白蛋白结合型紫杉醇三周疗和剂量密集疗治疗晚期胰腺癌的疗效观察  

Observation on the efficacy of nab-paclitaxel for tri-weekly and dose-dense chemotherapy in the treatment of advanced pancreatic cancer

作　　者：孙宁 范晓娜 李恒震 代宜胜 姜丹[1] 陈卓 卢百琪 李志伟[1] SUN Ning;FAN Xiaona;LI Hengzhen;DAI Yisheng;JIANG Dan;CHEN Zhuo;LU Baiqi;LI Zhiwei(Department of Gastrointestinal Oncology,Harbin Medical University Cancer Hospital,Heilongjiang Harbin 150081,China)

机构地区：[1]哈尔滨医科大学附属肿瘤医院消化内科一病房,黑龙江哈尔滨150081

出　　处：《现代肿瘤医学》2023年第20期3805-3811,共7页Journal of Modern Oncology

基　　金：北京医学奖励基金会(编号:YXJL-2021-0678-0574);北京希思科临床肿瘤学研究基金会(编号:Y-HS2017-033);海燕科研基金重点项目(编号:JJZD2022-06)。

摘　　要：目的:探索白蛋白结合型紫杉醇传统三周疗和剂量密集化疗在一线治疗不可切除胰腺癌中的临床疗效和安全性。方法:回顾性收集2016年1月至2021年12月期间于我院接受白蛋白结合型紫杉醇传统三周疗的联合化疗(传统治疗组)与白蛋白结合型紫杉醇剂量密集化疗的联合化疗(剂量密集组)不可切除胰腺癌患者的病历资料,比较患者生存获益情况。主要研究终点是无进展生存期(progression-free survival,PFS)及总生存期(overall survival,OS)。次要研究终点是客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)及安全性。结果:一共有136名患者被纳入研究,40名患者接受白蛋白结合型紫杉醇传统三周疗,96名患者接受白蛋白结合型紫杉醇剂量密集化疗。传统治疗组中位PFS时间为5.5个月[95%置信区间(confidence interval,CI):4.6~7.7],剂量密集组中位PFS时间为5.9个月(95%CI:4.4~6.8)[风险比(hazard ratio,HR)=0.95,95%CI:0.63~1.41,P=0.77]。传统治疗组的中位OS时间为8.6个月(95%CI:7.2~12.6),剂量密集组中位OS时间为8.9个月(95%CI:7.3~10.8)(HR=0.99,95%CI:0.65~1.50,P=0.95),两组患者的PFS和OS均未有明显差异。传统治疗组和剂量密集组的客观缓解率分别为32.5%和27.1%(P=0.52),两组疾病控制率分别为62.5%和66.7%(P=0.64),没有达到统计学差异。安全性方面,传统治疗组和剂量密集组的3/4级血液学不良事件主要包括中性粒细胞减少(5.0%vs 27.1%)、白细胞减少(5.0%vs 18.8%)和贫血(10.0%vs 15.6%)。结论:白蛋白结合型紫杉醇传统三周疗和剂量密集化疗在一线治疗不可切除胰腺癌的临床疗效相当,但传统三周疗组具有更好便捷性,并且毒副反应更加可控、可预防,安全性更高。Objective:To explore the clinical efficacy and safety of conventional,tri-weekly nab-paclitaxel chemotherapy and dose-dense nab-paclitaxel chemotherapy in the first-line treatment of unresectable pancreatic cancer.Methods:From January 2016 to December 2021,medical records of patients with unresectable pancreatic cancer who received combination chemotherapy with tri-weekly,conventional nab-paclitaxel(conventional group)or dose-dense nab-paclitaxel(dose-dense group)at our hospital were retrospectively collected to compare the survival benefit of patients.The primary endpoints were progression-free survival(PFS)and overall survival(OS).The objective response rate(ORR),disease control rate(DCR),and safety were secondary endpoints.Results:The study comprised 136 participants,of whom 40 participants got conventional nab-paclitaxel chemotherapy,and 96 participants had dose-dense nab-paclitaxel chemotherapy.The median PFS in the conventional group was 5.5 months[95%confidence interval(CI):4.6~7.7],while in the dose-dense group it was 5.9 months(95%CI:4.4~6.8)[hazard ratio(HR)=0.95,95%CI:0.63~1.41,P=0.77].The median OS in the conventional group was 8.6 months(95%CI:7.2~12.6),while in the dose-dense group it was 8.9 months(95%CI:7.3~10.8)(HR=0.99,95%CI:0.65~1.50,P=0.95).The PFS and OS between the two groups were not significantly different.The ORR were 32.5%and 27.1%in the conventional and dose-dense groups,respectively(P=0.52),and the DCR was 62.5%and 66.7%in the two groups,respectively(P=0.64),which did not reach statistical differences.Neutropenia(5.0%vs 27.1%),leukopenia(5.0%vs 18.8%),and anemia(10.0%vs 15.6%)were the most frequent grade 3/4 hematological adverse events in the conventional and dense-dose groups,respectively.Conclusion:We discovered that the survival benefits of conventional,tri-weekly nab-paclitaxel chemotherapy were comparable to those of dose-dense nab-paclitaxel chemotherapy.On the contrary,the conventional group had the advantage of better convenience,the risks of hematological toxicity were easier

关 键 词：胰腺癌 白蛋白结合型紫杉醇 剂量密集 临床疗效 安全性 

分 类 号：R735.9[医药卫生—肿瘤]