TY - JOUR
T1 - Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC
T2 - FLAURA Japanese subset
AU - Ohe, Yuichiro
AU - Imamura, Fumio
AU - Nogami, Naoyuki
AU - Okamoto, Isamu
AU - Kurata, Takayasu
AU - Kato, Terufumi
AU - Sugawara, Shunichi
AU - Ramalingam, Suresh S.
AU - Uchida, Hirohiko
AU - Hodge, Rachel
AU - Vowler, Sarah L.
AU - Walding, Andrew
AU - Nakagawa, Kazuhiko
N1 - Funding Information:
The authors are grateful to all of the patients and families involved in this study. The authors thank all of the principal investigators: Toshiaki Takahashi from Shizuoka Cancer Center, Shizuoka, Japan; Kazuo Kasahara from Kanazawa University Hospital, Kanazawa, Japan; Kiyotaka Yoh from National Cancer Center Hospital East, Chiba, Japan; Masaharu Shinkai from Yokohama City University Medical Center, Kanagawa, Japan; Tsuneo Shimokawa from Yokohama Municipal Citizen’s Hospital, Kanagawa, Japan; Nobuyuki Katakami from Institute of Biomedical Research and Innovation Hospital, Hyogo, Japan; Makoto Maemondo from Miyagi Cancer Center, Miyagi, Japan; Shuji Murakami from Kanagawa Cancer Center, Kanagawa, Japan; Shinji Atagi from National Hospital Organization Kinki-chuo Chest Medical Center, Osaka, Japan; and Noriyuki Masuda from Kitasato University Hospital, Kanagawa, Japan. The authors thank Susan Cottrell, PhD, of Edanz Medical Writing for providing medical writing support, which was funded by AstraZeneca in accordance with Good Publication Practice three guidelines (www.ismpp.org/gpp3). The results of this study have previously been presented at ESMO 2017 and the Japan Lung Cancer Society 2017 conference.
Funding Information:
This work was supported by AstraZeneca. Osimertinib is being developed by AstraZeneca. The study sponsor contributed to the study design; the data collection, analysis and interpretation; and the decision to submit the article for publication.
Funding Information:
This study and the preparation of the manuscript were funded by AstraZeneca. Hirohiko Uchida, Rachel Hodge, Sarah L. Vowler, and Andrew Walding declare consultancy for AstraZeneca. Yuichiro Ohe, Fumio Imamura, and Shunichi Sugawara declare honoria from AstraZeneca. Yuichiro Ohe, Fumio Imamura, Naoyuki Nogami, Isamu Okamoto, Takayasu Kurata, Terufumi Kato, Shunichi Sugawara, Suresh S. Ramalingam, and Kazuhiko Nakagawa have received research funding from AstraZeneca. The remaining authors declare no conflicts of interest.
Publisher Copyright:
© The Author(s) 2018. Published by Oxford University Press. All rights reserved.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - Background: The FLAURA study was a multicenter, double-blind, Phase 3 study in which patients with previously untreated epidermal growth factor receptor mutation-positive advanced non-small-cell lung carcinoma were randomized 1:1 to oral osimertinib 80 mg once daily or standard-of-care (gefitinib 250 mg or erlotinib 150 mg, once daily) to compare safety and efficacy. In the overall FLAURA study, significantly better progression-free survival was shown with osimertinib versus standard-of-care. Methods: Selected endpoints, including progression-free survival (primary endpoint), overall survival, objective response rate, duration of response and safety were evaluated for the Japanese subset of the FLAURA study. Results: In Japan, 120 eligible Japanese patients were randomized to osimertinib (65 patients) or gefitinib (55 patients) treatment from December 2014 to June 2017. Median progression-free survival was 19.1 (95% confidence interval, 12.6, 23.5) and 13.8 (95% confidence interval, 8.3, 16.6) months with osimertinib and gefitinib, respectively (hazard ratio, 0.61; 95% confidence interval, 0.38, 0.99). Median overall survival was not reached in either treatment arm (data were immature). In the osimertinib and gefitinib arms, objective response rate was 75.4% (49/65) and 76.4% (42/55), and median duration of response from onset was 18.4 (95% confidence interval, not calculated) and 9.5 (95% confidence interval, 6.2, 13.9) months, respectively. The incidence of adverse events was similar in the two groups. The frequency of Grade ≥3 interstitial lung disease and pneumonitis in the two groups were the same (one patient). Conclusions: As the first-line therapy, osimertinib showed significantly improved efficacy versus gefitinib in the Japanese population of the FLAURA study. No new safety concerns were raised. Clinical trial registration: NCT02296125 (ClinicalTrials.gov).
AB - Background: The FLAURA study was a multicenter, double-blind, Phase 3 study in which patients with previously untreated epidermal growth factor receptor mutation-positive advanced non-small-cell lung carcinoma were randomized 1:1 to oral osimertinib 80 mg once daily or standard-of-care (gefitinib 250 mg or erlotinib 150 mg, once daily) to compare safety and efficacy. In the overall FLAURA study, significantly better progression-free survival was shown with osimertinib versus standard-of-care. Methods: Selected endpoints, including progression-free survival (primary endpoint), overall survival, objective response rate, duration of response and safety were evaluated for the Japanese subset of the FLAURA study. Results: In Japan, 120 eligible Japanese patients were randomized to osimertinib (65 patients) or gefitinib (55 patients) treatment from December 2014 to June 2017. Median progression-free survival was 19.1 (95% confidence interval, 12.6, 23.5) and 13.8 (95% confidence interval, 8.3, 16.6) months with osimertinib and gefitinib, respectively (hazard ratio, 0.61; 95% confidence interval, 0.38, 0.99). Median overall survival was not reached in either treatment arm (data were immature). In the osimertinib and gefitinib arms, objective response rate was 75.4% (49/65) and 76.4% (42/55), and median duration of response from onset was 18.4 (95% confidence interval, not calculated) and 9.5 (95% confidence interval, 6.2, 13.9) months, respectively. The incidence of adverse events was similar in the two groups. The frequency of Grade ≥3 interstitial lung disease and pneumonitis in the two groups were the same (one patient). Conclusions: As the first-line therapy, osimertinib showed significantly improved efficacy versus gefitinib in the Japanese population of the FLAURA study. No new safety concerns were raised. Clinical trial registration: NCT02296125 (ClinicalTrials.gov).
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U2 - 10.1093/jjco/hyy179
DO - 10.1093/jjco/hyy179
M3 - Article
C2 - 30508196
AN - SCOPUS:85059500264
SN - 0368-2811
VL - 49
SP - 29
EP - 36
JO - Japanese journal of clinical oncology
JF - Japanese journal of clinical oncology
IS - 1
ER -
