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)

被引：5

作者：

Sakata, Yoshihiko ^{[1
]}

Saito, Go ^{[2
]}

Sakata, Shinya ^{[3
]}

Oya, Yuko ^{[4
,5
]}

Tamiya, Motohiro ^{[6
]}

Suzuki, Hidekazu ^{[7
]}

Shibaki, Ryota ^{[8
]}

Okada, Asuka ^{[9
]}

Yokoyama, Toshihide ^{[10
]}

Matsumoto, Hirotaka ^{[11
]}

Otsuki, Taiichiro ^{[12
]}

Sato, Yuki ^{[13
]}

Junji, Uchida ^{[14
]}

Tsukita, Yoko ^{[15
]}

Inaba, Megumi ^{[16
]}

Ikeda, Hideki ^{[2
,17
]}

Arai, Daisuke ^{[18
]}

Maruyama, Hirotaka ^{[19
]}

Hara, Satoshi ^{[20
]}

Tsumura, Shinsuke ^{[21
]}

Morinaga, Jun ^{[22
]}

Sakagami, Takuro ^{[3
]}

机构：

[1] Saiseikai Kumamoto Hosp, Div Resp Med, 5-3-1 Chikami,Minami Ku, Kumamoto 8614193, Japan

[2] Chiba Univ, Grad Sch Med, Dept Respirol, 1-8-1 Inohana,Chuo Ku, Chiba, Chiba 2608670, Japan

[3] Kumamoto Univ Hosp, Dept Resp Med, 1-1-1 Honjo,Chuo Ku, Kumamoto 8608556, Japan

[4] Aichi Canc Ctr Hosp, Dept Thorac Oncol, 1-1 Kanokoden,Chikusa Ku, Nagoya, Aichi 4648681, Japan

[5] Fujita Hlth Univ, Sch Med, Dept Resp Med, Kutsukake Cho, Toyoake, Aichi 4701192, Japan

[6] Osaka Int Canc Inst, Dept Thorac Oncol, 3-1-69 Otemae,Chuo Ku, Osaka, Osaka 5418567, Japan

[7] Osaka Habikino Med Ctr, Dept Thorac Oncol, 3-7-1 Habikino, Habikino, Osaka 5838588, Japan

[8] Wakayama Med Univ, Internal Med 3, 811-1 Kimiidera, Wakayama, Wakayama 6418509, Japan

[9] Osaka City Gen Hosp, Dept Med Oncol, 2-13-22 Miyakojima Hondori,Miyakojima Ku, Osaka 5340021, Japan

[10] Kurashiki Cent Hosp, Dept Resp Med, 1-1-1 Miwa, Kurashiki, Okayama 7108602, Japan

[11] Hyogo Prefectural Amagasaki Gen Med Ctr, Dept Resp Med, 2-17-77 Higashinaniwa, Amagasaki, Hyogo 6608550, Japan

[12] Hyogo Med Univ, Dept Resp Med & Hematol, Sch Med, 1-1 Mukogawa Cho, Nishinomiya, Hyogo 6638501, Japan

[13] Kobe City Med Ctr Gen Hosp, Dept Resp Med, 2-1-1 Minatojimaminami,Chuo Ku, Kobe, Hyogo 6500047, Japan

[14] Natl Hosp Org Osaka Toneyama Med Ctr, Dept Thorac Oncol, 5-1-1 Toneyama, Toyonaka, Osaka 5608552, Japan

[15] Tohoku Univ, Grad Sch Med, Dept Resp Med, 1-1 Seiryo,Aoba Ku, Sendai, Miyagi 9808574, Japan

[16] Kumamoto City Hosp, Div Resp Med, 1-5-1 Tainoshima,Minami Ku, Kumamoto 8620965, Japan

[17] Kimitsu Chuo Hosp, Dept Resp Med, 1010 Sakurai, Kisarazu, Chiba 2928535, Japan

[18] Saiseikai Utsunomiya Hosp, Dept Internal Med, 911-1 Takebayashi, Utsunomiya, Tochigi 3210974, Japan

[19] Kumamoto Rosai Hosp, Dept Resp Med, Japan Org Occupat Hlth & Safety, 1670 Takehara, Yatsushiro, Kumamoto 8668533, Japan

[20] Itami City Hosp, Dept Resp Med, 1-100 Koyaike, Itami, Hyogo 6648540, Japan

[21] Kumamoto Reg Med Ctr, Dept Resp Med, 5-16-10 Honjo,Chuo Ku, Kumamoto 8600811, Japan

[22] Kumamoto Univ Hosp, Dept Clin Invest Biostat, 1-1-1 Honjo,Chuo Ku, Kumamoto 8608556, Japan

来源：

LUNG CANCER | 2023年 / 186卷

关键词：

Non-small cell lung cancer; EGFR mutation; First-line therapy; Osimertinib; Elderly; Real world; FACTOR RECEPTOR MUTATIONS; OPEN-LABEL; PHASE-II; GEFITINIB; CHEMOTHERAPY; MULTICENTER; ERLOTINIB; AFATINIB;

D O I：

10.1016/j.lungcan.2023.107426

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 treat-ment, 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.

引用

页数：10

共 32 条

[1] Osimertinib-Induced Cardiotoxicity A Retrospective Review of the FDA Adverse Events Reporting System (FAERS) [J].

