Osimertinib as first-line treatment for elderly patients with advanced EGFR mutation-positive non-small cell lung cancer in a real-world setting (OSI-FACT-EP)

Yoshihiko Sakata; Go Saito; Shinya Sakata; Yuko Oya; Motohiro Tamiya; Hidekazu Suzuki; Ryota Shibaki; Asuka Okada; Toshihide Yokoyama; Hirotaka Matsumoto; Taiichiro Otsuki; Yuki Sato; Uchida Junji; Yoko Tsukita; Megumi Inaba; Hideki Ikeda; Daisuke Arai; Hirotaka Maruyama; Satoshi Hara; Shinsuke Tsumura; Jun Morinaga; Takuro Sakagami

doi:10.1016/j.lungcan.2023.107426

Osimertinib as first-line treatment for elderly patients with advanced EGFR mutation-positive non-small cell lung cancer in a real-world setting (OSI-FACT-EP)

Lung Cancer. 2023 Dec:186:107426. doi: 10.1016/j.lungcan.2023.107426. Epub 2023 Nov 19.

Authors

Yoshihiko Sakata¹, Go Saito², Shinya Sakata³, Yuko Oya⁴, Motohiro Tamiya⁵, Hidekazu Suzuki⁶, Ryota Shibaki⁷, Asuka Okada⁸, Toshihide Yokoyama⁹, Hirotaka Matsumoto¹⁰, Taiichiro Otsuki¹¹, Yuki Sato¹², Uchida Junji¹³, Yoko Tsukita¹⁴, Megumi Inaba¹⁵, Hideki Ikeda¹⁶, Daisuke Arai¹⁷, Hirotaka Maruyama¹⁸, Satoshi Hara¹⁹, Shinsuke Tsumura²⁰, Jun Morinaga²¹, Takuro Sakagami³

Affiliations

¹ Division of Respiratory Medicine, Saiseikai Kumamoto Hospital, 5-3-1 Chikami, Minami-ku, Kumamoto 861-4193, Japan. Electronic address: [email protected].
² Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8670, Japan.
³ Department of Respiratory Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan.
⁴ Department of Thoracic Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan; Department of Respiratory Medicine, Fujita Health University School of Medicine, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan.
⁵ Department of Thoracic Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, Osaka 541-8567, Japan.
⁶ Department of Thoracic Oncology, Osaka Habikino Medical Center, 3-7-1 Habikino, Habikino, Osaka 583-8588, Japan.
⁷ Internal Medicine III, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Wakayama 641-8509, Japan.
⁸ Department of Medical Oncology, Osaka City General Hospital, 2-13-22 Miyakojima-hondori, Miyakojima-ku, Osaka 531-0021, Japan.
⁹ Department of Respiratory Medicine, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan.
¹⁰ Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, 2-17-77 Higashinaniwa, Amagasaki, Hyogo 660-8550, Japan.
¹¹ Department of Respiratory Medicine and Hematology, Hyogo Medical University, School of Medicine, 1-1, Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan.
¹² Department of Respiratory Medicine, Kobe City Medical Center General Hospital, 2-1-1 Minatojimaminami, Chuo-ku, Kobe, Hyogo 650-0047, Japan.
¹³ Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, 5-1-1 Toneyama, Toyonaka, Osaka, Osaka 560-8552, Japan.
¹⁴ Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo, Aoba-ku, Sendai, Miyagi 980-8574, Japan.
¹⁵ Division of Respiratory Medicine, Kumamoto Chuo Hospital, 1-5-1 Tainoshima, Minami-ku, Kumamoto 862-0965, Japan.
¹⁶ Department of Respirology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8670, Japan; Department of Respiratory Medicine, Kimitsu Chuo Hospital, 1010 Sakurai, Kisarazu, Chiba 292-8535, Japan.
¹⁷ Department of Internal Medicine, Saiseikai Utsunomiya Hospital, 911-1 Takebayashi, Utsunomiya, Tochigi 321-0974, Japan.
¹⁸ Department of Respiratory Medicine, Japan Organization of Occupational Health and Safety, Kumamoto Rosai Hospital, 1670 Takehara, Yatsushiro, Kumamoto 866-8533, Japan.
¹⁹ Department of Respiratory Medicine, Itami City Hospital, 1-100 Koyaike, Itami, Hyogo 664-8540, Japan.
²⁰ Department of Respiratory Medicine, Kumamoto Regional Medical Center, 5-16-10 Honjyo, Chuo-ku, Kumamoto 860-0811, Japan.
²¹ Department of Clinical Investigation (Biostatistics), Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan.

PMID: 37992594
DOI: 10.1016/j.lungcan.2023.107426

Abstract

Objectives: Osimertinib is the primary treatment for patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer. However, evidence of the outcomes of osimertinib treatment in patients over 75 years of age in the real-world setting is limited.

Materials and methods: This retrospective study analyzed the data of 538 patients (203 elderly and 335 non-elderly) with EGFR mutation-positive lung cancer in whom osimertinib was initiated as first-line treatment between August 2018 and December 2019. Patients over 75 years of age were classified as elderly. The data cut-off date was February 28, 2022.

Results: The progression-free survival (PFS) did not significantly differ between the elderly and non-elderly groups [elderly group: median PFS, 16.9 months (95 % confidence interval (CI), 14.3-20.2); non-elderly group: median PFS, 22.1 months (95 % CI: 19.5-26.3); hazard ratio (HR) for the elderly against the non-elderly: 1.21 (95 % CI: 0.98-1.50), p = 0.079]. However, the time to treatment failure (TTF) was significantly shorter in the elderly than in the non-elderly [elderly group: median TTF, 14.0 months (95 % CI: 0.98-1.50); non-elderly group: median TTF, 21.8 months (95 % CI: 18.2-24.6); HR for the elderly against the non-elderly: 1.46 (95 % CI: 1.20-1.77), p < 0.001]. Furthermore, the rate of treatment discontinuation because of adverse events was 28.6 % in the elderly and 14.9 % in the non-elderly (p < 0.001). Among patients who discontinued treatment, the conversion rate to second-line treatment was 39.6 % in the elderly and 72.8 % in the non-elderly. In addition, the median overall survival was 30 months (95 % CI: 25.8-37.7) in the elderly and not reached (NR) (95 % CI: NR-NR) in the non-elderly (p < 0.001).

Conclusion: In a real-world clinical setting, elderly patients receiving osimertinib as first-line treatment should be aware of the frequent inability to transition to second-line treatment due to adverse events.

Keywords: EGFR mutation; Elderly; First-line therapy; Non-small cell lung cancer; Osimertinib; Real world.

MeSH terms

Aged
Aniline Compounds / therapeutic use
Carcinoma, Non-Small-Cell Lung* / drug therapy
Carcinoma, Non-Small-Cell Lung* / genetics
ErbB Receptors / genetics
Humans
Lung Neoplasms* / chemically induced
Lung Neoplasms* / drug therapy
Lung Neoplasms* / genetics
Middle Aged
Mutation
Protein Kinase Inhibitors / therapeutic use
Retrospective Studies

Substances

osimertinib
Aniline Compounds
ErbB Receptors
Protein Kinase Inhibitors
EGFR protein, human