摘要
OBJECTIVE Pegylated liposomal doxorubicin （PLD; CAELYX ）, 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 objective of this open-label, noncomparative, observational study was to determine the efficacy and safety of PLD monotherapy or combination therapy with carboplatin for patients with cancer. recurrent or refractory ovarian 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 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.
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.
