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논문 기본 정보

자료유형
학술저널
저자정보
Alexander B. Olawaiye (University of Pittsburgh School of Medicine and Magee-Womens Hospital, Gynecologic Oncology Group, Pittsburgh, PA, USA) 김재원 (서울대학교) Andrea Bagameri (National Institute of Oncology, Budapest, Hungary) Erin Bishop (Medical College of Wisconsin, Gynecologic Oncology Group, Milwaukee, WI, USA) Anita Chudecka-Głaz (Pomeranian Medical University, Polish Gynecologic Oncology Group, Szczecin, Poland) Alix Devaux (Oncology Department of Grand Hôpital de Charleroi, Charleroi, Belgium) Laurence Gladieff (Institut Claudius Regaud-Institut Universitaire du Cancer de Toulouse Oncopole, Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, Toulouse, France) Mary E. Gordinier (Norton Cancer Institute, Louisville, KY, USA) Jacob Korach (Sheba Medical Center) Michael E. McCollum (Virginia Oncology Associates, Norfolk, VA, USA) Linda Mileshkin (Peter MacCallum Cancer Centre) Bradley J. Monk (Gynecologic Oncology Group Foundation; Florida Cancer Specialists and Research Institute, West Palm Beach, FL, USA) Shibani Nicum (University College London Cancer Institute, National Cancer Research Institute, London, UK) Angélica Nogueira-Rodrigues (Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil) Ana Oaknin (Medical Oncology Service, Vall d’Hebron Institute of Oncology, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain) David M. O’Malley (The Ohio State University and the James Cancer Center, Gynecologic Oncology Group, Columbus, OH, USA) Mauro Orlando (Eli Lilly Interamerica Inc., Argentina) Lyndah Dreiling (Corcept Therapeutics Incorporated, Menlo Park, CA, USA) Iulia C. Tudor (Corcept Therapeutics Incorporated, Menlo Park, CA, USA) Domenica Lorusso (Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico and Catholic University of the Sacred Heart, Multicentre Italian Trials in Ovarian)
저널정보
대한부인종양학회 Journal of Gynecologic Oncology Journal of Gynecologic Oncology Vol.35 No.4
발행연도
2024.7
수록면
1 - 10 (10page)
DOI
https://doi.org/10.3802/jgo.2024.35.e111

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초록· 키워드

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Background: Ovarian cancer has the highest mortality among gynecologic cancers,primarily because it typically is diagnosed at a late stage and because of the developmentof chemoresistance in recurrent disease. Improving outcomes in women with platinum-resistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoid receptor (GR) by cortisol has been shown to suppress the apoptotic pathways used bycytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteractcortisol’s antiapoptotic effects, enhancing chemotherapy’s efficacy. A previous phase 2study has shown that adding intermittently dosed relacorilant, a selective GR modulator,to nab-paclitaxel improved outcomes, including progression-free sur vival (PFS) and overallsur vival (OS), with minimal added toxicity, in women with recurrent platinum-resistantovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a largerpopulation. Methods: ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter studyin women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primar yperitoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of priorsystemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatmentwith bevacizumab, with documented progressive disease or intolerance to the most recenttherapy. There is no biomarker-based requirement for participant selection. Participantsare randomized 1:1 to receive intermittently dosed relacorilant in combination with nab-paclitaxel or nab-paclitaxel monotherapy. The study’s primar y efficacy endpoint is PFSas assessed by blinded independent central review. Secondar y efficacy endpoints includeOS, investigator-assessed PFS, objective response rate, best overall response, duration ofresponse, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is alsoevaluating safety and patient-reported outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT05257408; European Union DrugRegulating Authorities Clinical Trials Database Identifier: 2022-000662-18
#Relacorilant #Glucocorticoid Receptor #Nab-paclitaxel #Ovarian Neoplasms #Neoplasm Drug Resistance

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