紫杉醇脂质体在晚期乳腺癌中应用的真实世界研究

A real-world study on the efficacy and safety analysis of paclitaxel liposome in advanced breast cancer

目的探讨真实世界中紫杉醇脂质体在中国人群晚期乳腺癌中的应用情况及疗效。方法本研究为回顾性研究,收集中国11家医院2016年1月1日至2019年8月31日接受紫杉醇脂质体解救治疗的晚期乳腺癌患者的临床病理资料。研究主要观察指标为无进展生存时间(PFS),次要观察指标为客观缓解率(ORR)及安全性。生存分析采用Kaplan-Meier法,单因素分析采用Log rank检验,多因素分析采用Cox比例风险模型。结果 647例接受紫杉醇脂质体解救治疗的晚期乳腺癌患者中,一线治疗占比为43.3%(280/647),二线治疗占比为27.7%(179/647),三线及以上治疗占比为29.1%(188/647)。一线和二线治疗每周期中位总剂量均为260 mg,三线及以上治疗中位总剂量为240 mg。治疗中位周期数为6个周期,单药治疗中位周期数为4个周期,联合化疗或联合靶向药物治疗中位周期数为6个周期。全组647例患者中,采用紫杉醇脂质体联合卡培他滨±曲妥珠单抗方案治疗167例(25.8%),采用紫杉醇脂质体单药方案治疗123例(19.0%),采用紫杉醇脂质体联合铂类药物±曲妥珠单抗方案治疗119例(18.4%),采用紫杉醇脂质体联合曲妥珠单抗±帕妥珠单抗方案治疗108例(16.7%)。一线治疗和二线治疗患者的中位PFS(分别为5.5和5.5个月)长于三线及以上治疗的患者(4.9个月,均P<0.05);一线、二线、三线及以上治疗患者的ORR分别为46.7%、36.8%和28.2%。多因素分析显示,无事件生存时间和治疗线数是PFS的独立影响因素(均P<0.05)。患者常见不良反应为骨髓抑制、消化道反应、手足综合征、肝功能异常。结论紫杉醇脂质体在各类分子分型乳腺癌中广泛应用,有效且安全性良好。

Objective To explore the application and efficacy of paclitaxel liposome in the treatment of advanced breast cancer among Chinese population in the real world.Methods The clinical characteristics of patients with advanced breast cancer who received paclitaxel liposome as salvage treatment from January 1,2016 to August 31,2019 in 11 hospitals were collected and retrospectively analyzed.The primary outcome was progression free survival(PFS),and the secondary outcome included objective response rate(ORR)and safety.The survival curve was drawn by Kaplan-Meier analysis and the Cox regression model were used for the multivariate analysis.Results Among 647 patients with advanced breast cancer who received paclitaxel liposome,the first-line treatment accounted for 43.3%(280/647),the second-line treatment accounted for 27.7%(179/647),and the third-line and above treatment accounted for 29.1%(188/647).The median dose of first-line and second-line treatment was 260 mg per cycle,and 240 mg in third line and above treatment.The median period of paclitaxel liposome alone and combined chemotherapy or targeted therapy is 4 cycles and 6 cycles,respectively.In the whole group,167 patients(25.8%)were treated with paclitaxel liposome combined with capecitabine±trastuzumab(TX±H),123 patients(19.0%)were treated with paclitaxel liposome alone(T),and 119 patients(18.4%)were treated with paclitaxel liposome combined with platinum±trastuzumab(TP±H),108 patients(16.7%)were treated with paclitaxel liposome combined with trastuzumab±pertuzumab(TH±P).The median PFS of first-line and second-line patients(5.5 and 5.5 months,respectively)were longer than that of patients treated with third line and above(4.9 months,P<0.05);The ORR of the first line,second line,third line and above patients were 46.7%,36.8%and 28.2%,respectively.Multivariate analysis showed that event-free survival(EFS)and the number of treatment lines were independent prognostic factors for PFS.The common adverse events were myelosuppression,gastrointestinal reactions,hand foot syndrome and abnormal liver function.Conclusion Paclitaxel liposomes is widely used and has promising efficacy in multi-subtype advanced breast cancer.