Objective: Since 2007, S-1 plus cisplatin therapy has been recognized as the standard first-line treatment for advanced gastric cancer in Japan. However, no standard regimen has been established for patients refractory to first-line treatment. Furthermore, irinotecan and paclitaxel are considered key drugs for second-line treatment. Several studies have investigated the efficacy and tolerability of combination therapy with oxaliplatin, 5-fluorouracil and leucovorin (modified FOLFOX-6) for advanced gastric cancer. Here, we examined the efficacy and toxicity of modified FOLFOX-6 therapy in heavily pretreated patients with advanced gastric cancer refractory to 5-fluorouracil, irinotecan, cisplatin and taxanes.
Methods: Fourteen patients with advanced gastric cancer refractory to 5-fluorouracil, irinotecan, cisplatin and taxanes were included in the study. In modified FOLFOX-6 therapy, 85 mg/m(2) oxaliplatin, 400 mg/m(2) 5-fluorouracil and 200 mg/m(2) leucovorin on Day 1 were administered biweekly by intravenous infusion, followed by the administration of 2400 mg/m(2) 5-fluorouracil by a 46-h continuous infusion.
Results: The median age of the patients was 59 years (range, 22-74). A median of 5.5 (range, 1-13) chemotherapy cycles were administered. The overall response rate was 23.1% in patients with measurable lesions. Of the 12 patients with advanced gastric cancer refractory to cisplatin, 2 showed partial response (response rate, 18.2%). The progression-free survival was 90 days, and the median survival time from the initiation of modified FOLFOX-6 therapy was 268 days. Grade 3-4 toxicities most commonly observed included neutropenia (57%), anaemia (14%), thrombocytopenia (21%) and hyperammonaemia (7%).
Conclusions: Modified FOLFOX-6 therapy in patients refractory to 5-fluorouracil, irinotecan, cisplatin and taxanes may be a potential advanced gastric cancer therapeutic strategy.