Background:The first-line chemotherapy regimen for advanced gallbladder cancer(GBC)is gemcitabine plus platinum(GP),despite its efficacy is limited.The current investigation is a retrospective study to compare the saf...Background:The first-line chemotherapy regimen for advanced gallbladder cancer(GBC)is gemcitabine plus platinum(GP),despite its efficacy is limited.The current investigation is a retrospective study to compare the safety and efficacy between the modified FOLFIRINOX(mFOLFIRINOX)and gemcitabine plus oxaliplatin(GEMOX)as the first-line chemotherapy for unresectable locally advanced or metastatic GBC.Methods:The data of patients with unresectable locally advanced or metastatic GBC,who were treated with mFOLFIRINOX or GEMOX as the first-line therapy between April 2014 and April 2018 at Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine,were retrieved.This retrospective study evaluated the clinical characteristics,survival outcomes and adverse events.Results:A total of 44 patients(n=25 in mFOLFIRINOX,n=19 in GEMOX)were included.There were no significant differences between groups in baseline characteristics.The median progression free survival(mPFS)was 5.0 months in the mFOLFIRINOX group and 2.5 months in the GEMOX group[P=0.021;hazard ratio(HR),0.499;95%CI,0.266 to 0.937].The median overall survival(mOS)was 9.5 months in the mFOLFIRINOX group and 7.0 months in the GEMOX group(P=0.019;HR,0.471;95%CI,0.239 to 0.929).Disease control rate(DCR)was 76.0%in the mFOLFIRINOX group and 47.4%in the GEMOX group(P=0.051).The rate of grade 3-4 adverse events was 48%in the mFOLFIRINOX group and 36.8%in the GEMOX group(P=0.459).The incidence of grade 3-4 neutropenia and diarrhea were more common in the mFOLFIRINOX group,while the incidence of grade 3-4 thrombocytopenia and peripheral neuropathy were more common in the GEMOX group.Conclusions:mFOLFIRINOX might improve the poor prognosis of unresectable locally advanced or metastatic GBC,and the results need to be further verified by prospective clinical studies.展开更多
基金This work was supported by the National Natural Science Foundation of China(grant numbers 31620103910,81874181,82073206,81773043)the National Science and Technology Major Projects for“Major New Drugs Innovation and Development”(grant number 2019ZX09301158)+4 种基金Emerging Frontier Projects of Shanghai-Level Hospitals(grant number SHDC12018107)“Shuguang Program”supported by Shanghai Education Development Foundation and Shanghai Municipal Education Commission(grant number 20SG14)the Program of Shanghai Academic Research Leader(grant number 19XD1422700)the Peak Plateau Discipline Construction Project of Shanghai Jiaotong University School of Medicine(grant number 20181808)Clinical Research Program of Xinhua Hospital(19XHCR3D).
文摘Background:The first-line chemotherapy regimen for advanced gallbladder cancer(GBC)is gemcitabine plus platinum(GP),despite its efficacy is limited.The current investigation is a retrospective study to compare the safety and efficacy between the modified FOLFIRINOX(mFOLFIRINOX)and gemcitabine plus oxaliplatin(GEMOX)as the first-line chemotherapy for unresectable locally advanced or metastatic GBC.Methods:The data of patients with unresectable locally advanced or metastatic GBC,who were treated with mFOLFIRINOX or GEMOX as the first-line therapy between April 2014 and April 2018 at Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine,were retrieved.This retrospective study evaluated the clinical characteristics,survival outcomes and adverse events.Results:A total of 44 patients(n=25 in mFOLFIRINOX,n=19 in GEMOX)were included.There were no significant differences between groups in baseline characteristics.The median progression free survival(mPFS)was 5.0 months in the mFOLFIRINOX group and 2.5 months in the GEMOX group[P=0.021;hazard ratio(HR),0.499;95%CI,0.266 to 0.937].The median overall survival(mOS)was 9.5 months in the mFOLFIRINOX group and 7.0 months in the GEMOX group(P=0.019;HR,0.471;95%CI,0.239 to 0.929).Disease control rate(DCR)was 76.0%in the mFOLFIRINOX group and 47.4%in the GEMOX group(P=0.051).The rate of grade 3-4 adverse events was 48%in the mFOLFIRINOX group and 36.8%in the GEMOX group(P=0.459).The incidence of grade 3-4 neutropenia and diarrhea were more common in the mFOLFIRINOX group,while the incidence of grade 3-4 thrombocytopenia and peripheral neuropathy were more common in the GEMOX group.Conclusions:mFOLFIRINOX might improve the poor prognosis of unresectable locally advanced or metastatic GBC,and the results need to be further verified by prospective clinical studies.
