title: Early-stage hepatocellular carcinoma in patients with cirrhosis: long-term results of percutaneous image-guided radiofrequency ablation.
abstract: OBJECTIVE
  To perform a prospective, intention-to-treat clinical trial to determine the long-term survival rates of patients with hepatic cirrhosis and early-stage hepatocellular carcinoma (HCC) in whom percutaneous image-guided radiofrequency (RF) ablation was used as the sole first-line anticancer treatment.
  
  
  METHODS
  The study was performed with approval of the ethics committee, and written informed consent was obtained for all patients. From June 1, 1996, to January 1, 2003, 206 patients (143 men, 63 women; age range, 51-81 years; mean age, 67 years +/- 7) who were excluded from surgery and who had Child class A or B cirrhosis with either a single HCC less than or equal to 5 cm in diameter or multiple (as many as three) HCCs less than or equal to 3 cm in diameter each were enrolled. RF ablation was performed in 187 (91%) of 206 patients; 19 (9%) were excluded from RF treatment because of unfavorable tumor location. Follow-up ranged from 3 to 78 months (mean, 24 months +/- 21) and included measurement of alpha-fetoprotein level, ultrasonography at 3-month intervals, and spiral computed tomography at 6-month intervals. Patients were observed for recurrence of the treated tumor and for the emergence of new HCC tumors. Survival probabilities were estimated with the Kaplan-Meier method, and differences between survival curves were evaluated with the log-rank test.
  
  
  RESULTS
  At the end of the study, 145 patients were alive, and 61 were dead. In the intention-to-treat analysis, overall survival rates were 97% at 1 year, 67% at 3 years, and 41% at 5 years. Median survival was 49 months. In the 187 patients treated with RF ablation, overall survival rates were 97% at 1 year, 71% at 3 years, and 48% at 5 years. Median survival was 57 months. The difference between the two survival curves was not statistically significant (P=.5094). Survival of patients treated with RF ablation was dependent on Child class (P=.0006) and tumor multiplicity (P=.0133). Patients who had Child class A cirrhosis with solitary HCC (n=116) had 1-, 3-, and 5-year survival rates of 100%, 89% and 61%; median survival was 65 months. The 1-, 3-, and 5-year recurrence rates were 14%, 49%, and 81% for the emergence of new tumors and 4%, 10%, and 10% for local tumor progression.
  
  
  CONCLUSIONS
  RF ablation is an effective first-line treatment for cirrhotic patients with early-stage HCC who were excluded from surgery.
authors.affiliation: Division of Diagnostic and Interventional Radiology, Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Via Roma 67, I-56125 Pisa, Italy. lencioni@do.med.unipi.it
authors.forename: Riccardo
authors.initials: R
authors.lastname: Lencioni
authors.forename: Dania
authors.initials: D
authors.lastname: Cioni
authors.forename: Laura
authors.initials: L
authors.lastname: Crocetti
authors.forename: Chiara
authors.initials: C
authors.lastname: Franchini
authors.forename: Clotilde Della
authors.initials: CD
authors.lastname: Pina
authors.forename: Jacopo
authors.initials: J
authors.lastname: Lera
authors.forename: Carlo
authors.initials: C
authors.lastname: Bartolozzi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000150:complications* / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications*; D008113:Liver Neoplasms / Q000150:complications* / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D015641:Radiography, Interventional; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome