Abstract 1103P
Background
Osimertinib has demonstrated impressive efficacy as a first-line treatment for patients with advanced epidermal growth factor receptor (EGFR) mutation-positive (m+) lung cancer. Drug-related pneumonitis (DRP) is a potentially lethal complication of osimertinib treatment, but reliable real-world data are currently lacking.
Methods
We conducted a retrospective multicenter cohort study of patients who received osimertinib as a first-line treatment for advanced EGFR m+ non-small cell lung cancer (NSCLC) between August 2018 and December 2019. All chest computed tomography (CT) scans and clinical information during osimertinib exposure were collected until June 2020. The primary endpoint was DRP incidence identified through central review.
Results
A total of 452 patients from 18 institutions were evaluated. Eighty patients (18%) were diagnosed with DRP (all grades), and 21 patients (4.6%) had ≥grade 3 DRP. Among the patients with DRP, 46% were identified as having transient asymptomatic pulmonary opacity (TAPO). Regarding the CT patterns, organizing pneumonia, simple pulmonary eosinophilia, hypersensitivity pneumonia, diffuse alveolar damage, and non-specific interstitial pneumonia were found in 30, 21, 18, 9, and 2 patients (38%, 26%, 23%, 11%, and 3%), respectively. In multivariate analysis, smoking history was identified as an independent risk factor for DRP (hazard ratio: 1.72, 95% confidence interval: 1.01–2.89, P=0.046). In the 3-month landmark analysis, DRP was associated with poor treatment efficacy; however, the presence of TAPO did not negatively affect treatment efficacy.
Conclusions
For osimertinib treatment in first-line settings, the frequency of DRP was considerably elevated to 18 %, and half of these patients exhibited TAPO features.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
This study was supported by internal funding of Kobe City Medical Center General Hospital and Internal Medicine III, Wakayama Medical University.
Disclosure
Y. Sato: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Novartis, Pfizer, Taiho Pharmaceutical, Nippon Kayaku, Bristol Myers Squibb, Eli Lilly, Takeda, Kyowa Kirin. H. Sumikawa: Financial Interests, Personal, Advisory Board: Fujifilm Corporation; Financial Interests, Personal, Speaker’s Bureau: Shionogi Inc., Daiichi Sankyo Company, Gakken Medical Group Shujunsya Co. Ltd. T. Morimoto: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Toray, Tsumura; Financial Interests, Personal, Writing Engagements: Bristol-Myers Squibb, Kowa; Financial Interests, Personal, Advisory Role: Novartis. Y. Sakata: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, MSD, Taiho Pharmaceutical. Y. Oya: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Taiho Pharmaceutical, Daiichi Sankyo, Takeda, Amgen, Ono Pharmaceutical. M. Tamiya: Financial Interests, Personal, Research Grant: Boehringer Ingelheim, Ono Pharmaceutical, Bristol-Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Taiho Pharmaceutical, Eli Lilly Japan, Novartis, Asahi Kasei Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb, MSD, Bayer, Pfizer. H. Suzuki: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Bristol-Myers Squibb, Eli Lilly Japan, AstraZeneca. H. Matsumoto: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Taiho Pharmaceutical, Ono Pharmaceutical, Boehringer Ingelheim. T. Kijima: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca Co. Ltd. A. Hino: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Daiichi Sankyo, Taiho Pharmaceutical outside the submitted work. M. Inaba: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, AstraZeneca, Bristol Myers Squibb, Ono Pharmaceutical. Y. Tsukita: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Chugai Pharmaceutical. H. Ikeda: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, AstraZeneca, Bristol Myers Squibb, Ono Pharmaceutical. D. Arai: Financial Interests, Personal, Speaker’s Bureau: Taiho Pharmaceutical, AstraZeneca, Pfizer. H. Maruyama: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim. S. Sakata: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim, Taiho Pharmaceutical. D. Fujimoto: Financial Interests, Personal, Research Grant: Boehringer Ingelheim, AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Astra-Zeneca, Ono Pharmaceutical, Bristol Myers Squibb, Taiho Pharmaceutical, Chugai Pharmaceutical, MSD, Boehringer Ingelheim, Eli Lilly Japan, Novartis Pharma; Financial Interests, Personal, Advisory Role: AstraZeneca, Chugai Pharmaceutical. All other authors have declared no conflicts of interest.