The 70-gene signature in node positive breast cancer: 10-year follow-up of the observational RASTER study

S.B. Vliek, Valesca Pavlawna Retèl, C. Drukker, Jolien M. Bueno-de-Mesquita, Emiel J.Th. Rutgers, Harm van Tinteren, Marc J. van de Vijver, Jelle Wesseling, Willem H. van Harten, Sabine C. Linn

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Abstract

Background: In early stage breast cancer patients, with axillary lymph node metastasis, the 70-gene signature, MammaPrint® (MP) identifies patients with a High or Low Risk of distant breast cancer (BC) recurrence. For MP Low Risk (G(enomic)-low) in patients with up to 3 positive lymph nodes (N1-3), the MINDACT trial (Cardoso, NEJM 2016) showed that it might be safe to forgo adjuvant chemotherapy. Here we evaluated the prognostic value of MP at 10 years follow-up in patients with lymph node positive early stage BC.

Methods: Between 2004 and 2006 812 women with early stage BC participated in the observational RASTER trial (Bueno de Mesquita, Lancet Oncol, 2007). 181 patients were node positive and not included in the primary analysis, 176 of them gave consent for future research. On 164 tumor samples (FFPE) MP was performed retrospectively. Survival data was collected and samples were allocated to clinical high (C-high) or C-low risk as used in MINDACT. Patients with over 3 axillary lymph node metastases (N4+) were all considered C-high. 10-year distant-recurrence-free-interval (DRFI) was compared between subgroups based on the MP and clinical assessment.

Results: In 3 patients the clinical assesment could not be determined. Over 95% of patients received chemotherapy, 82.9% (136/164) of tumors were ER-positive and 18.3% (30/164) of patients had N4+. MP identified 47% (n = 77/164) as Low Risk, including 16,9% (13/77) with N4+. 10-year DRFI in patients N1-3 and G-Low or G-High was 94.9% and 80.7% respectively (HR 4.7; 95%CI 1.3-16.2). With the clinical assessment 13.7% (n = 22/161) were low risk, only one was diagnosed with distant BC recurrence. 10-years DRFI was 94.4% in C-low and 85.8% in C-high (HR 3.7 95%CI 0.5-28.5). In N4+ 10-years DRFI was 69.7%. Combining the clinical assessment with MP risk assessment in patients N1-3 the 10-years DRFI in clinical high risk patients was 95.2% for G-Low (n = 44) and 79.6% for G-High (n = 65) (HR 4.83 95%CI 1.1-21.4).

Conclusions: We again confirm the prognostic value of Mammaprintin BC patients with axillary lymph node involvement after 10 years follow up. In N1-3 patients with clinical high risk, MP can identify a subgroup with excellent prognosis after standard adjuvant systemic therapy
Original languageEnglish
Article number195P
JournalAnnals of oncology
Volume28
Issue number5
DOIs
Publication statusPublished - Sep 2017
EventESMO 2017 Congress: Integrating science into oncology for a better patient outcome - 40.427622, -3.704965, Madrid, Spain
Duration: 8 Sep 201712 Sep 2017
https://www.esmo.org/Conferences/Past-Conferences/ESMO-2017-Congress

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Observational Studies
Breast Neoplasms
Genes
Recurrence
Lymph Nodes
Neoplasm Metastasis
Adjuvant Chemotherapy
Neoplasms
Drug Therapy

