The Whole Picture of First-Line Osimertinib for EGFR Mutation-Positive Advanced NSCLC: Real-World Efficacy, Safety, Progression Pattern, and Posttreatment Therapy (Reiwa Study)

Kageaki Watanabe, MD; Yukio Hosomi, MD, PhD; Katsuhiko Naoki, MD, PhD; Yoshiro Nakahara, MD, PhD; Yoko Tsukita, MD, PhD; Hirotaka Matsumoto, MD, PhD; Kiyotaka Yoh, MD; Yasuhito Fujisaka, MD, PhD; Satoshi Takahashi, MD, PhD; Saori Takata, MD, PhD; Kazuhiro Usui, MD, PhD; Kazuma Kishi, MD, PhD; Go Naka, MD, PhD; Shu Tamano, MSS; Kohei Uemura, PhD; Hideo Kunitoh, MD, PhD

JTO Clinical and Research Reports (Nov 2024)

The Whole Picture of First-Line Osimertinib for EGFR Mutation-Positive Advanced NSCLC: Real-World Efficacy, Safety, Progression Pattern, and Posttreatment Therapy (Reiwa Study)

Kageaki Watanabe, MD,
Yukio Hosomi, MD, PhD,
Katsuhiko Naoki, MD, PhD,
Yoshiro Nakahara, MD, PhD,
Yoko Tsukita, MD, PhD,
Hirotaka Matsumoto, MD, PhD,
Kiyotaka Yoh, MD,
Yasuhito Fujisaka, MD, PhD,
Satoshi Takahashi, MD, PhD,
Saori Takata, MD, PhD,
Kazuhiro Usui, MD, PhD,
Kazuma Kishi, MD, PhD,
Go Naka, MD, PhD,
Shu Tamano, MSS,
Kohei Uemura, PhD,
Hideo Kunitoh, MD, PhD

Affiliations

Kageaki Watanabe, MD: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan; Corresponding author. Address for correspondence: Kageaki Watanabe, MD, Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22, Bunkyo-ku, Tokyo 113-8677, Japan.
Yukio Hosomi, MD, PhD: Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan
Katsuhiko Naoki, MD, PhD: Department of Respiratory Medicine, Kitasato University School of Medicine, Kanagawa, Japan
Yoshiro Nakahara, MD, PhD: Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan
Yoko Tsukita, MD, PhD: Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan
Hirotaka Matsumoto, MD, PhD: Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan
Kiyotaka Yoh, MD: Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan
Yasuhito Fujisaka, MD, PhD: Medical Oncology, Osaka Medical and Pharmaceutical University, Osaka, Japan
Satoshi Takahashi, MD, PhD: Department of Thoracic Surgery, Tokyo Medical University, Tokyo, Japan
Saori Takata, MD, PhD: Department of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan
Kazuhiro Usui, MD, PhD: Department of Respiratory Medicine, NTT Medical Center Tokyo, Tokyo, Japan
Kazuma Kishi, MD, PhD: Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan
Go Naka, MD, PhD: Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan
Shu Tamano, MSS: Biostatistics and Bioinformatics Course, Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Tokyo, Japan
Kohei Uemura, PhD: Department of Biostatistics and Bioinformatics, The Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan
Hideo Kunitoh, MD, PhD: Department of Chemotherapy, Japan Red Cross Medical Center, Tokyo, Japan

Journal volume & issue: Vol. 5, no. 11
p. 100720

Abstract

Read online

Introduction: Osimertinib is used as the first-line treatment for EGFR mutation-positive NSCLC. Nevertheless, its efficacy and safety in clinical practice remain to be fully elucidated and the pattern of progression and the optimal subsequent treatment after osimertinib remains unclear. Methods: This was a multicenter prospective observational study. EGFR mutation-positive patients with NSCLC who started first-line osimertinib from September 2018 to August 2020 were enrolled and followed up until August 2022. Results: A total of 583 patients received osimertinib. The median progression-free and overall survival were 20.0 (95% confidence interval [CI]: 17.6–21.7) months and 41.0 (95% CI: 37.1–44.1) months, respectively. Grade 3 or worse adverse events were observed in 136 patients (23.3%). Progression patterns were categorized as central nervous system only, oligo-progression, and multiple organs on the basis of the Response Evaluation Criteria in Solid Tumors—progressive disease and occurred in 37 (10.8%), 156 (45.4%), and 151 patients (43.9%). The patient’s condition on progression was asymptomatic in 195 patients (56.7%). Osimertinib was continued in 163 patients (47.4%) after confirming progression. In clinically stable population with progressive disease (n = 247), survival after progression was 13.3 (95% CI: 10.9–16.4) months for those who continued osimertinib beyond progressive disease (n = 124), and 24.1 (95% CI: 17.7–34.0) months for those who discontinued osimertinib (n = 123) (hazard ratio = 2.01, 95% CI: 1.38–2.91, p = 0.0002). Platinum plus pemetrexed had the best overall survival benefits after osimertinib. Conclusions: First-line osimertinib was found to have good effectiveness comparable to that reported in pivotal studies. Nevertheless, osimertinib should be discontinued among those who develop progression. Trial registration number: UMIN000038683

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

About the journal

Abstract

Keywords