Integrated analysis of older adults and patients with renal dysfunction in the IMpower130 and IMpower132 randomized controlled trials for advanced non-squamous non-small cell lung cancer

IF 4.5 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2024-10-01 DOI:10.1016/j.lungcan.2024.107859

Makoto Nishio , Satoshi Watanabe , Hibiki Udagawa , Naoko Aragane , Yuki Nakagawa , Yuki Kobayashi , Haruhiro Saito

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Abstract

Objectives

This exploratory integrated analysis of the randomized Phase III IMpower130 and IMpower132 trials evaluated the efficacy and safety of atezolizumab plus platinum-based chemotherapy in patients with non-small cell lung cancer (NSCLC) who were aged ≥75 years or had renal dysfunction.

Materials and methods

Chemotherapy-naïve patients with stage IV non-squamous NSCLC received atezolizumab-containing therapy or platinum-doublet chemotherapy in IMpower130 and IMpower132. This integrated analysis assessed efficacy (including overall survival [OS], progression-free survival [PFS], and objective response rates) and safety in the integrated population and in patients ≥75 years old. Subgroup analyses by baseline creatinine clearance (<45, 45 to <60, and ≥60 mL/min) were conducted for each study population.

Results

This integrated analysis included 1224 patients: 737 in the atezolizumab-containing group and 487 in the chemotherapy group. At data cutoff, the hazard ratio (HR) for PFS was 0.62 (95% CI: 0.54–0.71) in the integrated population and 0.59 (95% CI: 0.40–0.88) in the ≥75-years subgroup. The HR for OS was 0.81 (95% CI: 0.68–0.95) in the integrated population and 0.65 (95% CI: 0.39–1.07) in the ≥75-years subgroup. PFS and OS benefits with the atezolizumab combination vs chemotherapy were maintained across subgroups with varying renal function in IMpower130, and PFS benefits were maintained across subgroups in IMpower132.

Conclusions

The results of this post hoc integrated analysis of IMpower130 and IMpower132 show that the efficacy and safety of atezolizumab plus platinum-doublet chemotherapy is maintained in patients ≥75 years old and in patients with renal dysfunction.

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对IMpower130和IMpower132治疗晚期非鳞状非小细胞肺癌随机对照试验中的老年人和肾功能不全患者进行综合分析。

研究目的这项对随机III期IMpower130和IMpower132试验的探索性综合分析评估了阿特珠单抗联合铂类化疗对年龄≥75岁或肾功能不全的非小细胞肺癌（NSCLC）患者的疗效和安全性：化疗无效的IV期非鳞癌NSCLC患者在IMpower130和IMpower132中接受了阿特珠单抗或铂类双联化疗。这项综合分析评估了综合人群和年龄≥75岁患者的疗效（包括总生存期[OS]、无进展生存期[PFS]和客观反应率）和安全性。根据基线肌酐清除率进行了分组分析（结果：基线肌酐清除率为0.5%的患者为1例，基线肌酐清除率为0.5%的患者为2例）：该综合分析包括 1224 名患者：含阿替珠单抗组737例，化疗组487例。数据截止时，综合人群的 PFS 危险比（HR）为 0.62（95% CI：0.54-0.71），≥75 岁亚组的 PFS 危险比为 0.59（95% CI：0.40-0.88）。综合人群的OS HR为0.81（95% CI：0.68-0.95），≥75岁亚组的OS HR为0.65（95% CI：0.39-1.07）。在IMpower130中，阿特珠单抗联合化疗的PFS和OS获益在不同肾功能的亚组中保持不变，在IMpower132中，PFS获益在不同亚组中保持不变：结论：对IMpower130和IMpower132的事后综合分析结果表明，atezolizumab联合铂类双药化疗对年龄≥75岁的患者和肾功能不全患者的疗效和安全性保持不变。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lung Cancer 医学-呼吸系统

CiteScore

9.40

自引率

3.80%

发文量

407

审稿时长

25 days

期刊介绍： Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.