广泛期小细胞肺癌化疗后脑预防照射及颅外病变放疗的Ⅱ期临床研究  

Clinical effect of thoracic radiotherapy and prophylactic cranial irradiation in patients with extensive small cell lung cancer after chemotherapy：a phase II trial

作　　者：张文珏[1] 周宗玫[1] 陈东福[1] 梁军[1] 冯勤付[1] 张红星[1] 王小震[1] 惠周光[1] 肖泽芬[1] 吕纪马[1] 李峻岭[2] 王绿化[1] 

机构地区：[1]北京协和医学院中国医学科学院肿瘤医院肿瘤研究所放疗科,100021 [2]北京协和医学院中国医学科学院肿瘤医院肿瘤研究所内科,100021

出　　处：《中华放射肿瘤学杂志》2013年第5期365-368,共4页Chinese Journal of Radiation Oncology

基　　金：北京希望马拉松专项基金（N2010-8）

摘　　要：目的开展广泛期小细胞肺癌化疗有效的患者进行全脑预防照射及颅外病变放疗的前瞻性研究，评价疗效和不良反应。方法2010--2012年入组30例病理或细胞学确诊、经4—6周期PE或CE方案化疗有效的广泛期小细胞肺癌患者接受颅外病灶放疗（50～60Gy／25～30次）及全脑预防性照射（25Gy／10次）。采用RECIST1-1标准评估近期疗效、CTC3．0AE及RTOG放射损伤分级标准评价不良反应。结果全组共29例按计划完成颅外病灶放疗及全脑预防性照射。完全缓解率13％、部分缓解率27％、稳定率60％，疾病控制率100％。16例治疗有效后进展，其中单纯局部区域失败1例、远处失败15例（单纯远处失败9例，局部区域＋远处转移6例，共4例脑转移）。随访率100％，1年局部区域失败率、远处失败率分别为24％、51％，1年生存率、无瘤生存率分别为71％、37％。急性不良反应中≥2级血液学改变、放射性食管炎分别占33％、13％。结论广泛期小细胞肺癌化疗有效者行全脑预防照射及颅外病灶放疗近期疗效较好且耐受放疗，可减少颅内转移及局部复发率，但最终尚需扩大病例进一步研究。Objective To investigate the efficacy and safety of thoracic radiotherapy （TR） and prophylactic cranial irradiation （PCI） in patients with extensive small cell lung cancer （SCLC） who show response to chemotherapy. Methods From July 2010 to March 2012, 30 patients with a pathological or cytological diagnosis of extensive SCLC who showed response to 4-6 cycles of chemotherapy with carboplatin plus etoposide or chemotherapy with cisplatin plus etoposide were included in the study. The median age of patients was 57 years （range, 40--71 years）. All the patients received TR （50-60 Gy） and PCI （25 Gy）. The short-term efficacy was assessed by RECIST 1.1, and the toxicities were evaluated according to CTCAE 3.0 and RTOG radiation morbidity scoring criteria. Results Twenty-nine of the 30 patients completed the TR and PCI. Of these patients, 13% showed complete remission, 27% showed partial remission, and 60% showed stable disease, and the disease control rate was 100%. Progression was seen in 16 patients after effective treatment, including 1 patients with loeoregional failure （LRF） alone and 15 patients with distant failure （DF） （9 patients with DF alone and 6 patients with locoregional and distant metastases, 4 patients with brain metastasis）. The follow-up rate was 100%. The 1-year LRF rate and DF rate were 24% and 51% , respectively. The 1-year overall survival rate and disease-free survival rate were 71% and 37%, respectively. The acute toxicities included grade ≥2 hematological toxicity and grade ≥2 radiation esophagitis, which occurred in 33% and 13% of all patients. Conclusions TR and PCI have good short-term efficacy and safety in extensive SCLC patients with response to chemotherapy and can reduce brain metastases and local recurrence. However, further study is needed with a larger sample.

关 键 词：癌 小细胞肺 化学疗法 癌 小细胞肺 放射疗法 预防性全脑照射 U期临床研究 

分 类 号：R734.2[医药卫生—肿瘤]