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OC.10.1: RADIOFREQUENCY ABLATION VERSUS LASER ABLATION FOR THE TREATMENT OF SMALL HEPATOCELLULAR CARCINOMA: A RANDOMIZED CONTROLLED TRIAL
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Abstracts of the XVII National Congress of Digestive Diseases / Digestive and Liver Disease 43S (2011) S115–S264
G4 40/98 (40.8%). At univariate analysis SVR was associated with female sex (p=0.047), Italian ethnicity (p=0.004), absence of cirrhosis (p<0.001), low GGT serum levels (p<0.001), HC viremia <600,000 UI/l (p<0.001), absence of HIV coinfection (p=0.006), number of pts treated/year >50 (p=0.004), alpha 2a PEG-IFN treatment (p=0.009). At multivariate analysis genotype, HC viral load, cirrhosis and center size, but not PEG-IFN choice, were predictive of response. Conclusions: 1) The overall efficacy of combination therapy with PEG-IFNs & RBV in clinical practice overlaps the efficacy observed in Registration Trials; 2) higher prevalence of “easy to treat genotypes” accounts for this similar effectiveness; 3) cirrhosis, HCV genotype and viral load, but not BMI and PEG-IFN choice, account for effectiveness variability.
OC.10.1 RADIOFREQUENCY ABLATION VERSUS LASER ABLATION FOR THE TREATMENT OF SMALL HEPATOCELLULAR CARCINOMA: A RANDOMIZED CONTROLLED TRIAL G.G. Di Costanzo ∗ , R. Tortora, G. D’Adamo, A. Galeota Lanza, N. Carannante, F. Lampasi, M. De Luca, M.T. Tartaglione, C.M. Pacella Cardarelli Hospital, Naples, Italy Background and aim: Percutaneous thermal ablation is an effective treatment for small hepatocellular carcinoma (HCC) when surgery is unfeasible. Radiofrequency ablation (RFA) and laser ablation (LA) are different thermal techniques and there is the need for a comparison between them. Aim of the study was to prospectively evaluate tumor response after RFA or LA of small HCC in cirrhotic patients. Material and methods: From January 2009 to October 2010, 80 patients with 93 HCC nodules (single = 5.0cm or =3 nodules =3cm) randomly received either RFA (n=40) or LA (n=40) treatment. Primary outcome measures were complete tumor ablation (CTA) and time to recurrence (TTR). Secondary endpoint was overall survival (OS). Groups were comparable for median age (70 years), male/female (30/10-RFA, 27/13-LA), Child-Pugh A/B (36/40-RFA, 39/40-LA), and median diameter of HCC nodules (25mm-RFA, 27mm-LA). To establish the efficacy in terms of time-to-event measurement for TTR and OS in the two treatment groups, log-rank test was used. Results: Median follow-up was 9 (range 1-23) months. CTA was observed in 95% of cases in both groups. Overall HCC recurrence occurred in 17 (10 RFA and 7 LA) patients. Local recurrences were 4 in RFA group and 3 in LA group. TTR was 8±4 and 11±5 months in RFA and LA groups respectively (p=0.149). One-year survival probability was 94% in both groups. No significant treatment-related morbidity was registered in both groups.
OC.10.2 HEPATOCELLULAR CARCINOMA (HCC) IN CIRRHOSIS: LONG-TERM RESULTS OF PERCUTANEOUS RADIOFREQUENCY ABLATION OF BOTH THE NODULE AND THE PORTAL VENOUS TUMOR THROMBUS A. Giorgio ∗ , G. De Stefano, A. Di Sarno, N. Farella, U. Scognamiglio, A. De Rogatis, E. Trapanese, V. Giorgio A.O.D. Cotugno - IX Infectious Diseases and Interventional Ultrasound Unit, Napoli, Italy Background and aim: To report 5-year survival of percutaneous radiofrequency ablation (RFA) of both medium-sized Hepatocellular carcinoma (HCC) accompanied by portal venous tumor thrombus (PVTT) in cirrhotic patients. Material and methods: From January 2005 and January 2010 among 2847 consecutively registered patients with HCC seen at our Institution, 672 had HCC and PVTT; 57 of the 672 had a single HCC accompanied by main portal vein tumor thrombus (MPVTT). Thirty-five patients (27 men, mean age 73 years) with 35 HCC nodules 3.7-5 cm in diameter extending into the main portal trunk underwent Percutaneous RFA. Twenty-two matched patients (15 men, mean age 70 years) with 22 HCC nodules 3.6-5 cm in diameter extending into the main portal trunk refused RFA and composed the control group. Diagnosis of MPVTT was made with fine needle biopsy in all cases. RFA was performed first on the MPVTT and then on the HCC nodule. Efficacy of RFA was defined as complete necrosis of HCC (evaluated with enhanced CT one month after procedure) and complete recanalization of the MPV (evaluated with Color-Doppler within 30 days after procedure). Results: Complete necrosis of the HCC associate with complete recanalization of MPV was achieved in 67% of cases. No patient died. One patient had haemoperitoneum that healed spontaneously. Seven patients presented with ascites and 9 patients with increased transaminases: both these complications resolved within 7 days. The follow-up ranged between 8 and 68 months. The cumulative survival rates were 63, 41, 30, 20 and 20% at 1, 2, 3, 4,and 5 years respectively in the treated group, while in the control group (untreated patients) survival was 0% at 1 year (p<0.0001). Conclusions: Percutaneous RFA of both single intraparenchymal mediumsized HCCs accompanied by MPVTT, significantly prolongs long-term survival of cirrhotic patients compared with no treatment. The procedure is safe, with low rate of major complications and should be considered as a new and effective tool in the treatment of this subset of advanced HCC.
