期刊
JAPANESE JOURNAL OF CLINICAL ONCOLOGY
卷 43, 期 10, 页码 972-980出版社
OXFORD UNIV PRESS
DOI: 10.1093/jjco/hyt114
关键词
Phase III study; chemotherapy; gastric cancer; peritoneal metastasis
类别
资金
- National Cancer Center Research and Development Fund [23A-16, 23A-19]
- Health and Labor Sciences Research Grants for Clinical Cancer Research from the Ministry of Health, Labour and Welfare of Japan [14-Gan-36, 17-Gan-008, 20-Gan-008]
- [11S-3]
- [11S-4]
- [14S-3]
- [14S-4]
- [17S-3]
- [17S-5]
- [20S-3]
- [20S-6]
Owing to the risks of serious and sustained toxicity, anticancer drugs such as cisplatin and irinotecan cannot be readily administered to patients with gastric cancer and severe peritoneal metastasis. Therefore, a standard chemotherapy regimen has yet to be established for these types of patients. This randomized study investigated the utility of sequential methotrexate and 5-fluorouracil therapy vs. 5-fluorouracil continuous infusion for gastric cancer with peritoneal metastasis. Eligible patients had radiologically confirmed peritoneal metastasis with intestinal stenosis, peritoneal tumor or ascites. Treatment with 5-fluorouracil continuous infusion (800 mg/m(2)/day, ci, d1-5, q4w) or methotrexate and 5-fluorouracil therapy (methotrexate, 100 mg/m(2), bolus infusion, followed 3 h later by 5-fluorouracil, 600 mg/m(2), bolus infusion, with leucovorin rescue, q1w) was continued until disease progression or unacceptable toxicity. The projected sample size was 236, providing 80 power to detect a 40 increase in median overall survival in methotrexate and 5-fluorouracil therapy with a one-sided of 0.05. All 237 randomized patients were included in the primary analysis. The methotrexate and 5-fluorouracil therapy arm was not superior to the 5-fluorouracil continuous infusion arm (median survival time, 9.4 months in the 5-fluorouracil continuous infusion arm, 10.6 months in the methotrexate and 5-fluorouracil therapy arm; hazard ratio, 0.94; 95 confidence interval, 0.721.22; one-sided P 0.31). Frequencies of Grade 3 or higher neutropenia, Grade 3 or higher anorexia and treatment-related deaths were 0.9, 27.4 and 1.7, respectively, in the 5-fluorouracil continuous infusion arm, and 31.9, 33.6 and 0.9, respectively, in the methotrexate and 5-fluorouracil therapy arm. Methotrexate and 5-fluorouracil therapy is not suitable for use as standard therapy for advanced gastric cancer with peritoneal metastasis.
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