A Multicenter Phase II Randomized Trial of Docetaxel/Gemcitabine versus Docetaxel/Capecitabine as First-Line Treatment for Advanced Breast Cancer: A Gruppo Oncologico Italia Meridionale Study

Abstract

Objective: To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients. Methods: Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m² on day 1, gemcitabine 1,000 mg/m² on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m² on day 1, capecitabine 1,250 mg/m² twice daily on days 1–14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate. Results: Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7% [95% confidence interval (CI) 25.6–57.8]; arm B, 38.9% (95% CI 23–54.8). Median progression-free survival was 10.9 months (95% CI 8.1–13.7) in arm A and 10 months (95% CI 8.8–11.2) in arm B. Overall survival was 26 months (95% CI 22.0–30.0) in arm A and 28 months (95% CI 23.4–32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3–4 neutropenia in 13.8 and 19.4% of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9%) and hand-foot syndrome (11.1%), which occurred only in arm B. Conclusions: Both regimens were active and well tolerated in advanced breast cancer.