Incidence of and risk factors for immune checkpoint inhibitor–related pneumonitis in thoracic malignancies: a prospective multicenter study
Year: 2026
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Immune checkpoint inhibitors (ICIs) have fundamentally changed cancer treatment, but ICI-related pneumonitis (ICI-P) remains a major clinical concern. Although numerous studies have reported its incidence and risk factors, the retrospective nature of these studies makes accurate assessment difficult in a real-world clinical setting. PATIENTS AND METHODS: This prospective multicenter observational study enrolled patients with advanced or recurrent thoracic malignancies treated with nivolumab, pembrolizumab, or atezolizumab. Thoracic high-resolution computed tomography (HRCT) examinations were performed at the start of ICI therapy and at the onset of ICI-P. The primary endpoint was ICI-P incidence. The secondary endpoints included evaluation of risk factors, with a focus on the lung lesions present at ICI initiation. Fine-Gray analyses with 3 models were used to identify risk factors. RESULTS: Among 614 eligible patients, 78 (12.7%) developed ICI-P. During a median observation period of 14.4 months, 29 patients developed grade ≥3 pneumonitis and 7 patients died owing to ICI-P. In the multivariable Fine-Gray analyses, independent risk factors for ICI-P included heavy smoking history (>50 pack-years; subdistribution hazard ratio [SHR], 1.90; 95% confidence interval [CI], 1.17-3.10), baseline interstitial lung abnormalities (ILAs; SHR, 3.42; 95% CI, 2.05-5.71), use of PD-1 inhibitors (SHR, 2.15; 95% CI, 1.28-3.63), and immunochemotherapy (SHR, 2.16; 95% CI, 1.17-3.98). CONCLUSION: In this prospective real-world cohort, the incidence of ICI-P was relatively high, and ILAs detected by HRCT, heavy smoking history, and treatment with a PD-1 inhibitor alone or in combination with cytotoxic chemotherapy were identified as independent risk factors.
Source: The Oncologist
Authors: Yoshihiro Kitahara, Naoki Inui, Takafumi Koyauchi, Kazuhiro Asada, Koji Nishimoto, Shun Matsuura, Dai Hashimoto, Takashi Matsui, Masato Fujii, Nao Inami, Mitsuru Niwa, Keigo Koda, Hiroyuki Matsuda, Yusuke Kaida, Masaki Ikeda, Masaki Sato, Yasuhiro Ito, Yusuke Inoue, Hideki Yasui, Masato Karayama, Yuzo Suzuki, Hironao Hozumi, Kazuki Furuhashi, Noriyuki Enomoto, Tomoyuki Fujisawa, Kumi Ozaki, Shintaro Ichikawa, Satoshi Goshima, Takafumi Suda
Institutions: Hamamatsu University School of Medicine, Seirei Mikatabara General Hospital, Shizuoka General Hospital, Iwata City Hospital, Fujieda Municipal General Hospital, Seirei Hamamatsu General Hospital, Shizuoka City Hospital, Shizuoka City Shimizu Hospital, Hamamatsu Medical Center, Hamamatsu Rosai Hospital, Shizuoka Red Cross Hospital, Hamamatsu University Hospital, JA Shizuoka Koseiren ENSHU hospital, Shizuoka Saiseikai General Hospital, Takamatsu Red Cross Hospital, National Hospital Organization, Hamamatsu University
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,852
OpenAlex ID: W7214075530