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Vliek, S. B., Retèl, V. P., Drukker, C., Bueno-de-Mesquita, J. M., Rutgers, E. J. T., van Tinteren, H., ... Linn, S. C. (2017). The 70-gene signature in node positive breast cancer: 10-year follow-up of the observational RASTER study. Annals of oncology, 28(5), [195P]. https://doi.org/10.1093/annonc/mdx362.045
Vliek, S.B. ; Retèl, Valesca Pavlawna ; Drukker, C. ; Bueno-de-Mesquita, Jolien M. ; Rutgers, Emiel J.Th. ; van Tinteren, Harm ; van de Vijver, Marc J. ; Wesseling, Jelle ; van Harten, Willem H. ; Linn, Sabine C. / The 70-gene signature in node positive breast cancer : 10-year follow-up of the observational RASTER study. In: Annals of oncology. 2017 ; Vol. 28, No. 5.
@article{8568b307e2a74598ba5461d7f1ddce19,
title = "The 70-gene signature in node positive breast cancer: 10-year follow-up of the observational RASTER study",
abstract = "Background: In early stage breast cancer patients, with axillary lymph node metastasis, the 70-gene signature, MammaPrint{\circledR} (MP) identifies patients with a High or Low Risk of distant breast cancer (BC) recurrence. For MP Low Risk (G(enomic)-low) in patients with up to 3 positive lymph nodes (N1-3), the MINDACT trial (Cardoso, NEJM 2016) showed that it might be safe to forgo adjuvant chemotherapy. Here we evaluated the prognostic value of MP at 10 years follow-up in patients with lymph node positive early stage BC.Methods: Between 2004 and 2006 812 women with early stage BC participated in the observational RASTER trial (Bueno de Mesquita, Lancet Oncol, 2007). 181 patients were node positive and not included in the primary analysis, 176 of them gave consent for future research. On 164 tumor samples (FFPE) MP was performed retrospectively. Survival data was collected and samples were allocated to clinical high (C-high) or C-low risk as used in MINDACT. Patients with over 3 axillary lymph node metastases (N4+) were all considered C-high. 10-year distant-recurrence-free-interval (DRFI) was compared between subgroups based on the MP and clinical assessment.Results: In 3 patients the clinical assesment could not be determined. Over 95{\%} of patients received chemotherapy, 82.9{\%} (136/164) of tumors were ER-positive and 18.3{\%} (30/164) of patients had N4+. MP identified 47{\%} (n = 77/164) as Low Risk, including 16,9{\%} (13/77) with N4+. 10-year DRFI in patients N1-3 and G-Low or G-High was 94.9{\%} and 80.7{\%} respectively (HR 4.7; 95{\%}CI 1.3-16.2). With the clinical assessment 13.7{\%} (n = 22/161) were low risk, only one was diagnosed with distant BC recurrence. 10-years DRFI was 94.4{\%} in C-low and 85.8{\%} in C-high (HR 3.7 95{\%}CI 0.5-28.5). In N4+ 10-years DRFI was 69.7{\%}. Combining the clinical assessment with MP risk assessment in patients N1-3 the 10-years DRFI in clinical high risk patients was 95.2{\%} for G-Low (n = 44) and 79.6{\%} for G-High (n = 65) (HR 4.83 95{\%}CI 1.1-21.4).Conclusions: We again confirm the prognostic value of Mammaprintin BC patients with axillary lymph node involvement after 10 years follow up. In N1-3 patients with clinical high risk, MP can identify a subgroup with excellent prognosis after standard adjuvant systemic therapy",
author = "S.B. Vliek and Ret{\`e}l, {Valesca Pavlawna} and C. Drukker and Bueno-de-Mesquita, {Jolien M.} and Rutgers, {Emiel J.Th.} and {van Tinteren}, Harm and {van de Vijver}, {Marc J.} and Jelle Wesseling and {van Harten}, {Willem H.} and Linn, {Sabine C.}",
note = "Poster abstract",
year = "2017",
month = "9",
doi = "10.1093/annonc/mdx362.045",
language = "English",
volume = "28",
journal = "Annals of oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "5",

}

Vliek, SB, Retèl, VP, Drukker, C, Bueno-de-Mesquita, JM, Rutgers, EJT, van Tinteren, H, van de Vijver, MJ, Wesseling, J, van Harten, WH & Linn, SC 2017, 'The 70-gene signature in node positive breast cancer: 10-year follow-up of the observational RASTER study' Annals of oncology, vol. 28, no. 5, 195P. https://doi.org/10.1093/annonc/mdx362.045

The 70-gene signature in node positive breast cancer : 10-year follow-up of the observational RASTER study. / Vliek, S.B.; Retèl, Valesca Pavlawna; Drukker, C.; Bueno-de-Mesquita, Jolien M.; Rutgers, Emiel J.Th.; van Tinteren, Harm; van de Vijver, Marc J.; Wesseling, Jelle; van Harten, Willem H.; Linn, Sabine C.

In: Annals of oncology, Vol. 28, No. 5, 195P, 09.2017.

Research output: Contribution to journalConference articleAcademicpeer-review

TY - JOUR

T1 - The 70-gene signature in node positive breast cancer

T2 - 10-year follow-up of the observational RASTER study

AU - Vliek, S.B.

AU - Retèl, Valesca Pavlawna

AU - Drukker, C.

AU - Bueno-de-Mesquita, Jolien M.

AU - Rutgers, Emiel J.Th.

AU - van Tinteren, Harm

AU - van de Vijver, Marc J.

AU - Wesseling, Jelle

AU - van Harten, Willem H.

AU - Linn, Sabine C.

