1st Oncology Department, Metropolitan Hospital, Athens, Greece.
BMC Med. 2010 Jan 7;8:3. doi: 10.1186/1741-7015-8-3.
Platinum-based combinations are the standard second-line treatment for platinum-sensitive ovarian cancer (OC). This randomized phase II study was undertaken in order to compare the combination of carboplatin and pegylated liposomal doxorubicin (LD) with carboplatin and paclitaxel (CP) in this setting.
Patients with histologically confirmed recurrent OC, at the time of or more than 6 months after platinum-based chemotherapy, were randomized to six cycles of CP (carboplatin AUC5 + paclitaxel 175 mg/m2, d1q21) or CLD (carboplatin AUC5 + pegylated LD 45 mg/m2, d1q28).
A total of 189 eligible patients (CP 96, CLD 93), with a median age of 63 years, median Performance Status (PS) 0 and a median platinum free interval (PFI) of 16.5 months, entered the study. Discontinuation due to toxicity was higher in the CP patients (13.5% versus 3%, P = 0.016). The overall response rate was similar: CP 58% versus CLD 51%, P = 0.309 (Complete Response; CR 34% versus 23%) and there was no statistical difference in time-to-progression (TTP) or overall survival (OS; TTP 10.8 months CP versus 11.8 CLD, P = 0.904; OS 29.4 months CP versus 24.7 CLD, P = 0.454). No toxic deaths were recorded. Neutropenia was the most commonly seen severe toxicity (CP 30% versus CLD 35%). More frequent in CLD were severe thrombocytopenia (11% versus 2%, P = 0.016), skin toxicity and Palmar-plantar erythrodysesthesia (PPE) grade 1-2 (38% versus 9%, P< 0.001), while grade 3 neurotoxicity and alopecia were higher in CP (7% versus 0%, P = 0.029, 20% versus 5%, P = 0.003). PS and PFI were independent prognostic factors for TTP and OS.
The combination of pegylated LD with carboplatin is effective, showing less neurotoxicity and alopecia than paclitaxel-carboplatin. It thus warrants a further phase III evaluation as an alternative treatment option for platinum-sensitive OC patients.
Australian New Zealand Clinical Trials Registry: ACTRN12609000436279.
铂类药物联合治疗是铂类敏感卵巢癌（OC）的标准二线治疗方法。本研究旨在比较卡铂联合聚乙二醇脂质体阿霉素（LD）与卡铂联合紫杉醇（CP）在该人群中的疗效。
组织学证实为复发性 OC 患者，在铂类化疗时或铂类化疗后 6 个月以上，随机分为 6 个周期 CP（卡铂 AUC5+紫杉醇 175mg/m2，d1q21）或 CLD（卡铂 AUC5+聚乙二醇脂质体阿霉素 45mg/m2，d1q28）组。
共纳入 189 例符合条件的患者（CP 组 96 例，CLD 组 93 例），中位年龄 63 岁，中位 PS 0 分，中位无铂间期（PFI）16.5 个月。CP 组因毒性而停药的患者比例较高（13.5%比 3%，P=0.016）。两组总缓解率相似：CP 组为 58%，CLD 组为 51%，P=0.309（完全缓解率；CR 34%比 23%），无进展生存期（TTP）或总生存期（OS）无统计学差异：CP 组 TTP 为 10.8 个月，CLD 组为 11.8 个月，P=0.904；CP 组 OS 为 29.4 个月，CLD 组为 24.7 个月，P=0.454。无治疗相关死亡病例。中性粒细胞减少是最常见的严重毒性（CP 组 30%，CLD 组 35%）。CLD 组更常见严重血小板减少症（11%比 2%，P=0.016）、皮肤毒性和掌跖红细胞感觉不良（PPE）1-2 级（38%比 9%，P<0.001），而 CP 组 3 级神经毒性和脱发发生率较高（7%比 0%，P=0.029；20%比 5%，P=0.003）。PS 和 PFI 是 TTP 和 OS 的独立预后因素。
卡铂联合聚乙二醇脂质体阿霉素有效，神经毒性和脱发发生率低于紫杉醇-卡铂。因此，它值得进一步进行 III 期评估，作为铂类敏感 OC 患者的另一种治疗选择。
澳大利亚新西兰临床试验注册中心：ACTRN12609000436279。
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