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 TsumuraJun Morinaga, Takuro Sakagami

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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.

Original languageEnglish
Article number107426
JournalLung Cancer
Publication statusPublished - 12-2023

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research


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