洛铂联合紫杉醇与卡铂联合紫杉醇一线治疗局部晚期或转移性非小细胞肺癌随机对照、多中心Ⅲ期临床研究的肺鳞癌亚组分析  

A randomized, controlled, multicenter phase Ⅲ study to compare lobaplatin/paclitaxel vs. carboplatin/paclitaxel as the first-line therapy in Chinese patients with advanced non-small cell lung cancer:Subgroup analysis of lung squamous carcinoma

作　　者：秦叔逵[1] 程颖[1,2] 罗林华[1] 李进 石建华[1,4] 陈振东[1,5] 刘巍 黄诚 张贺龙[1,8] 欧阳学农 伍钢[1,10] 刘文超 郭其森[1,12] 梁军 于浩 孙旭 周炜[1,15] QIN Shukui;CHENG Ying;LUO Linhua;LI Jin;SHI Jianhua;CHEN Zhendong;LIU Wei;HUANG Cheng;ZHANG Helong;OUYANG Xuenong;WU Gang;LIU Wenchao;GUO Qisen;LIANG Jun;YU Hao;SUN Xu;ZHOU Wei(Cancer Center of Bayi Hospital,Nanjing University of Chinese Medicine,Nanjing 210002,China)

机构地区：[1]南京中医药大学附属八一医院肿瘤中心,南京210002 [2]吉林省肿瘤医院肿瘤科,130021 [3]同济大学附属东方医院肿瘤科,200120 [4]临沂市肿瘤医院肿瘤科,276001 [5]安徽医科大学第二附属医院肿瘤科,230601 [6]北京大学肿瘤医院肿瘤科,100036 [7]福建省肿瘤医院肿瘤科,350014 [8]空军军医大学唐都医院肿瘤科,710038 [9]解放军900医院肿瘤科,350025 [10]华中科技大学附属协和医院肿瘤科,430023 [11]空军军医大学西京医院肿瘤科,710032 [12]山东省肿瘤医院肿瘤科,250117 [13]北京大学国际医院肿瘤科,102206 [14]南京医科大学公共卫生学院统计生物学系,211166 [15]贵州益佰制药股份有限公司医学部,550005

出　　处：《临床肿瘤学杂志》2019年第7期621-626,共6页Chinese Clinical Oncology

基　　金：国家“863计划”重点课题资助项目(2006AA020608)

摘　　要：目的进一步比较洛铂联合紫杉醇(TL)方案与卡铂联合紫杉醇(TC)方案一线治疗局部晚期或转移性非小细胞肺癌随机对照、多中心Ⅲ期临床研究(HNCA001)中肺鳞癌亚组患者的数据,了解其有效性和安全性的差异。方法专门分析该研究中纳入的初治IIIB/IV期肺鳞癌患者的数据,包括TL组(紫杉醇175 mg/m^2静滴,d1;洛铂30 mg/m^2静滴,d2)和TC组(紫杉醇175 mg/m^2静滴,d1;卡铂AUC=5静滴,d2),两方案均以21天为1个周期,最多治疗6个周期。根据RECIST 1.1版标准和NCI CTC 3.0版标准,分别评估客观疗效和不良事件(AE)。主要研究终点为无进展生存期(PFS),次要研究终点包括总生存期(OS)、客观有效率(ORR)、疾病控制率(DCR)、安全性和生活质量。结果13家研究中心共入组122例肺鳞癌患者,其中TL组58例,TC组64例。有效性指标中,TL组和TC组肺鳞癌患者的中位PFS、中位OS、ORR和DCR分别为5.13个月和4.73个月(P=0.0669),14.53个月和12.17个月(P=0.6735),37.04%和34.92%(P=0.8484),81.48%和76.19%(P=0.5079)。安全性方面,TL组和TC组AE总体发生率和3、4级AE发生率分别为92.86%和100.00%(P=0.0447),60.71%和78.13%(P=0.0467)。生活质量方面,TL组EQ-VAS指标在化疗第4、5、6周期,肺癌问卷13总分在化疗第6周期和LCSS平均症状负担指数在化疗第2、4周期优于TC组(P<0.05)。结论TL方案一线治疗晚期肺鳞癌与TC方案的疗效基本相当,但是安全性和生活质量可能较优。因此,含洛铂的TL方案可以作为国人晚期肺鳞癌一线治疗的替代选择,值得推广应用。Objective To observe the subgroups data of advanced lung squamous carcinoma in the HNCA001 phaseⅢtrial,and further compare the efficacy and safety of lobaplatin plus paclitaxel(TL)regimen vs.carboplatin plus paclitaxel(TC)regimen as the first-line therapy in Chinese population of advanced NSCLC.Methods In the HNCA001 trial,advanced lung squamous carcinoma patients with stage IIIB/IV were analyzed,including TL group(paclitaxel 175 mg/m^2 iv d1 and lobaplatin 30 mg/m^2 iv d2)and TC group(paclitaxel 175 mg/m^2 d1 and carboplatin AUC=5 iv d2),and 21 days was a cycle for at most 6 cycles.The objective efficacy and adverse events(AE)were assessed according to RECIST 1.1 and NCI CTC 3.0 criteria,respectively.The primary endpoint was progression-free survival(PFS).The secondary endpoints included overall survival(OS),objective response rate(ORR),disease control rate(DCR),safety and quality of life.Results A total of 122 patients with advanced lung squamous carcinoma were randomly enrolled from 13 centers in China,including 58 patients in TL group and 64 patients in TC group.In terms of efficacy,the median PFS of TL group and TC group was 5.13 months vs.4.73 months(P=0.0669),the median OS was 14.53 months vs.12.17 months(P=0.6735).ORR was 37.04%vs.34.92%(P=0.8484)and DCR was 81.48%vs.76.19%(P=0.5079),respectively.In terms of safety,the overall incidence of AEs and grade 3/4 AEs in TL and TC groups were 92.86%vs.100.00%(P=0.0447)and 60.71%vs.78.13%(P=0.0467),respectively.Some indicators of TL group were better that those of TC group in quality of life.Conclusion The efficacy of TL regimen was almost the same with that of TC regimen for patients with advanced lung squamous carcinoma,but safety and quality of life of TL regimen may be a little bit better.Thus,TL regimen may offer an alternative first-line therapy choice for Chinese patients with advanced lung squamous carcinoma.

关 键 词：肺鳞癌 化学治疗 洛铂 卡铂 紫杉醇 

分 类 号：R734.2[医药卫生—肿瘤]