Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study.

PURPOSE: Advanced hepatocellular carcinoma (HCC) not eligible for local therapies has limited chances of cure. Sorafenib is a multikinase inhibitor with proven activity in advanced HCC. Octreotide is used in this setting with conflicting results. Treatment with sorafenib and long-acting octreotide was tested in advanced HCC to evaluate safety and activity. METHODS: Fifty patients with advanced HCC, Child-Pugh A or B, received sorafenib at a dosage of 800 mg/day for 28 days with a following week of rest and long-acting octreotide at a dose of 40 mg, administered every 28 days. RESULTS: All patients were assessable for safety and efficacy. Sixteen patients out of 50 (34%) were naïve from other therapies, while all the others were previously treated with local and/or systemic treatments. We achieved 5 partial responses (10%), 33 stable diseases (66%) and 12 progressions of disease (24%). Median time to progression was 7.0 months (95% CI, 3.0-10.9 months), and median overall survival was 12 months (95% CI, 6.3-17.4 months). Treatment was well tolerated. Diarrhoea (6%) and hypertension (4%) were the most frequent grade 3 toxicities. CONCLUSIONS: Our data suggest that the combination between sorafenib and long-acting octreotide is active and well tolerated in patients with advanced HCC and could represent another efficacious chance for the management of this population.

Percutaneous sonographically guided saline-enhanced radiofrequency ablation of hepatocellular carcinoma.

OBJECTIVE: The purpose of our study was to analyze the efficacy, side effects, and short-term complications of saline-enhanced percutaneous radiofrequency ablation performed under sonographic guidance in a series of cirrhotic patients with hepatocellular carcinoma. SUBJECTS AND METHODS. Between September 2000 and June 2002, 84 patients (55 men and 29 women) with cirrhosis who ranged in age from 48 to 74 years (mean age, 64 years) and who had 95 hepatocellular carcinomas (seven patients had two tumors and two patients had three tumors) were treated with high frequency-induced thermotherapy. The diameters of the tumors ranged from 1.5 to 8.5 cm (mean, 3.6 cm). The efficacy of radiofrequency ablation was evaluated with triphasic contrast-enhanced CT performed 4 weeks after the procedure. RESULTS: Posttreatment CT showed complete necrosis in 73 (77%) of 95 hepatocellular carcinomas in 62 patients. Complete necrosis based on tumor size was seen in 40 (95%) of 42 tumors with diameters equal to or smaller than 3 cm, 32 (71%) of 45 tumors with diameters between 3.1 and 5.0 cm, and one (12%) of eight tumors with diameters larger than 5.0 cm. Twenty-two hepatocellular carcinomas showed incomplete necrosis. None of the patients experienced major complications. Four patients were lost to follow-up. The length of the follow-up period ranged from 4 to 22 months (mean, 10 months). One patient died 8 months after the radiofrequency ablation treatment. All the remaining patients are still alive. During the follow-up period, eight (10%) of 80 patients showed a local recurrence on sonography and CT. CONCLUSION: Our experience suggests that percutaneous radiofrequency ablation of hepatocellular carcinoma with high frequency-induced thermotherapy is safe and effective in the treatment of hepatocellular carcinomas equal to or smaller than 3 cm, fairly effective for hepatocellular carcinomas between 3 and 5 cm, and ineffective for tumors larger than 5 cm.