Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial

Suzette Delaloge; Martine Piccart; Emiel Rutgers; Saskia Litière; Laura J. van’t Veer; Franchette van den Berkmortel; Etienne Brain; Aleksandra Dudek-Peric; Miguel Gil-Gil; Patricia Gomez; Florentine S. Hilbers; Zaman Khalil; Susan Knox; Sherko Kuemmel; Georg Kunz; Anne Lesur; Jean Yves Pierga; Peter Ravdin; Isabel T. Rubio; Mahasti Saghatchian; Tineke J. Smilde; Alastair M. Thompson; Giuseppe Viale; Gabriele Zoppoli; Peter Vuylsteke; Konstantinos Tryfonidis; Coralie Poncet; Jan Bogaerts; Fatima Cardoso; Karen Benn; Eva Ciruelos; Sabine Corochan; Julia Cuny; Lorena de la Pena; Mauro DeLorenzi; Inge Eekhout; Oleg Gluz; Vassilis Golfinopoulos; Theodora Goulioti; Nadia Harbeck; Valérie Hilal; Jerome Lemonnier; Michał Ławniczak; Luca Marini; Erika Matos; Peppi Morales; Kirsten Murray; Urlike Nitz; Rodolfo Passalaqua; Jolanda Remmelzwaal; Leen Slaets; Christos Sotiriou; Carolyn Straehle; Mark Straley; Nathalie Theron; Renata Todeschini; Milanka Urunkar; Kim Aalders; Jacques Bines; Philippe Bedard; Ivana Bozovic; Sofia Braga; Carlos Castaneda; Aleksandar Celebic; Camelia Colichi; Carmen Criscitiello; Lissandra Dal Lago; Gaston Demonty; Caroline Drukker; Fei Fei; Michela Lia; Sherene Loi; Stella Mook; Camilo Moulin; Roman Sreseli; Gustavo Werutsky; Sabine Corachan; Aleksandra Dudek-Peric; Lorraine Wheeler; Nicolas Dif; Giovanna Rizzetto; Melanie Beauvois; Livia Meirsman; Hilde Breyssens; Nuria Decker; Kristel Engelen; Anita Akropovic; Jillian Harrison; Frederic Henot; Miet Celis; Britt de Jongh; Inge Delmotte; Valéry Daubie; Roel Goossens; Nils Helsen; Laetitia Hourt; Sven Janssen; Virginie Soete; Kaat Vansevenant; Catherine Hermans

doi:10.1200/JCO.19.01371

Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial

Suzette Delaloge, Martine Piccart, Emiel Rutgers, Saskia Litière, Laura J. van’t Veer, Franchette van den Berkmortel, Etienne Brain, Aleksandra Dudek-Peric, Miguel Gil-Gil, Patricia Gomez, Florentine S. Hilbers, Zaman Khalil, Susan Knox, Sherko Kuemmel, Georg Kunz, Anne Lesur, Jean Yves Pierga, Peter Ravdin, Isabel T. Rubio, Mahasti SaghatchianTineke J. Smilde, Alastair M. Thompson, Giuseppe Viale, Gabriele Zoppoli, Peter Vuylsteke, Konstantinos Tryfonidis, Coralie Poncet, Jan Bogaerts, Fatima Cardoso, Karen Benn, Eva Ciruelos, Sabine Corochan, Julia Cuny, Lorena de la Pena, Mauro DeLorenzi, Inge Eekhout, Oleg Gluz, Vassilis Golfinopoulos, Theodora Goulioti, Nadia Harbeck, Valérie Hilal, Jerome Lemonnier, Michał Ławniczak, Luca Marini, Erika Matos, Peppi Morales, Kirsten Murray, Urlike Nitz, Rodolfo Passalaqua, Jolanda Remmelzwaal, Leen Slaets, Christos Sotiriou, Carolyn Straehle, Mark Straley, Nathalie Theron, Renata Todeschini, Milanka Urunkar, Kim Aalders, Jacques Bines, Philippe Bedard, Ivana Bozovic, Sofia Braga, Carlos Castaneda, Aleksandar Celebic, Camelia Colichi, Carmen Criscitiello, Lissandra Dal Lago, Gaston Demonty, Caroline Drukker, Fei Fei, Michela Lia, Sherene Loi, Stella Mook, Camilo Moulin, Roman Sreseli, Gustavo Werutsky, Sabine Corachan, Aleksandra Dudek-Peric, Lorraine Wheeler, Nicolas Dif, Giovanna Rizzetto, Melanie Beauvois, Livia Meirsman, Hilde Breyssens, Nuria Decker, Kristel Engelen, Anita Akropovic, Jillian Harrison, Frederic Henot, Miet Celis, Britt de Jongh, Inge Delmotte, Valéry Daubie, Roel Goossens, Nils Helsen, Laetitia Hourt, Sven Janssen, Virginie Soete, Kaat Vansevenant, Catherine Hermans

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Abstract

© 2020 by American Society of Clinical Oncology PURPOSE MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen. PATIENTS AND METHODS R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety. RESULTS Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]). CONCLUSION Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.

