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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): 564-569    DOI: 10.3760/cma.j.issn.1004-4221.2018.06.006
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培美曲塞+顺铂或多西他赛+顺铂同期胸部IMRT治疗Ⅳ期肺腺癌的疗效和安全性
李梅, 耿一超, 杨文刚, 马筑, 李青松, 王羽, 罗大先, 胡银祥, 欧阳伟炜, 刘凌枫, 苏胜发, 卢冰
550004 贵阳,贵州医科大学附属医院/贵州省肿瘤医院胸部肿瘤科 贵州医科大学肿瘤学教研室
Clinical efficacy and safety of randomized phase 2 trial of pemetrexed-cisplatin or docetaxel-cisplatin plus thoracic intensity-modulated radiation therapy in patients with stage IV lung adenocarcinoma
Li Mei, Geng Yichao, Yang Wengang, Ma Zhu, Li Qingsong, Wang Yu, Luo Daxian, Hu Yinxiang, Ouyang Weiwei, Liu Lingfeng, Su Shengfa, Lu Bing
Department of Thoracic Oncology, Affiliated Hospital of Guizhou Medical University,Guizhou Cancer Hospital, Teaching and Research Section of Oncology, Guizhou Medical University, Guiyang 550004,China
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摘要 目的 探讨培美曲塞+顺铂(PP)或多西他赛+顺铂(DP)同期胸部调强放疗(IMRT)治疗晚期肺腺癌的临床疗效和毒副作用。方法 将2011年—2016年1月贵州省肿瘤医院收治的EGFR突变未知或野生型的Ⅳ期肺腺癌随机分为PP组(50例)和DP组(51例)。2组患者均接受同期胸部IMRT,处方剂量60~70 Gy。主要研究终点为1年生存率,次要研究终点为不良反应。结果 PP组和DP组的总有效率(CR+PR)分别为68%和72%(P=0.617);中位生存时间分别为19.6个月(95%CI:13.9~25.3)和12.1个月(95%CI:10.7~13.5);1、2、3年生存率分别为72.0%、28.0%、16.0%和52.9%、17.6%、13.7%(P=0.049)。PP组和DP组3—4级白细胞分别下降48%和63%(P=0.098);3—4级粒细胞分别减少34%和65%(P=0.002);3-4级血红蛋白发生率分别为38%和10%(P=0.024);3—4级血小板分别降低为40%和14%(P=0.003)。2组患者2级急性放射性肺炎(P=0.625)和3级放射性食管炎(P=0.484)发生率相似,无≥3级的放射性肺炎及≥4级的放射性食管炎。结论 培美曲塞+顺铂治疗晚期肺腺癌同期放化疗的疗效优于多西他赛+顺铂,急性放射性食管炎与肺炎相似,血液学不良反应各有优势,患者可耐受。临床试验注册 中国临床试验注册中心(ChiCTR-TRC-13004184)。
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作者相关文章
李梅
耿一超
杨文刚
马筑
李青松
王羽
罗大先
胡银祥
欧阳伟炜
刘凌枫
苏胜发
卢冰
关键词 Ⅳ期肺腺癌放射疗法调强适形培美曲塞多西他赛Ⅱ期研究    
AbstractObjective To evaluate the clinical efficacy and toxicity of concurrent pemetrexed-cisplatin (PP) or docetaxel-cisplatin (DP) with intensity-modulated radiation therapy (IMRT) in patients with stage ⅠV lung adenocarcinoma. Methods Stage IV lung adenocarcinoma patients with unknown EGFR mutation status or wild-type admitted to Guizhou Cancer Hospital from 2011 to 2016 were randomly assigned into the PP (n=50) and DP groups (n=51).All patients received concurrent IMRT of the chest at a prescription dose of 60-70 Gy. Primary endpoint was 1-year survival rate, and secondary endpoint was acute toxicity. Results The overall response rate was 68.0% and 72.5% in the PP and DP groups (χ2=0.250, P=0.617). The median survival time was 19.6 months (95%CI 13.9-25.3) versus 12.1 months (95%CI 10.7-13.5) in the PP and DP groups. The 1-, 2-and 3-year overall survival rates were 72.0% versus 52.9%, 28.0% versus 17.6%, and 16.0% versus 13. 7%, respectively in the PP and DP groups (P=0.049). In the PP and DP groups, the incidence of grade 3-4 leukopenia was declined by 48% and 63%(P=0.098), and the incidence of grade 3-4 neutropenia was decreased by 34% and 65%(P=0.002), the incidence of grade 3-4 anemia was reduced by 38% and 10%(P=0.024), and the incidence of grade 3-4 thrombocytopenia was declined by 40% and 14%(P=0.003). The incidence rate of grade 2 pneumonitis (P=0.625) and grade 3 esophagitis (P=0.484) were similar in both groups. No patients experienced ≥grade 3 pneumonitis or ≥ grade 4 radiation esophagitis. Conclusions Pemetrexed-cisplatin combined with chemoradiotherapy yields higher clinical efficacy compared with docetaxel-cisplatin plus concurrent chemoradiation in the treatment of stage ⅠV lung adenocarcinoma. The incidence of radiation pneumonitis and esophagitis is similar. The incidence and severity of hematological toxicity does not significantly differ between two groups. Treatment-related toxicity is tolerable in both groups. Clinical Trial Registration Chinese Clinical Trial Registry (ChiCTR-TRC-13004184).
Key wordsStage IV lung adenocarcinoma    Radiotherapy, Intensity-Modulated    Pemetrexed    Docetaxel    Phase 2 trial   
收稿日期: 2017-03-20     
基金资助:贵州省教育厅创新群体重大研究项目(黔教合KY字[2016]032);贵州省科技计划项目(黔科合LG字[2012]062,黔科合SZ[2014]3021)
通讯作者: 苏胜发,Email:sushengfa2005@163.com;卢冰,Email:lbgymaaaa@163.com   
引用本文:   
李梅,耿一超,杨文刚等. 培美曲塞+顺铂或多西他赛+顺铂同期胸部IMRT治疗Ⅳ期肺腺癌的疗效和安全性[J]. 中华放射肿瘤学杂志, 2018, 27(6): 564-569.
Li Mei,Geng Yichao,Yang Wengang et al. Clinical efficacy and safety of randomized phase 2 trial of pemetrexed-cisplatin or docetaxel-cisplatin plus thoracic intensity-modulated radiation therapy in patients with stage IV lung adenocarcinoma[J]. Chinese Journal of Radiation Oncology, 2018, 27(6): 564-569.
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