注射用核糖核酸Ⅱ改善晚期胰腺癌化疗患者整体获益可能性的真实世界研究

目的:评价注射用核糖核酸Ⅱ联合化疗在真实世界中治疗晚期胰腺癌的疗效和安全性。方法:基于LinkDoc数据库纳入2012年至2018年就诊于河南省肿瘤医院等10家研究中心且确诊为局部进展期和晚期胰腺癌的患者923例,试验组采用化疗联合注射用核糖核酸Ⅱ治疗,对照组采用单纯化疗治疗。采用倾向性评分匹配的方法均衡两组的基线信息,比较两组间的总生存期(overall survival,OS)、无进展生存期(progression-free survival,PFS)及不良事件和化疗相关不良反应的发生率。结果:试验组和对照组的中位OS分别为7.5个月和6.7个月,中位PFS分别为3.7个月和3.3个月,差异均无统计学意义(P>0.05)。试验组不良事件发生率略低于对照组(88.7%vs 92.1%),试验组化疗相关不良反应发生率略高于对照组(64.1%vs 57.1%),差异均无统计学意义(P>0.05)。结论:注射用核糖核酸Ⅱ联合化疗治疗晚期胰腺癌具有生存获益趋势,无肝转移患者是潜在的优势人群,该结论尚需前瞻性研究进一步确证。

A real-world study of the potential for overall benefits:Ribonucleic acid for injection Ⅱ combined with chemotherapy for advanced pancreatic cancer

Objective:To evaluate the efficacy and safety of ribonucleic acid for injection Ⅱ combined with chemotherapy in the treatment of advanced pancreatic cancer（PC） in the real world.Methods:We included 923 patients with advanced PC from 2012 to 2018 from the LinkDoc database involving 10 research centers such as Henan Cancer Hospital.Patients in the experimental group treated by chemotherapy combined with ribonucleic acid for injection Ⅱ,control group adopts only chemotherapy treatment.The baseline information of the two groups was balanced by the method of propensity score matching（PSM).The overall survival（OS),progression-free survival（PFS) and the incidence of adverse events and chemotherapy-related adverse reactions（ADR) were compared between the two groups.Results:The median OS of the treatment group and the control group was 7.5 months and 6.7 months respectively（P＞0.05）,and the median PFS was 3.7 months and 3.3 months respectively（P＞0.05）.The incidence of adverse events in the treatment group was slightly lower than the control group（88.7% vs 92.1%，P＞0.05),and the incidence of chemotherapy-related adverse reactions in the treatment group was slightly higher than that in the control group（64.1% vs 57.1%，P＞0.05).Conclusion:Ribonucleic acid for injection Ⅱ combined with chemotherapy in the treatment of advanced pancreatic cancer has a trend of survival benefit,patients without liver metastasis might benefit more,but this conclusion remains to be confirmed by well-designed prospective study.