nodes1


The RxPONDER study shows that1:

  • For patients with Recurrence Score® results 0-25, the number of positive nodes including micromets, did not correlate with benefit from chemotherapy.
  • The lack of benefit from chemotherapy was observed regardless of number of positive nodes.

1. Kalinsky et al. NEJM 2021.

The Oncotype DX test is the “preferred” assay for Nmic, HR+, HER2-, postmenopausal breast cancer patients to predict chemotherapy benefit1**


The National Comprehensive Cancer Network® (NCCN) updated their guidelines for breast cancer based on RxPONDER study results:1

  • The Oncotype DX® test is the only assay recognized by the NCCN Guidelines® to predict adjuvant chemotherapy benefit.
  • It is the only assay classified as the “preferred” test in postmenopausal pN1mi and N1 patients with HR+, HER2-negative breast cancer.

*National Comprehensive Cancer Network® (NCCN®) are registered trademarks of NCCN.

** Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023. © 2023 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. NCCN does not endorse any product or therapy. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.4.2023., https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

Ki-67 status is not predictive of adjuvant chemotherapy benefit1


Two independent studies from the IBCSG showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671


In the German prospective WSG PlanB trial, Ki-67 expression was assessed centrally1:

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • About 1 in 10 patients with Ki-67 values of <10% had a Recurrence Score® result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant proportion of patients with a Ki-67 value of ≤10% result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1


Two independent studies from the IBCSG showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671


In the German prospective WSG PlanB, Ki-67 expression was assessed centrally.1

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • More than 10% of patients with Ki-67 values 10-19% had a Recurrence Score® result 26-1001 and may benefit from adjuvant chemotherapy.

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant proportion of patients with a Ki-67 value of 10%-20% result 26-1001 and may benefit from adjuvant chemotherapy.2-3

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Paik et al. J Clin Oncol. 2006; 3. Geyer et al. npj Breast Cancer. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1


Two independent studies from the IBCSG showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671


In the German prospective WSG PlanB, Ki-67 expression was assessed centrally1:

The results show that:

  • Ki-67 values centrally assessed had only a weak to moderate correlation with the Recurrence Score® results.1
  • Ki-67 values 20-39% do not give a clear indication whether there is an adjuvant chemotherapy benefit or not.2-3

1. Adapted from Gluz et al. J Clin Oncol. 2016.

Relationship between Recurrence Score® results and Ki-671


The CLALIT real-world registry suggests that1:

  • There is weak to moderate correlation between Ki-67 values and the Recurrence Score® results.
  • A significant proportion of patients with Ki-67 values between 20-40% have Recurrence Score® results 0-25.

1. Ben-Baruch et al. St.Gallen. 2013.

Ki-67 does not predict Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany confirmed that1:

  • Ki-67 values have a weak to moderate correlation with the Recurrence Score® results.
  • A high proportion of patients with a Ki-67 value of ≥20% had a Recurrence Score® result of 0-251 and may not benefit from adjuvant chemotherapy.2

1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018.

Ki-67 status is not predictive of adjuvant chemotherapy benefit1


Two independent studies from the IBCSG showed that1:

  • Relative treatment effect was independent of Ki-67.

1. Viale et al. J Natl Cancer Inst. 2008.

Prospective data show a distribution of Recurrence Score® results across all ranges of Ki-671


In the German prospective WSG PlanB, Ki-67 expression was assessed centrally.1:

The results show that:

  • Ki-67 values centrally assessed had a weak to moderate correlation with the Recurrence Score® results.1
  • About 1 out 10 of patients with Ki-67 value of >39% have Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.2

1. Adapted from Gluz et al. J Clin Oncol. 2016; 2. Sparano et al. N Engl J Med. 2018.

Comparison of Ki-67 staining and Recurrence Score® results in clinical practice1


A retrospective analysis from routine clinical practice in Germany reported1:

  • An overall high discordance of 45% between Ki-67 (20% as cutoff) and the Recurrence Score® result (25 as cutoff).
  • A significant number of patients with a Ki-67 value of >40% had Recurrence Score® results 0-251 and may not benefit from adjuvant chemotherapy.2
1. Walter et al. Geburtshilfe Frauenheilkd. 2020; 2. Sparano et al. N Engl J Med. 2018.
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