食管癌术后复发患者调强放疗同步化疗(5-Fu+奈达铂)的Ⅱ期临床研究  

Phase Ⅱ Study of Intensity-Modulated Radiotherapy Combined with 5-Fluorouracil and Nedaplatin Chemotherapy in Recurrent Esophageal Carcinoma after Curative Operation

作　　者：陶华[1] 孔诚[1] 陆进成[1] 

机构地区：[1]江苏省肿瘤医院放疗科,南京210009

出　　处：《肿瘤防治研究》2012年第10期1261-1264,共4页Cancer Research on Prevention and Treatment

基　　金：江苏省肿瘤医院中青年基金资助项目(ZQ200903)

摘　　要：目的评价食管癌根治术后复发患者调强放疗同步化疗(5-Fu+奈达铂)的近期疗效和不良反应。方法选取2009年6月—2010年6月44例符合入组条件的食管癌术后复发患者,均采用调强放疗同步化疗(5-Fu+奈达铂)方案进行治疗。调强放疗:GTV给量60 Gy/30f,2.0Gy/f;CTV给量54 Gy/30f,1.8Gy/f。同步化疗在放疗的第1周和第4周进行,具体为:5-Fu 750 mg/(m2.d),d1～5,奈达铂80 mg/(m2.d),d1。主要观察终点是1年生存率,次要观察终点是不良反应。结果全组总有效率为86%(38/44)。1年和2年总生存率分别为72.7%和60%。1年和2年无进展生存率分别为63.6%和36.6%。放化疗期间出现Ⅰ、Ⅱ和Ⅲ度骨髓抑制的患者分别为16%(7/44)、50%(22/44)和34%(15/44);出现Ⅰ度和Ⅱ度胃肠道反应的患者分别为45%(20/44)、55%(24/44);出现Ⅰ度和Ⅱ度肝/肾功能生化指标异常的患者分别为77%(34/44)、23%(10/44),未发现Ⅲ度及以上胃肠道及肝/肾功能生化指标异常者。所有不良反应经对症处理后均好转,全组患者均顺利完成放化疗计划,无疗程中断或延迟者。结论食管癌根治术后复发患者进行调强放疗同步化疗(5-Fu+奈达铂)的近期疗效好,不良反应小,值得进行Ⅲ期临床研究。Objective To analyze the feasibility and safety of postoperative recurrent esophageal carcinoma patients treated by intensity-modulated radiotherapy combined with 5-Fluorouracil（5-Fu） and nedaplatin chemo- therapy. Methods Forty four esophageal carcinoma patients suffered recurrence after their definitive resection in our department from June 2009 to June 2010. Intensity-modulated radiotherapy combined with 5-Fu and nedaplatin chemotherapy was performed in the patients（gross tumor volume, GTV） of IMRT was prescribed to 60 Gy/ 30f,2.0 Gy/f and 5-Fu and nedaplatin concurrent chemotherapy was used by 5 Fu 750 mg/（m2 - d） ,dl 5,nedaplatin 811 mg/（m2 . d）,dl at week 1 and week 4. The primary endpoint was 1-year survival rate and the second endpoint was toxicity related to the treatment. Results The overall response rate （CR ＋ PR） was 86% （38/44）. 1- and 2 year overall survival rate was 72.7% and 60%, respectively. 1 and 2- year progression free survival rate was 63. 6% and 36. 6%, respectively. Univariate analysis outcome showed that only recurrent site was related with prognosis （X2 = 22. 848, P = 11. 000）. All the patients undergone this treatment smoothly. Grade I , II and III leukocytopenia was observed in 16% （7/44）,5（1% （22/44）, and 34 % （15/44） patients, respectively. Grade l, and II digestive tract toxicity was observed in 45% （20/44）,55% （24/44） patients,respectively. Grade I ,and II liver/renal toxicity was observed in 77 % （34/44）, and 23 % （ 10/44） patients, respectively. Over grade 3 digestive tract and liver/renal toxici ty were not found. All the toxicities were gone after corresponding therapy. Conclusion Concurrent chemotherapy with 5 Fu and nedaplatin plus intensity-modulated radiotherapy is an effective and feasible regimen and would be considered as a better option for postoperative recurrent esophageal carcinoma patients,which could be deserved to be applied to phase III clinical trial.

关 键 词：食管癌 复发 放疗 化疗 

分 类 号：R735.1[医药卫生—肿瘤]