A phase II study of docetaxel as salvage chemotherapy in advanced gastric cancer after failure of fluoropyrimidine and platinum combination chemotherapy

Purpose Fluoropyrimidine (F) and platinum (P) combination chemotherapy has been widely used as a first-line treatment of advanced gastric cancer (AGC). Docetaxel has shown promising activity against this disease. In this study, we explored the efficacy and safety of docetaxel monotherapy as salvage chemotherapy in AGC after F and P combination chemotherapy failed. Materials and methods From October 2004 to October 2005, 49 eligible patients were enrolled in this study. The median treatment-free interval was 28.0 days, and 81.6% of patients had suffered cancer progression within 4 months after the withdrawal of first-line chemotherapy. Docetaxel was given IV at a dose of 75 mg/m(2) every 3 weeks, together with dexamethasone prophylaxis. Results A total of 182 cycles of docetaxel were administered with a median of 3 (range 1-9) cycles. From an intention-to- treat analysis, eight patients achieved objective response with a response rate of 16.3% (95% CI, 6.0-26.6). The median response duration was 4.7 months. A total of 20 patients showed stable disease, but 17 patients suffered disease progression. At a median follow-up duration of 11.3 months for surviving patients (range 6.3-18.8 months), the median time to disease progression was 2.5 months (95% CI, 2.3-2.7) and the median overall survival time since the start of docetaxel monotherapy was 8.3 months (95% CI, 6.7-9.8). Grade 3/4 neutropenia and febrile neutropenia occurred in 18.4% of patients and in 5.4% of cycles. The incidence of non-hematologic toxicities of grade 3 or worse was asthenia 32.7%, diarrhea 10.2% and peripheral sensory neuropathy 8.2%. Conclusion Docetaxel at 75 mg/m(2) is active against AGC as second-line chemotherapy after prior exposure to F and P combination chemotherapy. The toxicity profile is moderate.