Clinical efficacy of GEMOX regimen combined with targeted therapy for advanced gallbladder cancer / 中华消化外科杂志

ABSTRACT

Objective To evaluate the clinical efficacy of gemcitabine-oxaliplatin (GEMOX) regimen combined with targeted therapy for advanced gallbladder cancer.Methods The retrospective descriptive study was conducted.The clinical data of 21 patients with advanced gallbladder cancer who were admitted to the Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine between January 2016 and December 2017 were collected,including 8 males and 13 females,aged from 28 to 80 years,with the age of (58± 12)years.Patients received GEMOX regimen combined with targeted therapy.According to the results of gene test,patients selected tageted therapy with Cetuximab,Herceptin or Apatinib.Observation indicators:(1) gene test situations;(2) situations of GEMOX regimen combined with targeted therapy;(3) adverse reactions of GEMOX regimen combined with targeted therapy.Measurement data with normal distribution were represented as Mean±SD,and measurement data with skewed distribution were described as M (range).Count data were represented as absolute number or percentage.The survival curve and rate were respectively drawn and calculated using the Kaplan-Meier method.The survival analysis was done using the Log-rank test.Results (1) Gene test situations:of 21 patients,19 were confirmed as K-ras wild type,including 13 of single K-ras wild type,4 of K-ras wild type combined with human epidermal growth factor receptor 2 (HER2),2 of K-ras wild type combined with vascular endothelial growth factor receptor 2 (VEGFR2);5 were detected positive HER2,including 1 of single positive HER2,4 of positive HER2 combined with K-ras wild type;3 were detected positive VEGFR2,including 1 of single positive VEGFR2,2 of positive VEGFR2 combined with K-ras wild type.Two and 19 patients had 0 and l of Eastern Cooperative Oncology Group score.(2) Situations of GEMOX regimen combined with targeted therapy:all the 21 patients underwent ≥ 2 courses of GEMOX regimen combined with targeted therapy.Among the 21 patients,0,4,9 and 8 were respectively detected in the complete remission (CR),partial remission (PR),stable disease (SD) and disease progression (PD).Fourteen patients (13 of single K-ras wild type and 1 of K-ras wild type combined with positive VEGFR2) received GEMOX regimen combined with Cetuximab therapy,including 0 with CR,4 with PR,5 with SD and 5 with PD;5 patients (1 of single positive HER2 and 4 of positive HER2 combined with K-ras wild type) received GEMOX regimen combined with Herceptin therapy,including 0 with CR,0 with PR,2 with SD and 3 with PD;2 patients (1 of single positive VEGFR2 and 1 of positive VEGFR2 combined with K-ras wild type) received GEMOX regimen combined with Apatinib therapy,including 0 with CR,0 with PR,2 with SD and 0 with PD.The objective response rate was 19.0％ (4/21) and disease control rate was 61.9％(13/21) in the 21 patients.The median onset time was 1.8 months in the 21 patients.The 3-,6-and 9-month progression free survival (PFS) rates and median PFS time were respectively 90.5％,71.4％,58.5％ and 10.7 months.The 6-and 12-month overall survival rates were respectively 90.2％ and 58.6％,and median overall survival (OS) time was 15.5 months in the 21 patients.The PFS and OS time were 8.4 months and 10.4 months in the 7 patients combined with jaundice,10.5 months and 14.8 months in the 14 patients without jaundice,with no statistically significant difference (x2 =0.868,0.774,P＞0.05).(3) Adverse reactions of GEMOX regimen combined with targeted therapy:the most common adverse events were skin rash and digestive tract reactions.No serious adverse event occurred during the therapy.All the adverse events were improved after symptomatic treatments.Conclusion GEMOX regimen combined with targeted therapy for advanced gallbladder cancer has good outcomes,less adverse reactions and higher safety.