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

Asan Medical Center

Status: Completed

Conditions: Epithelial Ovarian Cancer

Treatments: Drug: Niraparib

Study type: Observational

Funder types: Other

Identifiers

NCT06086665

S2022-2461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 850 patients

Sex: Female

Volunteers: No 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

Trial design

850 participants in 4 patient groups

Observation cohort (Cohort A)

Description:

All patients who did not receive any kind of maintenance therapy for primary epithelial ovarian cancer from Dec 2019 to Dec 2022

Cohort B

Description:

All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting

Treatment:

Drug: Niraparib

Cohort C

Description:

All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting

Treatment:

Drug: Niraparib

Cohort D

Description:

All patients who received or who are receiving salvage niraparib therapy for recurrent epithelial ovarian cancer in 4th line or more line setting

Treatment:

Drug: Niraparib