OBJECTIVE Pegylated liposomal doxorubicin (PLD; CAELYX(R)), a novel formulation of doxorubicin with enhanced therapeutic efficacy and reduced toxicity, has demonstrated improved progression-free survival in recurrent or refractory ovarian cancer. The Abstract:OBJECTIVE of this open-label, non-comparative, observational study was to determine the efficacy and safety of PLD monotherapy or combination therapy with carboplatin for patients with recurrent or refractory ovarian cancer.METHODS Sixty-two patients with recurrent or refractory ovarian cancer who completed a platinum-based chemotherapy regimen and demonstrated platinum sensitivity for first-line treatment at least 6 months prior to study entry were enrolled in 20 centers in China. PLD was given as monotherapy (50 mg/m2 infused over 60 minutes) or as combination therapy (30 mg/m2 1-hour infusion) with carboplatin (area under the curve 5 mg-min/mL 1-hour infusion) on day 1 every 28 days for 4 cycles. The primary endpoint was Abstract:OBJECTIVE response (OR) rate or CA-125 level. Secondary endpoints included time to response, time-to-progression, health-related quality of life, and safety.RESULTS Overall, 48% of the 62 evaluable patients achieved a confirmed OR. More patients receiving PLD and carboplatin achieved an OR vs the PLD monotherapy group (63% vs. 37%). The median time to response and disease progression was 58.5 days and 56.0 days, respectively. Overall and drug-related adverse events were reported for 39% and 34%, respectively. The most commonly reported adverse events were stomatitis (22.6%) and palmar-plantar erythroderma (9.7%). Two deaths were reported.CONCLUSION PLD is an effective and well tolerated agent in women with recurrent or refractory epithelial ovarian cancer.