Original language	American English
Pages (from-to)	1186-1197
Number of pages	12
Journal	Journal of Clinical Oncology
DOIs	https://doi.org/10.1200/JCO.19.01371
State	Published - 10 Apr 2020

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10.1200/JCO.19.01371

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Delaloge, S., Piccart, M., Rutgers, E., Litière, S., van’t Veer, L. J., van den Berkmortel, F., Brain, E., Dudek-Peric, A., Gil-Gil, M., Gomez, P., Hilbers, F. S., Khalil, Z., Knox, S., Kuemmel, S., Kunz, G., Lesur, A., Pierga, J. Y., Ravdin, P., Rubio, I. T., ... Hermans, C. (2020). Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial. Journal of Clinical Oncology, 1186-1197. https://doi.org/10.1200/JCO.19.01371

@article{0598cfa647d74235aba01cd3e25ec59d,

title = "Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial",

abstract = "{\textcopyright} 2020 by American Society of Clinical Oncology PURPOSE MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen. PATIENTS AND METHODS R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety. RESULTS Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]). CONCLUSION Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.",

author = "Suzette Delaloge and Martine Piccart and Emiel Rutgers and Saskia Liti{\`e}re and {van{\textquoteright}t Veer}, {Laura J.} and {van den Berkmortel}, Franchette and Etienne Brain and Aleksandra Dudek-Peric and Miguel Gil-Gil and Patricia Gomez and Hilbers, {Florentine S.} and Zaman Khalil and Susan Knox and Sherko Kuemmel and Georg Kunz and Anne Lesur and Pierga, {Jean Yves} and Peter Ravdin and Rubio, {Isabel T.} and Mahasti Saghatchian and Smilde, {Tineke J.} and Thompson, {Alastair M.} and Giuseppe Viale and Gabriele Zoppoli and Peter Vuylsteke and Konstantinos Tryfonidis and Coralie Poncet and Jan Bogaerts and Fatima Cardoso and Karen Benn and Eva Ciruelos and Sabine Corochan and Julia Cuny and {de la Pena}, Lorena and Mauro DeLorenzi and Inge Eekhout and Oleg Gluz and Vassilis Golfinopoulos and Theodora Goulioti and Nadia Harbeck and Val{\'e}rie Hilal and Jerome Lemonnier and Micha{\l} {\L}awniczak and Luca Marini and Erika Matos and Peppi Morales and Kirsten Murray and Urlike Nitz and Rodolfo Passalaqua and Jolanda Remmelzwaal and Leen Slaets and Christos Sotiriou and Carolyn Straehle and Mark Straley and Nathalie Theron and Renata Todeschini and Milanka Urunkar and Kim Aalders and Jacques Bines and Philippe Bedard and Ivana Bozovic and Sofia Braga and Carlos Castaneda and Aleksandar Celebic and Camelia Colichi and Carmen Criscitiello and {Dal Lago}, Lissandra and Gaston Demonty and Caroline Drukker and Fei Fei and Michela Lia and Sherene Loi and Stella Mook and Camilo Moulin and Roman Sreseli and Gustavo Werutsky and Sabine Corachan and Aleksandra Dudek-Peric and Lorraine Wheeler and Nicolas Dif and Giovanna Rizzetto and Melanie Beauvois and Livia Meirsman and Hilde Breyssens and Nuria Decker and Kristel Engelen and Anita Akropovic and Jillian Harrison and Frederic Henot and Miet Celis and {de Jongh}, Britt and Inge Delmotte and Val{\'e}ry Daubie and Roel Goossens and Nils Helsen and Laetitia Hourt and Sven Janssen and Virginie Soete and Kaat Vansevenant and Catherine Hermans",

year = "2020",

month = apr,

day = "10",

doi = "10.1200/JCO.19.01371",

language = "American English",

pages = "1186--1197",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

}

Delaloge, S, Piccart, M, Rutgers, E, Litière, S, van’t Veer, LJ, van den Berkmortel, F, Brain, E, Dudek-Peric, A, Gil-Gil, M, Gomez, P, Hilbers, FS, Khalil, Z, Knox, S, Kuemmel, S, Kunz, G, Lesur, A, Pierga, JY, Ravdin, P, Rubio, IT, Saghatchian, M, Smilde, TJ, Thompson, AM, Viale, G, Zoppoli, G, Vuylsteke, P, Tryfonidis, K, Poncet, C, Bogaerts, J, Cardoso, F, Benn, K, Ciruelos, E, Corochan, S, Cuny, J, de la Pena, L, DeLorenzi, M, Eekhout, I, Gluz, O, Golfinopoulos, V, Goulioti, T, Harbeck, N, Hilal, V, Lemonnier, J, Ławniczak, M, Marini, L, Matos, E, Morales, P, Murray, K, Nitz, U, Passalaqua, R, Remmelzwaal, J, Slaets, L, Sotiriou, C, Straehle, C, Straley, M, Theron, N, Todeschini, R, Urunkar, M, Aalders, K, Bines, J, Bedard, P, Bozovic, I, Braga, S, Castaneda, C, Celebic, A, Colichi, C, Criscitiello, C, Dal Lago, L, Demonty, G, Drukker, C, Fei, F, Lia, M, Loi, S, Mook, S, Moulin, C, Sreseli, R, Werutsky, G, Corachan, S, Dudek-Peric, A, Wheeler, L, Dif, N, Rizzetto, G, Beauvois, M, Meirsman, L, Breyssens, H, Decker, N, Engelen, K, Akropovic, A, Harrison, J, Henot, F, Celis, M, de Jongh, B, Delmotte, I, Daubie, V, Goossens, R, Helsen, N, Hourt, L, Janssen, S, Soete, V, Vansevenant, K & Hermans, C 2020, 'Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial', Journal of Clinical Oncology, pp. 1186-1197. https://doi.org/10.1200/JCO.19.01371

