局限期小细胞肺癌胸部放疗靶区的前瞻性随机对照研究  

Final report of a prospective randomized study on thoracic radiotherapy target volumes for limited- stage small cell lung cancer

作　　者：胡晓[1] 包勇 徐裕金[1] 张力[4] 王谨[1] 马红莲[1] 金莹[2] 徐晓玲[2] 宋正波[2] 彭芳[3] 唐华容[1] 方敏[1] 孔月[1] 陈梦圆[1] 董百强[1] 余新民[2] 卢红阳[2] 张沂平[2] 范云[2] 陈明[1] Hu Xiao;Bao Yong;Xu Yujin;Zhang Li;Wang Jin;Ma Honglian;Jin Ying;Xu Xiaoling;Song Zhengbo;Peng Fang;Tang Huarong;Fang Min;Kong Yue;Chert Mengyuan;Dong Baiqiang;Yu Xinmin;Lu Hongyang;Zhang Yiping;Fan Yun;Chen Ming(Department of Radiation Oncology ,Department of Medical Oncology ,Zhejiang Cancer Hospital,Zhejiang Provincial Key Laboratory of Radiation Oncology,Hangzhou 310022,China;Department of Radiation Oncology,First Affiliated Hospital of Sun Yat-sen University,Guangzhou 510060,China;Department of Medical Oncology,Cancer Center of Sun Yat-sen University,Guangzhou 510060,China)

机构地区：[1]浙江省肿瘤医院放疗科/浙江省放射肿瘤学重点实验室,杭州310022 [2]浙江省肿瘤医院放疗科/浙江省放射肿瘤学化疗科,杭州310022 [3]中山大学附属第一医院放疗科,广州510060 [4]中山大学肿瘤防治中心化疗科,广州510060

出　　处：《中华放射肿瘤学杂志》2018年第12期1046-1050,共5页Chinese Journal of Radiation Oncology

基　　金：国家自然科学基金(81402540、81401911、81672972);国家卫生计生委科学研究基金-浙江省医药卫生重大科技计划(省部共建计划)项目(WKI-ZJ-1701)。

摘　　要：目的 通过开展前瞻性随机对照研究探讨局限期小细胞肺癌( SCLC)胸部不同放疗靶区对预后的影响.方法 选取2002-2017年中山大学肿瘤医院及浙江省肿瘤医院收治的接受2程EP方案诱导化疗后无疾病进展的309例局限期 SCLC 患者.随机分为照射化疗后残留肿瘤组(159例)和照射化疗前原发病灶组(150例). 2个组患者均采用累及野照射纵隔阳性淋巴结的完整结区.胸部放疗采用45 Gy分30次3周完成,2 次/d,与第3程EP方案化疗同步进行.共化疗4-6程.放化疗后疗效评价完全缓解及部分缓解的患者接受全脑预防性放疗25 Gy分10次2周完成或30 Gy分15次3周完成.采用Kaplan-Meier法分析生存数据.结果 照射化疗后残留肿瘤组和化疗前原发病灶组 1、 2、 5年局部控制率分别为 79. 4%、 61. 5%、 60. 1%和 79. 8%、 66. 5%、 57. 3% ( P=0. 73).化疗后残留肿瘤组和化疗前原发病灶组中位生存时间分别为22. 1个月(95%CI:18.2~26. 0)和26. 9个月(95%CI:23.5~30. 3),1、3、5、7年总生存率分别为 81. 1%、31. 6%、23. 9%、 22. 2%和85. 3%、36. 6%、26. 1%、20. 0%(P=0. 51).化疗后残留肿瘤组和化疗前原发病灶组2-3级急性放射性食管炎发生率分别为32. 9%和43. 2%(P=0. 01),2-3级肺纤维化发生率分别为2. 0%和10. 9% (P=0. 01).结论 对于诱导化疗后的局限期SCLC,胸部放疗可仅照射化疗后残留原发灶,纵隔淋巴结引流区可常规采用累及野放疗.Objective In view of the controversy over radiotherapy target volume for patients with limited-stage small cell lung cancer ( SCLC), a prospective randomized controlled trial was conducted to compare the impact of different radiotherapy target volumes on prognosis. Methods After 2 cycles of EP chemotherapy,patients without progressive disease were randomly assigned to receive thoracic radiotherapy (TRT) to either the post-or pre-chemotherapy primary tumour extent as study arm or control. Involved field radiotherapy (IFRT) to the entire metastatic lymph node regions was applied for both arms. TRT consisted of 45 Gy/30Fx/19 d administered concurrently with cycle 3 chemotherapy. Prophylactic cranial irradiation was administered to patients achieved complete or partial remission. Kaplan-Meier method was used for survival analysis. Results Between June 2002 and December 2017,159 and 150 patients were randomly assigned to study arm and control respectively. The 1-,2-,and 5-year local/regional control rates were 79. 4%,61. 5% and 60. 1% respectively in the study arm versus 79. 8%,66. 5%,and 57. 3% in the control arm (P=0. 73). The median OS time was 22. 1 months in the study arm (95%CI,18. 2-26. 0 months) and 26. 9 months (95%CI,23. 5-30. 3 months) in the control arm,the 1-,3-,5-,and 7-year OS rates were 81. 1%,31. 6%, 23. 9% and 22. 2% respectively in the study arm versus 85. 3%,36. 6%,26. 1% and 20. 0% in the control arm (P=0. 51).Grade 2-3 acute esophagitis was developed in 32. 9% and 43. 2% of patients respectively in study arm and control arm (P=0. 01),while grade 2-3 pulmonary fibrosis was observed in 2. 0% and 10. 9% of patients ( P= 0. 01 ) respectively. Conclusions For patients with limited-stage SCLC who received induction chemotherapy,thoracic radiotherapy can be limited to post-chemotherapy tumour extent and IFRT can be routinely applied.

关 键 词：肺肿瘤/放射疗法 放疗靶区 前瞻陛研究 

分 类 号：R734.2[医药卫生—肿瘤] R730.55[医药卫生—临床医学]