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논문 기본 정보

자료유형
학술저널
저자정보
Kan Yonemori (National Cancer Center Hospital, Tokyo, Japan) Keiichi Fujiwara (Saitama Medical University International Medical Center) Kosei Hasegawa (Saitama Medical University International Medical Center) Mayu Yunokawa (The Cancer Institute Hospital of Japanese Foundation for Cancer Research) Kimio Ushijima (Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan) Shiro Suzuki (Aichi Cancer Center Hospital, Nagoya, Japan) Ayumi Shikama (University of Tsukuba) Shinichiro Minobe Tomoka Usami (Department of Obstetrics and Gynecology, Ehime University Hospital, Ehime, Japan) 김재원 (서울대학교) 김병기 (성균관대학교) Peng-Hui Wang (Taipei Veterans General Hospital, Taipei, Taiwan) Ting-Chang Chang (Department of Obstetrics and Gynecology, Linkou Chang Gung Memorial Hospital and Chang Gung University Medical College, Kueishan, Taoyuan City, Taiwan) Keiko Yamamoto (Oncology Science Unit, MSD K.K., Tokyo, Japan) Shirong Han (Biostatistics & Research Decision Sciences, MSD K.K., Tokyo, Japan) Jodi McKenzie (Eisai Inc., Nutley, NJ, USA) Robert J. Orlowski (Global Clinical Development, Merck & Co., Inc., Rahway, NJ, USA) Takuma Miura (Clinical Oncology, Eisai Co., Ltd., Tokyo, Japan)
저널정보
대한부인종양학회 Journal of Gynecologic Oncology Journal of Gynecologic Oncology Vol.35 No.2
발행연도
2024.3
수록면
1 - 13 (13page)
DOI
https://doi.org/10.3802/jgo.2024.35.e40

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초록· 키워드

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Objective: In the global phase 3 Study 309/KEYNOTE-775 (NCT03517449) at the first interimanalysis, lenvatinib+pembrolizumab significantly improved progression-free sur vival (PFS),overall sur vival (OS), and objective response rate (ORR) versus treatment of physician’schoice chemotherapy (TPC) in patients with previously treated advanced/recurrentendometrial cancer (EC). This explorator y analysis evaluated outcomes in patients enrolledin East Asia at the time of prespecified final analysis. Methods: Women ≥18 years with histologically confirmed advanced, recurrent, or metastaticEC with progressive disease after 1 platinum-based chemotherapy (2 if 1 given in neoadjuvant/adjuvant setting) were enrolled. Patients were randomized 1:1 to lenvatinib 20 mg orallyonce daily plus pembrolizumab 200 mg intravenously ever y 3 weeks (≤35 cycles) or TPC(doxorubicin or paclitaxel). Primar y endpoints were PFS per RECIST v1.1 by blindedindependent central review and OS. No alpha was assigned for this subgroup analysis. Results: Among 155 East Asian patients (lenvatinib+pembrolizumab, n=77; TPC, n=78),median follow-up time (data cutoff: March 1, 2022) was 34.3 (range, 25.1–43.0) months. Hazard ratios (HRs) with 95% confidence inter vals (CIs) for PFS (lenvatinib+pembrolizumabvs. TPC) were 0.74 (0.49–1.10) and 0.64 (0.44–0.94) in the mismatch repair proficient(pMMR) and all-comer populations, respectively. HRs (95% CI) for OS were 0.68 (0.45–1.02)and 0.61 (0.41–0.90), respectively. ORRs were 36% with lenvatinib+pembrolizumab and 22%with TPC (pMMR) and 39% and 21%, respectively (all-comers). Treatment-related adverseevents occurred in 97% and 96% (grade 3–5, 74% and 72%), respectively. Conclusion: Lenvatinib+pembrolizumab provided clinically meaningful benefit withmanageable safety compared with TPC, supporting its use in East Asian patients withpreviously treated advanced/recurrent EC. Trial Registration: ClinicalTrials.gov Identifier: NCT03517449

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