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Hokkaido University Collection of Scholarly and Academic Papers >
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Phase II study of niraparib in recurrent or persistent rare fraction of gynecologic malignancies with homologous recombination deficiency (JGOG2052)
| Title: | Phase II study of niraparib in recurrent or persistent rare fraction of gynecologic malignancies with homologous recombination deficiency (JGOG2052) |
| Authors: | Asano, Hiroshi Browse this author | | Oda, Katsutoshi Browse this author | | Yoshihara, Kosuke Browse this author | | Ito, Yoichi M. Browse this author →KAKEN DB | | Matsumura, Noriomi Browse this author | | Shimada, Muneaki Browse this author | | Watari, Hidemichi Browse this author →KAKEN DB | | Enomoto, Takayuki Browse this author |
| Keywords: | Gynecologic Neoplasms | | Leiomyosarcoma | | Homologous Recombination Repair | | Gene | | Mutation | | Poly(ADP-ribose) Polymerase Inhibitors |
| Issue Date: | Jul-2022 |
| Publisher: | Korean Society of Gynecologic Oncology and Colposcopy |
| Journal Title: | Journal of gynecologic oncology |
| Volume: | 33 |
| Issue: | 4 |
| Start Page: | e55 |
| Publisher DOI: | 10.3802/jgo.2022.33.e55 |
| Abstract: | Background: Poly (adenosine diphosphate)-ribose polymerase (PARP) inhibitors for tumors with homologous recombination deficiency (HRD), including pathogenic mutations in BRCA1/2, have been developed. Genomic analysis revealed that about 20% of uterine leiomyosarcoma (uLMS) have HRD, including 7.5%-10% of BRCA1/2 alterations and 4%-6% of carcinomas of the uterine corpus, and 2.5%-4% of the uterine cervix have alterations of BRCA1/2. Preclinical and clinical case reports suggest that PARP inhibitors may be effective against those targets. The Japanese Gynecologic Oncology Group (JGOG) is now planning to conduct a new investigator-initiated clinical trial, JGOG2052. Methods: JGOG2052 is a single-arm, open-label, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of niraparib monotherapy for a recurrent or persistent rare fraction of gynecologic malignancies with BRCA1/2 mutations except for ovarian cancers. We will independently consider the effect of niraparib for uLMS or other gynecologic malignancies with BRCA1/2 mutations (cohort A, C) and HRD positive uLMS without BRCA1/2 mutations (cohort B). Participants must have 1-3 lines of previous chemotherapy and at least one measurable lesion according to RECIST (v.1.1). Niraparib will be orally administered once a day until lesion exacerbation or unacceptable adverse events occur. Efficacy will be evaluated by imaging through an additional computed tomography scan every 8 weeks. Safety will be measured weekly in cycle 1 and every 4 weeks after cycle 2 by blood tests and physical examinations. The sample size is 16-20 in each of cohort A and B, and 31 in cohort C. Primary endpoint is the objective response rate. |
| Type: | article |
| URI: | http://hdl.handle.net/2115/86783 |
| Appears in Collections: | 医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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