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的随机对照、多中心Ⅲ期临床研究的老年亚组报告  

A randomized, controlled, multicenter phase Ⅲ study to compare lobaplatin/paclitaxel versus carboplatin/paclitaxel as the first-line therapy in Chinese patients with advanced non-small cell lung cancer: Subgroup analysis of the patients over 60 years old

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 [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 [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

出　　处：《临床肿瘤学杂志》2019年第8期732-737,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(NSCLC)随机对照、多中心Ⅲ期临床研究(HNCA001)中60岁以上老年患者的数据,了解其有效性和安全性。方法专门分析该研究中纳入的60岁以上NSCLC患者数据,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。结果全国13家中心,入组60岁以上患者共123例,其中TL组59例和TC组64例。有效性指标中,TL组和TC组的中位PFS均为5.50个月,但是两组75%PFS分别为11.93个月和7.60个月;大概7个月后两组的PFS曲线开始明显分开。两组PFS的HR=0.604(95%CI:0.380~0.958,P=0.0304)。TL组和TC组的ORR、DCR和中位OS分别为32.73%和43.75%(P=0.2593),85.45%和81.25%(P=0.6270),14.43个月和13.87个月(P=0.7770)。安全性方面,TL和TC组AE的总发生率分别为91.38%和100.00%(P=0.0221),3、4级AE和药品不良反应的发生率分别为63.79%和84.38%(P=0.0122),56.90%和82.81%(P=0.0026)。生活质量方面,TL组EQ-VAS评分第2、3、4、6个周期指标均优于TC组(P<0.05)。结论对于60岁以上的老年人群,与TC方案相比,TL方案的疗效较好且安全性和生活质量更好。因此,含洛铂的TL方案可作为老年晚期NSCLC患者一线治疗的优选方案。Objective To further compare the efficacy and safety of lobaplatin plus paclitaxel(TL)regimen with carboplatin plus paclitaxel(TC)regimen in the first-line treatment of locally advanced or metastatic non-small cell lung cancer(NSCLC)in elderly patients over 60 years of age in a multicenter phase III clinical study(HNCA001).Methods In the HNCA001 trial,advanced elderly NSCLC patients over 60 years old were analyzed,including TL group(paclitaxel 175 mg/m^2 iv d1and lobaplatin 30 mg/m^2 iv d2)and TC Group(paclitaxel 175 mg/m^2 d1and carboplatin AUC=5 iv d2),and 21 days was a cycle for at most 6 cycles.The objective efficacy and adverse event(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 123 patients over 60 years old were randomly enrolled from 13 centers in China,including 59 patients in TL group and 64 patients in TC group.In terms of efficacy,the median PFS in TL group and TC group were both 5.50 months.However,the PFS(P75)of both groups were 11.93 months and 7.60 months,respectively.About 7 months later,the two PFS curves of TL and TC group began to diverge significantly.HR of PFS for both groups was 0.604(95%CI:0.380-0.958,P=0.0304).The ORR,DCR and median OS were 32.73%vs.43.75%(P=0.2593),85.45%vs.81.25%(P=0.6270)and 14.43 months vs.13.87 months(P=0.7770).In terms of safety,the overall incidence of AE and grade 3/4 AE in TL and TC groups were 91.38%vs.100%(P=0.0221)and 63.79%vs.84.38%(P=0.0122).The overall incidence of grade 3/4 adverse drug reactions in TL and TC groups were 56.90%vs.82.81%(P=0.0026).The indicators EQ-VAS at cycle 2,3,4 and 6 in TL group were better than those in TC group in quality of life.Conclusion The efficacy,safety and quality of life of TL regimen are better than those of TC regimen.TL regimen may offer an alternative first-line therapy choice for

关 键 词：非小细胞肺癌 老年患者 化学治疗 洛铂 卡铂 紫杉醇 

分 类 号：R734.2[医药卫生—肿瘤]