OBJECTIVE Pegylated liposomal doxorubicin (PLD;CAELYX~(?)), a novel formulation of doxorubicin with enhancedtherapeutic efficacy and reduced toxicity, has demonstratedimproved progression-free survival in recurrent or refractoryovarian cancer. The objective of this open-label, noncomparative,observational study was to determine the efficacyand safety of PLD monotherapy or combination therapy withcarboplatin for patients with recurrent or refractory ovariancancer.METHODS Sixty-two patients with recurrent or refractoryovarian cancer who completed a platinum-based chemotherapyregimen and demonstrated platinum sensitivity for first-linetreatment at least 6 months prior to study entry were enrolledin 20 centers in China. PLD was given as monotherapy (50mg/m~2 infused over 60 minutes) or as combination therapy(30 mg/m~2 1-hour infusion) with carboplatin (area under thecurve 5 mg.min/mL 1-hour infusion) on day 1 every 28 daysfor 4 cycles. The primary endpoint was objective response (OR)rate or CA-125 level. Secondary endpoints included time toresponse, time-to-progression, health-related quality of life, andsafety.RESULTS Overall, 48% of the 62 evaluable patients achieveda confirmed OR. More patients receiving PLD and carboplatinachieved an OR vs the PLD monotherapy group (63% vs. 37%).The median time to response and disease progression was58.5 days and 56.0 days, respectively. Overall and drug-relatedadverse 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 deathswere reported.CONCLUSION PLD is an effective and well tolerated agentin women with recurrent or refractory epithelial ovarian cancer. OBJECTIVE Pegylated liposomal doxorubicin (PLD; CAELYX®), a novel formulation of doxorubicin with enhanced therapeutic efficacy and reduced toxicity, has demonstrated progressive-free survival in recurrent or refractoryovarian cancer. The objective of this open-label, noncomparative, observational study was to determine the efficacy and safety of PLD monotherapy or combination therapy withcarboplatin for patients with recurrent or refractory ovarian cancer. METHODS Sixty-two patients with recurrent or refractoryovarian cancer who completed a platinum-based chemotherapyregimen and demonstrated platinum sensitivity for first-line treatment at least 6 months Prior to study entry were enrolledin 20 centers in China. PLD was given as monotherapy (50 mg / m ~ 2 infused over 60 minutes) or as combination therapy (30 mg / m ~ 2 1-hour infusion) with carboplatin mg.min / mL 1-hour infusion) on day 1 every 28 days for 4 cycles. The primary endpoint was objective response (OR) rate o Secondary endpoints included time toresponse, time-to-progression, health-related quality of life, andsafety.RESULTS Overall, 48% of the 62 evaluable patients achieveda confirmed OR. More patients receiving PLD and carboplatinachieved an OR vs 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. most commonly reported adverse events were stomatitis (22.6%) and palmar-plantar erythroderma (9.7%). Two deaths reported. CONCLUSION PLD is an effective and well tolerated agent in women with recurrent or refractory epithelial ovarian cancer.