OC.10.3 HEPATOCELLULAR CARCINOMA IN CIRRHOSIS EXTENDED IN THE MAIN PORTAL VEIN: A RANDOMISED CONTROLLED TRIAL COMPARING PERCUTANEOUS RADIOFREQUENCY ABLATION OF BOTH HEPATOCELLULAR CARCINOMA NODULES AND THE PORTAL VENOUS TUMOR THROMBUS PLUS SORAFENIB WITH SORAFENIB ALONE A. Giorgio ∗ , N. Farella, A. Di Sarno, G. De Stefano, U. Scognamiglio, A. De Rogatis, E. Trapanese, V. Giorgio A.O.D. Cotugno - IX Infectious Diseases and Interventional Ultrasound Unit, Napoli, Italy
Conclusions: In our experience, LA was as effective as RFA in inducing the complete necrosis of HCC nodules. TTR seems to be slightly longer in LA group, but data have to be evaluated at the end of the follow-up.
Background and aim: To compare 3-year survival of patients with Hepatocellular carcinoma (HCC) and neoplastic portal vein tumor thrombus (PVTT) treated with Percutaneous Radiofrequency ablation (RFA) of both HCC and PVTT plus Sorafenib (combination group) with Sorafenib alone. Material and methods: Seventy-nine Child-Pugh A naïve cirrhotic patients with HCC and PVTT were randomly assigned to receive RFA of both HCC and PVTT plus Sorafenib (N=39) or Sorafenib alone (n=40). Inclusion criteria: a) single HCC <6.5 cm and PVTT, b) three HCC nodules no more than 5 cm with PVTT. RFA was performed first on the PVTT and then on the HCC. Sorafenib treatment (800 mg/die) started soon after the RFA of both HCC and PVTT and soon after diagnosis in Sorafenib alone. Results: Sorafenib induced adverse events in 37% of the combination group and in 39% of the Sorafenib alone group, so far, the dropped–out were 25% in
Abstracts of the XVII National Congress of Digestive Diseases / Digestive and Liver Disease 43S (2011) S115–S264
G4 40/98 (40.8%). At univariate analysis SVR was associated with female sex (p=0.047), Italian ethnicity (p=0.004), absence of cirrhosis (p<0.001), low GGT serum levels (p<0.001), HC viremia <600,000 UI/l (p<0.001), absence of HIV coinfection (p=0.006), number of pts treated/year >50 (p=0.004), alpha 2a PEG-IFN treatment (p=0.009). At multivariate analysis genotype, HC viral load, cirrhosis and center size, but not PEG-IFN choice, were predictive of response. Conclusions: 1) The overall efficacy of combination therapy with PEG-IFNs & RBV in clinical practice overlaps the efficacy observed in Registration Trials; 2) higher prevalence of “easy to treat genotypes” accounts for this similar effectiveness; 3) cirrhosis, HCV genotype and viral load, but not BMI and PEG-IFN choice, account for effectiveness variability.
OC.10.1 RADIOFREQUENCY ABLATION VERSUS LASER ABLATION FOR THE TREATMENT OF SMALL HEPATOCELLULAR CARCINOMA: A RANDOMIZED CONTROLLED TRIAL G.G. Di Costanzo ∗ , R. Tortora, G. D’Adamo, A. Galeota Lanza, N. Carannante, F. Lampasi, M. De Luca, M.T. Tartaglione, C.M. Pacella Cardarelli Hospital, Naples, Italy Background and aim: Percutaneous thermal ablation is an effective treatment for small hepatocellular carcinoma (HCC) when surgery is unfeasible. Radiofrequency ablation (RFA) and laser ablation (LA) are different thermal techniques and there is the need for a comparison between them. Aim of the study was to prospectively evaluate tumor response after RFA or LA of small HCC in cirrhotic patients. Material and methods: From January 2009 to October 2010, 80 patients with 93 HCC nodules (single = 5.0cm or =3 nodules =3cm) randomly received either RFA (n=40) or LA (n=40) treatment. Primary outcome measures were complete tumor ablation (CTA) and time to recurrence (TTR). Secondary endpoint was overall survival (OS). Groups were comparable for median age (70 years), male/female (30/10-RFA, 27/13-LA), Child-Pugh A/B (36/40-RFA, 39/40-LA), and median diameter of HCC nodules (25mm-RFA, 27mm-LA). To establish the efficacy in terms of time-to-event measurement for TTR and OS in the two treatment groups, log-rank test was used. Results: Median follow-up was 9 (range 1-23) months. CTA was observed in 95% of cases in both groups. Overall HCC recurrence occurred in 17 (10 RFA and 7 LA) patients. Local recurrences were 4 in RFA group and 3 in LA group. TTR was 8±4 and 11±5 months in RFA and LA groups respectively (p=0.149). One-year survival probability was 94% in both groups. No significant treatment-related morbidity was registered in both groups.
