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背景与目的:同期放化疗治疗中晚期食管癌已成为推荐的标准疗法,但局部失控率仍达44%～54%。本研究应用新型放射增敏剂希美纳(甘氨双唑钠,sodium glyci-didazole,CM-Na)联合同期放化疗治疗中晚期食管癌,探讨联合方案中希美纳的最大耐受剂量(m axim um tolerance dose,M TD),为Ⅱ期临床试验推荐使用剂量。方法:22例经病理确诊的中晚期食管鳞癌患者按入组标准进入本研究。希美纳剂量按改良Fibonacci法以400m g·(m2·d)-1作为起始剂量,逐级递增至600m g·(m2·d)-1、700m g·(m2·d)-1、800m g·(m2·d)-1。入组患者依次进入4个等级剂量组,每组不少于3例。4组采用相同的同期放化疗方案:常规连续放疗程式,6周放疗总量为60Gy;放疗1、5周分别予5-FU500m g·(m2·d)-1+DDP20m g·(m2·d)-1静脉滴注,连续5天,每天1次。每周1、3、5放疗前1h予希美纳静脉滴注。结果:在非血液系统毒性方面,4个剂量组均未发现神经系统毒性、心脏毒性和肾毒性,但化疗期间伴轻度胃肠道不良反应;800m g·(m2·d)-1组2例出现Ⅲ度放射性食管炎,2例出现Ⅳ度血清转氨酶升高。血液系统毒性方面,800m g·(m2·d)-1组1例出现Ⅲ度血小板减少,余为Ⅲ度以下。根据肿瘤缓解评价标准,治疗结束时,CR27%(6/22),PR68%(15/22),SD5%(1/22);治疗结束后1个?
BACKGROUND & OBJECTIVE: Radiotherapy and chemotherapy combined with concurrent esophageal cancer has become the recommended standard therapy, but the local out-of-control rate still reaches 44% -54%. In this study, a new radiosensitizer, simethrine (sodium glyci-didazole, CM-Na) combined with concurrent chemoradiotherapy for advanced esophageal cancer was used in this study to explore the maximum tolerated dose (m axim um tolerance dose, M TD), recommended for the phase Ⅱ clinical trial dose. Methods: Twenty-two patients with advanced esophageal squamous cell carcinoma confirmed by pathology were enrolled in this study according to the standard of intervention group. According to the modified Fibonacci method, the dose of simelane was increased from 400m g · (m2 · d) -1 to 600m g · (m2 · d) -1,700m g · (m2 · d) -1,800m g · (m2 · d) -1. Patients entered the group followed by 4 levels dose group, each group of not less than 3 cases. The same concurrent chemoradiotherapy regimen was used in the four groups: conventional continuous radiotherapy, the total amount of 6 weeks radiotherapy was 60Gy; radiotherapy for 1,5 weeks were given to 5-FU 500m g · (m2 · d) -1 + DDP20m g · (m2 · d ) -1 intravenous infusion for 5 consecutive days, 1 day. 1, 3, 5 weekly radiotherapy before Shimei Na intravenous infusion. Results: No neurotoxicity, cardiotoxicity and nephrotoxicity were found in the four dose groups in the non-hematological toxicity group, but mild gastrointestinal adverse reactions were observed during the chemotherapy. In the 800 m g · (m2 · d) -1 group 2 Ⅲ cases of radiation esophagitis occurred, 2 cases of Ⅳ degree serum aminotransferase increased. In the aspect of hematological toxicity, one case had a degree III thrombocytopenia in 800 m g · (m 2 · d) -1 group, and the remaining degree was below Ⅲ degree. According to the tumor remission evaluation criteria, CR27% (6/22), PR68% (15/22) and SD5% (1/22) at the end of treatment;