Adjuvant FOLFOX-4 in patients with radically resected gastric cancer: tolerability, and prognostic factors.

Purpose: To evaluate the toxicity and efficacy of the FOLFOX-4 regimen as adjuvant chemotherapy in patients with gastric cancer after radical surgery. Methods: Fifty-four patients (1 stage Ib, 6 stage II, 22 stage IIIa, 14 stage IIIb and 11 stage IV) received 8-12 cycles of FOLFOX-4 (oxaliplatin 85 mg/m2, day 1; leucovorin 100 mg/m2 i.v. days 1 and 2; 5fluorouracil 400 mg /m2 i.v. bolus days 1 and 2, and 600 mg /m2 in 22 hours i.v. continuous infusion days 1 and 2; every 14 days). Toxicity was recorded at each cycle according to the National Cancer Institute Common Toxicity Criteria. Disease-free (DFS) and overall survival (OS) were calculated according to the Kaplan-Meier method. Results: Thirty-eight patients (70.4%) completed the prescribed number of cycles of chemotherapy. The toxicity was mild. Grade 3-4 neutropenia occurred in 57% of patients, thrombocytopenia and anemia in 2% of cases. Peripheral neuropathy was experienced by 46% of patients (grade 4 in 2% of cases). Five patients experienced grade 3 gastrointestinal toxicity. After a median follow up of 33.1 months, 17 patients relapsed and 17 deceased. The mean observed DFS and OS were 49.7 (range 40.7-58.8) and 57.9 (range 49.6-66.2) months, respectively. At univariate analysis, females and patients who had received < 8 cycles of chemotherapy had a significantly worse probability of DFS and OS. The Cox model showed gender to be independent factors affecting DFS. Conclusions: Adjuvant FOLFOX-4 is feasible and well tolerated in patients radically resected for gastric cancer. Receiving < 4 months of adjuvant FOLFOX-4 could be detrimental for prognosis.