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目的:探讨奈达铂(NDP)加氟脲苷(FUDR)方案应用于食管癌同步放化疗时的最大耐受剂量(MTD)并观察其毒副反应。方法:共入选13例初治食管鳞癌患者。放射治疗采用常规分割方法,照射剂量为60Gy/30次,6周。同步化疗采用剂量递增方法,起始剂量为NDP 20 mg.m-2,FUDR 300 mg.m-2,d 1用药,以后每周用药1次,共6次。递增剂量为NDP 5 mg.m-2,FUDR 50 mg.m-2。DLT定义为3级或3级以上毒性反应。每剂量组至少5例,如无剂量限制毒性(DLT)出现则进入下一剂量组,直到出现DLT。出现DLT的前一剂量即为MTD。结果:DLT为3级放射性食管炎,发生于NDP 30 mg.m-2,FUDR 400 mg.m-2剂量水平,共有2例患者发生;其前一剂量水平NDP 25 mg.m-2,FUDR 350 mg.m-2即为MTD。主要毒性反应为放射性食管炎、放射性肺炎、厌食、呕吐、白细胞减少、血小板下降和肝功能损害。结论:食管癌同步放化疗奈达铂加氟脲苷每周方案的最大耐受量为NDP 25 mg.m-2,FUDR 350 mg.m-2。
Objective: To investigate the maximum tolerated dose (MTD) of esophageal cancer with concurrent chemoradiotherapy with NDP and FUDR and to observe its toxicity. Methods: A total of 13 patients with newly diagnosed esophageal squamous cell carcinoma were enrolled. Radiotherapy using conventional segmentation method, irradiation dose of 60Gy / 30 times for 6 weeks. Synchronous chemotherapy with dose escalation method, the initial dose of NDP 20 mg.m-2, FUDR 300 mg.m-2, d 1 medication, once a week after treatment, a total of 6 times. Increasing doses of NDP 5 mg.m-2, FUDR 50 mg.m-2. DLT is defined as grade 3 or above toxicity. Each dose group of at least 5 cases, such as no dose-limiting toxicity (DLT) appeared before entering the next dose group until DLT. The first dose of DLT is MTD. Results: DLT was grade 3 radiation esophagitis and occurred in NDP 30 mg.m-2 and FUDR 400 mg.m-2 dose levels, with a total of 2 patients. The former dose level of NDP 25 mg.m-2, FUDR 350 mg.m-2 is MTD. The main toxicities are radiation esophagitis, radiation pneumonitis, anorexia, vomiting, leukopenia, thrombocytopenia and impaired liver function. CONCLUSIONS: The maximum tolerated weekly schedule for esophageal cancer with concurrent chemoradiation NDP and fluorouridine is NDP 25 mg.m-2 and FUDR 350 mg.m-2.