Cancer Chemotherapy and Pharmacology

, Volume 66, Issue 5, pp 837–844

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


    • Medical Oncology Unit“San Giovanni di Dio” Hospital
  • Liliana Montella
    • Medical Oncology Unit“San Giovanni di Dio” Hospital
  • Michele Caraglia
    • Department of Biochemistry and BiophysicsSecond University of Naples
  • Luigi Maiorino
    • Oncology Unit “San Gennaro” Hospital
  • Gregorio Cennamo
    • Medical Oncology Unit“San Giovanni di Dio” Hospital
  • Vincenzo Montesarchio
    • Medical Oncology “Cotugno” Hospital
  • Guido Piai
    • AO San Sebastiano
  • Antonio Febbraro
    • Medical Oncology, Fatebenefratelli
  • Luciano Tarantino
    • Hepatology and Interventional Ultrasound Unit“San Giovanni di Dio” Hospital
  • Elena Capasso
    • Senology Unit
  • Giovannella Palmieri
    • Department of Molecular and Clinical Endocrinology and OncologyUniversity “Federico II”
  • Rosario Guarrasi
    • Medical Oncology Unit“San Giovanni di Dio” Hospital
  • Maddalena Bianco
    • “San Leonardo” Hospital
  • Rosanna Mamone
    • Radiology and Diagnostic Imaging Unit “San Giovanni di Dio” Hospital
  • Clementina Savastano
    • Medical Oncology “Ruggi d’Aragona” Hospital
  • Agata Pisano
    • Medical Oncology “S. Maria delle Grazie” Hospital
  • Bruno Vincenzi
    • Medical Oncology Campus Biomedico
  • Antonietta Sabia
    • Medical Oncology Unit“S. Maria della Pietà”
  • Alberto D’Agostino
    • Surgery Division Unit“Loreto Mare”
  • Vincenzo Faiola
    • Medical Oncology Unit“San Giovanni di Dio” Hospital
  • Raffaele Addeo
    • Medical Oncology Unit“San Giovanni di Dio” Hospital
Original Article

DOI: 10.1007/s00280-009-1226-z

Cite this article as:
Prete, S.D., Montella, L., Caraglia, M. et al. Cancer Chemother Pharmacol (2010) 66: 837. doi:10.1007/s00280-009-1226-z



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.


SorafenibLong-acting octreotideHepatocellular carcinoma

Copyright information

© Springer-Verlag 2009