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

2009; Springer Science+Business Media; Volume: 66; Issue: 5 Linguagem: Inglês

10.1007/s00280-009-1226-z

1432-0843

Salvatore Del Prete, Liliana Montella, Michele Caraglia, Luigi Maiorino, Gregorio Cennamo, Vincenzo Montesarchio, G. Piai, Antonio Febbraro, Luciano Tarantino, Elena Capasso, Giovannella Palmieri, Rosario Guarrasi, M. Bianco, Rosanna Mamone, Clementina Savastano, Agata Pisano, Bruno Vincenzi, Antonietta Sabia, Alberto D’Agostino, Vincenzo Faiola, Raffaele Addeo,

Liver physiology and pathology

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. 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. 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. 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.