OBJECTIVE: To compare percutaneous ethanol injection (PEI), the standard approach which has been used for many years to treat early non-surgical hepatocellular carcinoma (HCC) in cirrhotic patients, and radiofrequency ablation (RFA), which has become an interesting alternative. MATERIAL AND METHODS: A randomized trial was carried out on 139 cirrhotic patients in Child-Pugh classes A/B with 1-3 nodes of HCC (diameter 15-30 mm), for a total of 177 lesions. Patients were randomized to receive RFA (n=70) or PEI (n=69). The primary end-point was complete response (CR) 1 year after the percutaneous ablation of all HCC nodes identified at baseline. Secondary end-points were: early (30-50 days) CR, complications, survival and costs. RESULTS: In an intention-to-treat analysis, 1-year CR was achieved in 46/70 (65.7%) and in 25/69 (36.2%) patients treated by RFA and PEI, respectively (p=0.0005). For lesions >20 mm in diameter, there was a larger CR rate in the RFA group (68.1% versus 26.3%). An early CR was obtained in 67/70 (95.7%) patients treated by RFA compared with 42/64 (65.6%) patients treated by PEI (p=0.0001). Complications occurred in 10 and 12 patients treated by RFA and PEI, respectively. The overall survival rate was not significantly different in the RFA versus PEI arm (adjusted hazard ratio=0.88, 95% CI: 0.50-1.53). There was an incremental health-care cost of 8286 euro for each additional patient successfully treated by RFA. CONCLUSIONS: The 1-year CR rate after percutaneous treatment of early HCC was significantly better with RFA than with PEI but did not provide a clear survival advantage in cirrhotic patients.
RCT Entities:
OBJECTIVE: To compare percutaneous ethanol injection (PEI), the standard approach which has been used for many years to treat early non-surgical hepatocellular carcinoma (HCC) in cirrhotic patients, and radiofrequency ablation (RFA), which has become an interesting alternative. MATERIAL AND METHODS: A randomized trial was carried out on 139 cirrhotic patients in Child-Pugh classes A/B with 1-3 nodes of HCC (diameter 15-30 mm), for a total of 177 lesions. Patients were randomized to receive RFA (n=70) or PEI (n=69). The primary end-point was complete response (CR) 1 year after the percutaneous ablation of all HCC nodes identified at baseline. Secondary end-points were: early (30-50 days) CR, complications, survival and costs. RESULTS: In an intention-to-treat analysis, 1-year CR was achieved in 46/70 (65.7%) and in 25/69 (36.2%) patients treated by RFA and PEI, respectively (p=0.0005). For lesions >20 mm in diameter, there was a larger CR rate in the RFA group (68.1% versus 26.3%). An early CR was obtained in 67/70 (95.7%) patients treated by RFA compared with 42/64 (65.6%) patients treated by PEI (p=0.0001). Complications occurred in 10 and 12 patients treated by RFA and PEI, respectively. The overall survival rate was not significantly different in the RFA versus PEI arm (adjusted hazard ratio=0.88, 95% CI: 0.50-1.53). There was an incremental health-care cost of 8286 euro for each additional patient successfully treated by RFA. CONCLUSIONS: The 1-year CR rate after percutaneous treatment of early HCC was significantly better with RFA than with PEI but did not provide a clear survival advantage in cirrhotic patients.
Authors: Al B Benson; Thomas A Abrams; Edgar Ben-Josef; P Mark Bloomston; Jean F Botha; Bryan M Clary; Anne Covey; Steven A Curley; Michael I D'Angelica; Rene Davila; William D Ensminger; John F Gibbs; Daniel Laheru; Mokenge P Malafa; Jorge Marrero; Steven G Meranze; Sean J Mulvihill; James O Park; James A Posey; Jasgit Sachdev; Riad Salem; Elin R Sigurdson; Constantinos Sofocleous; Jean-Nicolas Vauthey; Alan P Venook; Laura Williams Goff; Yun Yen; Andrew X Zhu Journal: J Natl Compr Canc Netw Date: 2009-04 Impact factor: 11.908
Authors: Francesco Bellissimo; Marilia Rita Pinzone; Bruno Cacopardo; Giuseppe Nunnari Journal: World J Gastroenterol Date: 2015-11-14 Impact factor: 5.742
Authors: Virginia Hernandez-Gea; Fanny Turon; Annalisa Berzigotti; Augusto Villanueva Journal: World J Gastroenterol Date: 2013-02-28 Impact factor: 5.742