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

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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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Author information

Authors and Affiliations

  1. Medical Oncology Unit, “San Giovanni di Dio” Hospital, Via Giovanni XXII, 80020, Frattaminore, Naples, Italy

    Salvatore Del Prete, Liliana Montella, Gregorio Cennamo, Rosario Guarrasi, Vincenzo Faiola & Raffaele Addeo

  2. Oncology Unit “San Gennaro” Hospital, Naples, Italy

    Luigi Maiorino

  3. Department of Biochemistry and Biophysics, Second University of Naples, Naples, Italy

    Michele Caraglia

  4. Medical Oncology “Cotugno” Hospital, Naples, Italy

    Vincenzo Montesarchio

  5. AO San Sebastiano, Caserta, Italy

    Guido Piai

  6. Medical Oncology, Fatebenefratelli, Benevento, Italy

    Antonio Febbraro

  7. Hepatology and Interventional Ultrasound Unit, “San Giovanni di Dio” Hospital, Frattaminore, Naples, Italy

    Luciano Tarantino

  8. Senology Unit, Arzano, Naples, Italy

    Elena Capasso

  9. Department of Molecular and Clinical Endocrinology and Oncology, University “Federico II”, Naples, Italy

    Giovannella Palmieri

  10. “San Leonardo” Hospital, Castellammare di Stabia, ASL NA5, Naples, Italy

    Maddalena Bianco

  11. Radiology and Diagnostic Imaging Unit “San Giovanni di Dio” Hospital, Frattaminore, Naples, Italy

    Rosanna Mamone

  12. Medical Oncology “Ruggi d’Aragona” Hospital, Salerno, Italy

    Clementina Savastano

  13. Medical Oncology “S. Maria delle Grazie” Hospital, Pozzuoli, Naples, Italy

    Agata Pisano

  14. Medical Oncology Campus Biomedico, Rome, Italy

    Bruno Vincenzi

  15. Medical Oncology Unit, “S. Maria della Pietà”, Nola, Italy

    Antonietta Sabia

  16. Surgery Division Unit, “Loreto Mare”, Naples, Italy

    Alberto D’Agostino

Authors
  1. Salvatore Del Prete
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  2. Liliana Montella
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  3. Michele Caraglia
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  4. Luigi Maiorino
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  5. Gregorio Cennamo
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  6. Vincenzo Montesarchio
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  7. Guido Piai
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  8. Antonio Febbraro
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  9. Luciano Tarantino
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  10. Elena Capasso
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  11. Giovannella Palmieri
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  12. Rosario Guarrasi
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  13. Maddalena Bianco
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  14. Rosanna Mamone
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  15. Clementina Savastano
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  16. Agata Pisano
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  17. Bruno Vincenzi
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  18. Antonietta Sabia
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  19. Alberto D’Agostino
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  20. Vincenzo Faiola
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  21. Raffaele Addeo
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Corresponding author

Correspondence to Salvatore Del Prete.

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Prete, S.D., Montella, L., Caraglia, M. et al. Sorafenib plus octreotide is an effective and safe treatment in advanced hepatocellular carcinoma: multicenter phase II So.LAR. study. Cancer Chemother Pharmacol 66, 837–844 (2010). https://doi.org/10.1007/s00280-009-1226-z

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  • DOI: https://doi.org/10.1007/s00280-009-1226-z

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