A phase II study of capecitabine plus oxaliplatin (XELOX) as first-line therapy for patients with advanced gastric cancer

4079 Background: The combination chemotherapy of capecitabine and cisplatin showed considerable activity and good feasibility in patients with advanced gastric cancer. Oxaliplatin has a more favorable toxicity profile compared to cisplatin. The purpose of the study is to evaluate the efficacy and toxicity of capecitabine plus oxaliplatin combination chemotherapy in previously untreated patients with advanced gastric carcinoma. Methods: Patients received intravenous oxaliplatin 130 mg/m2 over 2 hours on day 1 plus oral capecitabine 1000 mg/m2 twice daily on days 1–14, every 3 weeks. Treatment was continued until progression of disease or intolerable toxicities with a maximum of 8 cycles. All the measurability and response evaluations were reviewed and confirmed by one investigator. Results: Total 54 patients were enrolled (37 men, 17 women). The median age was 57 years (range 29–70). Among these 54 patients, fifty-two patients were evaluable. A total 311 cycles of chemotherapy were delivered. The overall response rate was 63% (95% CI, 50–76%), with complete response in 2 patient and partial responses in 32 patients. After a median follow-up of 13 months, median progression-free survival was 5.8 months (95% CI, 4.4–7.2 months); median overall survival was 11.9 months (95% CI, 8.8–15.1 months). The treatment was generally well tolerated. The most common haematological adverse event was anaemia (70% of patients). Grade 3- 4 neutropenia was observed in 4 patients and neutropenic fever was experienced in only 1 patient. Four patients had G3 thrombocytopenia, which was accompanied by G3 gastrointestinal bleeding. The most common non-haematological toxicities were neuropathy (70%), vomiting (50%), diarrohea (33%), and hand-foot syndrome (39%). But, G3–4 toxicities were rare. There was one treatment related death which was associated with grade IV neutropenic sepsis. Conclusion: XELOX was active and well tolerated as a first-line therapy for advanced gastric carcinoma. No significant financial relationships to disclose.