食管癌后程加速超分割调强适形放疗及联用尼妥珠单抗的研究

目的 比较食管癌后程加速超分割调强适形放疗和后程加速超分割调强适形放疗联用尼妥珠单抗的疗效与毒性.方法 64例无远处转移的初治、评估认为无法耐受同步放化疗的食管鳞状细胞癌患者随机分组,32例行后程加速超分割调强适形放疗（后超调强组）：先行放疗41.4 Gy/23次,共5周,后行放疗27 Gy/18次,共2周;32例行后程加速超分割调强适形联合尼妥珠单抗治疗（联合组）：放射治疗方法同后超调强组,在放射治疗的开始时同期均加用6～8周的尼妥珠单抗（200 mg,静脉滴注,1次/周,共6～8周）,从放疗第1天起执行.观察指标主要包括食管和肺的近期急性反应和后期放射损伤、过敏等不良反应以及临床受益率、1～3年局控率、无瘤生存率、总体生存率等.结果 后超调强组和联合组患者在放射性食管炎、放射性肺炎、骨髓抑制、消化道反应、皮疹、过敏等不良反应的发生方面差异无统计学意义（P＞0.05）.晚期并发症主要表现为食管狭窄和肺纤维化,两组比较差异无统计学意义（P＞0.05）.联合组有1例患者出现过敏性休克后放弃治疗.后超调强组和联合组患者临床受益率分别为75.0％（24/32）、93.7％（30/32）,两组差异有统计学意义（P＜0.05）.联合组总生存率和无瘤生存率均高于后超调强组,但差异无统计学意义（P＞0.05）.结论 后程加速超分割调强适形放疗联合尼妥珠单抗治疗食管癌临床受益率明显高于后超调强组,但无瘤生存率和总体生存率的差别无统计学意义;后程加速超分割调强适形放疗联合尼妥珠单抗治疗食管癌未明显增加不良反应,部分可能出现过敏反应,应注意预防和加强处理.

Clinical study on late course accelerated hyperfractionated intensity modulated radiation therapy plus nimotuzumab for esophageal carcinoma

Objective To compare the treatment result and the toxicity between the late course accelerated hyperfractionated intensity modulated radiation therapy （LCAF） and LCAF plus nimotuzumab for esophageal carcinoma.Methods 64 patients with esophageal squamous cell carcinoma without distance relapse and cannot tolerate the concurrent chemoradiotherapy were randomized into two groups.32 patients in group of LCAF received the first stage of radiation with a dose of 41.4 Gy/23 f/5 weeks,and then received the second stage of radiation with a dose of 27 Gy/18 f/2 weeks.32 patients in group of combination were treated by the same way plus nimotuzumab.The toxicity,the late reaction,the response rate,local control rate,distant-metastasis-free survivalrate and total survivalrate were compared between the two groups.Results The incidence of toxicity including radiation esophagitis,radiation pneumonitis,myelosuppression,gastrointestinal reaction,tetter and allergy showed no significant difference between group LCAF and group combination （P 〉 0.05）.The incidence of late complications as esophagostenosis and lung fibrosis have no significance between group LCAF and group combination （P 〉 0.05）.One patient in group of combination appeared anaphylactic shock and gave up the treatment.The response rate in group of combination was significant improved compared with group of LCAF （75.0 % vs 93.7 %,P 〈 0.05）.The over survival rate and the distant-metastasis-fiee survival rate in group of combination were higher than those in group of LCAF,but showed no statistical significance （P 〉 0.05）.Conclusions Most patients of esophageal carcinoma have good tolerance of LCAF plus nimotuzumab.Anaphylactic reaction maybe appear while accepting nimotuzumab which need be mentioned.The over survival rate and the distant-metastasis-free survival rate of LCAF plus nimotuzumab are advantage,but has no statistical significance,LCAF combined with nimotuzmab has a higher clinical benefit.