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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, Suzette;
- Piccart, Martine;
- Rutgers, Emiel;
- Litière, Saskia;
- van 't Veer, Laura J;
- van den Berkmortel, Franchette;
- Brain, Etienne;
- Dudek-Peric, Aleksandra;
- Gil-Gil, Miguel;
- Gomez, Patricia;
- Hilbers, Florentine S;
- Khalil, Zaman;
- Knox, Susan;
- Kuemmel, Sherko;
- Kunz, Georg;
- Lesur, Anne;
- Pierga, Jean-Yves;
- Ravdin, Peter;
- Rubio, Isabel T;
- Saghatchian, Mahasti;
- Smilde, Tineke J;
- Thompson, Alastair M;
- Viale, Giuseppe;
- Zoppoli, Gabriele;
- Vuylsteke, Peter;
- Tryfonidis, Konstantinos;
- Poncet, Coralie;
- Bogaerts, Jan;
- Cardoso, Fatima
- et al.
Published Web Location
https://doi.org/10.1200/jco.19.01371Abstract
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.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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