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目的确定同期放化疗食管癌时顺铂(PDD)和氟尿嘧啶(5-Fu)方案的中国人最大耐受量(MTD)并观察其毒副反应。方法15例初治食管癌患者成为研究对象。全程常规分割照射,总剂量60 Gy分30次。同期化疗采用改良Fibonacci法,从低剂量逐渐上升到高剂量,起始剂量为PDD 37.5 mg/m~2第1天,5-Fu 500 mg/m~2第1~5天,28 d为1个周期,共4个周期。递增剂量为PDD 7.5mg/m~2,5-Fu 100mg/m~2,每剂量组至少3例,如无剂量限制毒性(DLT)出现则进入下一剂量组,直至出现DLT,DLT的次一剂量即为MTD。结果DLT为3级放射性食管炎,发生于PDD 60 mg/m~2,5-Fu 700 mg/m~2剂量水平;则其次一剂量PDD 52.5 mg/m~2,5-Fu 700 mg/m~2即为MTD。主要毒副反应为放射性食管炎、白细胞减少、恶心呕吐和厌食。结论同期放化疗食管癌PF方案的中国人最大耐受量为PDD 52.5mg/m~2第1天,5-Fu 700 mg/m~2第1~5天,28 d为1个周期,共4个周期。
Objective To determine the maximum tolerated dose (MTD) of Chinese people in cisplatin (PDD) and fluorouracil (5-Fu) regimens in the same period of radiotherapy and chemotherapy and to observe the side effects. Methods 15 cases of newly diagnosed esophageal cancer patients become the research object. The whole routine split irradiation, the total dose of 60 Gy points 30 times. During the same period of chemotherapy, the improved Fibonacci method was used to gradually increase from low dose to high dose. The initial dose of PDD was 37.5 mg / m ~ 2 on the first day, 5-Fu 500 mg / m ~ 2 on the first day, 1 cycle, a total of 4 cycles. Increasing dose of PDD 7.5mg / m ~ 2,5-Fu 100mg / m ~ 2, at least 3 per dose group, if no dose-limiting toxicity (DLT) appeared then enter the next dose group until DLT, DLT The second dose is the MTD. Results DLT was grade 3 esophagitis, which occurred at dose levels of PDD 60 mg / m ~ 2,5-Fu 700 mg / m ~ 2, followed by a dose of PDD 52.5 mg / m ~ 2,5-Fu 700 mg / m ~ 2 is the MTD. The main side effects of radiation esophagitis, leukopenia, nausea and vomiting and anorexia. Conclusions The maximal tolerability of Chinese patients receiving radiotherapy and chemotherapy for esophageal cancer with PF was 52.5 mg / m 2 on the first day, 5-Fu 700 mg / m 2 on the first day, and 28 days was on the first day. A total of 4 cycles.