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. 2021 Dec:159:144-153.
doi: 10.1016/j.ejca.2021.09.041. Epub 2021 Nov 5.

Osimertinib as first-line treatment for advanced epidermal growth factor receptor mutation-positive non-small-cell lung cancer in a real-world setting (OSI-FACT)

Yoshihiko Sakata  1 , Shinya Sakata  2 , Yuko Oya  3 , Motohiro Tamiya  4 , Hidekazu Suzuki  5 , Ryota Shibaki  6 , Asuka Okada  7 , Hiroshi Kobe  8 , Hirotaka Matsumoto  9 , Takashi Yokoi  10 , Yuki Sato  11 , Takeshi Uenami  12 , Go Saito  13 , Yoko Tsukita  14 , Megumi Inaba  15 , Hideki Ikeda  16 , Daisuke Arai  17 , Hirotaka Maruyama  18 , Satoshi Hara  19 , Shinsuke Tsumura  20 , Jun Morinaga  21 , Takuro Sakagami  2
Affiliations

Osimertinib as first-line treatment for advanced epidermal growth factor receptor mutation-positive non-small-cell lung cancer in a real-world setting (OSI-FACT)

Yoshihiko Sakata et al. Eur J Cancer. 2021 Dec.

Abstract

Background: Osimertinib is the standard of care in the initial treatment for advanced epidermal growth factor receptor (EGFR) mutation-positive lung cancer. However, clinical data and reliable prognostic biomarkers are insufficient.

Methods: We performed a retrospective multicentre cohort study for 538 EGFR mutation-positive patients, who received osimertinib as the initial treatment between August 2018 and December 2019. The main outcome was progression-free survival (PFS).

Results: The median observation period was 14.7 months (interquartile range 11.4-20.0). The median PFS was 20.5 months (95% confidence interval [CI] 18.6-not reached). Multivariate analysis showed that sex (male) (hazard ratio [HR] 1.99, 95% CI 1.35-2.93, P = 0.001), malignant effusions (HR 1.51, 95% CI 1.11-2.04, P = 0.008), liver metastasis (HR 1.55, 95% CI 1.03-2.33, P = 0.037), advanced unresectable cases (HR 1.71, 95% CI, 1.04-2.82, P = 0.036), mutation type and programmed cell death-ligand 1 (PD-L1) expression were associated with PFS. The L858R (HR 1.55, 95% CI 1.01-2.38, P = 0.043) and uncommon mutations (HR 3.15, 95% CI 1.70-5.83, P < 0.001) were associated with PFS. PD-L1 expression of 1-49% (HR 1.66, 95% CI 1.05-2.63, P = 0.029), ≥50% (HR 2.24, 95% CI 1.17-4.30, P = 0.015) and unknown (HR 1.53, 95% CI 1.05-2.22, P = 0.026) was associated with PFS. The main reasons for treatment discontinuation among 219 patients were disease progression (44.3%), pneumonitis (25.5%) and other adverse events (16.0%).

Conclusion: During initial treatment with osimertinib, PD-L1 expression is significantly related to PFS. Adverse events are a noteworthy reason for discontinuation.

Keywords: Adverse events; Discontinuation; EGFR mutation; Multicentre study; Multivariate analysis; Non–small-cell lung cancer; Osimertinib; Pneumonitis; Progression-free survival; Real-world.

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Conflict of interest statement

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Yo.S. reported receiving personal fees from Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, MSD and Taiho Pharmaceutical outside the submitted work. S.S. reported receiving personal fees from Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim and Taiho Pharmaceutical, outside the submitted work. Y.O. reported receiving personal fees from Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Taiho Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Amgen and Ono Pharmaceutical, outside the submitted work. M.T. reported receiving grants and personal fees from Boehringer Ingelheim, Ono Pharmaceutical and Bristol Myers Squibb and personal fees from Chugai Pharmaceutical, AstraZeneca, Taiho Pharmaceutical, Eli Lilly Japan, Asahi Kasei Pharmaceutical, MSD and Pfizer, outside the submitted work. H.S. reported receiving personal fees from Chugai Pharmaceutical, MSD and AstraZeneca, outside the submitted work. A.O. reported receiving personal fees from Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim and MSD, outside the submitted work. H.M. reported receiving personal fees from Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Taiho Pharmaceutical, Ono Pharmaceutical and Boehringer Ingelheim, outside the submitted work. T.Y. reported receiving grants and personal fees from Ono Pharmaceutical and personal fees from Chugai Pharmaceutical, Bristol Myers Squibb, Boehringer Ingelheim, AstraZeneca, Eli Lilly, MSD and Taiho Pharmaceutical, outside the submitted work. Yu.S. reported receiving personal fees from AstraZeneca, Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Novartis, Pfizer, Taiho Pharmaceutical, Nippon Kayaku, Bristol Myers Squibb and Kyowa Kirin, outside the submitted work. T.U. reported receiving personal fees from Chugai Pharmaceutical and AstraZeneca, outside the submitted work. G.S. reported receiving personal fees from Ono Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, Novartis Pharma and Taiho Pharmaceutical, outside the submitted work. Y.T. reported receiving personal fees from AstraZeneca and Chugai Pharmaceutical, outside the submitted work. M.I. reported receiving personal fees from Chugai Pharmaceutical, AstraZeneca, Boehringer Ingelheim, Taiho Pharmaceutical and MSD outside the submitted work. H.I. reported receiving personal fees from Chugai Pharmaceutical, AstraZeneca, Bristol Myers Squibb and Ono Pharmaceutical, outside the submitted work. D.A. reported receiving personal fees from Taiho Pharmaceutical, AstraZeneca and Pfizer, outside the submitted work. T.S. reported receiving personal fees from AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Eli Lilly, GlaxoSmithKline, KYORIN Pharmaceutical, Meiji Pharmaceutical, MSD, NOVARTIS, Ono Pharmaceutical, Pfizer and Taiho Pharmaceutical outside the submitted work.