Pegylated Liposomal Doxorubicin as a Single Agent or as Combination Therapy with Carboplatin in Patients with Recurrent or Refractory Epithelial Ovarian Cancer

查看全文 作　　者：Beihua [2]Kong;Yunong [3]Gao;Lingying [4]Wu;Ziting [5]Li;Yile [6]Chen;Mengda [7]Li;Yongliang [8]Gao;Ding [9]ga;Zhilan [10]Peng;[1]KengShen 机构地区：[1]Peking Union Medical College Hospital, Beijing, China;[2]Shandong University Qilu Hospital, Jinan, Shandong Province, China;[3]Beijing Oncology Hospital, Beijing, China;[4]Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing, China;[5]Fudan University Cancer Hospital, Shanghai, China;[6]Hunan Province Oncology Hospital, Changsha, Hunan Province, China;[7]Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong Province, China;[8]Zhejiang Province Oncology Hospital, Hangzhou, Zhejiang Province, China;[9]Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei Province, China;[10]West China Second Hospital of Sichuan University, Chengdu, Sichuan Province 出　　处：《Clinical oncology and cancer resexreh》索引2009年第6卷第6期,共7页 摘　　要：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. 关 键 词：联合治疗 聚乙二醇 卵巢癌 阿霉素 脂质体 卡铂 复发 单药