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中华放射肿瘤学杂志
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中华放射肿瘤学杂志  2018, Vol. 27 Issue (6): 559-563    DOI: 10.3760/cma.j.issn.1004-4221.2018.06.005
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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
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摘要 目的 观察放疗联合易瑞沙治疗不能手术且不能行同步放化疗的局部晚期非小细胞肺癌患者的客观有效率、生存和安全性。方法 选取不能手术且不能行同步放化疗的局部晚期NSCLC患者,接受胸部IMRT,同期易瑞沙250 mg 1 次/d。结果 2014—2017年入组30例,可分析29例。疗后1个月疗效评价CR、PR、SD、PD分别0、21、6、2例,疾病控制率(CR+PR+SD)为93%,客观有效率(CR+PR)为72%。中位随访25个月,死亡14例,存活15例;23例患者出现疾病进展,其中局部进展18例,远处转移14例。全组中位生存时间 26个月,中位PFS 11个月,1、2年OS和PFS分别为79%和44%、55%和18%。单因素分析显示吸烟史、分期对OS有影响(P=0.035、0.031),分期、原发灶直径、GTV和PTV对PFS有影响(P=0.000、0.016、0.039、0.030);多因素分析显示分期和PTV体积为PFS的独立预后因素(P=0.000、0.012)。3级急性不良反应共2例,2级急性放射性肺炎7例。结论 对于不能手术且不能行同步放化疗的局部晚期非小细胞肺癌,放疗联合易瑞沙的治疗,客观有效率较高,患者耐受良好,远期疗效有待进一步观察。
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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
关键词 肺肿瘤/调强放射疗法肺肿瘤/分子靶向疗法治疗结果    
AbstractObjective 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.
Key wordsLung neoplasm/intensity-modulated radiotherapy    Lung neoplasm/molecular targeted therapy    Therapeutic outcome   
收稿日期: 2018-01-07     
基金资助:中国老年学学会老年肿瘤专业委员会(CGOS-02-2014-1-1-01500)
通讯作者: 梁军,Email:liang23400@163.com   
引用本文:   
付志雪,杨旭,王文卿等. 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[J]. 中华放射肿瘤学杂志, 2018, 27(6): 559-563.
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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