Phase II study of gemcitabine in combination with vinorelbine versus gemcitabine followed by vinorelbine for metastatic breast cancer

Background No clear data are available concerning the superiority of combination chemotherapy to sequential therapy using agents beyond 1st or 2nd line chemotherapy for treating patients with metastatic breast cancer. Methods Patients were randomized to receive a combination of gemcitabine and vinorelbine or gemcitabine until disease progression followed by vinorelbine monotherapy. Quality of life was assessed using EORTC QLQ-C30 questionnaires. Results Forty-two patients were randomized to the combination arm and 40 were randomized to the sequential arm. Baseline characteristics were well balanced between the arms. The median number of chemotherapy cycles was 4 (range, 1–23) for the combination arm and 6 (range, 1–25) for the sequential arm. Patients receiving combination therapy had a higher composite response rate (26.8% vs. 12.5%; P = 0.106) but a shorter median time to treatment failure (3.6 vs. 4.4 months, P = 0.252) as compared to patients receiving sequential monotherapy. Median overall survival for the combination and sequential arms was 10.6 months and 8.9 months, respectively (P = 0.436). Toxicities were manageable and similar in both arms. Quality of life measurements in global health, role, and social function were superior in the combination arm (P < 0.05). Conclusions Combined gemcitabine and vinorelbine therapy appears comparable to sequential monotherapy for heavily pretreated patients with metastatic breast cancer as demonstrated by improved quality of life outcomes with similar therapeutic efficacies and incidences of adverse events.