Better Invasive Disease–Free Survival With Epirubicin/Cyclophosphamide and Docetaxel vs Epirubicin/Docetaxel and Capecitabine in Breast Cancer
In a Spanish phase III trial (GEICAM/2003-10) reported in the Journal of Clinical Oncology, Martín et al found that invasive disease–free survival was improved with adjuvant epirubicin/cyclophosphamide (EC) followed by docetaxel (EC-T) vs epirubicin/docetaxel followed by capecitabine (ET-X) in patients with node-positive early breast cancer. No difference in overall survival was observed.
Study Details
In this open-label trial, 1,384 women with node-positive (T1–3, N1–3) disease from 58 sites in Spain were randomized between February 2004 and February 2007 to receive adjuvant ET (90 and 75 mg/m2 for four cycles) followed by X (1,250 mg/m2 twice a day on days 1–14 for four cycles; n = 715) or EC (90 and 600 mg/m2 for four cycles) followed by T (100 mg/m2 for four cycles; n = 669) in 3-week cycles. The primary endpoint was invasive disease–free survival.
Overall, patients had a median age of 51 years, 98% had a Karnofsky performance status ≥ 90%, 53% were premenopausal. T stage was T1, T2, and T3 in 48%, 47%, and 5%, and 66%, 25%, and 9% had one to three, four to nine, or more than nine involved nodes; 34.5% of tumors were poorly differentiated, 14.5% were grade 1, 84% were ductal carcinoma, 84% were hormone receptor–positive, and 10% were HER2-positive.
Survival Outcomes
After a median follow-up of 6.6 years, 5-year invasive disease–free survival was 82% in the ET-X group vs 86% in the EC-T group (hazard ratio [HR] = 1.30, P = .03). Five-year overall survival was 92% vs 93% (HR = 1.13, P = .46). After adjuvant chemotherapy, approximately 79% of patients received radiotherapy, and 83% received endocrine therapy.
Adverse Events
The most frequent grade 3 or 4 adverse events for ET-X vs EC-T were neutropenia (10% vs 19%; febrile neutropenia in 7% in both), fatigue (11% vs13%), diarrhea (11% vs 3%), hand-foot syndrome (20% vs 2%), mucositis (5% vs 6%), vomiting (5% vs 5%), and myalgia (1% vs 4.5%). In an alopecia substudy, incomplete scalp hair recovery was more common in the EC-T group (30% vs 14%), and patients in the EC-T group wore wigs significantly longer (8.35 vs 6.03 months; both P < .001).
The investigators concluded: “Invasive disease-free survival, but not [overall survival], was significantly superior for patients with node-positive early [breast cancer] who received the adjuvant standard schedule EC-T than for those who received the experimental ET-X regimen. Toxicity profiles differed substantially across arms.”
The study was supported by Roche Farma S.A., Sanofi, Pfizer, and Amgen.
Miguel Martín, MD, PhD, of Universidad Complutense, Madrid, Spain, is the corresponding author of the Journal of Clinical Oncology article.
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