| BackgroundPrimary hepatocellular carcinoma(HCC) is one of the common malignant tumor of digestive tract in china, and it’s pathogenesis is not clear.China’s large number of hepatitis B patients that lead to cirrhosis of the liver is the main reason of HCC, Aflatoxin and other chemical carcinogens also have certain correlation with HCC.In recent years, with the development of imaging technology(ultrasound angiography, CT, Specific magnetic resonance) and the increase of test marker and human’s health awareness, more and more liver cancer were detected in the early or middle stage. But only 30% of HCC patients can obtained certain effect from the positive treatment, such as liver transplantation, liver resection, radiofrequency ablation. So far, the treatment of primary liver cancer is still have not clear standards or guidelines. The treatment of liver cancer is single or overlapping treatment with liver transplantation, liver resection, local ablation, hepatic arterial chemoembolization, percutaneous ethanol injection, biological treatment, et al. RFA is internationally recognized treatment of liver cancer, especially for cirrhosis and liver function damaged patients. RFA has a good application prospect for cancer patients. RFA was also used in the palliative treatment of advanced hepatocellular carcinoma which can’t be resected. RFA has been widely applied in clinic because of its’ safety and effectiveness. Research has shown that RFA and traditional operation had no difference in the treatment of early HCC and some scholars believe that RFA can be used as the preferred treatment for early HCC. TACE can cause tumor necrosis effect by embolization of tumor blood vessels and the targeting of chemotherapeutics to delay the progression of tumor and to improve the survival time. So it was now commonly used in the palliative treatment of advanced hepatocellular carcinoma. RFA and TACE have became the most commonly used minimally invasive treatment of HCC, and it can reduce the impact on liver function.But RFA is prone to lead to residual lesions and satellite lesions,resulting in recurrence and metastasis of HCC because of its’ own limitations and shortcomings. How to reduce residual lesions after radiofrequency ablation of liver cancer and to reduce the recurrence rate is the problem to be solved at now. TACE can find residual lesions and satellite lesions that may exist after RFA treatment.RFA and TACE combined treatment can play a synergistic effect and improve the therapeutic effect of early hepatocellular carcinoma patients.Therefore, we design an adjuvant TACE therapy of early hepatocellular carcinoma after RFA in order to get better curative effect of early HCC patients, and to get the best treatment plan, to provide evidence of treatment of early hepatocellular carcinoma.ObjectiveWe used prospective randomized control as the main method to compare the short term and long term curative effect of RFA group and RFA combined with TACE group for the treatment of HCC in early stage. We assessed the value of RFA combined with TACE to explore the methods to improve the curative effect of minimally invasive therapy for early hepatocellular carcinoma,provided clinical and theoretical basis of the treatment of early hepatocellular carcinoma.MethodThis study was strictly accorded with the prospective randomized control study design and learn from the successful experience of clinical trials at home and abroad. Comprehensive data of domestic and foreign literature has shown that the 3 years disease-free survival rate of early hepatocellular carcinoma after RFA treatment is about 20%-40%. This project may be expected to increase 3 year disease-free survival rate of about 10-20%. The significant difference is 0.05, detection efficiency(power, P) value is 0.90. The number of cases in each group is 70 according to statistics formula. We collected a total of 140 cases from October 7, 2011 to April 2, 2014 in accordance with the inclusion criteria and exclusion criteria,and stratified them according to tumor diameter.We divided into two group:tumor diameter less than 3cm and greater than 3cm but less than 5cm, more than two tumors we calculated the sum of the diameter of tumor. We randomly divided the patients into the RFA group and RFA combined with TACE group in accordance with the principle of hierarchical processing. The specific implementation according to the Zelen method.70 cases in RFA group(tumor diameter less than 3cm: 45 cases, tumor diameter greater than 3cm but less than 5cm:25 cases) and 70 cases in RFA+TACE group(tumor diameter less than 3cm:43 cases, tumor diameter greater than 3cm but less than 5cm:27 cases). t test or X2 test were used to compare comparability of clinical data. The disease-free survival time was from the beginning of operation to the diagnosis of recurrence and the overall survival time was from the beginning of operation to death or full 3 years follow-up period. The single factor analysis to estimate disease-free survival rate and overall survival rate of patients was Kaplan-Meier method,Log-rank method was used to estimate the difference of disease-free survival rate and overall survival rate of each group. The indicator relevant with disease-free survival rate and overall survival rate in the results of single factor analysis come into multi factor analysis Multivariate analysis using Cox regression model and screening the independent Postoperative index that influencing the disease-free survival rate and overall survival rate.Significant statistical differences were set at 0.05. Statistical analysis using SPSS 17 for windows to analysis statistical data.ResultsThe total loss rate of patients visit in the two groups was 6.4%(RFA 5/70, RFA+TACE 4/70). All patients were followed up for more than 1 years, 97 patients were followed up for more than 2 years and 46 patients were followed up for more than 3 years. This research shows that: the 1 years, 2 years, 3 year cumulative survival rates were 91.3%, 69.8% and 53% in RFA group and 94.3%, 85.8% and 75.1% in RFA+TACE group respectively. There are significant differences(P=0.044) between the two groups of the overall level of the survival curve by Log-rank test. The 1 years, 2 years, 3 year disease free survival rates were 69.9%, 44.2% and 30.0% in RFA group and 81.3%, 57.5% and 44.0% in RFA+TACE group respectively. There were significant differences between the two groups(P=0.011). With the patients that tumor diameter less than 3cm, the 1 years, 2 years, 3 year cumulative survival rates were 97.4%, 77.5% and 71.0% in RFA group and 94.0%, 84.5% and 71.3% in RFA+TACE group respectively. There were no significant difference between the two groups(P=0.565). The 1 years, 2 years, 3 year disease free survival rates were 83.3%, 54.7% and 37.7% in RFA group and 81.8%, 60.0% and 42.8% in RFA+TACE group respectively. There were no significant difference between the two groups(P=0.234). With the patients that tumor diameter greater than 3cm but less than 5cm, the 1 years, 2 years, 3 year cumulative survival rates were 85.7%, 59.0% and 39.3% in RFA group and 94.0%, 76.3% and 59.6% in RFA+TACE group respectively. There was no significant difference between the two groups(P=0.064). The 1 years, 2 years, 3 year disease free survival rates were 49.3%, 34.9% and 23.3% in RFA group and 75.0%, 52.2% and 44.8% in RFA+TACE group respectively.There were significant differences between the two groups(P=0.036). RFA+TACE treatment for early stage HCC need two operation,and these will increase the hospitalization cost of patients and the incidence of complications, and prolonged hospitalization.But there were no statistical differences between the patients quality of life. Two groups’ patients had no major complications and no deaths during hospitalization.Conclusion1. TACE treatment after RFA is safe and feasible.2. TACE treatment after RFA would increase the hospitalization cost and the incidence of complications, and prolonged hospitalization.But there were no statistical differences between the patients quality of life.3. For the patients with early HCC(Milan standard), TACE treatment after RFA can improve disease-free survival rate and overall survival rate of patients.4. For the patients with HCC that tumor diameter less than 3cm, There were no significant difference in overall survival rate and tumor free survival rate between TACE treatment after RFA group and RFA group.5. For the patients with HCC that tumor diameter greater than 3cm but less than 5cm, TACE treatment after RFA can improve disease-free survival rate, but there was no significant difference in overall survival rate. |
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