改良FOLFIRINOX方案二线治疗吉西他滨治疗失败的晚期胰腺癌:一项回顾性研究

Second-line mFOLFIRINOX for patients with unresectable advanced pancreatic cancer after first-line gemcitabine failure: a retrospective study

目的初步评估改良的FOLFIRINOX方案(奥沙利铂+伊立替康+氟尿嘧啶)治疗既往一线吉西他滨化疗失败的晚期胰腺癌的疗效及安全性。方法回顾性收集2014—2019年间华西医院腹部肿瘤科收治的经改良FOLFIRINOX(mFOLFIRINOX)方案二线治疗的22例晚期胰腺癌患者资料,这些患者均接受了以吉西他滨为基础的一线化疗。收集这些患者的临床病理特征、治疗方案、治疗相关毒性反应、影像学资料及生存资料。结果22例患者中位年龄56.5岁,PS评分为0~1分,中位化疗周期数4.5个。客观反应率为9%(2/22),局部控制率为68%(15/22),中位无进展生存期为4.5个月,中位总生存期为9.2个月。单因素分析肝外转移患者中位总生存期较肝转移者短(5.7个月:10.5个月,P=0.028),PS评分1分患者中位总生存期较PS评分0分者短(4.8个月:10.2个月,P=0.003)。多因素分析显示PS评分1分、肿瘤部位位于胰头、肝外转移是不良预后因素。3、4级中性粒细胞减少18%,血小板减少14%,呕吐18%,腹泻14%。结论初步发现mFOLFIRINOX方案二线治疗体能状态良好的晚期胰腺癌患者不良反应可耐受,能带来一定疗效,值得进一步研究。

Objective The purpose of this study was to evaluate the efficacy and safety of modified FOLFIRINOX(oxaliplatin+irinotecan+5-fluorouracil)as a second-line treatment for gemcitabine refractory advanced pancreatic cancer.Methods A retrospective study was carried out on patients with advanced pancreatic cancer who were treated with FOLFIRINOX as a second-line therapy and were refractory to gemcitabine-based chemotherapy from October 2014 to June 2019 in the Department of Abdominal Oncology,West China Hospital,Sichuan University.The clinicopathological characteristics,therapeutic regimen,treatment-related toxicity,imaging data and survival data of these patients were collected.Results A total of 22 patients were included.All patients were PS score of 0-1.The median age was 56.5 years old.The median number of chemotherapy cycles was 4.5 cycles.Objective response rate(ORR)was 9%,disease control rate(DCR)was 68%,median progression free survival(PFS)was 4.5 months,and median overall survival(OS)was 9.2 months.In univariate analysis,patients with extrahepatic disease had a significantly shorter OS time than patients with only liver metastasis(5.7 months vs 10.5 months,P=0.028).The median OS time of patients with PS score of 1 was shorter than patients with PS score of 0(4.8 month vs 10.2 months,P=0.003).Multivariate analysis showed that PS score of 1,tumor site in the head of the pancreas,and extrahepatic metastases were associated with poor overall survival.The incidences of grade 3/4 toxicities of neutropenia,thrombocytopenia,vomiting and diarrhea were 18%,14%,18%,and 14%respectively.Conclusions mFOLFIRINOX showed acceptable toxicity and promising efficacy for gemcitabine refractory advanced pancreatic cancer with good physical performance.However,further prospective randomized controlled trials are required to evaluate the efficacy and toxicities of this regimen.