The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer (REFIRM)

1. To evaluate the efficacy and safety of niraparib in Korean women with primary and recurrent epithelial ovarian cancer who underwent niraparib maintenance therapy
2. To evaluate the efficacy and safety of salvage niraparib therapy in Korean women with heavily pretreated epithelial ovarian cancer.

Study Overview

• Status: Completed
• Conditions: Epithelial Ovarian Cancer
• Intervention / Treatment: Drug: Niraparib

Detailed Description

It has been three years since niraparib was introduced into Korea, and about 600 Korean patients with epithelial ovarian cancer have been treated with this drug. The efficacy and safety of niraparib in primary and recurrent epithelial ovarian cancer were well demonstrated in the NOVA trial and the PRIMA trial, and the efficacy and safety of niraparib in heavily pretreated epithelial ovarian cancer patients were confirmed in the -QUADRA trial. However, safety and efficacy data in Korean women are still scanty. The purpose of this study was to evaluate the safety and efficacy of niraparib in Korean women with primary and recurrent epithelial ovarian cancer.

• Study Type: Observational
• Enrollment (Actual): 850

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 138-736
    • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Considering the nature of retrospective study, sample size cannot be calculated based on reference. The investigators have a plan to collect the patient data as much as possible from multi-centers.

Description

Inclusion Criteria:

• Patients were diagnosed with all histologic type of epithelial ovarian cancer
• Observation cohort (Cohort A): All patients who did not receive any kind of maintenance therapy for primary epithelial ovarian cancer from Dec 2019 to Dec 2022

• Treatment cohort: Epithelial ovarian cancer patients who treated with niraparib as maintenance treatment in any line from Dec 2019 to Dec 2022

  • Cohort B: All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting
  • Cohort C: All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting
  • Cohort D: All patients who received or who are receiving salvage niraparib therapy for recurrent epithelial ovarian cancer in 4th line or more line setting

Exclusion Criteria:

• Borderline ovarian tumor
• Malignant ovarian germ cell tumor
• Malignant sex-cord stroma tumor
• Other malignancy within 5 years of diagnosis of epithelial ovarian cancer excluding carcinoma in situ of uterine cervix, endometrium, bladder, stomach, papillary thyroid cancer, and non-melanoma skin cancer

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation cohort (Cohort A); All patients who did not receive any kind of maintenance therapy for primary epithelial ovarian cancer from Dec 2019 to Dec 2022
Cohort B; All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting	Drug: Niraparib; Niraparib
Cohort C; All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting	Drug: Niraparib; Niraparib
Cohort D; All patients who received or who are receiving salvage niraparib therapy for recurrent epithelial ovarian cancer in 4th line or more line setting	Drug: Niraparib; Niraparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Obtain a survival curve using the Kaplan-Meir method in all cohorts, and compare the survival rates between cohort A vs cohort B in total patients, BRCA WT and mutation patients using the log-rank test. Multivariate survival analysis will be performed using Cox's proportional hazard model.	3 years
Safety analysis	The fraction that adverse events occurred, the fraction that dose modification occurred, the fraction that dose delay occurred, and the fraction that treatment discontinuation occurred were calculated, respectively. The comparison of the fractions between groups will be done by the Chi-square test or the Fisher exact test. Comparison of means between groups will be done by Student t test or Mann-Whitney U test.	3 years
Overall survival analysis	Obtain a survival curve using the Kaplan-Meir method in all cohorts, and compare the survival rates between cohort A vs cohort B in total patients, BRCA WT and mutation patients using the log-rank test. Multivariate survival analysis is performed using Cox's proportional hazard model.	3 years

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: National Cancer Center, Korea; Samsung Medical Center; Seoul St. Mary's Hospital; Pusan National University Hospital; Seoul National University Hospital; Inje University; Kyungpook National University Chilgok Hospital; Gangnam Severance Hospital; Severance Hospital; Keimyung University Dongsan Medical Center; Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; niraparib
• Other Study ID Numbers: S2022-2461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No