Adjuvant chemoradiation for gastric cancer with infusional 5-fluorouracil and cisplatin: a phase I study

[摘要] ObjectiveThis phase I study aimed to determine the maximal tolerated dose of cisplatin administered every 2 weeks with infusional 5-fluorouracil (5FU) and concurrent radiation therapy (RT) in patients after complete resec­tion of gastric adenocarcinoma. MethodsPatients with resected stage IB to IV (M0) gastric adenocarcinoma were treated with 12 weeks of in­fusional 5FU (200 mg/m 2daily) and with RT (45 Gy in 25 fractions starting on day 16). Cisplatin was administered in escalating doses (0, 20, 30, and 40 mg/m 2 ) in weeks 1, 3, 5, and 7. In the final co­hort, patients received an additional dose of cisplatin (40 mg/m 2 ) in week 9. ResultsAmong the 34 patients [median age: 56 years (range: 31-77 years)] who were assessable for toxicity, 5 ex­perienced dose-limiting toxicities: 1 sepsis (cohort 1), 1 fatigue (cohort 2), 3 upper gastrointestinal toxicity (1 in cohort 2, 2 in cohort 5). Cohort 5 exceeded the maximal tolerated dose. Median follow-up was 2.5 years (range: 0.3-5 years). The 3-year overall and relapse-free survival rates were 86% and 71% respectively; median survival was not reached. ConclusionsCisplatin was well tolerated in combination with in­fusional 5FU and RT, showing promising activity in the adjuvant treatment of gastric cancer. Infusional 5FU 200 mg/m 2daily for 12 weeks with cisplatin 40 mg/m 2in weeks 1, 3, 5, and 7 and with concurrent RT 45 Gy in 25 fractions, starting at day 16, is being explored in a phase II study at our institution.

[学科分类] 肿瘤学