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改良FOLFIRINOX与吉西他滨为基础的化疗方案在进展期胰腺癌治疗中的对比研究
作者:钱元  郑松  贾长库 
单位:南京医科大学附属杭州医院肿瘤内科  浙江 杭州 310006 杭州市第一人民医院肿瘤内科  浙江 杭州 310006 杭州市肿瘤医院肿瘤内科  浙江 杭州 310006 浙江中医药大学附属杭州第一医院肿瘤内科  浙江 杭州 310006 杭州市第一人民医院肝胆胰外科  浙江 杭州 310006 
关键词:胰腺肿瘤/药物治疗 改良FOLFIRINOX 吉西他滨 预后 
DOI:R735.9;R730.53
出版年,卷(期):页码:2018,33(3):237-245
摘要:

目的 对比吉西他滨(gemcitabine,G)为基础的一线化疗方案及改良FOLFIRINOX (modified FOLFIRINOX,mFOLFIRINOX)方案治疗不可切除进展期胰腺癌的疗效性及安全性。方法 回顾性收集接受指南一级推荐化疗方案治疗的不可切除进展期胰腺癌患者70例。其中,37例接受吉西他滨单药、吉西他滨加替吉奥(gemcitabine plus S-1,GS)或吉西他滨加白蛋白紫杉醇一线化疗(A组),33例接受mFOLFIRINOX方案一线化疗(B组)。mFOLFIRINOX方案奥沙利铂和伊立替康分别减至70 mg/m2和145 mg/m2,其余药物剂量和用法不变。设定主要研究终点为总生存期(overall survival,OS)、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)、3/4级不良反应事件发生率。结果 A组和B组患者中位OS (8.3个月vs 13.5个月),中位PFS (4.3个月vs 6.1个月),两组比较差异均具有统计学意义(均P<0.05)。62例完成临床评效,两组ORR分别为16.2%和36.4%(P>0.05)。A组最常见3/4级不良反应为中性粒细胞减少(16.2%)、发热性感染(10.8%)、血小板减少(8.1%)、过敏反应(8.1%)及腹泻(8.1%);B组为中性粒细胞减少(12365bet娱乐官网网址.1%)、周围神经病变(9.1%)及腹泻(9.1%)。结论 对于不可切除的进展期胰腺癌患者,相较于吉西他滨为基础的一线化疗方案,使用mFOLFIRINOX生存获益更佳且耐受性相当。

Objective To compare the efficacy and safety of modified FOLFIRINOX (mFOLFIRINOX) therapy and gemcitabine(G)-based first-line chemotherapy in the treatment of unresectable advanced pancreatic cancer.Methods The clinical data of 70 unresectable advanced pancreatic cancer patients who were guided for first-line chemotherapy were retrospectively collected. Among the patients,37 patients received G-based first-line chemotherapy including gemcitabine(G) alone,gemcitabine plus S-1 (GS) and gemcitabine plus nab-paclitaxel (group A),33 patients were treated with mFOLFIRINOX (group B). In the mFOLFIRINOX regimen,oxaliplatin and irinotecan were reduced to 70 mg/m2 and 145 mg/m2 respectively,whereas the dosages of other drugs were maintained. The primary endpoints were overall survival(OS) and progression-free survival(PFS). The secondary endpoints were objective response rate(ORR) and grade 3/4 adverse events (AEs).Results The median OS were 8.3 months and 13.5 months in group A and group B respectively,and the PFS were 4.3 months and 6.1 months respectively (both P<0.05). Sixty-two patients completed the analysis of clinical efficacy. The ORR were 16.2% and 36.4% in group A and group B respectively(P>0.05). Moreover,the most common grade 3/4 AEs in group A were neutropenia (16.2%),febrile neutropenia(10.8%),thrombocytopenia(8.1%),allergic reaction(8.1%) and diarrhea(8.1%). In group B,neutropenia (12.1%),neuropathy(9.1%) and diarrhea(9.1%) were the most frequently observed AEs.Conclusion Modified FOLFIRINOX regimen has significantly improved efficacy with comparable adverse effects in the treatment of advanced pancreatic cancer,as compared with gemcitabine-based chemotherapy.

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