한빛사논문
- 조회456
Yoo-Na Kim 1, Boram Park 2, Jae Weon Kim 3, Byoung Gie Kim 4, Sang Wun Kim 1, Hee Seung Kim 3, Chel Hun Choi 4, Myong Cheol Lim 5, Natalie Yl Ngoi 6 7, David Sp Tan 6 7 8 9, Jung-Yun Lee 10,*
1Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Korea.
2Biomedical Statistics Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea.
3Department of Obstetrics and Gynecology, Seoul National University, Seoul, Korea.
4Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
5Gynecologic Cancer Branch & Center for Uterine Cancer, National Cancer Center, Goyang, Korea.
6Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
7Department of Haematology-Oncology, National University Cancer Institute, National University Hospital, Singapore, Singapore.
8National University of Singapore (NUS) Centre for Cancer Research (N2CR), Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
9Cancer Science Institute, National University of Singapore, Singapore, Singapore.
10Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Korea.
*Corresponding author: correspondence to Jung-Yun Lee
Abstract
In this multicenter, open-label, single-arm, Phase II study with Simon two-stage optimum design (NCT04361370), we investigate the efficacy and safety of triplet maintenance (olaparib, pembrolizumab, bevacizumab) in patients with platinum-sensitive recurrent ovarian cancer who are wild-type for BRCA 1/2. A total of 44 patients were enrolled, and the median follow-up duration was 22.9 months (interquartile range: 17.4-24.7). The primary outcome was 6-months progression-free survival (PFS), which was 88.6% (95% confidence interval [CI] 75.4-96.2), meeting the pre-specified primary endpoint. The secondary outcomes reported here include median PFS, 12-months PFS, and overall survival and safety. The median PFS was 22.4 months (20.4-∞), with a 12-months PFS rate of 84.0% (95% CI 69.3-92.0). The median overall survival was 28.6 months (27.3-∞). The combination demonstrated tolerable toxicity with manageable side effects. Other secondary outcomes include time-to-progression, time to subsequent treatment, time to second treatment and PFS2; however, this data is not reported, as treatment is still ongoing in a majority of patients. Exploratory analysis shows that patients who were homologous recombination deficiency-positive or had a programmed death-ligand 1 combined positive score ≥1 showed a favorable response (P = 0.043 and P < 0.001, respectively). Thus, triplet maintenance shows durable efficacy with tolerable safety in patients with platinum-sensitive recurrence.
논문정보
- Research article
- 2023년 09월 (BRIC 등록일 2023-09-09)
- 국내(교신)+국외 연구진
- 의약학 > 응용의학
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