改良FOLFIRINOX方案一线治疗晚期转移性胰腺癌

摘要

[目的]探讨改良FOLFIRINOX(mFOLFIRINOX)方案为一线治疗晚期转移性胰腺癌的疗效和毒副反应.[方法]回顾性收集2012年12月至2016年12月在中山大学孙逸仙纪念医院接受mFOLFIRINOX方案化疗的20例晚期转移性胰腺癌患者资料,每3个化疗周期后进行影像学检查评估疗效,并观察相关毒副反应.mFOLFIRINOX方案为奥沙利铂60 mg/m2,伊立替康150 mg/m2,5-FU400 mg/m2静脉推注、2400 mg/m2持续静脉输注.主要研究终点为中位生存时间,次要研究终点为客观缓解率以及不良反应发生率(中性粒细胞减少、恶心呕吐、腹泻、周围神经病).[结果]20例患者中,4例患者因不符合入组标准被排除,共有16例患者可评价疗效.全组中位年龄为55岁(43~67岁),男性7例,女性9例.中位化疗周期为4.5个(3~15个).5例获得部分缓解, 9例稳定,2例进展,客观反应率为31.3%(5/16).中位随访时间为14.1(2.7~24.5)个月,中位生存时间为16.6个月(95%CI,11.36~21.84),6个月、12个月的生存率分别为80%和55.6%.3例患者出现3-4级不良反应.[结论]mFOLFIRINOX方案一线治疗晚期转移性胰腺癌效果好,不良反应发生率较低.%[Objective]To investigate efficacy and toxicity of a new modified FOLFIRINOX regimen(mFOLFIRI-NOX)as first-line chemotherapy for the patients with metastatic pancreatic adenocarcinoma(MPC).[Methods]20 patients with metastatic pancreatic adenocarcinoma(MPC)accepted mFOLFIRINOX arm(oxaliplatin 60 mg/m2,irinotecan 150 mg/m2,bolus of 5-FU 400 mg/m2,continuous infusion of 5-FU 2 400 mg/m2)first-line treatment and evaluated the curative effect and side effect after 3 cycles by imaging and laboratory at Sun Yat-sen Memorial Hospital from December 2012 to December 2016.The primary endpoint was overall survival(OS).The second endpoint was response rate(ORR) and toxicity.[Results]Four patients were excluded according to exclusion criteria. A total of 16 patients were enrolled including 7 males and 9 females.The median age is 55 years(ranging from 43 to 67 years).The median cycle of chemo-therapy was 4.5(3-15). The ORR was 31.3% including 5 patients with partial response,9 patients with stable disease and 2 patients with progression disease.The median follow-up duration was 14.1(2.7-24.5)months.The median OS was 16.6 months(95%CI,11.36-21.84). Overall survival rates at 6,12months were 80%and 55.6%,respectively. Three patients were presented grade 3-4 adverse events.[Conclusion]The new mFOLFIRINOX regimen improved survival of patients with MPC with tolerated toxicity as first line treatment.