Therapeutic options remain limited for patients with ovarian cancer who experience recurrence or progression following platinum-based chemotherapy. This study investigated the antitumor activity and tolerability of pegylated liposomal doxorubicin (PLD) in individuals with varying degrees of platinum sensitivity, including partial sensitivity, resistance, and refractoriness. In this multicenter, prospective, open-label trial with a single treatment arm, patients diagnosed with partially platinum-resistant, platinum-sensitive, or platinum-refractory ovarian cancer were treated with PLD at a dose of 40 mg/m² administered every 28 days for up to six cycles. The primary outcome measure was time to disease progression. Secondary outcomes included overall survival, tumor response, disease stabilization, patient-reported quality of life, and treatment safety. Changes in serum CA125 levels and variations in the platinum-free interval were examined as exploratory parameters. Between June 2017 and November 2020, 167 patients met the eligibility criteria and were analyzed. Median time without disease progression was 6.8 months (95% CI, 4.4–9.3), while median overall survival reached 19.1 months (95% CI, 15.0–23.3). Objective tumor regression occurred in 32.3% of patients, and 60.5% achieved disease control. A decline in CA125 after the initial treatment cycle was strongly associated with improved treatment outcomes, with higher response and disease control rates compared with patients lacking an early biomarker reduction (all P < .05). Severe (grade ≥3) adverse events were observed in fewer than 10% of participants, and serious treatment-related events occurred in 3.9%. No fatalities attributable to PLD were recorded. PLD provided meaningful clinical benefit with a favorable safety profile in ovarian cancer patients who had limited responsiveness to platinum-based therapy, supporting its use as a therapeutic option in this difficult-to-treat population.
