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Open Access 01-02-2025 | NSCLC | Research

Efficacy and safety of nivolumab and ipilimumab with or without chemotherapy for unresectable non-small cell lung cancer: a multicenter retrospective observational study

Authors: Toshiyuki Sumi, Yutaro Nagano, Keiki Yokoo, Tatsuru Ishikawa, Hirotaka Nishikiori, Osamu Honjo, Sayaka Kudo, Masami Yamazoe, Shun Kondoh, Makoto Shioya, Mitsuo Otsuka, Midori Hashimoto, Hayato Yabe, Yusuke Tanaka, Yuta Sudo, Masahiro Yanagi, Mamoru Takahashi, Hirofumi Chiba

Published in: Cancer Immunology, Immunotherapy | Issue 2/2025

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Abstract

Introduction

Compared to platinum-based therapies, a combination of ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) has demonstrated improved outcomes in advanced non-small cell lung cancer (NSCLC), albeit with higher rates of immune-related adverse events (irAEs). This multicenter retrospective study evaluated the efficacy and safety of nivolumab and ipilimumab with or without chemotherapy (NI and NICT) in real-world clinical settings.

Methods

We enrolled 215 treatment-naïve NSCLC patients who received NI or NICT between December 2020 and May 2023 at 14 institutions in Japan. Severe irAEs (Grade ≥ 3) were assessed using the Common Terminology Criteria for Adverse Events. Progression-free survival (PFS) and overall survival (OS) were evaluated using Kaplan–Meier methods and propensity score matching.

Results

Of 215 patients, 104 and 111 received NI and NICT, respectively. The median PFS was 5.3 and 5.9 months for NI and NICT, respectively. The median OS was 22.1 and 19.2 months for NI and NICT, respectively. High fever within 3 weeks of treatment initiation and high tumor burden were indicators of severe irAEs. Grade 3 or higher irAEs occurred in 36.5% patients in the NI group and 50.5% patients in the NICT group, with higher treatment-related mortality in the NICT group (5.4% vs. 1.9% in NI).

Conclusions

NI and NICT showed comparable efficacies in PFS and OS. However, NICT had a higher incidence of severe irAEs and treatment-related mortality. High tumor burden and early high fever were predictors of severe irAEs. Further research is warranted to optimize the efficacy and safety of NICT for NSCLC treatment.
Appendix
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Metadata
Title
Efficacy and safety of nivolumab and ipilimumab with or without chemotherapy for unresectable non-small cell lung cancer: a multicenter retrospective observational study
Authors
Toshiyuki Sumi
Yutaro Nagano
Keiki Yokoo
Tatsuru Ishikawa
Hirotaka Nishikiori
Osamu Honjo
Sayaka Kudo
Masami Yamazoe
Shun Kondoh
Makoto Shioya
Mitsuo Otsuka
Midori Hashimoto
Hayato Yabe
Yusuke Tanaka
Yuta Sudo
Masahiro Yanagi
Mamoru Takahashi
Hirofumi Chiba
Publication date
01-02-2025
Publisher
Springer Berlin Heidelberg
Published in
Cancer Immunology, Immunotherapy / Issue 2/2025
Print ISSN: 0340-7004
Electronic ISSN: 1432-0851
DOI
https://doi.org/10.1007/s00262-024-03890-4

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