Publicaciones científicas
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
Delaloge S 1,2, Piccart M 3, Rutgers E 4, Litière S 5, van 't Veer LJ 6, van den Berkmortel F 7, Brain E 8, Dudek-Peric A 5, Gil-Gil M 9, Gomez P 10, Hilbers FS 11, Khalil Z 12, Knox S 13, Kuemmel S 14, Kunz G 15, Lesur A 16, Pierga JY 8,17, Ravdin P 18, Rubio IT 19, Saghatchian M 1, Smilde TJ 20, Thompson AM 21, Viale G 22, Zoppoli G 23, Vuylsteke P 24, Tryfonidis K 5, Poncet C 5, Bogaerts J 5, Cardoso F 25; MINDACT investigators and the TRANSBIG Consortium.
1 Gustave Roussy, Villejuif, France.
2 Unicancer Breast Group, Paris, France.
3 Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
4 Netherlands Cancer Institute, Amsterdam, the Netherlands.
5 European Organization for Research and Treatment of Cancer, Brussels, Belgium.
6 Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.
7 Zuyderland Medisch Centrum, Heerlen-Geleen, the Netherlands.
8 Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.
9 Institut Catala D'Oncologia-Institut d'Investigacio Biomedica de Bellvitge, L'Hospitalet, Barcelona, Spain.
10 Hospital General Vall D'Hebron, Barcelona, Spain.
11 Breast International Group, Brussels, Belgium.
12 Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
13 Europa Donna-The European Breast Cancer Coalition, Milan, Italy.
14 Breast Unit Kliniken Essen-Mitte, Westdeutsche Studiengruppe, Mönchengladbach, Germany.
15 St Johannes Hospital, Dortmund, Germany.
16 Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, France.
17 Institut Curie Paris Sciences et Lettres, Université de Paris, Paris, France.
18 The University of Texas Health Sciences Center, San Antonio, TX.
19 Clinica Universidad de Navarra-Site Madrid, Madrid, Spain.
20 Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, the Netherlands.
21 Baylor University College of Medicine, Houston, TX.
22 University of Milan and European Institute of Oncology-Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.
23 University of Genoa and Azienda Ospedaliera Universitaria San Martino, Genova, Italy.
24 Centre Hospitalier Universitaire, Université Catholique de Louvain, Namur, Belgium.
25 Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.
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.
CITA DEL ARTÍCULO J Clin Oncol. 2020 Feb 21:JCO1901371. doi: 10.1200/JCO.19.01371
Nuestros autores
