Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study

NCT05734911CompletedOBSERVATIONAL

Summary

In order to explore the real situation of niraparib in clinical application more comprehensively and deeply, we conducted the first multicenter, real-world study in China. This large observational study used real-world data to assess the effectiveness and safety of niraparib as maintenance therapy in patients with advanced ovarian cancer (AOC) in China and investigated clinical factors associated with prolonged benefits of niraparib so as to achieve the maximum clinical benefit of patients.

Key Facts

Lead Sponsor

Zhongda Hospital

Enrollment

199

Start Date

2019-01-01

Completion Date

2022-12-31

Study Type

OBSERVATIONAL

Official Title

Real-world Data From a Multi-center Study: Insights to the Effectiveness and Safety in Patients With Ovarian Cancer Receiving Niraparib as First-line Maintenance Therapy

Interventions

Niraparib

Conditions

Ovarian Neoplasms

Eligibility

Age Range

26 Years – 78 Years

Sex

FEMALE

Inclusion Criteria:

* 18 years of age or older
* diagnosed with histologically confirmed ovarian cancer (International Federation of Gynecology and Obstetrics \[FIGO\] Stage II-IV)
* underwent surgery and first-line chemotherapy and were treated with niraparib as maintenance therapy
* the date to start maintenance therapy with niraparib is from January 2019 to December 2021

Exclusion Criteria:

* had experienced other malignancies within the previous 5 years
* enrolled in clinical trials in which investigators were blinded to the treatments
* with a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

Outcome Measures

Primary Outcomes

progression-free survival(PFS)

time from the date of initiation of maintenance therapy with niraparib to the date of disease progression in our study

Time frame: up to 29 months

Secondary Outcomes

time to treatment discontinuation (TTD)

time from the date of initiation of maintenance therapy with niraparib to the date of treatment discontinuation in our study

Time frame: up to 29months

time to first subsequent therapy (TFST)

time from the date of initiation of maintenance therapy with niraparib to the date of first subsequent therapy from any cause in our study

Time frame: up to 13 months

Locations

Zhongda hospital, Nanjing, China

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.