Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer

Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer and the Establishment and Promotion of Its Standardized Application System

1. Study Introduction This non-interventional real-world study enrolls patients with ovarian cancer who receive niraparib as first-line maintenance therapy under routine clinical care. All patients receive physician-prescribed standard treatment without any study intervention. The administration of niraparib and concomitant medications is performed in accordance with the approved product labeling and individual clinical conditions. This study collects and analyzes real-world data concerning medication use, clinical efficacy and safety outcomes. It aims to evaluate the real-world efficacy, safety and treatment patterns of niraparib first-line maintenance therapy and explore the correlation between HRD-related biomarkers and clinical response. The results will enrich evidence-based data and support individualized optimal treatment strategies for ovarian cancer patients.
2. Study Objectives 2.1 Primary Objective To evaluate the real-world efficacy of niraparib as first-line maintenance therapy in patients with advanced epithelial ovarian cancer, based on progression-free survival (PFS), chemotherapy-free interval (CFI), time to first subsequent therapy (TFST), and overall survival (OS).

2.2 Secondary Objectives First, to evaluate the real-world safety of niraparib first-line maintenance therapy by assessing adverse events (AEs) and serious adverse events (SAEs). Second, to characterize real-world treatment patterns of niraparib, including patient baseline characteristics, initial dose, time interval from chemotherapy completion to maintenance initiation, dose adjustment, treatment interruption or discontinuation and relevant reasons, as well as concomitant and combination treatments.

2.3 Exploratory Objective To explore the association between homologous recombination deficiency (HRD)-related biomarkers and therapeutic efficacy of niraparib first-line maintenance therapy in real-world settings.

Inclusion Criteria

1. Female patients aged ≥ 18 years.
2. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
3. Histological subtype of high-grade serous carcinoma or high-grade endometrioid adenocarcinoma.
4. Received only prior first-line platinum-based chemotherapy and achieved complete response (CR) or partial response (PR) to chemotherapy.
5. Patients who received niraparib maintenance therapy in clinical practice.

Exclusion Criteria

1. Patients with comorbidities that, in the investigator's judgment, would seriously endanger patient safety or interfere with medication administration.
2. Patients receiving anti-tumor drugs for other concurrent malignant neoplasms.
3. Pregnant or breastfeeding patients.