Comparative Study Of Therapeutic Efficacy Of Systemic Therapy With FOLFOX-6 And Hepatic Arterial Infusion For Hepatic Metastases From Colorectal Cancer

Objective:The purpose of this study was to compare efficacy and side effects of systemic therapy combination of oxaliplatin and flurouracil(FOLFOX-6)versus hepatic arterial infusion chemotherapy with 5-FU in patients having undergone hepatic metastasis after colorectal cancer operation.And to analyze the factors that would effect the prognosis of these patients' without operational therapy.Methods:1.This study was prospective sample randomly designed and control study,46 patients who had sighed the informed consents were allocated into two groups:the general chemotherapy group(Trial Group includes 26)and the hepatic arterial infusion chemotherapy group(Control Group includes 20 cases).The Trial Group:take the FOLFOX-6 proposal:the first day oxaliplatin,ivgtt.100mg/m2;Calcium Folinate,ivgtt.400mg/m2;5-FU,â…°.â…´.400 mg/m2.Then 5-FU,2.4g/m2,during the 1-2days,46 hours continuous ivgtt,were needed.2 weeks would be one treat cycle.As the Control Group is concerned,Femoral artery puncturing were arranged by the Seldinger skills,then we sent the catheter to the hepatic artery or the proper hepatic artery directly,where the hepatic arterial infusion chemotherapy begin.It includes 5-FU 0.8-1.0,Cisplatin 60-80mg,HCPT 30mg,Calcium Folinate 0.1,one treat circle includes 4 weeks.The main observation targets were total effective rate,the ratio of the disease controlling,the poison and side effects,quality of life,the total survival rate,then the response.2.The clinical characters of the 46 patients who had undergone hepatic metastasis after colorectal cancer operation were recorded.Mono-factor analysis to the prognosis was done with Kaplan-Meier,and poly-factor analysis to the prognosis was done with the Cox mode.Results:1.Overall survival was significantly longer for systemic treatment versus HAI(median, 15.0±5.8 v 11.2±5.6 months;P＜0.05),1 year survival rate:70.38%v 47.96%,means a significant statistics difference(P=0.024),2 year survival rate:30.03%v 8.56%,means no significant statistics difference(P=0.520).2.The overall response rate(CR+PR)between the two groups was statistically significant(50% v 10%;P=0.011),disease control rate(CR+PR)were 69.2%v 40%,The difference was statistically significant(P=0.047).3.The patients' Physical state scaled with Karnofsky score improved from 73.79±7.75 v 78. 5±5.87 to 74.48±9.48 v 75.5±6.05.The PS scale have no statistically significant difference during the treatment.(P=0.126).4.The side effects mainly included myelosuppression(53.8%v 15%;P＜0.05),grade≥3 was 2 and 0 case;gastrointestinal tract reaction(84.6%v 60%;P＞0.05),of all was 1-2 grade; diarrhea(11.5%v 5%;P＞0.05);peripheral neurotoxicity(15.4%v 0%;P＞0.05).5.Using the Kaplan-Meier method and log-rank univariate analysis,There was significant variables include:whether invasive lesions serosa,the distribution of liver metastases,liver lesions largest diameter,the number of liver metastases,primary carcinoma of lymph node metastasis and what treatment.Single factor analysis of a statistically significant risk factors; Cox model with multi-factor analysis found:diameter of the largest liver metastases(X₇),liver lesions number(X₈),primary carcinomas whether saturated serosal layer(X₄)and treatment modalities(X₁₁)for an independent prognostic risk factors.We get the risk function expression: h(t)=h₀(t)exp(1.730X₈+1.428X₄-1.349X₁₁+1.326X₇)。Conclusions:1.The oxaliplatin-based chemotherapy FOLFOX-6 proposal had a better response rate and disease control than the traditional 5-FU to the main hepatic artery Interventional chemotherapy treatment;FOLFOX-6 had a higher incidence of myelosuppression.No difference at the physical impact of the state could be considered.2.The systemic chemotherapy scheme combination of oxaliplatin and flurouracil(FOLFOX-6) has a better response rate,an improved median and a better long-term results,compared with the hepatic arterial infusion chemotherapy with 5-FU.3.Patients having undergone hepatic metastasis after colorectal cancer operation,the largest hepatic metastasis diameter＞5cm,multiple hepatic metastasis and the primary lesions soak serosal layer,all suggest poor prognosis.The oxaliplatin-based chemotherapy had a better prognosis.4.At the period of 10-14 months after systemic chemotherapy scheme combination of oxaliplatin and flurouracil(FOLFOX-6),patients had the greatest risk of death caused by the metastasis, interventional therapy should be considered.5.Operational radical cure for the primary tumor and the metastasis should be taken to patients without hepatic metastasis,systemic medicine therapy and/or hepatic arterial infusion chemotherapy should be considered if the hepatic metastasis cannot be removed by operation,the traditional hepatic arterial infusion recommend refining,it is worth doing further studying on the hepatic arterial infusion and the general chemotherapy combination...