白蛋白紫杉醇治疗晚期乳腺癌疗效和安全性的多中心真实世界研究

Multi-center real world study of the efficacy and safety of albumin-bound paclitaxel in the treatment of advanced breast cancer

目的探讨白蛋白紫杉醇治疗晚期转移性乳腺癌的疗效及安全性。方法收集2013—2019年于中国医学科学院肿瘤医院、北京市朝阳区三环肿瘤医院、山东省肿瘤医院、郑州大学第一附属医院和河北大学附属医院接受白蛋白紫杉醇单药或联合方案治疗的晚期乳腺癌患者的临床病理资料,评价患者的治疗疗效和安全性。生存分析采用Kaplan-Meier法,生存率的比较采用Log rank检验。结果203例晚期乳腺癌患者中位无进展生存时间为4个月,中位总生存时间(OS)为14个月;客观缓解率(ORR)为36.0%,疾病控制率(DCR)为81.3%。Luminal型、人表皮生长因子受体2(HER-2)过表达型及三阴性乳腺癌接受白蛋白紫杉醇治疗的ORR分别为37.3%、45.5%和31.0%,DCR分别为85.5%、68.2%和78.9%。复发转移后白蛋白紫杉醇在一线或者二线治疗与三线以上治疗患者比较,OS分别为22个月和11个月(P<0.001),ORR分别为44.9%和30.4%,DCR分别为87.2%和77.6%(P=0.018);既往接受过传统紫杉类治疗再次行白蛋白紫杉醇治疗的患者,ORR为35.8%,DCR为82.1%。全组203例患者中,常见不良反应为手足麻木,其发生率为64.5%(131/203),Ⅰ~Ⅱ度患者占比61.1%(124/203);其他不良反应为白细胞下降(56.2%,114/203)、恶心、呕吐(36.9%,75/203)、血红蛋白下降(21.2%,43/203)、血小板下降(18.7%,38/203)和肝功能不全(18.2%,37/203)。结论白蛋白紫杉醇单药或者联合方案对晚期乳腺癌各种分子亚型、传统紫杉类耐药、多线化疗失败的患者仍有疗效,早期使用预后更佳,不良反应可控可管理,具有良好临床应用价值。

Objective To observe the efficacy and safety of albumin-bound paclitaxel in the treatment of metastatic breast cancer.Methods Multi-center data of patients who accepted single-drug albumin-bound paclitaxel or combination regimens from 2013 to 2019 were collected and the efficacy and safety were evaluated.Kaplan-Meier method was used for survival analysis,while Log-rank test was used to compare the survival rates.Results A total of 203 advanced breast cancer cases were enrolled.The median progression-free survival time(PFS)lasted for 4 months,the median overall survival(OS)was 14 months,objective response rate(ORR)was 36.0%while the disease control rate(DCR)was 81.3%.The ORRs of Luminal,human epidermal growth factor receptor 2(HER2)overexpression and triple-negative breast cancer patients underwent albumin-bound paclitaxel treatment were 37.3%,45.5%and 31.0%,respectively,the DCRs were 85.5%,68.2%and 78.9%,respectively.The OS of patients with relapse or metastasis who accepted less than two and more than two chemotherapy regimens were 22 months and 11 months(P<0.0001),the ORRs were 44.9%vs 30.4%,DCRs were 87.2%vs 77.6%(P=0.018).The ORR and DCR of patients who accepted traditional paclitaxel treatment before the albumin-bound paclitaxel treatment were 35.8%and 82.1%,respectively.The common adverse reaction of these patients was numbness of limbs,which incidence rate was 64.5%(131/203),and 61.1%(124/203)were degree 1 to 2.Other adverse reactions including decreased white blood cells,which incidence rate was 56.1%(114/203);nausea and vomit,which incidence rate was 36.9%(75/203);anemia,which incidence rate was 21.2%(43/203);decreased platelet,which incidence rate was 18.7%(38/203);hepatic dysfunction,which incidence rate was 18.2%(37/203).Conclusions Albumin-bound paclitaxel single or combination regimen is still significant efficient for various molecular subtypes of breast cancer patients or patients with traditional paclitaxel resistance or multi-line chemotherapy failure.Early usage has better prognosis,controllable adverse reaction and prominent clinical application value.