A phase II study of capecitabine plus oxaliplatin as first-line chemotherapy in elderly patients with advanced gastric cancer.

OBJECTIVE: This study aimed at assessing the efficacy and safety of oxaliplatin plus oral capecitabine (XELOX regimen) as first-line chemotherapy in elderly patients with advanced gastric cancer (AGC).

PATIENTS AND METHODS: Forty-six eligible patients aged ≥70 years with previously untreated AGC received oxaliplatin 130 mg/m(2) intravenously over a 2-hour period on day 1 plus oral capecitabine 850 mg/m(2) twice daily on days 1-14, every 3 weeks.

RESULTS: All patients were evaluable for toxicity and 45 patients for efficacy. A median of 6 cycles (range 1-8) was administered. The overall response rate was 48.9% (95% CI 34-64) with 1 complete response, 21 partial responses, 15 stable diseases and 8 progressions. Median time to progression was 6.0 months (95% CI 3.9-8.1), and the median overall survival was 10.0 months (95% CI 8.6-11.4). Toxicity was fairly mild. Grade 3 toxicities included neutropenia (6.5%), thrombocytopenia (2.2%), nausea (2.2%), vomiting (4.3%), diarrhea (4.3%) as well as peripheral neuropathy (2.2%); grade 4 toxicities occurred in none of the patients.

CONCLUSION: The XELOX regimen with capecitabine at a lower dose of 850 mg/m(2) is active, fairly tolerable and conveniently delivered as first-line chemotherapy for elderly AGC patients.