OBJECTIVES: Advanced ovarian cancer (aOC) has a high mortality rate despite treatment. This SLR was designed to identify randomized clinical trials (RCTs) that evaluated first-line and/or first-line maintenance treatments currently in use or under evaluation to gain a better understanding of clinical outcomes, trial heterogeneity, and the underlying unmet need for improved treatment options for patients with aOC.

METHODS: Per the specified protocol, the Embase, Medline, CENTRAL, CDSR, and DARE databases were searched between 01Jan2010 and 24Mar2023 for English-language publications reporting RCT efficacy and safety results for patients with stage III/IV OC who received first-line and/or first-line maintenance treatment (any except radiotherapy). A supplementary congress search from 01Jan2020 to 24Mar2023 was conducted to identify newer trials. Dual data screening and extraction were conducted using predefined templates. Quality assessment, including risk of bias, was performed using standardized tools.

RESULTS: The SLR identified 10 RCTs (82 total publications) that were categorized into 3 groups by timing of randomization and treatment approach. Three trials evaluated first-line therapies (most common comparator carboplatin plus paclitaxel), 2 trials evaluated first-line plus maintenance treatments (carboplatin plus paclitaxel and bevacizumab followed by bevacizumab maintenance) and 5 trials evaluated first-line maintenance only (olaparib±bevacizumab, niraparib, or rucaparib). Carboplatin-based chemotherapy was the most common first-line treatment evaluated. Poly(ADP-ribose) polymerase (PARP) inhibitors were exclusively evaluated in the maintenance setting across multiple patient populations. Progression-free survival (PFS) was the most frequently reported outcome, with wide variations across and within trial categories (median PFS [any definition], total population, all treatment arms: first-line only, 4.8–19.0 months; first-line plus maintenance, 10.3–19.9 months; maintenance only, 8.2 months–not reached). Clinical heterogeneity precluded cross-trial comparisons.

CONCLUSIONS: Maintenance strategies dominated the focus of recent research in aOC stages, with limited treatment options available in the first-line setting except for platinum-based chemotherapy. Substantial heterogeneity was observed across trial designs.