Anand, Kartik ;

Ensor, Joe ;

Trachtenberg, Barry ;

Bernicker, Eric H. .

JACC: CARDIOONCOLOGY, 2019, 1 (02) :172-178

[2] Older patients with EGFR mutation-positive non-small cell lung cancer treated with afatinib in clinical practice: A subset analysis of the non-interventional GIDEON study [J].

Brueckl, Wolfgang M. ;

Reck, Martin ;

Schaefer, Harald ;

Neben, Kai ;

Griesinger, Frank ;

Rawluk, Justyna ;

Krueger, Stefan ;

Kokowski, Konrad ;

Ficker, Joachim H. ;

Moeller, Miriam ;

Schueler, Andrea ;

Laack, Eckart .

JOURNAL OF GERIATRIC ONCOLOGY, 2023, 14 (01)

[3] A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients: The SPIRAL-0 Study [J].

Chihara, Yusuke ;

Takeda, Takayuki ;

Goto, Yasuhiro ;

Nakamura, Yoichi ;

Tsuchiya-Kawano, Yuko ;

Nakao, Akira ;

Onoi, Keisuke ;

Hibino, Makoto ;

Fukuda, Minoru ;

Honda, Ryoichi ;

Yamada, Takahiro ;

Taniguchi, Ryusuke ;

Sakamoto, Sinjiro ;

Date, Koji ;

Nagashima, Seiji ;

Tanzawa, Shigeru ;

Minato, Koichi ;

Nakatani, Koichi ;

Izumi, Miiru ;

Shimose, Takayuki ;

Kishimoto, Junji ;

Uchino, Junji ;

Takayama, Koichi .

ONCOLOGIST, 2022, 27 (11) :903-E834

[4] Cardiac Safety of Osimertinib: A Review of Data [J].

Ewer, Michael S. ;

Tekumalla, Sri Harsha ;

Walding, Andrew ;

Atuah, Kwame N. .

JOURNAL OF CLINICAL ONCOLOGY, 2021, 39 (04) :328-+

[5] A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer [J].

Igawa, Satoshi ;

Kasajima, Masashi ;

Ono, Taihei ;

Ozawa, Takahiro ;

Kakegawa, Mikiko ;

Kusuhara, Seiichiro ;

Sato, Takashi ;

Nakahara, Yoshiro ;

Fukui, Tomoya ;

Yokoba, Masanori ;

Kubota, Masaru ;

Mitsufuji, Hisashi ;

Sasaki, Jiichiro ;

Naoki, Katsuhiko .

CANCER MANAGEMENT AND RESEARCH, 2021, 13 :8695-8705

[6] A phase II study of afatinib treatment for elderly patients with previously untreated advanced non-small-cell lung cancer harboring EGFR mutations [J].

Imai, Hisao ;

Kaira, Kyoichi ;

Suzuki, Kensuke ;

Anzai, Masaki ;

Tsuda, Takeshi ;

Ishizuka, Tamotsu ;

Kuwako, Tomohito ;

Naruse, Ichiro ;

Nemoto, Kenji ;

Uchino, Junji ;

Morozumi, Nobutoshi ;

Ishihara, Shinichi ;

Minato, Koichi ;

Hisada, Takeshi .

LUNG CANCER, 2018, 126 :41-47

[7] Phase II study of erlotinib in elderly patients with non-small cell lung cancer harboring epidermal growth factor receptor mutations [J].

Inoue, Yusuke ;

Inui, Naoki ;

Asada, Kazuhiro ;

Karayama, Masato ;

Matsuda, Hiroyuki ;

Yokomura, Koshi ;

Koshimizu, Naoki ;

Imokawa, Shiro ;

Yamada, Takashi ;

Shirai, Toshihiro ;

Kasamatsu, Norio ;

Suda, Takafumi .

CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2015, 76 (01) :155-161

[8] Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non-Small Cell Lung Cancer [J].

Kazandjian, Dickran ;

Gong, Yutao ;

Keegan, Patricia ;

Pazdur, Richard ;

Blumenthal, Gideon M. .

JAMA ONCOLOGY, 2019, 5 (10) :1481-1485

[9] First-line gefitinib treatment in elderly patients (aged ≥75 years) with non-small cell lung cancer harboring EGFR mutations [J].

Kuwako, Tomohito ;

Imai, Hisao ;

Masuda, Tomomi ;

Miura, Yosuke ;

Seki, Kaori ;

Yoshino, Reiko ;

Kaira, Kyoichi ;

Utsugi, Mitsuyoshi ;

Shimizu, Kimihiro ;

Sunaga, Noriaki ;

Tomizawa, Yoshio ;

Ishihara, Shinichi ;

Ishizuka, Takao ;

Mogi, Akira ;

Hisada, Takeshi ;

Minato, Koichi ;

Takise, Atsushi ;

Saito, Ryusei ;

Yamada, Masanobu .

CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2015, 76 (04) :761-769

[10] Participation of Older Adults in Clinical Trials for New Drug Applications and Biologics License Applications From 2010 Through 2019 [J].

Lau, S. W. Johnny ;

Huang, Yue ;

Hsieh, Julie ;

Wang, Shenggang ;

Liu, Qi ;

Slattum, Patricia W. ;

Schwartz, Janice B. ;

Huang, Shiew-Mei ;

Temple, Robert .

JAMA NETWORK OPEN, 2022, 5 (10) :E2236149

← 1 2 3 4 →