Abstract
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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Siemerink, E.J.M., Drenth, A.F.J., Mulder, N.H. et al. Phase II study of oxaliplatin, UFT, and leucovorin in patients with metastatic gastric cancer. Gastric Cancer 13, 95–100 (2010). https://doi.org/10.1007/s10120-010-0545-4
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DOI: https://doi.org/10.1007/s10120-010-0545-4