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IMRT联合易瑞沙对不能手术不能同步放化疗局部晚期NSCLCⅡ期临床研究初步结果
付志雪, 杨旭, 王文卿, 邓垒, 张涛, 毕楠, 王小震, 陈东福, 周宗玫, 王绿化, 梁军
100021 北京,国家癌症中心/中国医学科学院北京协和医学院肿瘤医院放疗科
IMRT combined with Iressa for patients with locally advanced non-small cell lung cancer unsuitable for surgery or concurrent chemoradiotherapy:the preliminary results of a phase Ⅱ clinical trial
Fu Zhixue, Yang Xu, Wang Wenqing, Deng Lei, Zhang Tao, Bi Nan, Wang Xiaozhen, Chen Dongfu, Zhou Zongmei, Wang Luhua, Liang Jun
Department of Radiation Oncology,National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 10021,China
Abstract：Objective To observe the objective response rate,survival and safety of radiotherapy combined with Iressa for patients with locally advanced non-small cell lung cancer (NSCLC) unsuitable for surgery or concurrent chemoradiotherapy. Methods The patients with locally advanced NSCLC unsuitable for surgery or concurrent chemoradiotherapy were recruited and received thoracic intensity-modulated radiotherapy (IMRT) combined with Iressa 250 mg daily. Results A total of 30 patients were enrolled between July 2014 and March 2017. Twenty-nine patients were analyzed. At 1 month after radiotherapy,the complete response (CR) was 0,partial response (PR) was 21(72%),stable disease (SD) was 6(21%),progressive disease (PD) was 2(7%),the disease control rate (CR+PR+SD) was 93%,and the objective response rate was 72%. The median follow-up time was 25 months. Fourteen (48%) patients died,and 15(52%) survived. Twenty-three (79%) patients obtained PD including local progression in 18(62%) and distant metastasis in 14(48%). The median survival time (MST) was 26 months and the median PFS was 11 months. The 1-year OS and PFS were 79% and 44%,and the 2-year OS and PFS were 55% and 18%. Univariate analysis demonstrated that smoking history and disease stage were influencing factors for OS (P=0.035,0.031). Moreover,disease stage,the primary tumor diameter,the volume of GTV and PTV were influencing factors for PFS (P=0.000,0.016,0.039,0.030). Multivariable analysis revealed that disease stage and the volume of PTV were independent prognostic factors for PFS (P=0.000,0.012).Two patients (7%) developed grade 3 acute adverse events and 7(24%) experienced grade 2 acute irradiation pneumonitis. Conclusions For patients with locally advanced NSCLC unsuitable for surgery or concurrent chemoradiotherapy,IMRT combined with Iressa yields high objective response rate and well tolerance. The long-term clinical efficacy remains to be validated.
Fu Zhixue,Yang Xu,Wang Wenqing et al. IMRT combined with Iressa for patients with locally advanced non-small cell lung cancer unsuitable for surgery or concurrent chemoradiotherapy:the preliminary results of a phase Ⅱ clinical trial[J]. Chinese Journal of Radiation Oncology, 2018, 27(6): 559-563.
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2018, Vol. 27 
