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
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
收藏
页数:10
相关论文
共 32 条
[11]   Adequacy of Inclusion of Older Adults in NIH-Funded Phase III Clinical Trials [J].
Lockett, Jaron ;
Sauma, Samir ;
Radziszewska, Barbara ;
Bernard, Marie A. .
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY, 2019, 67 (02) :218-222
[12]   First-Line Gefitinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations NEJ 003 Study [J].
Maemondo, Makoto ;
Minegishi, Yuji ;
Inoue, Akira ;
Kobayashi, Kunihiko ;
Harada, Masao ;
Okinaga, Shoji ;
Morikawa, Naoto ;
Oizumi, Satoshi ;
Tanaka, Tomoaki ;
Isobe, Hiroshi ;
Kudoh, Shoji ;
Hagiwara, Koichi ;
Nukiwa, Toshihiro ;
Gemma, Akihiko .
JOURNAL OF THORACIC ONCOLOGY, 2012, 7 (09) :1417-1422
[13]   Gefitinib or Chemotherapy for Non-Small-Cell Lung Cancer with Mutated EGFR. [J].
Maemondo, Makoto ;
Inoue, Akira ;
Kobayashi, Kunihiko ;
Sugawara, Shunichi ;
Oizumi, Satoshi ;
Isobe, Hiroshi ;
Gemma, Akihiko ;
Harada, Masao ;
Yoshizawa, Hirohisa ;
Kinoshita, Ichiro ;
Fujita, Yuka ;
Okinaga, Shoji ;
Hirano, Haruto ;
Yoshimori, Kozo ;
Harada, Toshiyuki ;
Ogura, Takashi ;
Ando, Masahiro ;
Miyazawa, Hitoshi ;
Tanaka, Tomoaki ;
Saijo, Yasuo ;
Hagiwara, Koichi ;
Morita, Satoshi ;
Nukiwa, Toshihiro .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (25) :2380-2388
[14]   A phase II study of first-line afatinib for patients aged ≥75 years with EGFR mutation-positive advanced non-small cell lung cancer: North East Japan Study Group trial NEJ027 [J].
Minegishi, Yuji ;
Yamaguchi, Ou ;
Sugawara, Shunichi ;
Kuyama, Shoichi ;
Watanabe, Satoshi ;
Usui, Kazuhiro ;
Mori, Masahide ;
Hataji, Osamu ;
Nukiwa, Toshihiro ;
Morita, Satoshi ;
Kobayashi, Kunihiko ;
Gemma, Akihiko .
BMC CANCER, 2021, 21 (01)
[15]   Low-Dose Erlotinib Treatment in Elderly or Frail Patients With EGFR Mutation-Positive Non-Small Cell Lung Cancer A Multicenter Phase 2 Trial [J].
Miyamoto, Shingo ;
Azuma, Koichi ;
Ishii, Hidenobu ;
Bessho, Akihiro ;
Hosokawa, Shinobu ;
Fukamatsu, Nobuaki ;
Kunitoh, Hideo ;
Ishii, Mari ;
Tanaka, Hiroshi ;
Aono, Hiromi ;
Nakahara, Yoshiro ;
Kusaka, Kei ;
Hosomi, Yukio ;
Kikuchi, Norihiro ;
Mori, Yoshiaki ;
Itani, Hidetoshi ;
Hamada, Akinobu ;
Yamada, Kazuhiko ;
Okamoto, Hiroaki .
JAMA ONCOLOGY, 2020, 6 (07)
[16]   Original Research Pharmacokinetic and pharmacogenomic analysis of low-dose afatinib treatment in elderly patients with EGFR mutation-positive non-small cell lung cancer [J].
Mizugaki, Hidenori ;
Oizumi, Satoshi ;
Fujita, Yuka ;
Harada, Toshiyuki ;
Nakahara, Yoshiro ;
Takashina, Taichi ;
Ko, Ryo ;
Watanabe, Kageaki ;
Hotta, Takamasa ;
Minemura, Hiroyuki ;
Saeki, Sho ;
Asahina, Hajime ;
Nakamura, Keiichi ;
Nakamura, Hiromi ;
Hosoda, Fumie ;
Yagishita, Shigehiro ;
Hamada, Akinobu .
EUROPEAN JOURNAL OF CANCER, 2022, 160 :227-234
[17]   Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer [J].
Mok, T. S. ;
Wu, Y. -L. ;
Ahn, M. -J. ;
Garassino, M. C. ;
Kim, H. R. ;
Ramalingam, S. S. ;
Shepherd, F. A. ;
He, Y. ;
Akamatsu, H. ;
Theelen, W. S. M. E. ;
Lee, C. K. ;
Sebastian, M. ;
Templeton, A. ;
Mann, H. ;
Marotti, M. ;
Ghiorghiu, S. ;
Papadimitrakopoulou, V. A. .
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 376 (07) :629-640
[18]   Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma. [J].
Mok, Tony S. ;
Wu, Yi-Long ;
Thongprasert, Sumitra ;
Yang, Chih-Hsin ;
Chu, Da-Tong ;
Saijo, Nagahiro ;
Sunpaweravong, Patrapim ;
Han, Baohui ;
Margono, Benjamin ;
Ichinose, Yukito ;
Nishiwaki, Yutaka ;
Ohe, Yuichiro ;
Yang, Jin-Ji ;
Chewaskulyong, Busyamas ;
Jiang, Haiyi ;
Duffield, Emma L. ;
Watkins, Claire L. ;
Armour, Alison A. ;
Fukuoka, Masahiro .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (10) :947-957
[19]   First-line gefitinib for elderly patients with advanced NSCLC harboring EGFR mutations. A combined analysis of North-East Japan Study Group studies [J].
Morikawa, Naoto ;
Minegishi, Yuji ;
Inoue, Akira ;
Maemondo, Makoto ;
Kobayashi, Kunihiko ;
Sugawara, Shunichi ;
Harada, Masao ;
Hagiwara, Koichi ;
Okinaga, Shoji ;
Oizumi, Satoshi ;
Nukiwa, Toshihiro ;
Gemma, Akihiko .
EXPERT OPINION ON PHARMACOTHERAPY, 2015, 16 (04) :465-472
[20]   Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset [J].
Ohe, Yuichiro ;
Imamura, Fumio ;
Nogami, Naoyuki ;
Okamoto, Isamu ;
Kurata, Takayasu ;
Kato, Terufumi ;
Sugawara, Shunichi ;
Ramalingam, Suresh S. ;
Uchida, Hirohiko ;
Hodge, Rachel ;
Vowler, Sarah L. ;
Walding, Andrew ;
Nakagawa, Kazuhiko .
JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2019, 49 (01) :29-36