학술논문
Real-World Data on Subsequent Therapy for First-Line Osimertinib-Induced Pneumonitis: Safety of EGFR-TKI Rechallenge (Osi-risk Study TORG-TG2101)
Document Type
Original Paper
Author
Nishioka, Naoya; Imai, Hisao; Endo, Masahiro; Notsu, Akifumi; Doshita, Kosei; Igawa, Satoshi; Yokouchi, Hiroshi; Ninomiya, Takashi; Tokito, Takaaki; Soda, Sayo; Fujiwara, Takasato; Asao, Tetsuhiko; Nakamichi, Shinji; Kawamura, Takahisa; Inomata, Minehiko; Nakashima, Kazuhisa; Ito, Kentaro; Goto, Yasuhiro; Umeda, Yukihiro; Hirai, Soichi; Ushio, Ryota; Yokoo, Keiki; Takeda, Takayuki; Fukui, Tomoya; Ishihara, Masashi; Osaki, Takashi; Kubo, Sousuke; Fujiwara, Takumi; Yamamoto, Chie; Tsuda, Takeshi; Tamura, Nobumasa; Hosokawa, Shinobu; Chihara, Yusuke; Ikeda, Satoshi; Furuya, Naoki; Nakahara, Yoshiro; Miura, Satoru; Okamoto, Hiroaki
Source
Targeted Oncology. 19(3):423-433
Subject
Language
English
ISSN
1776-2596
1776-260X
1776-260X
Abstract
Background: Although osimertinib is a promising therapeutic agent for advanced epidermal growth factor receptor (EGFR) mutation-positive lung cancer, the incidence of pneumonitis is particularly high among Japanese patients receiving the drug. Furthermore, the safety and efficacy of subsequent anticancer treatments, including EGFR-tyrosine kinase inhibitor (TKI) rechallenge, which are to be administered after pneumonitis recovery, remain unclear.Objective: This study investigated the safety of EGFR-TKI rechallenge in patients who experienced first-line osimertinib-induced pneumonitis, with a primary focus on recurrent pneumonitis.Patients and Methods: We retrospectively reviewed the data of patients with EGFR mutation-positive lung cancer who developed initial pneumonitis following first-line osimertinib treatment across 34 institutions in Japan between August 2018 and September 2020.Results: Among the 124 patients included, 68 (54.8%) patients underwent EGFR-TKI rechallenge. The recurrence rate of pneumonitis following EGFR-TKI rechallenge was 27% (95% confidence interval [CI] 17–39) at 12 months. The cumulative incidence of recurrent pneumonitis was significantly higher in the osimertinib group than in the first- and second-generation EGFR-TKI (conventional EGFR-TKI) groups (hazard ratio [HR] 3.1; 95% CI 1.3–7.5; p = 0.013). Multivariate analysis revealed a significant association between EGFR-TKI type (osimertinib or conventional EGFR-TKI) and pneumonitis recurrence, regardless of severity or status of initial pneumonitis (HR 3.29; 95% CI 1.12–9.68; p = 0.03).Conclusions: Osimertinib rechallenge after initial pneumonitis was associated with significantly higher recurrence rates than conventional EGFR-TKI rechallenge.