A phase II study of modified FOLFOX as first-line chemotherapy in elderly patients with advanced gastric cancer.

The aim of this study was to evaluate the efficacy and safety of biweekly oxaliplatin in combination with continuous infusional 5-fluorouracil and leucovorin (modified FOLFOX regimen) in elderly patients with advanced gastric cancer (AGC). Forty-six eligible patients older than 65 years with previously untreated AGC received oxaliplatin 85 mg/m intravenously over a 2-h period on day 1, together with leucovorin 400 mg/m over 2 h, followed by a 46-h infusion of 5-fluorouracil 2600 mg/m every 2 weeks. All patients were evaluable for efficacy and toxicity. A median of seven cycles (range 1-12) was administered. The overall response rate was 45.6% [95% confidence interval (CI): 31-61%] with two complete responses, 19 partial responses, 15 stable diseases, and 10 progressions. Median time to progression was 6.2 months (95% CI: 4.6-7.8) and median overall survival was 9.8 months (95% CI: 8.2-11.4). Toxicity was fairly mild. Grade 3 toxicities included neutropenia (8.7%), nausea (4.3%), vomiting (4.3%), diarrhea (2.2%); and grade 4 toxicities occurred in none of the patients. Grades 1-2 peripheral neuropathy was reported in 43.5% of patients. The modified FOLFOX regimen is active, well tolerated as first-line chemotherapy for elderly patients aged above 65 years with AGC.