Preoperative Immune-Related Adverse Events in Resectable NSCLC Treated With Neoadjuvant Nivolumab Plus Chemotherapy - A Multicenter Retrospective Analysis

Q: How common were preoperative immune-related adverse events in resectable NSCLC treated with neoadjuvant nivolumab plus chemotherapy?

Preoperative irAEs were observed in 18.5% of patients (n=24).

Q: What clinical outcomes differed between patients with and without preoperative irAEs?

Patients with irAEs had a lower neoadjuvant therapy completion rate and a higher incidence of cancelled surgery compared with those without irAEs.

Q: Which exploratory factors were identified as predictors of preoperative irAEs?

Tumor size greater than 3.8 cm and eosinophil fraction greater than or equal to 2.0% were identified as exploratory predictors.

Sep 29, 2026

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Preoperative immune-related adverse events (irAEs) during neoadjuvant chemoimmunotherapy for resectable non-small cell lung cancer (NSCLC) remain insufficiently characterized. A prespecified multicenter retrospective subanalysis evaluated 130 resectable NSCLC patients (stage IIA-IIIB) treated with neoadjuvant nivolumab plus platinum-doublet chemotherapy across 29 Japanese institutions, comparing patients with versus without preoperative irAEs. Exploratory logistic regression assessed predictive risk factors, while outcomes included therapy completion, surgical cancellation, resection endpoints, and perioperative safety. Preoperative irAEs occurred in 18.5% and were linked to lower completion rates and higher cancellation of surgery, with exploratory predictors including larger tumor size and higher eosinophil fraction.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages9

Reading Time23 min

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Abstract

Introduction

Methods

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ORIGINAL ARTICLE Preoperative Immune-Related Adverse Events in Resectable NSCLC Treated With Neoadjuvant Nivolumab Plus Chemotherapy: A Multicenter Retrospective Analysis Takuya Watanabe, MD,a,* Kotaro Nomura, MD,b Shinkichi Takamori, MD,c,d Shinya Tane, MD,e Shuta Ohara, MD,f Hana Oiki, MD,f Shinya Katsumata, MD,g Makoto Endo, MD,h Satoshi Takamori, MD,h Marina Nakatsuka, MD,h Hironori Tenpaku, MD,i Ryuji Nakamura, MD,j Hirotsugu Notsuda, MD,k Kei Namba, MD,l Kentaro Minegishi, MD,m Masayuki Tanahashi, MD,a Masahiro Tsuboi, MD,b Junichi Soh, MD,n Mototsugu Shimokawa, MD,o Yasuhisa Ohde, MDg aDivision of Thoracic Surgery, Respiratory Disease Center, Seirei Mikatahara General Hospital, Hamamatsu, Japan bDepartment of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan cDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan dDepartment of Thoracic and Breast Surgery, Oita University Faculty of Medicine, Oita, Japan eDivision of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan fDivision of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka-Sayama, Japan gDivision of Thoracic Surgery, Shizuoka Cancer Center, Shizuoka, Japan hDepartment of Thoracic Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan iDepartment of Thoracic and Cardiovascular Surgery, Kuwana City Medical Center, Kuwana, Japan jDepartment of Thoracic and Pediatric Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan kDepartment of Thoracic Surgery, Institute of Development, Aging, and Cancer, Tohoku University, Sendai, Japan lDepartment of Surgery, Okayama Rosai Hospital, Okayama, Japan mDepartment of Thoracic Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan nDepartment of Thoracic Surgery, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan oDepartment of Biostatistics, Graduate School of Medicine, Yamaguchi University, Ube, Japan Received 21 August 2025; revised 29 September 2025; accepted 24 October 2025 Available online - 30 October 2025 ABSTRACT Introduction: Preoperative immune-related adverse events (irAEs) during neoadjuvant chemoimmunotherapy for resectable non-small cell lung cancer (NSCLC) remain poorly characterized. We aimed to evaluate their frequency, clinical impact, and associated risk factors. Methods: This prespecified subanalysis of the multicenter CReGYT-04 Neo-Venus study retrospectively examined 130 patients with resectable NSCLC (stage IIA-IIIB, Union for International Cancer Control, eighth edition) treated with neoadjuvant nivolumab plus platinum-doublet chemotherapy. Clinical data were collected from 29 Japanese institutions. Patients were stratified according to the presence or absence of preoperative irAEs. Exploratory logistic regression was used to identify predictive factors. Results: Preoperative irAEs were observed in 18.5% of the patients (n = 24) . Patients with irAEs had a significantly lower neoadjuvant therapy completion rate (58.3% versus 92.5%, p <0.001) and a higher incidence of cancelled surgery (21.7% versus 5.8%, p = 0.029) than those without irAEs. There were 18 patients (78.3%) with irAEs who underwent surgical resection. R0 resection was achieved in *Corresponding author. Address for correspondence: Takuya Watanabe, MD, Division of Thoracic Surgery, Respiratory Disease Center, Seirei Mikatahara General Hospital, 3453 Mikatahara-cho, Chuo-ku, Hamamatsu, Shizuoka, 433-8558, [Japan. E-mail:](Japan. E-mail: watanabechoke@gmail.com)[ watanabechoke@gmail.com](Japan. E-mail: watanabechoke@gmail.com) [Cite this article as: Watanabe T](Cite this article as: Watanabe T), Nomura K, Takamori S, et al. Preoperative immune-related adverse events in resectable NSCLC treated with neoadjuvant nivolumab plus chemotherapy: amulticenter retrospective analysis. JTO Clin Res Rep 2026;

FAQs

How common were preoperative immune-related adverse events in resectable NSCLC treated with neoadjuvant nivolumab plus chemotherapy?

Preoperative irAEs were observed in 18.5% of patients (n=24).

What clinical outcomes differed between patients with and without preoperative irAEs?

Patients with irAEs had a lower neoadjuvant therapy completion rate and a higher incidence of cancelled surgery compared with those without irAEs.

Which exploratory factors were identified as predictors of preoperative irAEs?

Tumor size greater than 3.8 cm and eosinophil fraction greater than or equal to 2.0% were identified as exploratory predictors.

Sep 29, 2026

Upload by Adam