白蛋白结合型紫杉醇治疗晚期难治性乳腺癌的疗效及安全性分析

背景与目的：白蛋白结合型紫杉醇通过将紫杉醇与人血白蛋白相结合新型制剂方式提高了紫杉醇的疗效，目前主要应用于疾病进展迅速或联合化疗后复发的晚期乳腺癌。本研究对白蛋白结合型紫杉醇治疗晚期难治性乳腺癌的疗效和安全性进行探讨。方法：收集2009年7月-2014年1月在北京大学肿瘤医院接受白蛋白结合型紫杉醇单药或联合方案化疗的患者的临床资料，筛选疾病进展迅速和多线治疗后患者，每2个周期评价疗效，每周期评价不良反应，随访患者生存情况。结果：共58例难治性晚期乳腺癌患者入组，均可评价疗效，67.2%(39/58)为三线以上化疗患者，32.8%(19/58)接受一、二线解救化疗的均为辅助化疗后1年内复发、疾病进展迅速的患者，58例中84.5%的患者伴有内脏转移，93.1%的患者既往使用过紫杉类药物。化疗的客观有效率为13.8%(8/58)，临床控制率为60.3%(35/58)，中位无疾病进展时间为4.0个月，总生存时间为10.1个月。其中23例三阴性乳腺癌患者的客观有效率为13.0%，临床控制率56.5%，中位无疾病进展时间为4.1个月，总生存时间为6.6个月。3～4度不良反应主要为血液学毒性，中性粒细胞减低的发生率34.5%(20/58)，粒细胞缺乏性发热发生率5.2%(3/58)，贫血12.1%(7/58)，血小板减低6.9%(4/58)。结论：白蛋白结合型紫杉醇单药及联合方案是进展迅速或多线治疗失败的难治性晚期乳腺癌的一种治疗选择，对既往接受过紫杉类药物治疗和晚期三阴性乳腺癌也显示出一定疗效，且毒副作用可耐受。

Albumin-bound paclitaxel for treatment of patients with refractory metastatic breast cancer

Background and purpose: Nab-paclitaxel (Abraxane) is an albumin-bound form of paclitaxel that utilizes the natural properties of albumin to improve paclitaxel delivery to the tumor. It has recently been approved for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within short time after adjuvant chemotherapy. The purpose of this study was to evaluate the efficacy and safety of albumin-bound paclitaxel in patients with aggressive and refractory metastatic breast cancer (MBC). Methods: A total of 58 patients with MBC were enrolled into this study from Jul. 2009 to Jan. 2014. All patients received albumin-bound paclitaxelbased chemotherapy. The adverse reactions were evaluated every cycle, and the short-term response was evaluated every two cycles. The patients were followed-up, and the survival was analyzed. Results: 58 patients with refractory MBC were evaluable for response, 67.2% of patients received multiple line (≥3 lines) chemotherapy, 32.8% of patients with first and second line of chemotherapy were involved metastasis within one year after adjuvant chemotherapy, 84.5% of patients with visceral metastasis and 93.1% with prior taxane treatment. The objective response rate (ORR) was 13.8%, and disease control rate (DCR) was 60.3%, the median progression free survival (PFS) was 4.0 months, and the overall survival (OS) was 10.1 months. For 23 patients with triple negative breast cancer, ORR was 13.0% and DCR was 56.5%, the median PFS was 4.1 months, and OS was 6.6 months. The main toxicity was myelosuppression (grades 3 and 4 neutropenia, anemia and thombocytopenia were seen in 34.5%, 12.1% and 6.9% of patients, respectively), gastrointestinal reactions, sensory neuropathy, myodynia/arthragia, fatigue, alopecia and so on. Conclusion: The albumin-bound paclitaxel-based chemotherapy can be used in aggressive and refractory MBC. It also showed antitumor activity in taxanes-resistance patients and triple negative patients with good safety and tolerance.