晚期胰腺癌常用一线化疗方案真实世界临床疗效观察  

Real-world clinical efficacy of common first-line chemotherapy regimens for advanced pancreatic cancer

作　　者：孙宁 范晓娜 李恒震 张文静 刘金爽 代宜胜 姜丹[1] 李志伟[1] SUN Ning;FAN Xiaona;LI Hengzhen;ZHANG Wenjing;LIU Jinshuang;DAI Yisheng;JIANG Dan;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9期1690-1695,共6页Journal of Modern Oncology

基　　金：北京医学奖励基金会(编号:YXJL-2021-0678-0574);海燕科研基金重点项目(编号:JJZD2022-06)。

摘　　要：目的:比较白蛋白结合型紫杉醇联合吉西他滨(AG)、白蛋白结合型紫杉醇联合替吉奥(AS)、吉西他滨联合奥沙利铂(GEMOX)、吉西他滨联合替吉奥(GS)方案在真实世界一线治疗晚期胰腺癌的有效性及安全性。方法:回顾性分析2016年1月至2021年6月于我院诊治的165例晚期胰腺癌患者的病例资料,根据化疗方案不同分为四组:AG组(n=40)、AS组(n=31)、GEMOX组(n=31)、GS组(n=63),按照实体肿瘤临床疗效评价标准(RECIST)1.1版本评估临床疗效和常见不良事件评价标准(CTCAE)5.0版本评估患者的不良反应,主要研究终点为总生存期(overall survival,OS)和无进展生存期(progression-free survival,PFS),次要研究终点为客观缓解率(objective response rate,ORR)和疾病控制率(disease control rate,DCR)以及治疗相关不良反应,采用Cox风险比例模型分析影响患者预后的因素。结果:165例患者的中位OS时间为10.5个月,中位PFS时间为6.0个月,AG、AS、GEMOX、GS方案中位OS时间分别为8.4、11.4、9.0、11.2个月(P=0.048)。AG、AS、GEMOX、GS方案中位PFS时间分别为5.1、6.1、5.8、7.2个月(P=0.280),AS、GS组的中位OS和PFS时间相对较长。四组患者的ORR分别达27.5%、32.3%、29.0%、30.2%(P=0.977),四组患者的DCR分别达70.0%、80.6%、67.7%、79.4%(P=0.461),AS、GS方案具有较好的疾病控制率,优于AG、GEMOX方案,但是差异无统计学意义。此外,AG、AS、GEMOX、GS方案的皮疹、骨髓抑制、胃肠道反应等化疗副作用发生率相近,差异无统计学意义(P>0.05)。单因素分析结果显示化疗方案、初始肝转移、化疗前癌胚抗原(CEA)值、CA19-9值以及化疗周期数是影响胰腺癌预后的重要因素(P<0.05),多因素分析结果显示CA19-9值≥1000 U/mL(HR=1.68,95%CI:1.12~2.51,P<0.05)、GS方案化疗(HR=0.56,95%CI:0.36~0.87,P<0.05)以及化疗周期数≥4(HR=0.50,95%CI:0.35~0.70,P<0.001)是胰腺癌预后的独立影响因素。结论:GS、AS方案在一线治疗晚期胰Objective:To compare the efficacy and safety of nab-paclitaxel combined with gemcitabine(AG),nab-paclitaxel combined with S-1(AS),gemcitabine combined with oxaliplatin(GEMOX),and gemcitabine combined with S-1(GS)regimens in the real-world first-line treatment of advanced pancreatic cancer.Methods:The data of 165 patients with advanced pancreatic cancer from January 2016 to June 2021 were analyzed retrospectively.According to different chemotherapy regimens,they were divided into four groups:AG group(n=40),AS group(n=31),GEMOX group(n=31),and GS group(n=63).The clinical efficacy and safety were evaluated according to Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1 and Common Terminology Criteria for Adverse Events(CTCAE)version 5.0.The primary end points were overall survival(OS)and progression-free survival(PFS).The secondary end points were objective response rate(ORR),disease control rate(DCR),and treatment-related adverse events.Cox regression analysis was performed on the factors that may affect the overall survival of patients.Results:The median OS of 165 patients was 10.5 months and the median PFS was 6.0 months.The median OS of AG,AS,GEMOX,and GS were 8.4,11.4,9.0,and 11.2 months,respectively(P=0.048).The median PFS of AG,AS,GEMOX,and GS regimens were 5.1,6.1,5.8,and 7.2 months,respectively(P=0.280).The median OS and PFS were relatively long in the AS and GS groups.The ORR of patients in the four groups reached 27.5%,32.3%,29.0%,and 30.2%,respectively(P=0.977).The DCR of the four groups were 70.0%,80.6%,67.7%,and 79.4%,respectively(P=0.461).AS and GS regimens had better disease control rate,which was significantly better than AG and GEMOX regimens.In addition,the incidence of side effects of chemotherapy such as rash,bone marrow suppression,and gastrointestinal reaction in AG,AS,GEMOX,and GS regimens was similar,and the difference was not statistically significant(P>0.05).Univariate analysis showed that chemotherapy regimen,initial liver metastasis,CEA value,CA19-9 value,and the number of c

关 键 词：晚期胰腺癌 临床疗效 不良反应 预后分析 

分 类 号：R735.9[医药卫生—肿瘤]