爱必妥联合同期放化疗治疗局部晚期鼻咽癌的研究临床观察

发布时间：2018-05-30 05:18

  本文选题：爱必妥 + 鼻咽癌　； 参考：《广西医科大学》2010年硕士论文

【摘要】： 目的：评价爱必妥联合同期放化疗治疗局部晚期鼻咽癌的近期临床疗效及安全性。 方法和材料：本次研究承担了由中山大学肿瘤医院牵头的爱必妥联合同期放化疗治疗鼻咽癌的开放性、单组Ⅱ期多中心临床研究(A phase II study of cetuximab (Erbitux(?)) in NPC with ChemoRadiothErapy, ENCORE)的其中部分研究。多中心研究纳入局部晚期鼻咽癌(Ⅲ～Ⅳb, UICC/AJCC,2002,6~(th))病人100例,采用统一标准对所有病人予以同期放化疗／西妥昔单抗。本研究选取9例(多中心实验病人7例,非多中心实验病人2例)符合ENCORE研究纳入标准的经病理确诊的初治局部晚期鼻咽癌患者进入实验组,给予同期放化疗／爱比妥治疗,同期选取临床资料具有可比性并且接受同样放化疗方案的21例患者进入对照组。实验组予以同期顺铂80mg／m2,每3周1次,爱必妥第一周400 mg／m2,其后每周250 mg／m2,直至放疗结束,并给予调强放疗(intensity modulated radiotherapy,IMRT)(GTVnx、GTVnd、CTV1、CTV2处方剂量分别为66～75.9、66～70、64、54 Gy,1次／天,5天／周,共6～7周完成)。鼻咽和上颈部靶体积采用IMRT技术照射,下颈部靶体积采用下颈前野常规照射。对照组予的同步放化疗方案同实验组。治疗相关不良反应按照NCI常见不良反应标准第3版(Common Terminology Criteria for Adverse Events,CTCAE V3.0)分级评价。疗效按照实体瘤疗效反应评价标准(Response Evaluation Criteria In Solid Tumors, RECIST)进行评估。 结果： 疗效：两组病人的治疗后3月的局部控制率均为100%,实验组和对照组的1年无远处转移生存率分别为(5／7)71.4%、(18／21)85.7%,差异没有统计学意义(P=0.367)；多中心研究结果显示：全组病人治疗结束后3月局部控制率为99%。 急性毒性反应：除了黏膜反应、痤疮样皮疹外,大部分急性毒性反应均在1-2度,很少出现3度急性毒性反应,实验组和对照组的急性毒性反应比较没有明显差异(P0.05)。多中心研究结果显示：爱必妥配合同步放化疗治疗局部晚期鼻咽癌,患者耐受性好,不良反应较轻,没有4级不良反应。 结论： (1)爱比妥配合同步放化疗近期疗效显著,其长期疗效有待观察。 (2)爱必妥配合同期放化疗治疗局部晚期鼻咽癌安全性较好,病人可以耐受。
[Abstract]:Objective: To evaluate the short-term efficacy and safety of IBI in combination with concurrent chemoradiotherapy in the treatment of locally advanced nasopharyngeal carcinoma.
Methods and materials: This study took part in the partial study of the A phase II study of cetuximab (Erbitux (Erbitux (?)) in NPC with ChemoRadiothErapy, ENCORE), which was led by the Cancer Hospital of the Cancer Hospital of the Zhongshan University, in partial study of the in NPC with ChemoRadiothErapy, ENCORE). 100 patients with advanced nasopharyngeal carcinoma (III ~ IV B, UICC/AJCC, 2002,6~ (th)) were treated with the same standard for concurrent chemoradiotherapy and cetuximab. This study selected 9 cases (7 cases of multi center experimental patients and 2 cases of non multicenter experimental patients), which were in conformity with the standard of ENCORE study for the primary locally advanced nasopharyngeal carcinoma patients. In the experimental group, 21 cases of cisplatin (cisplatin 80mg / m2, 1 times per 3 weeks, 400 mg / m2 per week, 250 mg / m2 per week) were given at the same time with the comparison of clinical data and the same chemotherapy regimen. The dosage of intensity modulated radiotherapy, IMRT) (GTVnx, GTVnd, CTV1, CTV2 was 66 ~ 75.9,66 ~ 70,64,54 Gy, 1 times / day, 5 days / week, for a total of 6~7 weeks). The target volume of the nasopharynx and upper neck was irradiated with IMRT technique and the lower neck target volume was routinely irradiated in the lower neck field. The synchronous radiotherapy and chemotherapy regimen given in the control group was the same as the experimental group. The treatment related adverse reactions were graded according to the standard third version of the common NCI adverse reaction standard (Common Terminology Criteria for Adverse Events, CTCAE V3.0). The curative effect was evaluated according to the evaluation criteria of the response to solid tumor response (Response Evaluation Criteria).
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