Pemetrexed in combination with oxaliplatin as a first-line therapy for advanced gastric cancer: a multi-institutional phase II study.

This clinical trial assessed the efficacy of pemetrexed combined with oxaliplatin (PEMOX) in patients with advanced gastric cancer (AGC).Forty-four patients with untreated AGC were enrolled to evaluate response rate (RR). Patients received pemetrexed (500 mg/m(2)) with vitamin supplementation and oxaliplatin (120 mg/m(2)) every 21 days for six cycles or until disease progression occurred.Median age was 62 years (range 26-76). The majority of patients (93\%) had metastatic disease. Sixteen of the 44 patients achieved confirmed response [RR 36\%; 95\% confidence interval (CI) 22\% to 52\%]; four complete responses and 12 partial responses (complete and partial responses according to the RECIST guidelines are the confirmed-responses observed in the study population). Median time to tumor progression (TTP) was 6.2 months (95\% CI 4.3-7.5) and median survival was 10.8 months (95\% CI 7.7-17.2). A total of 220 cycles were administered, with a median of six cycles. Most common grade 3/4 toxic effects were neutropenia in 41\% of patients (19\% of cycles) and thrombocytopenia in 11\% of patients (4\% of cycles). Treatment delays or dose reductions for toxicity occurred in 10\% and 5\% of cycles, respectively.PEMOX is active and well tolerated in AGC. RR, TTP, and survival were comparable to those achieved in studies using different 5-fluorouracil (5-FU)-oxaliplatin combinations, without the inconvenience of prolonged 5-FU schedules.