CAJ | 학술논문

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。
배경여목적：백단백결합형자삼순통과장자삼순여인혈백단백상결합신형제제방식제고료자삼순적료효，목전주요응용우질병진전신속혹연합화료후복발적만기유선암。본연구대백단백결합형자삼순치료만기난치성유선암적료효화안전성진행탐토。방법：수집2009년7월—2014년1월재북경대학종류의원접수백단백결합형자삼순단약혹연합방안화료적환자적림상자료，사선질병진전신속화다선치료후환자，매2개주기평개료효，매주기평개불량반응，수방환자생존정황。결과：공58례난치성만기유선암환자입조，균가평개료효，67.2%(39/58)위삼선이상화료환자，32.8%(19/58)접수일、이선해구화료적균위보조화료후1년내복발、질병진전신속적환자，58례중84.5%적환자반유내장전이，93.1%적환자기왕사용과자삼류약물。화료적객관유효솔위13.8%(8/58)，림상공제솔위60.3%(35/58)，중위무질병진전시간위4.0개월，총생존시간위10.1개월。기중23례삼음성유선암환자적객관유효솔위13.0%，림상공제솔56.5%，중위무질병진전시간위4.1개월，총생존시간위6.6개월。3～4도불량반응주요위혈액학독성，중성립세포감저적발생솔34.5%(20/58)，립세포결핍성발열발생솔5.2%(3/58)，빈혈12.1%(7/58)，혈소판감저6.9%(4/58)。결론：백단백결합형자삼순단약급연합방안시진전신속혹다선치료실패적난치성만기유선암적일충치료선택，대기왕접수과자삼류약물치료화만기삼음성유선암야현시출일정료효，차독부작용가내수。
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 efifcacy 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 paclitaxel-based 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.