Radiofrequency ablation versus laser ablation for the treatment of small hepatocellular carcinoma in cirrhosis: a randomized trial.

BACKGROUND AND AIM: In patients with cirrhosis and small hepatocellular carcinoma (HCC), thermal ablation is currently recognized as an effective local treatment. Among thermal procedures, radiofrequency ablation (RFA) is the most diffusely used and is the standard against which any new treatment should be compared. In retrospective studies, laser ablation (LA) resulted as safe and effective as RFA. Therefore, we performed a non-inferiority randomized trial comparing RFA with LA in patients with cirrhosis and HCC within Milan criteria. METHODS: Overall, 140 patients with 157 HCC nodules were randomly assigned to receive RFA or LA. The primary end-point was the proportion of complete tumor ablation (CTA). Secondary end-points were time to local progression (TTLP) and overall survival (OS). RESULTS: Per patient CTA rates after RFA and LA were 97.4% (95% CI, 91.0-99.3) and 95.7% (88.1-98.5), respectively (difference = 1.4%, 95% CI from -6.0% to + 9.0%). Per nodule CTA rates for RFA and LA were 97.4% (91.0-99.3) and 96.3% (89.6-98.7), respectively (difference = 1.1%, from -5.7% to + 8.1%). The mean TTLP was comparable between RFA group (42.0 months; 95% CI, 36.83-47.3) and LA group (46.7 months; 95% CI, 41.5-51.9) (P = .591). The mean OS was 42 months in both groups and survival probability at 1 and 3 years was 94% and 89% in RFA group, and 94% and 80% in LA group. CONCLUSION: LA resulted not inferior to RFA in inducing the CTA of HCC nodules and therefore it should be considered as an evaluable alternative for thermal ablation of small HCC in cirrhotic patients.

A novel needle guide system to perform percutaneous laser ablation of liver tumors using the multifiber technique.

BACKGROUND: Previous studies have shown that laser ablation with the multifiber technique is effective in the treatment of liver tumors. However, the correct positioning of multiple needles may be challenging. PURPOSE: To investigate the use of a novel needle guide system that was developed to perform percutaneous laser ablation of liver tumors with the multifiber technique under ultrasonographic guidance. MATERIAL AND METHODS: Between February 2009 and June 2011, 116 patients (104 hepatocellular carcinomas and 12 metastases) with 127 liver nodules (median diameter, 3.0 cm; range, 1.5-6.0) were treated. Nineteen nodules were in high-risk locations. A needle guide with separate channels to insert two needles in a parallel position and at a prefixed distance was used. RESULTS: Needles were positioned inside the target nodule easily and quickly, and correct spacing (1.5-1.8 cm) between light sources was immediately achieved. Complete tumor ablation was achieved in a single session in 112 (88.2%) lesions. In nodules ≤3.0 cm and >3.0 cm in size, ablation was complete in 93.6% and 79.6% of cases, respectively. Of note, complete ablation was achieved in 91.7% of nodules up to 5.0 cm. CONCLUSION: With the new guidance system, needles could be inserted in parallel fashion, which facilitated positioning the needles in geometrical configurations to maximize the ablative effect. Worthy of note, the complete ablation rate in nodules >3.0 cm using the new guide system was higher than what has been reported in the literature so far.

Impact of age on toxicity and efficacy of sorafenib-targeted therapy in cirrhotic patients with hepatocellular carcinoma.

The incidence of hepatocellular carcinoma (HCC) is increasing worldwide and the proportion of older patients with HCC is expected to steadily rise in the next years. Sorafenib is the standard of care for patients with advanced HCC but there is a lack of detailed data on how older patients with cirrhosis tolerate this drug. Therefore, we aimed to evaluate the impact of age on the effects of sorafenib-targeted therapy in patients with HCC and cirrhosis. We analyzed a consecutive cohort of HCC patients not eligible for surgery or locoregional treatment, with Child-Pugh score ≤ 7, and an Eastern Cooperative Oncology Group performance status of 0-1, treated with sorafenib. Clinical outcomes and treatment-related adverse events (AEs) were compared between younger (< 70 years) and older (≥ 70 years) patients. Overall, 150 patients, 90 in the younger (median age 60 years) and 60 in the older (median age 72 years) group, were evaluated. Treatment duration was 4 months in both groups. The median time to progression and overall survival were longer in older than in younger group (12 vs. 8 months and 16 vs. 12 months, respectively), although the differences did not reach a statistical significance. Grade 3-4 AEs were more frequently observed in younger than in older group (15.7 vs. 9.2 %, respectively; p = .0146). In field practice, sorafenib treatment in elderly patients with cirrhosis and HCC resulted at least as effective and safe as in younger patients. However, severe AEs occurred more frequently in younger patients.

Safety and effectiveness of sorafenib in patients with hepatocellular carcinoma in clinical practice.

BACKGROUND: Sorafenib is currently the only approved systemic treatment for hepatocellular carcinoma. AIM: to evaluate safety and effectiveness of sorafenib in the field of practice. METHODS: We report a single-centre experience on 116 advanced hepatocellular carcinoma patients treated with sorafenib between February 2008 and March 2011. Every 4 weeks, adverse events were graded using Common Toxicity Criteria version 3.0, and every 3 months tumour response was assessed according to modified Response Evaluation Criteria in Solid Tumours for hepatocellular carcinoma. RESULTS: Cirrhosis was present in 95.7% of patients (83.6% Child-Pugh A class), hepatitis C was the main etiological factor. Median therapy duration was 3 months and median daily dose was 642 mg. Median time-to-radiological progression in the per-protocol population was 12 months and median overall survival in the intention-to-treat population was 13 months. 91.4% of patients experienced mild adverse events (grade 1 or 2), the most frequent were gastrointestinal and dermatological. Jaundice and bleeding were the main causes of definitive drug discontinuation. 3-month overall disease control rate was 70.6%: stable disease in 37.2%, partial response in 30.8%, and complete response in 2.6% patients. The 3-month radiological response correlated with overall survival. CONCLUSIONS: In daily clinical practice, sorafenib confirmed its safety and efficacy in hepatocellular carcinoma patients.