Outcomes of Modified FOLFOX-6 as First Line Treatment in Patients with Advanced Gastric Cancer in a Single Institution; Retrospective Analysis

Abstract

I n t r o d u c t i o n Increasing early diagnosis of gastric cancer has improved the survival rate. However, the prognosis for recurrent or unresectable gastric cancer remains poor. Various chemotherapy regimens have been developed for advanced gastric cancer patients based on the understanding that chemotherapy can increase the length and quality of life (1). However, only 10% of patients treated with chemotherapy survive for longer than 2 years (2). The older-generation 5-fluorouracil (FU) and cisplatin-based combination regimens have proven unsatisfactory, with a response rate of only 11% to 20%, and a median survival time ranging between 6 and 8 months (3,4). In recent randomized trials of a new-generation regimen with oral 5-FU and irinotecan, the overall response rate ranged from 25% to 41% (5,6). However, there remains no standard chemotherapeutic regimen for advanced gastric cancer due to concerns of chemotherapy-induced toxicity and inconsistent treatment responses. Oxaliplatin, a new-generation alkylating agent that inhibits DNA Purpose Treatment options for patients with advanced gastric cancer remain limited. Few studies have investigated the efficacy and tolerability of the combination regimen of oxaliplatin and 5-fluorouracil with leucovorin for patients with advanced gastric cancer. The goal of this study was to examine the efficacy and toxicity of a modified FOLFOX-6 (mFOLFOX-6) regimen as a first-line chemotherapy regimen for patients with advanced gastric cancer. Materials and Methods From March, 2006, to December, 2007, 82 patients with advanced gastric cancer received 100 mg/m 2 oxaliplatin and 100 mg/m 2 leucovorin on the first day of treatment, followed by 2,400 mg/m 2 of 5-fluorouracil on the first and second days of treatment every 2 weeks as a first-line treatment. Results The median age of the enrolled patients was 62 years (range; 30�75). Out of 82 patients, 34 cases (41.5%) were recurrent cases after curative resection, and the other 48 cases were unresectable or non-curative resectable cases. Their response was evaluated every 6 weeks. The overall response rate was 40.2%, with 2 (2.4%) complete response and 31 (37.8%) partial responses. The median time to progression (TTP) and overall survival (OS) time were 6.0 months (95% confidence interval [CI]: 4.69�7.31) and 13.0 months (7.99�18.0), respectively. The grade 3�4 hematologic toxicities observed included neutropenia (34.1%), thrombocytopenia (7.3%), and anemia (1.2%). The gastrointestinal toxicities observed included grade 3�4 nausea (9.8%) and vomiting (7.3%). Six patients (7.3%) experienced grade 3 neuropathy. No treatment-related deaths were recorded. Conclusion The modified FOLFOX-6 regimen is effective and well tolerated as a first-line chemotherapy regimen for patients with advanced gastric cancer.