Objective: This systematic review analyzed phase III trials in platinum-resistant ovarian cancer to understand their poor outcomes and guide future trials.
Methods: A systematic review adhering to PRISMA guidelines was conducted. PubMed/Medline, Cochrane Library CENTRAL, and EMBASE were searched for randomized phase III trials (2010-January 2024) involving patients with platinum-resistant ovarian cancer.
Results: Fifteen studies (5,468 patients) were included. Platinum resistance was defined by the interval between last platinum administration and recurrence/progression. Heterogeneity existed in defining platinum-refractory patients. Experimental arms included chemotherapy (4 trials), immune checkpoint inhibitors, anti-angiogenic agents, targeted agents, or antibody-drug conjugates (2 trials each), and others (3 trials). Control arms consistently used single-agent chemotherapy (paclitaxel, gemcitabine, pegylated liposomal doxorubicin, or topotecan). Only four trials had biomarker-selected populations. Most trials (except TRINOVA1, AURELIA, and MIRASOL) showed no progression-free survival benefit. Only MIRASOL had statistically significant overall survival improvement.
Conclusion: Negative outcomes likely stem from various factors, including inconsistent platinum resistance definitions, inadequate control arm benchmarks, and suboptimal biomarker use. A deeper understanding of tumor biology and its integration into trial design is crucial to enhance drug development in this patient population, aiming for improved efficacy while preserving quality of life.
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