TY - JOUR

T1 - Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial

AU - Delaloge, Suzette

AU - Piccart, Martine

AU - Rutgers, Emiel

AU - Litière, Saskia

AU - van’t Veer, Laura J.

AU - van den Berkmortel, Franchette

AU - Brain, Etienne

AU - Dudek-Peric, Aleksandra

AU - Gil-Gil, Miguel

AU - Gomez, Patricia

AU - Hilbers, Florentine S.

AU - Khalil, Zaman

AU - Knox, Susan

AU - Kuemmel, Sherko

AU - Kunz, Georg

AU - Lesur, Anne

AU - Pierga, Jean Yves

AU - Ravdin, Peter

AU - Rubio, Isabel T.

AU - Saghatchian, Mahasti

AU - Smilde, Tineke J.

AU - Thompson, Alastair M.

AU - Viale, Giuseppe

AU - Zoppoli, Gabriele

AU - Vuylsteke, Peter

AU - Tryfonidis, Konstantinos

AU - Poncet, Coralie

AU - Bogaerts, Jan

AU - Cardoso, Fatima

AU - Benn, Karen

AU - Ciruelos, Eva

AU - Corochan, Sabine

AU - Cuny, Julia

AU - de la Pena, Lorena

AU - DeLorenzi, Mauro

AU - Eekhout, Inge

AU - Gluz, Oleg

AU - Golfinopoulos, Vassilis

AU - Goulioti, Theodora

AU - Harbeck, Nadia

AU - Hilal, Valérie

AU - Lemonnier, Jerome

AU - Ławniczak, Michał

AU - Marini, Luca

AU - Matos, Erika

AU - Morales, Peppi

AU - Murray, Kirsten

AU - Nitz, Urlike

AU - Passalaqua, Rodolfo

AU - Remmelzwaal, Jolanda

AU - Slaets, Leen

AU - Sotiriou, Christos

AU - Straehle, Carolyn

AU - Straley, Mark

AU - Theron, Nathalie

AU - Todeschini, Renata

AU - Urunkar, Milanka

AU - Aalders, Kim

AU - Bines, Jacques

AU - Bedard, Philippe

AU - Bozovic, Ivana

AU - Braga, Sofia

AU - Castaneda, Carlos

AU - Celebic, Aleksandar

AU - Colichi, Camelia

AU - Criscitiello, Carmen

AU - Dal Lago, Lissandra

AU - Demonty, Gaston

AU - Drukker, Caroline

AU - Fei, Fei

AU - Lia, Michela

AU - Loi, Sherene

AU - Mook, Stella

AU - Moulin, Camilo

AU - Sreseli, Roman

AU - Werutsky, Gustavo

AU - Corachan, Sabine

AU - Dudek-Peric, Aleksandra

AU - Wheeler, Lorraine

AU - Dif, Nicolas

AU - Rizzetto, Giovanna

AU - Beauvois, Melanie

AU - Meirsman, Livia

AU - Breyssens, Hilde

AU - Decker, Nuria

AU - Engelen, Kristel

AU - Akropovic, Anita

AU - Harrison, Jillian

AU - Henot, Frederic

AU - Celis, Miet

AU - de Jongh, Britt

AU - Delmotte, Inge

AU - Daubie, Valéry

AU - Goossens, Roel

AU - Helsen, Nils

AU - Hourt, Laetitia

AU - Janssen, Sven

AU - Soete, Virginie

AU - Vansevenant, Kaat

AU - Hermans, Catherine

PY - 2020/4/10

Y1 - 2020/4/10

N2 - © 2020 by American Society of Clinical Oncology PURPOSE MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen. PATIENTS AND METHODS R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety. RESULTS Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]). CONCLUSION Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.

AB - © 2020 by American Society of Clinical Oncology PURPOSE MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen. PATIENTS AND METHODS R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety. RESULTS Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]). CONCLUSION Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.

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UR - https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85083003495&origin=inward

U2 - 10.1200/JCO.19.01371

DO - 10.1200/JCO.19.01371

M3 - Article

SN - 0732-183X

SP - 1186

EP - 1197

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

ER -

Standard anthracycline based versus docetaxel-capecitabine in early high clinical and/or genomic risk breast cancer in the EORTC 10041/BIG 3-04 MINDACT phase III trial

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