A multicenter cohort study of osimertinib compared with afatinib as first-line treatment for EGFR-mutated non-small-cell lung cancer from practical dataset: CJLSG1903

被引：37

作者：

Ito, K. ^{[1
,2
]}

Morise, M. ^{[3
]}

Wakuda, K. ^{[4
]}

Hataji, O. ^{[1
]}

Shimokawaji, T. ^{[5
]}

Takahashi, K. ^{[6
]}

Furuya, N. ^{[7
]}

Takeyama, Y. ^{[8
]}

Goto, Y. ^{[9
]}

Abe, T. ^{[10
]}

Kato, T. ^{[11
]}

Ozone, S. ^{[3
]}

Ikeda, S. ^{[12
]}

Kogure, Y. ^{[13
]}

Yokoyama, T. ^{[14
]}

Kimura, M. ^{[15
]}

Yoshioka, H. ^{[16
]}

Murotani, K. ^{[17
]}

Kondo, M. ^{[9
]}

Saka, H. ^{[18
]}

机构：

[1] Matsusaka Municipal Hosp, Yokohama City Univ Sch Med, Matsusaka, Mie, Japan

[2] Yokohama City Univ, Dept Biostat, Sch Med, Yokohama, Kanagawa, Japan

[3] Nagoya Univ, Dept Resp Med, Grad Sch Med, Nagoya, Aichi, Japan

[4] Shizuoka Canc Ctr, Div Thorac Oncol, Shizuoka, Japan

[5] Niigata Canc Ctr Hosp, Dept Internal Med, Niigata, Japan

[6] Anjo Kosei Hosp, Dept Resp Med, Anjo, Aichi, Japan

[7] St Marianna Univ, Div Resp Med, Dept Internal Med, Sch Med, Kawasaki, Kanagawa, Japan

[8] Toyohashi Municipal Hosp, Dept Resp Med, Toyohashi, Aichi, Japan

[9] Fujita Hlth Univ, Dept Resp Med, Sch Med, Toyoake, Aichi, Japan

[10] Ogaki Municipal Hosp, Dept Resp Med, Gifu, Japan

[11] Aichi Med Univ, Div Resp Med & Allergol, Sch Med, Nagakute, Aichi, Japan

[12] Kanagawa Cardiovasc & Resp Ctr, Dept Resp Med, Yokohama, Kanagawa, Japan

[13] Natl Hosp Org Nagoya Med Ctr, Dept Resp Med, Nagoya, Aichi, Japan

[14] Japanese Red Cross Nagoya Daiichi Hosp, Dept Resp Med, Nagoya, Aichi, Japan

[15] Toyota Mem Hosp, Dept Resp Med, Toyota, Aichi, Japan

[16] Kansai Med Univ Hosp, Dept Thorac Oncol, Hirakata, Osaka, Japan

[17] Kurume Univ, Biostat Ctr, Kurume, Fukuoka, Japan

[18] Matsunami Gen Hosp, Dept Resp Med, Gifu, Japan

来源：

ESMO OPEN | 2021年 / 6卷 / 03期

关键词：

non-small-cell lung cancer; EGFR mutation; osimertinib; afatinib; real world data; GROWTH-FACTOR RECEPTOR; OPEN-LABEL; PHASE-III; CHEMOTHERAPY; GEFITINIB; ERLOTINIB;

D O I：

10.1016/j.esmoop.2021.100115

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: FLAURA, the prospective trial of osimertinib as a first-line therapy compared with first-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), did not show superior survival benefit for osimertinib in either the subgroup of Asians or the subgroup with the L858R mutation. In addition, the superiority of osimertinib compared with second-generation EGFR-TKI is thus far unclear. Patients and methods: We reviewed the clinical data of all consecutive patients who were treated with osimertinib or afatinib as first-line therapy between May 2016 and October 2019 from 15 institutions in Japan. We defined the groups based on first-line EGFR-TKI as the afatinib group and the osimertinib group. Outcomes included time to discontinuation of any EGFR-TKI (TD-TKI), overall survival (OS), and time to treatment failure, with propensity score analysis carried out as an exploratory analysis in the survival and subgroup analyses. Results: A total of 554 patients were enrolled. Data on 326 patients in the osimertinib group, and 224 patients in the afatinib group were analyzed. TD-TKI adjusted by propensity score in the afatinib and osimertinib groups was 18.6 months (95% confidence interval 15.8 to 22.0) and 20.5 months (95% confidence interval 13.8 to not reached), respectively, without significant difference (P = 0.204). OS adjusted by propensity score favored the afatinib group with a significant difference (P = 0.018). Subgroup analysis with propensity score showed that patients with 1858R and without brain metastasis had superior survival benefit with afatinib compared with osimertinib (P < 0.001). Conclusions: TD-TKI in the afatinib group was not significantly prolonged compared with the osimertinib group in the practical data. In the exploratory analysis of patients with L858R-mutated non-small-cell lung cancer without brain metastasis, afatinib showed more benefit in OS over osimertinib.

