目的 探讨改良FOLFIRINOX方案(mFOLFIRINOX)治疗进展期胰腺癌的疗效和安全性.方法 前瞻性收集2014年4月至2015年10月在浙江大学医学院附属第二医院接受mFOLFIRINOX方案化疗的35例进展期胰腺癌患者资料,其中局部进展期胰腺癌(LAPC) 18例,转移性胰腺癌(MPC) 17例.mFOLFIRINOX方案为伊立替康降至135 mg/m2体表面积(原方案剂量的75%),奥沙利铂降至68 mg/m2体表面积(原方案剂量的80%),取消氟尿嘧啶静脉滴注.主要研究终点设为无进展生存期,次要研究终点为总体生存期、反应率、不良反应及LAPC患者的手术转化率.结果 35例患者中,6例因社会经济原因放弃治疗,其余29例患者的化疗周期为2 ~13个,中位化疗周期为5个.化疗反应为部分缓解者16例、为稳定者10例、为进展者3例,客观反应率为55.2%;9例LAPC患者化疗后行手术治疗,手术为R0切除6例.中位随访时间8个月(3~21个月),6个月和12个月的生存率分别为92.6%和57.9%,无进展生存时间为7个月.9例患者出现3~4度不良反应,经过相应处理均能维持原方案化疗.结论 mFOLFIRINOX方案治疗进展期胰腺癌效果较好,不良反应较轻,患者耐受性好.
Objective To explore efficacy and safety of modified FOLFIRINOX (mFOLFIRINOX) regimen by dose attenuation in locally advanced pancreatic cancer(LAPC) and metastatic pancreatic cancer (MPC).Methods Between April 2014 and October 2015,35 patients with LAPC (n =18) or MPC (n =17) were treated with mFOLFIRINOX regimen (irinotecan 135 mg/m2,oxaliplatin 68 mg/m2,5-FU 2 400 mg/m2,no bolus of 5-FU,leucovorin 400 mg/m2) in the Second Affiliated Hospital of Zhejiang University School of Medicine.The primary end point was progression free survival.The second end points were overall survival,objective response rate,adverse effects,surgical resection rate for LAPC.Results Among 35 patients,6 patients(17.1%) who dropped out and received less than 2 cycles were excluded for response analysis.Among the other 29 patients,9 patients had grade 3 or 4 adverse effects.No patients ceased treatment due to adverse effects.The 29 patients received 5 (2-13) cycles were evaluated by efficacy and found partial remission in 16 cases,stable disease in 10 cases,progression disease in 3 cases.Response rate was 55.2%.Nine patients with LAPC accomplished surgery after neoadjuvant treatment without perioperative complication and death,and 6 patients accepted R0 resection.Conclusions The mFOLFIRINOX regimen used in the study is well-tolerated in Chinese population with high treatment efficacy on patients with LAPC and MPC.Further investigation of efficacy and adverse effects on more advanced pancreatic cancer patients is necessary.