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01-10-2010 | Original Article

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

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

Published in: Cancer Chemotherapy and Pharmacology | Issue 5/2010

Abstract

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.

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Title: Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study
Authors: Salvatore Del Prete
Liliana Montella
Michele Caraglia
Luigi Maiorino
Gregorio Cennamo
Vincenzo Montesarchio
Guido Piai
Antonio Febbraro
Luciano Tarantino
Elena Capasso
Giovannella Palmieri
Rosario Guarrasi
Maddalena Bianco
Rosanna Mamone
Clementina Savastano
Agata Pisano
Bruno Vincenzi
Antonietta Sabia
Alberto D’Agostino
Vincenzo Faiola
Raffaele Addeo
Publication date: 01-10-2010
Publisher: Springer-Verlag
Published in: Cancer Chemotherapy and Pharmacology / Issue 5/2010
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-009-1226-z

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Abstract

Purpose

Methods

Results

Conclusions

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