Phase II study of oxaliplatin, UFT, and leucovorin in patients with metastatic gastric cancer
2010
Siemerink, Ester J. M | Drenth, Annemieke F. J | Mulder, Nanno H | Plukker, John T. M | Hospers, Geke A. P
Background The present study evaluated the efficacy and safety of oxaliplatin, UFT, and leucovorin in metastatic gastric cancer. Methods Patients received intravenous oxaliplatin 130 mg/m² on day 1, followed by oral UFT capsules (350 mg/m² per day) and leucovorin tablets (90 mg/day), every 8 h, for 14 days, in a 3-week cycle. Results Twenty-three patients (61% with ≥2 metastatic sites), median age of 60 years (range, 39-69 years) were entered. Based on intention-to-treat analysis, one complete response and seven partial responses were found, resulting in an overall response rate (RR) of 35% (95% confidence interval [CI], 16-54), a median time to progression of 4 months (95% CI, 0.5-7.5), and a median overall survival (OS) of 8 months (95% CI, 4.5-11.5). The 1-year survival rate was 26%. Three patients did not complete the first course of 2 weeks; 1 died suddenly on day 16 with fatal lung embolism; 1 had rapid progressive disease and 1 experienced gastric hemorrhage on day 15 — both these patients withdrew. In the 20 patients assessable for toxicity no grade 4 toxicity occurred, grade 3 toxicity consisted of anemia in 1, diarrhea in 2, and neurotoxicity in 3 patients. No hand-foot syndrome (HFS) occurred. Conclusion Oxaliplatin is an effective drug in gastric cancer, but, as previously reported, its feasibility in combination with capecitabine is hampered due to combined hand-foot-based toxicity. The present phase II study of a combination of oxaliplatin with UFT and leucovorin appears to have efficacy and tolerability comparable to two other drug regimens used in gastric cancer, without the HFS problem.
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