OC.10.2 HEPATOCELLULAR CARCINOMA (HCC) IN CIRRHOSIS: LONG-TERM RESULTS OF PERCUTANEOUS RADIOFREQUENCY ABLATION OF BOTH THE NODULE AND THE PORTAL VENOUS TUMOR THROMBUS A. Giorgio ∗ , G. De Stefano, A. Di Sarno, N. Farella, U. Scognamiglio, A. De Rogatis, E. Trapanese, V. Giorgio A.O.D. Cotugno - IX Infectious Diseases and Interventional Ultrasound Unit, Napoli, Italy Background and aim: To report 5-year survival of percutaneous radiofrequency ablation (RFA) of both medium-sized Hepatocellular carcinoma (HCC) accompanied by portal venous tumor thrombus (PVTT) in cirrhotic patients. Material and methods: From January 2005 and January 2010 among 2847 consecutively registered patients with HCC seen at our Institution, 672 had HCC and PVTT; 57 of the 672 had a single HCC accompanied by main portal vein tumor thrombus (MPVTT). Thirty-five patients (27 men, mean age 73 years) with 35 HCC nodules 3.7-5 cm in diameter extending into the main portal trunk underwent Percutaneous RFA. Twenty-two matched patients (15 men, mean age 70 years) with 22 HCC nodules 3.6-5 cm in diameter extending into the main portal trunk refused RFA and composed the control group. Diagnosis of MPVTT was made with fine needle biopsy in all cases. RFA was performed first on the MPVTT and then on the HCC nodule. Efficacy of RFA was defined as complete necrosis of HCC (evaluated with enhanced CT one month after procedure) and complete recanalization of the MPV (evaluated with Color-Doppler within 30 days after procedure). Results: Complete necrosis of the HCC associate with complete recanalization of MPV was achieved in 67% of cases. No patient died. One patient had haemoperitoneum that healed spontaneously. Seven patients presented with ascites and 9 patients with increased transaminases: both these complications resolved within 7 days. The follow-up ranged between 8 and 68 months. The cumulative survival rates were 63, 41, 30, 20 and 20% at 1, 2, 3, 4,and 5 years respectively in the treated group, while in the control group (untreated patients) survival was 0% at 1 year (p<0.0001). Conclusions: Percutaneous RFA of both single intraparenchymal mediumsized HCCs accompanied by MPVTT, significantly prolongs long-term survival of cirrhotic patients compared with no treatment. The procedure is safe, with low rate of major complications and should be considered as a new and effective tool in the treatment of this subset of advanced HCC.
OC.10.3 HEPATOCELLULAR CARCINOMA IN CIRRHOSIS EXTENDED IN THE MAIN PORTAL VEIN: A RANDOMISED CONTROLLED TRIAL COMPARING PERCUTANEOUS RADIOFREQUENCY ABLATION OF BOTH HEPATOCELLULAR CARCINOMA NODULES AND THE PORTAL VENOUS TUMOR THROMBUS PLUS SORAFENIB WITH SORAFENIB ALONE A. Giorgio ∗ , N. Farella, A. Di Sarno, G. De Stefano, U. Scognamiglio, A. De Rogatis, E. Trapanese, V. Giorgio A.O.D. Cotugno - IX Infectious Diseases and Interventional Ultrasound Unit, Napoli, Italy
Conclusions: In our experience, LA was as effective as RFA in inducing the complete necrosis of HCC nodules. TTR seems to be slightly longer in LA group, but data have to be evaluated at the end of the follow-up.
Background and aim: To compare 3-year survival of patients with Hepatocellular carcinoma (HCC) and neoplastic portal vein tumor thrombus (PVTT) treated with Percutaneous Radiofrequency ablation (RFA) of both HCC and PVTT plus Sorafenib (combination group) with Sorafenib alone. Material and methods: Seventy-nine Child-Pugh A naïve cirrhotic patients with HCC and PVTT were randomly assigned to receive RFA of both HCC and PVTT plus Sorafenib (N=39) or Sorafenib alone (n=40). Inclusion criteria: a) single HCC <6.5 cm and PVTT, b) three HCC nodules no more than 5 cm with PVTT. RFA was performed first on the PVTT and then on the HCC. Sorafenib treatment (800 mg/die) started soon after the RFA of both HCC and PVTT and soon after diagnosis in Sorafenib alone. Results: Sorafenib induced adverse events in 37% of the combination group and in 39% of the Sorafenib alone group, so far, the dropped–out were 25% in