比较免疫检查点抑制剂加化疗或伊匹单抗加尼伐单抗治疗PD-L1 TPS（1-49 %）的NSCLC患者：TOPGAN2023-01。

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2024-11-05 DOI:10.1016/j.ejca.2024.115117

Hisashi Tanaka , Tomonori Makiguchi , Takehiro Tozuka , Yosuke Kawashima , Tomohiro Oba , Ryosuke Tsugitomi , Junji Koyama , Yuichi Tambo , Shinsuke Ogusu , Masafumi Saiki , Hiroshi Gyotoku , Tsukasa Hasegawa , Eisaku Miyauchi , Tomoaki Sonoda , Ryota Saito , Katsumi Nakatomi , Toshio Sakatani , Keita Kudo , Yuko Tsuchiya-Kawano , Makoto Nishio

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引用次数: 0

摘要

简介免疫检查点抑制剂（ICIs）加化疗现已成为治疗非小细胞肺癌（NSCLC）的标准疗法。对于程序性死亡配体1（PD-L1）肿瘤比例评分（TPS）为1-49%的NSCLC患者，ICI加化疗（ICI-chemo）或伊匹单抗加尼伐单抗（I-N）疗法是否更优，尚未进行评估：这项多中心回顾性研究纳入了TPS评分为1-49%、开始一线化疗的NSCLC患者。采用倾向评分匹配分析法调整各种混杂因素并评估疗效：共有401名患者入选，其中308人接受了ICI-化疗，93人接受了基于I-N的治疗。ICI-化疗组的中位OS为21.0个月，I-N疗法组为20.0个月。经过倾向评分匹配后，ICI-化疗组和基于I-N疗法组的OS或PFS没有差异（OS：危险比（HR），0.83；95%置信区间[CI]，0.54-1.26；PFS：HR，0.72；95% CI，0.52-1.00）。在 PD-L1 TPS 为 25-49% 的患者中，ICI-化疗组的 OS 有上升趋势（OS：HR，0.30；95% CI，0.09-0.85）。ICI-化疗组中有26.2%的患者中断了治疗，I-N疗法组中有41.9%的患者中断了治疗：结论：在PD-L1 TPS 1-49%的患者中，ICI-化疗组和I-N疗法组的生存率没有显著差异。根据亚组分析结果，ICI-chemo治疗TPS为25-49%的NSCLC可能更具优势。

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Comparison of immune checkpoint inhibitor plus chemotherapy or ipilimumab plus nivolumab-based therapy for NSCLC patients with PD-L1 TPS (1–49 %): TOPGAN2023-01

Introduction

Immune checkpoint inhibitors (ICIs) plus chemotherapy is now a standard treatment for non-small cell lung cancer (NSCLC). Whether ICI plus chemotherapy (ICI-chemo) or ipilimumab plus nivolumab (I-N)-based therapy is superior for patients with NSCLC with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) of 1–49 % has not been evaluated.

Methods

This multicenter retrospective study included NSCLC patients with a TPS score of 1–49 %, who began first-line chemotherapy. Propensity score matching analysis was used to adjust for various confounders and evaluate treatment efficacy.

Results

A total of 401 patients were enrolled, of whom 308 received ICI-chemo and 93 received I-N-based therapy. The median OS was 21.0 months in the ICI-chemo group and 20.0 months in the I-N-based therapy group. After propensity score matching, there was no difference in OS or PFS between the ICI-chemo group and the I-N-based therapy group (OS: hazard ratios (HR), 0.83; 95 % confidence interval [CI], 0.54–1.26, PFS: HR, 0.72; 95 % CI, 0.52–1.00). Among PD-L1 TPS 25–49 %, there was a tendency for OS to be favorable for the ICI-chemo group (OS: HR, 0.30; 95 % CI, 0.09–0.85). Treatment discontinuation occurred for 26.2 % of the patients in the ICI-chemo group and 41.9 % in the I-N-based therapy group.

Conclusions

Among PD-L1 TPS 1–49 %, there was no significant difference in survival outcomes between the ICI-chemo group and the I-N-based therapy group. Based on the results of a subgroup analysis, ICI-chemo may be superior for treating NSCLC with a TPS of 25–49 %.

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.