N1 - Poster abstract

PY - 2017/9

Y1 - 2017/9

N2 - Background: In early stage breast cancer patients, with axillary lymph node metastasis, the 70-gene signature, MammaPrint® (MP) identifies patients with a High or Low Risk of distant breast cancer (BC) recurrence. For MP Low Risk (G(enomic)-low) in patients with up to 3 positive lymph nodes (N1-3), the MINDACT trial (Cardoso, NEJM 2016) showed that it might be safe to forgo adjuvant chemotherapy. Here we evaluated the prognostic value of MP at 10 years follow-up in patients with lymph node positive early stage BC.Methods: Between 2004 and 2006 812 women with early stage BC participated in the observational RASTER trial (Bueno de Mesquita, Lancet Oncol, 2007). 181 patients were node positive and not included in the primary analysis, 176 of them gave consent for future research. On 164 tumor samples (FFPE) MP was performed retrospectively. Survival data was collected and samples were allocated to clinical high (C-high) or C-low risk as used in MINDACT. Patients with over 3 axillary lymph node metastases (N4+) were all considered C-high. 10-year distant-recurrence-free-interval (DRFI) was compared between subgroups based on the MP and clinical assessment.Results: In 3 patients the clinical assesment could not be determined. Over 95% of patients received chemotherapy, 82.9% (136/164) of tumors were ER-positive and 18.3% (30/164) of patients had N4+. MP identified 47% (n = 77/164) as Low Risk, including 16,9% (13/77) with N4+. 10-year DRFI in patients N1-3 and G-Low or G-High was 94.9% and 80.7% respectively (HR 4.7; 95%CI 1.3-16.2). With the clinical assessment 13.7% (n = 22/161) were low risk, only one was diagnosed with distant BC recurrence. 10-years DRFI was 94.4% in C-low and 85.8% in C-high (HR 3.7 95%CI 0.5-28.5). In N4+ 10-years DRFI was 69.7%. Combining the clinical assessment with MP risk assessment in patients N1-3 the 10-years DRFI in clinical high risk patients was 95.2% for G-Low (n = 44) and 79.6% for G-High (n = 65) (HR 4.83 95%CI 1.1-21.4).Conclusions: We again confirm the prognostic value of Mammaprintin BC patients with axillary lymph node involvement after 10 years follow up. In N1-3 patients with clinical high risk, MP can identify a subgroup with excellent prognosis after standard adjuvant systemic therapy

AB - Background: In early stage breast cancer patients, with axillary lymph node metastasis, the 70-gene signature, MammaPrint® (MP) identifies patients with a High or Low Risk of distant breast cancer (BC) recurrence. For MP Low Risk (G(enomic)-low) in patients with up to 3 positive lymph nodes (N1-3), the MINDACT trial (Cardoso, NEJM 2016) showed that it might be safe to forgo adjuvant chemotherapy. Here we evaluated the prognostic value of MP at 10 years follow-up in patients with lymph node positive early stage BC.Methods: Between 2004 and 2006 812 women with early stage BC participated in the observational RASTER trial (Bueno de Mesquita, Lancet Oncol, 2007). 181 patients were node positive and not included in the primary analysis, 176 of them gave consent for future research. On 164 tumor samples (FFPE) MP was performed retrospectively. Survival data was collected and samples were allocated to clinical high (C-high) or C-low risk as used in MINDACT. Patients with over 3 axillary lymph node metastases (N4+) were all considered C-high. 10-year distant-recurrence-free-interval (DRFI) was compared between subgroups based on the MP and clinical assessment.Results: In 3 patients the clinical assesment could not be determined. Over 95% of patients received chemotherapy, 82.9% (136/164) of tumors were ER-positive and 18.3% (30/164) of patients had N4+. MP identified 47% (n = 77/164) as Low Risk, including 16,9% (13/77) with N4+. 10-year DRFI in patients N1-3 and G-Low or G-High was 94.9% and 80.7% respectively (HR 4.7; 95%CI 1.3-16.2). With the clinical assessment 13.7% (n = 22/161) were low risk, only one was diagnosed with distant BC recurrence. 10-years DRFI was 94.4% in C-low and 85.8% in C-high (HR 3.7 95%CI 0.5-28.5). In N4+ 10-years DRFI was 69.7%. Combining the clinical assessment with MP risk assessment in patients N1-3 the 10-years DRFI in clinical high risk patients was 95.2% for G-Low (n = 44) and 79.6% for G-High (n = 65) (HR 4.83 95%CI 1.1-21.4).Conclusions: We again confirm the prognostic value of Mammaprintin BC patients with axillary lymph node involvement after 10 years follow up. In N1-3 patients with clinical high risk, MP can identify a subgroup with excellent prognosis after standard adjuvant systemic therapy

U2 - 10.1093/annonc/mdx362.045

DO - 10.1093/annonc/mdx362.045

M3 - Conference article

VL - 28

JO - Annals of oncology

JF - Annals of oncology

SN - 0923-7534

IS - 5

M1 - 195P

ER -