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

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT06086665

Collaborator

Samsung Medical Center (Other), Seoul National University Hospital (Other), Severance Hospital (Other), Gangnam Severance Hospital (Other), Keimyung University Dongsan Medical Center (Other), Kyungpook National University Chilgok Hospital (Other), Seoul St. Mary's Hospital (Other), National Cancer Center, Korea (Other), Pusan National University Yangsan Hospital (Other), Inje University (Other), Pusan National University Hospital (Other)

850

Enrollment

Location

Actual Duration (Months)

24.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Cancer	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 Design

Study Type:

Observational

Actual Enrollment :

850 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2019

Actual Primary Completion Date :

Oct 31, 2022

Actual Study Completion Date :

Oct 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Progression-free survival [3 years]
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.
Safety analysis [3 years]
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.
Overall survival analysis [3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul		Korea, Republic of	138-736

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong-Yeol Park, MD, PhD, Professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT06086665

Other Study ID Numbers:

S2022-2461

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Niraparib

Study Results

No Results Posted as of Oct 17, 2023