引用

页数：8

共 19 条

[1] Preclinical Comparison of Osimertinib with Other EGFR-TKIs in EGFR-Mutant NSCLC Brain Metastases Models, and Early Evidence of Clinical Brain Metastases Activity [J].

Ballard, Peter ;

Yates, James W. T. ;

Yang, Zhenfan ;

Kim, Dong-Wan ;

Yang, James Chih-Hsin ;

Cantarini, Mireille ;

Pickup, Kathryn ;

Jordan, Angela ;

Hickey, Mike ;

Grist, Matthew ;

Box, Matthew ;

Johnstrom, Peter ;

Varnas, Katarina ;

Malmquist, Jonas ;

Thress, Kenneth S. ;

Janne, Pasi A. ;

Cross, Darren .

CLINICAL CANCER RESEARCH, 2016, 22 (20) :5130-5140

[2] Osimertinib versus Standard of Care EGFR TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC: FLAURA Asian Subset [J].

Cho, Byoung Chul ;

Chewaskulyong, Busayamas ;

Lee, Ki Hyeong ;

Dechaphunkul, Arunee ;

Sriuranpong, Virote ;

Imamura, Fumio ;

Nogami, Naoyuki ;

Kurata, Takayasu ;

Okamoto, Isamu ;

Zhou, Caicun ;

Cheng, Ying ;

Cho, Eun Kyung ;

Voon, Pei Jye ;

Lee, Jong-Seok ;

Mann, Helen ;

Saggese, Matilde ;

Reungwetwattana, Thanyanan ;

Ramalingam, Suresh S. ;

Ohe, Yuichiro .

JOURNAL OF THORACIC ONCOLOGY, 2019, 14 (01) :99-106

[3] Preclinical Comparison of the Blood-brain barrier Permeability of Osimertinib with Other EGFR TKIs [J].

Colclough, Nicola ;

Chen, Kan ;

Johnstrom, Peter ;

Strittmatter, Nicole ;

Yan, Yumei ;

Wrigley, Gail L. ;

Schou, Magnus ;

Goodwin, Richard ;

Varnas, Katarina ;

Adua, Sally J. ;

Zhao, Minghui ;

Nguyen, Don X. ;

Maglennon, Gareth ;

Barton, Peter ;

Atkinson, James ;

Zhang, Lin ;

Janefeldt, Annika ;

Wilson, Joanne ;

Smith, Aaron ;

Takano, Akihiro ;

Arakawa, Ryosuke ;

Kondrashov, Mikhail ;

Malmquist, Jonas ;

Revunov, Evgeny ;

Vazquez-Romero, Ana ;

Moein, Mohammad Mahdi ;

Windhorst, Albert D. ;

Karp, Natasha A. ;

Finlay, M. Raymond, V ;

Ward, Richard A. ;

Yates, James W. T. ;

Smith, Paul D. ;

Farde, Lars ;

Cheng, Zack ;

Cross, Darren A. E. .

CLINICAL CANCER RESEARCH, 2021, 27 (01) :189-201

[4] Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: updated analysis of the observational GioTag study [J].

Hochmair, Maximilian J. ;

Morabito, Alessandro ;

Hao, Desiree ;

Yang, Cheng-Ta ;

Soo, Ross A. ;

Yang, James C-H ;

Gucalp, Rasim ;

Halmos, Balazs ;

Wang, Lara ;

Maerten, Angela ;

Cufer, Tanja .

FUTURE ONCOLOGY, 2019, 15 (25) :2905-2913

[5] Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: an observational study [J].

Hochmair, Maximilian J. ;

Morabito, Alessandro ;

Hao, Desiree ;

Yang, Cheng-Ta ;

Soo, Ross A. ;

Yang, James C-H ;

Gucalp, Rasim ;

Halmos, Balazs ;

Wang, Lara ;

Golembesky, Amanda ;

Maerten, Angela ;

Cufer, Tanja .

FUTURE ONCOLOGY, 2018, 14 (27) :2861-2874

[6] Epidermal growth factor receptor: mechanisms of activation and signalling [J].

Jorissen, RN ;

Walker, F ;

Pouliot, N ;

Garrett, TPJ ;

Ward, CW ;

Burgess, AW .

EXPERIMENTAL CELL RESEARCH, 2003, 284 (01) :31-53

[7] 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

[8] 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

[9] 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

[10] Observational Study of Treatment Patterns in Patients with Epidermal Growth Factor Receptor (EGFR) Mutation-Positive Non-Small Cell Lung Cancer After First-Line EGFR-Tyrosine Kinase Inhibitors [J].

Nadler, Eric ;

Pavilack, Melissa ;

Espirito, Janet L. ;

Clark, Jamyia ;

Fernandes, Ancilla .

ADVANCES IN THERAPY, 2020, 37 (02) :946-954

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