Department of Oncology, University Hospital Basel, Basel.
Breast Center, Kantonsspital St Gallen, St Gallen.
Ann Oncol. 2011 Jan;22(1):80-85. doi: 10.1093/annonc/mdq319. Epub 2010 Jul 1.
pegylated liposomal doxorubicin (PLD) and bevacizumab are active agents in the treatment of metastatic breast cancer (MBC). We carried out a multicenter, single-arm phase II trial to evaluate the toxicity and efficacy of PLD and bevacizumab as first-line treatment in MBC patients.
bevacizumab (10 mg/kg) and PLD (20 mg/m(2)) were infused on days 1 and 15 of a 4-week cycle for a maximum of six cycles. Thereafter, bevacizumab monotherapy was continued at the same dose until progression or toxicity. The primary objective was safety and tolerability, and the secondary objective was to evaluate efficacy of the combination.
thirty-nine of 43 patients were assessable for the primary end point. Eighteen of 39 patients (46%, 95% confidence interval 30% to 63%) had a grade 3 toxicity. Sixteen (41%) had grade 3 palmar-plantar erythrodysesthesia, one had grade 3 mucositis, and one severe cardiotoxicity. Secondary end point of overall response rate among 43 assessable patients was 21%.
in this nonrandomized single-arm trial, the combination of bimonthly PLD and bevacizumab in locally recurrent and MBC patients demonstrated higher than anticipated toxicity while exhibiting only modest activity. Based on these results, we would not consider this combination for further investigation in this setting.
聚乙二醇脂质体阿霉素（PLD）和贝伐单抗是转移性乳腺癌（MBC）治疗中的有效药物。我们进行了一项多中心、单臂的 II 期临床试验，以评估 PLD 和贝伐单抗作为 MBC 患者一线治疗的毒性和疗效。
贝伐单抗（10mg/kg）和 PLD（20mg/m²）于每 4 周周期的第 1 天和第 15 天输注，最多进行 6 个周期。此后，以相同剂量继续使用贝伐单抗单药治疗，直至疾病进展或出现毒性。主要终点为安全性和耐受性，次要终点为评估联合治疗的疗效。
43 例患者中有 39 例可评估主要终点。39 例患者中有 18 例（46%，95%置信区间 30%至 63%）出现 3 级毒性。16 例（41%）出现 3 级手掌-足底红斑感觉异常，1 例出现 3 级粘膜炎，1 例出现严重的心脏毒性。43 例可评估患者的次要终点总缓解率为 21%。
在这项非随机单臂试验中，每月两次 PLD 和贝伐单抗联合治疗局部复发性和转移性乳腺癌患者的毒性高于预期，而疗效仅为适度。基于这些结果，我们不会考虑将该联合方案用于该治疗环境的进一步研究。
