Docetaxel plus Oxaliplatin in Combination with Capecitabine as First-Line Treatment for Advanced Gastric Cancer

Objective: In the present phase II study, we evaluated the efficacy and safety of a docetaxel-oxaliplatin-capecitabine combination as a first-line treatment in patients with advanced gastric cancer. Patients and Methods: A total of 27 patients (18 males) with histologically confirmed inoperable gastric adenocarcinoma were recruited. Docetaxel was given (50 mg/m(2) i.v.) on day 1 followed by oxaliplatin (75 mg/m(2) i.v.) also on day 1. Capecitabine (2,750 mg/m(2)) was given orally as two daily divided doses from days 1 to 7. Cycles were repeated every 2 weeks. All patients had measurable disease and 18 of them had a performance status (WHO) of 0. Results: A total of 240 treatment cycles were administered. All patients were evaluable for toxicity. Four patients who discontinued treatment early (having received only 3 chemotherapy cycles) were included as non-responders in an intention-to-treat response analysis. Complete response, partial response, stable disease and progressive disease were observed in 4 (15%), 12 (44%), 3 (11%) and 8 (30%) patients, respectively. The observed response rate was 59%, and the disease control rate (complete response + partial response + stable disease) was 70%. At the time of analysis, 6 patients were still alive and the median survival was 18.0 months. The most common grade III/IV toxicities observed were neutropenia (5%), diarrhea (2%), palmar-plantar erythrodysesthesia (2%) and neurotoxicity (1%). All other toxicities were mostly of grade I/II and easily manageable. Conclusion: The combination of docetaxel, oxaliplatin and capecitabine in the described mode of administration represents a relatively active and well-tolerated regimen in patients with advanced gastric cancer and warrants further evaluation. Copyright (C) 2011 S. Karger AG, Basel