한빛사논문
- 조회252
Oh, Do-Youn1,2; Ikeda, Masafumi3; Lee, Choong-kun4; Rojas, Carlos5; Hsu, Chih-Hung6; Kim, Jin Won7; Shen, Lin8; Furuse, Junji9; Park, Joon Oh10; Borad, Mitesh11; de Braud, Filippo12; Bridgewater, John13; Lee, Sunyoung S.14; Moehler, Markus15; Audhuy, Francois16; Osada, Motonobu17; Sato, Masashi17; Yoo, Changhoon18
1Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea
2Integrated Major in Innovative Medical Science, Seoul National University Graduate School, Seoul, Republic of Korea
3National Cancer Center Hospital East, Kashiwa, Japan
4Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
5Bradford Hill Centro de Investigación Clínica, Santiago, Chile
6National Taiwan University Hospital, Taipei, Taiwan
7Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea
8Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China
9Kanagawa Cancer Center, Yokohama, Japan
10Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
11Mayo Clinic, Phoenix, AZ, USA
12University of Milan, Fondazione IRCCS Istituto Nazionale del Tumori, Milan, Italy
13University College London Cancer Institute, London, UK
14The University of Texas MD Anderson Cancer Center, Houston, TX, USA
15Mainz University Hospital, Mainz, Germany
16Merck Serono S.A.S., Lyon, France, an affiliate of Merck KGaA, Darmstadt, Germany
17Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany
18Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
Correspondence : Do-Youn Oh
Abstract
Background and aims: We compared the safety and efficacy of bintrafusp alfa (BA) in combination with gemcitabine+cisplatin (GemCis), to those of GemCis alone, in patients with biliary tract cancer (BTC).
Approach and results: This randomized, double-blind, placebo-controlled, adaptive design phase 2/3 trial (NCT04066491) included treatment-naïve adults with locally advanced/metastatic BTC. Patients (N=297) were randomized to receive an intravenous infusion of BA (2400 mg once/3 wk) plus GemCis (gemcitabine 1000 mg/m2+cisplatin 25 mg/m2 on days 1 and 8/3 wk; 8 cycles) (BA group, n=148) or placebo+GemCis (placebo group, n=149). The primary endpoint was overall survival (OS). For adaptation analysis (phase 2-phase 3; data cut-off: May 20, 2021), efficacy was assessed in the first 150 patients who were antibiotic-naïve, when 80 progression-free survival events had occurred and ≥19 weeks of follow-up had been completed (BA, n=73; placebo, n=77). Median OS (95% CI) for the BA (11.5 mo [9.3-not estimable, NE]) and placebo (11.5 mo [10.0-NE]) groups was comparable (hazard ratio 1.23 [95% CI 0.66-2.28]; p=0.7394); OS data maturity was 27.2% (41 events/151 patients). The most common grade ≥3 treatment-related adverse event was anemia (BA, 26.0%; placebo, 22.8%). Bleeding adverse events were reported more frequently in the BA group (28.8%) versus the placebo group (7.4%). Deaths within 60 days of the first dose were reported in 7.5% and 1.3% of patients in the BA and placebo groups, respectively.
Conclusions: BA+GemCis did not provide a clinically meaningful benefit compared to GemCis alone as first-line treatment for BTC and the study was discontinued early (terminated: August 20, 2021).
논문정보
- Research article
- 2024년 06월 (BRIC 등록일 2024-06-17)
- 국내(교신)+국외 연구진
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