Recurrent epithelial ovarian carcinoma: A randomized phase III study of pegylated liposomal doxorubicin versus topotecan
Recurrent epithelial ovarian carcinoma: A randomized phase III study of pegylated liposomal doxorubicin versus topotecan
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DOI：
10.1200/jco.2001.19.14.3312
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发表时间：
2001-07-15
影响因子：
45.3
通讯作者：
Lacave, AJ
中科院分区：
文献类型：
--
作者：
Gordon, AN;Fleagle, JT;Lacave, AJ
目的：比较聚乙二醇脂质体阿霉素（PLD）和拓扑替康在一线铂类化疗后复发或无反应的上皮性卵巢癌患者中的疗效和安全性。患者和方法：患有可测量和可评估疾病的患者随机接受PLD 50 mg/m2每4周1小时输注或托泊替康1.5 mg/m2/d，每3周连续5天。患者进行前瞻性分层铂敏感性和存在或不存在的巨大diseases.Results：共474例患者进行了治疗（239 PLD和235拓扑替康）。他们构成意向治疗人群。两组的总体无进展生存率相似（P = 0.095）。PLD和托泊替康的总体缓解率分别为19.7%和17.0%（P = 0.390）。PLD组的中位总生存时间为60周，拓扑替康组为56.7周。铂类药物敏感患者的数据分析显示，PLD对无进展生存期的获益具有统计学意义（P = 0.037），PLD的中位数为28.9周，而托泊替康为23.3周。对于总生存期，PLD显著上级于托泊替康（P = 0.008），中位生存期为108周，而托泊替康为71.1周。铂难治性亚组显示出支持托泊替康的非统计学显著生存趋势（P = .455）。严重的血液毒性与拓扑替康更常见，更有可能与剂量调整，或生长因子或血液制品utilization.Conclusion：疗效相当，有利的安全性，方便的剂量支持的作用PLD作为CT有价值的治疗选择，在这个患者群体。(C)2001年，美国临床肿瘤学会。
Purpose: To compare the efficacy and safety of pegylated liposomal doxorubicin (PLD) and topotecan in patients with epithelial ovarian carcinoma that recurred after or didn't respond to first-line, platinum-based chemotherapy.Patients and Methods: patients with measurable and assessable disease were randomized to receive either PLD 50 mg/m(2) as a 1-hour infusion every 4 weeks or topotecan 1.5 mg/m(2)/d for 5 consecutive days every 3 weeks. Patients were stratified prospectively for platinum sensitivity and for the presence or absence of bulky disease.Results: A total of 474 patients were treated (239 PLD and 235 topotecan). They comprised the intent-to-treat population. The overall progression-free survival rates were similar between the two arms (P = .095). The overall response rates for PLD and topotecan were 19.7% and 17.0%, respectively (P = .390). Median overall survival times were 60 weeks for PLD and 56.7 weeks for topotecan. Data analyzed in platinum-sensitive patients demonstrated a statistically significant benefit from PLD for progression-free survival (P = .037), with medians of 28.9 for PLD versus 23.3 weeks for topotecan. For overall survival, PLD was significantly superior to topotecan (P = .008), with a median of 108 weeks versus 71.1 weeks. The platinum-refractory subgroup demonstrated a nonstatistically significant survival trend in favor of topotecan (P = .455). Severe hematologic toxicity was more common with topotecan and was more likely to be associated with dosage modification, or growth factor or blood product utilization.Conclusion: The comparable efficacy, favorable safety profile, and convenient dosing support the role of PLD as ct valuable treatment option in this patient population. (C) 2001 by American Society of Clinical Oncology.