title: Increased survival in hepatocellular carcinoma with iodine-125 implantation plus radiofrequency ablation: a prospective randomized controlled trial.
abstract: OBJECTIVE
  The purpose of this study was to evaluate whether use of combined radiofrequency ablation (RFA) and percutaneous iodine-125 ((125)I) seed implantation results in better progression-free survival compared with the use of RFA alone in patients with hepatocellular carcinoma.
  
  
  METHODS
  136 patients were randomly assigned to undergo HCC treatment with RFA and percutaneous iodine-125 seed implantation (RFA-(125)I, n=68) or RFA-only (n=68). A total of 91 patients had hepatitis B viral infection in both groups. Rates of tumour recurrence and overall survival were evaluated.
  
  
  RESULTS
  The probabilities of recurrence at 1-, 3-, and 5-years were 4.5%, 22.1%, and 39.8% in the RFA-(125)I group; and 14.8%, 35.3%, and 57.4% in the RFA-only group, respectively. The recurrence rate in the RFA-(125)I group was significantly lower than in the RFA-only group (HR, 0.508; 95% CI, 0.317-0.815; p=0.004 by log-rank test). Local and intrahepatic recurrence was significantly lower in the RFA-(125)I group than in the RFA-only group (7.3% vs. 22.0%, p=0.012 by log-rank test; 17.6% vs. 32.3%, p=0.041 by log-rank test). The probabilities of survival at 1-, 3-, and 5-years were 100%, 86.7%, and 66.1% in the RFA-(125)I group and 95.6%, 75.0%, and 47.0% in the RFA-only group, respectively. The survival rate in the RFA-(125)I group was significantly better than in the RFA-only group (HR, 0.502; 95% CI, 0.313-0.806; p=0.003 by log-rank test). Cox regression model indicated that the treatment group and tumour size were both recurrence-related and overall survival-related prognostic factors.
  
  
  CONCLUSIONS
  There were significant differences in overall survival and cumulative recurrence between RFA-(125)I and RFA-only for patients with small HCCs (⩽3 cm). Treatment with RFA-(125)I facilitated better local and intrahepatic tumour control and long-term survival compared with treatment of RFA alone. ClinicalTrials.gov Identifier: NCT01717729.
authors: Department of General Surgery, The Second People's Hospital of Guangdong Province, Guangdong Provincial Emergency Hospital, South Medical University, Guangzhou, People's Republic of China; Department of Hepatology Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: chky3213300@126.com.
authors: Kaiyun
authors: K
authors: Chen
authors: Department of Hepatology Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
authors: Guihua
authors: G
authors: Chen
authors: Department of General Surgery, The Second People's Hospital of Guangdong Province, Guangdong Provincial Emergency Hospital, South Medical University, Guangzhou, People's Republic of China.
authors: Hanning
authors: H
authors: Wang
authors: Department of Hepatology Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.
authors: Hua
authors: H
authors: Li
authors: Department of General Surgery, The Second People's Hospital of Guangdong Province, Guangdong Provincial Emergency Hospital, South Medical University, Guangzhou, People's Republic of China.
authors: Jinfeng
authors: J
authors: Xiao
authors: Department of General Surgery, The Second People's Hospital of Guangdong Province, Guangdong Provincial Emergency Hospital, South Medical University, Guangzhou, People's Republic of China.
authors: Xiaopeng
authors: X
authors: Duan
authors: Department of General Surgery, The Second People's Hospital of Guangdong Province, Guangdong Provincial Emergency Hospital, South Medical University, Guangzhou, People's Republic of China.
authors: Jiwen
authors: J
authors: He
authors: Department of General Surgery, The Second People's Hospital of Guangdong Province, Guangdong Provincial Emergency Hospital, South Medical University, Guangzhou, People's Republic of China.
authors: Ke
authors: K
authors: He
authors: Department of General Surgery, The Second People's Hospital of Guangdong Province, Guangdong Provincial Emergency Hospital, South Medical University, Guangzhou, People's Republic of China. Electronic address: guoan_66@163.com.
authors: Guoan
authors: G
authors: Xiang
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D001145:Arrhythmias, Cardiac / Q000453:epidemiology; D006528:Carcinoma, Hepatocellular / Q000401:mortality* / Q000628:therapy*; D017115:Catheter Ablation / Q000009:adverse effects / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007457:Iodine Radioisotopes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007970:Leukopenia / Q000453:epidemiology; D008113:Liver Neoplasms / Q000401:mortality* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000453:epidemiology; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D015995:Prevalence; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D007457:Iodine Radioisotopes
keywords: Hepatocellular carcinoma; Iodine-125 implantation; RCTs; Radiofrequency ablation; Safety; Survival