Patient Profile Navigator
Patient Profile Navigator
for all your HR+, HER2-, N0, 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 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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Your selected patient profile (test)
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
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
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
Your selected patient profile (test)
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.4
  • The Oncotype DX® test provides detailed estimates of chemotherapy benefit for patients ≤50 years based on the TAILORx and the NSABP-B20 trials1-3:
    • RS® result: 0-15: no significant CT benefit1-3
    • RS® result: 16-20: ~1.6% CT benefit1,5
    • RS® result: 21-25: ~6.5% CT benefit1,5
    • RS® result: 26-100: substantial CT benefit2-3

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. 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.4
  • 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 trials1-3:
    • RS® result: 0-25: no significant CT benefit1-3,5
    • RS® result: 26-100: substantial CT benefit1-3,5

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. Griggs. J Clin Oncol. 2012; 5. Sparano et al. N Engl J Med. 2019.
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.
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.
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

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 years1-4

    The results from TAILORx and NSAPB-20 suggest that1-4:

    • 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 with a high level of precision for patients younger ≤50 years old.3,4
    • For this age group studies determined:
      • RS® result: 0-15: no significant CT benefit1-3
      • RS® result: 16-20: ~1.6% CT benefit3,4
      • RS® result: 21-25: ~6.5% CT benefit3,4
      • 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.

    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 patients1-4

    The results from TAILORx and NSABP-20 suggest that1-4:

    • 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 with a high level of precision.1-4
    • For this age group studies demonstrated:
      • RS® result: 0-25: no significant CT benefit1-4
      • 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

    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.
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