OBJECTIVES: Ovarian cancer is a serious life-threatening and second most common gynecological cancer in the US. Poly ADP-Ribose Polymerase inhibitors (PARPi) are a new class of drugs for Platinum Sensitive Recurrent Ovarian Cancer (PSROC) patients. Individual drugs in this class such as olaparib, rucaparib, and niraparib have shown optimal efficacy and safety in their Phase III randomized clinical trials (RCTs). Previous meta-analysis shows that PARPi are well tolerated in PSROC patients on the basis of RCTs. A network meta-analysis (NMA) based on RCTs and real world evidence (RWE) has not been conducted yet. This research was conducted to assess the feasibility of such an NMA for PARPi.

METHODS: A comprehensive research was conducted using biomedical databases (Embase, Medline) and other sources (clinical trial registries, conferences) from January 2008 - December 2018 to identify phase III RCTs and RWE on clinical outcomes. The clinical data across studies was extracted and qualitatively appraised by two independent reviewers for the feasibility assessment.

RESULTS: 10 studies (six RWEs and four RCTs) were identified for PARPi as a maintenance therapy in PSROC patients with ≥2 prior lines of chemotherapies. The placebo-controlled multi-centric RCTs included were ARIEL3, SOLO2/ENGOT-Ov21, ENGOT-OV16/NOVA and SOLO2 comprising 717 (480, 237: PARPi versus placebo) BRCA mutation patients (age range: 36 - 84 years). RWE studies conducted in France, the Netherlands, the US, and globally included 432 BRCA mutation patients treated with PARPi (age range: 38 - 80 years). There was insufficient data on overall survival and multiple safety outcomes across studies. Progression free survival and adverse events such as fatigue, hematological and gastrointestinal toxicities were comparable.

CONCLUSIONS: Based on the assessment, a NMA is feasible to compare the clinical outcomes of all PARPi on the basis of RCTs and RWE. This will build higher confidence in the clinical performance of the PARPi.