POINTBREAK研究中非洲裔美国人的探索性亚组分析：培美曲塞-卡铂-贝伐单抗序贯培美曲塞-贝伐单抗维持治疗对比紫杉醇-卡铂-贝伐单抗序贯贝伐单抗维持治疗用于ⅢB/Ⅳ期非鳞状非小细胞肺癌患者

Exploratory Subset Analysis of African Americans From the PointBreak Study: Pemetrexed-Carboplatin-Bevacizumab Followed by Maintenance Pemetrexed-Bevacizumab Versus Paclitaxel-Carboplatin-Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB/IV Nonsquamous Non-Small-Cell Lung Cancer.

作者信息

Reynolds Craig H, Patel Jyoti D, Garon Edward B, Olsen Mark R, Bonomi Philip, Govindan Ramaswamy, Pennella Eduardo J, Liu Jingyi, Guba Susan C, Li Shi, Spigel David R, Hermann Robert C, Socinski Mark A, Obasaju Coleman K

机构信息

US Oncology Research, Ocala, FL.

Northwestern University Feinberg School of Medicine, Chicago, IL.

出版信息

Clin Lung Cancer. 2015 May;16(3):200-8. doi: 10.1016/j.cllc.2014.11.004. Epub 2014 Nov 18.

DOI:10.1016/j.cllc.2014.11.004

PMID:25516338

Abstract

INTRODUCTION

African Americans have a greater incidence of lung cancer than whites and have been underrepresented in clinical trials. In the PointBreak trial (pemetrexed-carboplatin-bevacizumab and maintenance pemetrexed-bevacizumab [PemCBev] vs. paclitaxel-carboplatin-bevacizumab and maintenance bevacizumab [PacCBev]), 10% of the patients were African American. PointBreak had negative findings; PemCBev did not demonstrate superior overall survival (OS).

MATERIALS AND METHODS

PointBreak subgroup efficacy and safety data were retrospectively analyzed: African Americans versus whites for PemCBev; PemCBev versus PacCBev in African Americans; and academic versus community settings for African Americans. Hazard ratios (HRs) and P values were derived from a multivariate Cox proportional hazards model after adjusting for covariates.

RESULTS

Of 939 intent-to-treat (ITT) patients, 94 were African American and 805 were white. African-American enrollment was uniform across the study sites (median, 1 African American per site). In the PemCBev arm, OS (HR, 1.125; P = .525), progression-free survival (PFS) (HR, 1.229; P = .251), response (P = .607), and toxicity profiles were similar in African Americans versus whites. For African Americans, OS (HR, 1.375; P = .209), PFS (HR, 0.902; P = .670), response (P = 1.000), and toxicity profiles were similar in the PemCBev versus PacCBev arm. For African Americans, no significant differences were seen in OS (HR, 0.661; P = .191) or PFS (HR, 0.969; P = .915) in academic versus community practice settings.

CONCLUSION

In the PemCBev arm, this exploratory analysis showed no significant differences between African Americans and whites for the efficacy outcomes or toxicity profiles. Consistent with the ITT population negative trial result, for African Americans, the median OS was not superior for either arm. For African Americans, PFS and OS were similar in the academic and community settings. Additional outcomes data for African Americans should be collected in lung cancer studies.

摘要

引言

非裔美国人肺癌发病率高于白人，且在临床试验中的代表性不足。在PointBreak试验（培美曲塞-卡铂-贝伐单抗及维持治疗用培美曲塞-贝伐单抗[PemCBev]对比紫杉醇-卡铂-贝伐单抗及维持治疗用贝伐单抗[PacCBev]）中，10%的患者为非裔美国人。PointBreak试验结果为阴性；PemCBev未显示出更好的总生存期（OS）。

材料与方法

对PointBreak试验亚组的疗效和安全性数据进行回顾性分析：PemCBev组中非裔美国人与白人对比；非裔美国人中PemCBev组与PacCBev组对比；以及非裔美国人在学术机构与社区机构中的情况对比。风险比（HRs）和P值来自多变量Cox比例风险模型，对协变量进行了校正。

结果

在939例意向性治疗（ITT）患者中，94例为非裔美国人，805例为白人。各研究地点的非裔美国人入组情况一致（中位数为每个地点1名非裔美国人）。在PemCBev组中，非裔美国人与白人在OS（HR，1.125；P = 0.525）、无进展生存期（PFS）（HR，1.229；P = 0.251）、缓解率（P = 0.607）及毒性特征方面相似。对于非裔美国人，PemCBev组与PacCBev组在OS（HR，1.375；P = 0.209）、PFS（HR，0.902；P = 0.670）、缓解率（P = 1.000）及毒性特征方面相似。对于非裔美国人，在学术机构与社区机构中，OS（HR，0.661；P = 0.191）或PFS（HR，0.969；P = 0.915）均无显著差异。