Evidence map›Paper›PMID 39751674›Full record

Observational studyCancer immunology, immunotherapy : CII2025

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

Toshiyuki Sumi, Yutaro Nagano, Keiki Yokoo, Tatsuru Ishikawa, Hirotaka Nishikiori, Osamu Honjo, Sayaka Kudo, Masami Yamazoe, Shun Kondoh, Makoto Shioya and 8 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cancer immunology, immunotherapy : CII, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Toshiyuki SumiDepartment of Pulmonary Medicine, Hakodate Goryoukaku Hospital, 38-3 Goryoukaku-Cho, Hakodate-Shi, Hokkaido, 040-8611, Japan. tsh715@gmail.com.
Yutaro NaganoDepartment of Respiratory Medicine and Allergology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Keiki YokooDepartment of Respiratory Medicine, Teine Keijinkai Hospital, Sapporo, Japan.
Tatsuru IshikawaDepartment of Respiratory Medicine and Allergology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Hirotaka NishikioriDepartment of Respiratory Medicine and Allergology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Osamu HonjoDepartment of Respiratory Medicine, Sapporo Minami-Sanjo Hospital, Sapporo, Japan.
Sayaka KudoDepartment of Respiratory Medicine, Kushiro City General Hospital, Kushiro, Japan.
Masami YamazoeDepartment of Respiratory Medicine, Hakodate Municipal Hospital, Hakodate, Japan.
Shun KondohDepartment of Respiratory Medicine, Steel Memorial Muroran Hospital, Muroran, Japan.
Makoto ShioyaDepartment of Respiratory Medicine, Otaru General Hospital, Otaru, Japan.
Mitsuo OtsukaDepartment of Respiratory Medicine, Hokkaido P.W.F.A.C Sapporo-Kosei Hospital, Sapporo, Japan.
Midori HashimotoDepartment of Respiratory Medicine, NTT-East Corporation Sapporo Medical Center, Sapporo, Japan.
Hayato YabeDepartment of Respiratory Medicine, Japan Community Healthcare Organization Sapporo Hokushin Hospital, Sapporo, Japan.
Yusuke TanakaDepartment of Respiratory Medicine and Allergology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Yuta SudoDepartment of Respiratory Medicine, Japanese Red Cross Asahikawa Hospital, Asahikawa, Japan.
Masahiro YanagiDepartment of Respiratory Medicine, Muroran City General Hospital, Muroran, Japan.
Mamoru TakahashiDepartment of Respiratory Medicine and Allergology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Hirofumi ChibaDepartment of Respiratory Medicine and Allergology, Sapporo Medical University School of Medicine, Sapporo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCompared 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.

methodsWe 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.

resultsOf 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).

conclusionsNI 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.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungIpilimumabLung NeoplasmsNivolumabAdultAgedAged, 80 and overFemaleHumansImmune Checkpoint InhibitorsMaleMiddle AgedRetrospective StudiesImmune Checkpoint InhibitorsIpilimumabNivolumabChemotherapyImmune-related adverse eventsIpilimumabNivolumabNon-small cell lung cancer

Identifiers

PMID39751674
PMCPMC11698699

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.