Your browser doesn't support javascript.
loading
Niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer: final results of a multicenter phase 2 study.
Aoki, Daisuke; Tabata, Tsutomu; Yanagida, Satoshi; Nakamura, Toshiaki; Kondo, Eiji; Hamanishi, Junzo; Harano, Kenichi; Hasegawa, Kosei; Hirasawa, Takeshi; Hori, Kensuke; Komiyama, Shinichi; Matsuura, Motoki; Nakai, Hidekatsu; Nakamura, Hiroko; Sakata, Jun; Takehara, Kazuhiro; Takekuma, Munetaka; Yokoyama, Yoshihito; Kase, Yoichi; Sumino, Shuuji; Soeda, Junpei; Kato, Ai; Suri, Ajit; Okamoto, Aikou; Sugiyama, Toru.
Afiliación
  • Aoki D; Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.
  • Tabata T; Akasaka Sanno Medical Center, International University of Health and Welfare Graduate School, Tokyo, Japan.
  • Yanagida S; Department of Obstetrics and Gynecology, Tokyo Women's Medical University, Tokyo, Japan.
  • Nakamura T; Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.
  • Kondo E; Department of Obstetrics and Gynecology, Kagoshima City Hospital, Kagoshima, Japan.
  • Hamanishi J; Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Mie, Japan.
  • Harano K; Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
  • Hasegawa K; Department of Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
  • Hirasawa T; Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
  • Hori K; Department of Obstetrics and Gynecology, Tokai University School of Medicine, Isehara, Japan.
  • Komiyama S; Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki, Japan.
  • Matsuura M; Department of Obstetrics and Gynecology, Toho University Faculty of Medicine, Tokyo, Japan.
  • Nakai H; Department of Obstetrics and Gynecology, Sapporo Medical University, Sapporo, Japan.
  • Nakamura H; Department of Obstetrics and Gynecology, Kindai University Faculty of Medicine, Osakasayama, Japan.
  • Sakata J; Department of Obstetrics and Gynecology, Kure Medical Center and Chugoku Cancer Center, National Hospital Organization, Kure, Japan.
  • Takehara K; Department of Gynecology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
  • Takekuma M; Department of Gynecologic Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
  • Yokoyama Y; Department of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.
  • Kase Y; Department of Obstetrics and Gynecology, Graduate School of Medicine, Hirosaki University, Hirosaki, Japan.
  • Sumino S; Clinical Science, Oncology Cell Therapy and Therapeutic Area Unit, Takeda Pharmaceutical Company Limited, Osaka, Japan.
  • Soeda J; Biostatistics, Japan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.
  • Kato A; Department of Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
  • Suri A; Department of Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
  • Okamoto A; Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
  • Sugiyama T; Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan. aikou7000@gmail.com.
J Gynecol Oncol ; 35(5): e114, 2024 Sep.
Article en En | MEDLINE | ID: mdl-39251349
ABSTRACT

OBJECTIVE:

To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.

METHODS:

This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs).

RESULTS:

20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4-78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9-26.9) and the disease control rate was 90.0% (95% CI=68.3-98.8). The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively.

CONCLUSION:

The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03759600.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Piperidinas / Inhibidores de Poli(ADP-Ribosa) Polimerasas / Indazoles Límite: Adult / Aged / Female / Humans / Middle aged País/Región como asunto: Asia Idioma: En Revista: J Gynecol Oncol Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Corea del Sur
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Piperidinas / Inhibidores de Poli(ADP-Ribosa) Polimerasas / Indazoles Límite: Adult / Aged / Female / Humans / Middle aged País/Región como asunto: Asia Idioma: En Revista: J Gynecol Oncol Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Corea del Sur