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

  • 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
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

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.

Keywords

SorafenibLong-acting octreotideHepatocellular carcinoma

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Salvatore Del Prete
    • 1
  • Liliana Montella
    • 1
  • Michele Caraglia
    • 3
  • Luigi Maiorino
    • 2
  • Gregorio Cennamo
    • 1
  • Vincenzo Montesarchio
    • 4
  • Guido Piai
    • 5
  • Antonio Febbraro
    • 6
  • Luciano Tarantino
    • 7
  • Elena Capasso
    • 8
  • Giovannella Palmieri
    • 9
  • Rosario Guarrasi
    • 1
  • Maddalena Bianco
    • 10
  • Rosanna Mamone
    • 11
  • Clementina Savastano
    • 12
  • Agata Pisano
    • 13
  • Bruno Vincenzi
    • 14
  • Antonietta Sabia
    • 15
  • Alberto D’Agostino
    • 16
  • Vincenzo Faiola
    • 1
  • Raffaele Addeo
    • 1
  1. 1.Medical Oncology Unit“San Giovanni di Dio” HospitalFrattaminore, NaplesItaly
  2. 2.Oncology Unit “San Gennaro” HospitalNaplesItaly
  3. 3.Department of Biochemistry and BiophysicsSecond University of NaplesNaplesItaly
  4. 4.Medical Oncology “Cotugno” HospitalNaplesItaly
  5. 5.AO San SebastianoCasertaItaly
  6. 6.Medical Oncology, FatebenefratelliBeneventoItaly
  7. 7.Hepatology and Interventional Ultrasound Unit“San Giovanni di Dio” HospitalFrattaminore, NaplesItaly
  8. 8.Senology UnitArzano, NaplesItaly
  9. 9.Department of Molecular and Clinical Endocrinology and OncologyUniversity “Federico II”NaplesItaly
  10. 10.“San Leonardo” HospitalNaplesItaly
  11. 11.Radiology and Diagnostic Imaging Unit “San Giovanni di Dio” HospitalFrattaminore, NaplesItaly
  12. 12.Medical Oncology “Ruggi d’Aragona” HospitalSalernoItaly
  13. 13.Medical Oncology “S. Maria delle Grazie” HospitalPozzuoli, NaplesItaly
  14. 14.Medical Oncology Campus BiomedicoRomeItaly
  15. 15.Medical Oncology Unit“S. Maria della Pietà”NolaItaly
  16. 16.Surgery Division Unit“Loreto Mare”NaplesItaly