한빛사논문
- 조회151
Young Kwang Chae1*ʃ, Megan Othus2, Sandip Pravin Patel3*ʃ, Kelly J. Wilkinson4, Emily M. Whitman-Purves5, Jayanthi Lea6, John M. Schallenkamp7, Nabil Adra8, Leonard J. Appleman9, Mitchell Alden10, Jessica Thomes Pepin11, John A. Ellerton12, Andrew Poklepovic13, Adam Walter14, Murtuza M. Rampurwala15, William R. Robinson16, Hye Sung Kim1,17, Liam Il-Young Chung1, Christine M. McLeod18, Gabby Lopez2, Helen X. Chen19, Elad Sharon19, Howard Streicher19, Christopher W. Ryan20, Charles D. Blanke21, Razelle Kurzrock,22ʃ
1Northwestern University, Chicago, IL;
2SWOG Statistics and Data Management Center, Seattle, WA;
3University of California at San Diego Moores Cancer Center, La Jolla, CA;
4University of Mississippi, Jackson, MS;
5The Mark H. Zangmeister Center/Columbus NCORP, Columbus, OH;
6UT Southwestern/Simmons Cancer Center-Dallas, Dallas, TX;
7Billings Clinic Cancer Center/Montana NCORP, Billings, MT;
8Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, IN;
9UPMC Hillman Cancer Center, Pittsburgh, PA;
10Doylestown Hospital, Thomas Jefferson University, Doylestown, PA;
11Metro Minnesota Community Oncology Research Consortium/Minnesota Oncology Hematology PA-Woodbury, MN;
12Nevada Cancer Research Foundation, Las Vegas, NV;
13Virginia Commonwealth University, Richmond, VA;
14ProMedica Flower Hospital, Sylvania, OH;
15University of Chicago Medicine, Orland Park, IL;
16Tulane University School of Medicine, New Orleans, LA;
17Temple University Hospital, Philadelphia, PA;
18SWOG Data Operations Center, Seattle, WA;
19National Cancer Institute, Investigational Drug Branch, Cancer Therapy Evaluation Program, Bethesda, MD;
20Oregon Health & Science University, Portland, OR;
21SWOG Group Chair’s Office, Knight Cancer Institute, Portland, OR;
22Medical College of Wisconsin, Milwaukee, WI
* = equal contribution; ʃ = corresponding authors
Corresponding authors:
Young Kwang Chae, M.D., M.P.H., M.B.A., Sandip Pravin Patel, M.D. , Razelle Kurzrock, M.D.
Abstract
Background: The role of dual checkpoint inhibition in advanced rare/ultra-rare non-epithelial ovarian cancers (NEOCs) is yet to be explored.
Methods: DART is a prospective, multicenter (1,016 US sites), multi-cohort, single-arm phase II trial conducted through the Early Therapeutics and Rare Cancer SWOG/NCI Committee, assessing ipilimumab (anti-CTLA-4) (1mg/kg every 6 weeks) and nivolumab (anti-PD-1) (240mg every 2 weeks) in adults with advanced NEOCs who lack beneficial standard therapy. Primary outcome was overall response rate [ORR; complete response (CR)/partial response (PR)]; secondary outcomes were progression-free survival (PFS), overall survival (OS), clinical benefit rate [CBR; stable disease (SD) ≥6 months plus ORR], and toxicity.
Results: Seventeen patients (median age: 64; number of prior therapies ranged from 0-8 with no immunotherapy exposure; 8 granulosa, 6 carcinosarcomas, 1 Sertoli-Leydig, 1 yolk sac, 1 Wolffian) were evaluated. In granulosa cell tumors, ORR was 25% (n=2/8; 1 CR, 1 PR) and CBR, 50% (n=4/8); PFS of 58.3 (CR), 50.7+ (PR), 30.4 (SD), and 8.7 (SD) months. Median PFS was 3.5 months (95% confidence intervals (CI) 1.7-11.2 months); median OS, 42.5 months (95% CI 10.1 months-not reached). One Sertoli-Leydig cell tumor showed a 22% regression (PFS 11.2 months). Carcinosarcomas had no response. Three participants (18%) discontinued treatment due to grade 3-4 adverse events.
Conclusions: Ipilimumab-nivolumab shows activity in treatment-refractory granulosa cell tumors, with 25% (n=2/8) of patients experiencing either CR or PR lasting over 4 years..
논문정보
- Research article
- 2024년 10월 (BRIC 등록일 2024-11-06)
- 국외 연구진
- 의약학 > 종양의학
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