Original Article

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 PreteAffiliated withMedical Oncology Unit, “San Giovanni di Dio” Hospital Email author 
  • , Liliana MontellaAffiliated withMedical Oncology Unit, “San Giovanni di Dio” Hospital
  • , Michele CaragliaAffiliated withDepartment of Biochemistry and Biophysics, Second University of Naples
  • , Luigi MaiorinoAffiliated withOncology Unit “San Gennaro” Hospital
  • , Gregorio CennamoAffiliated withMedical Oncology Unit, “San Giovanni di Dio” Hospital
  • , Vincenzo MontesarchioAffiliated withMedical Oncology “Cotugno” Hospital
  • , Guido PiaiAffiliated withAO San Sebastiano
  • , Antonio FebbraroAffiliated withMedical Oncology, Fatebenefratelli
  • , Luciano TarantinoAffiliated withHepatology and Interventional Ultrasound Unit, “San Giovanni di Dio” Hospital
    • , Elena CapassoAffiliated withSenology Unit
    • , Giovannella PalmieriAffiliated withMedical Oncology Unit, “San Giovanni di Dio” HospitalDepartment of Molecular and Clinical Endocrinology and Oncology, University “Federico II”
    • , Rosario GuarrasiAffiliated withMedical Oncology Unit, “San Giovanni di Dio” Hospital
    • , Maddalena BiancoAffiliated withMedical Oncology Unit, “San Giovanni di Dio” Hospital“San Leonardo” Hospital
    • , Rosanna MamoneAffiliated withMedical Oncology Unit, “San Giovanni di Dio” HospitalRadiology and Diagnostic Imaging Unit “San Giovanni di Dio” Hospital
    • , Clementina SavastanoAffiliated withMedical Oncology Unit, “San Giovanni di Dio” HospitalMedical Oncology “Ruggi d’Aragona” Hospital
    • , Agata PisanoAffiliated withMedical Oncology Unit, “San Giovanni di Dio” HospitalMedical Oncology “S. Maria delle Grazie” Hospital
    • , Bruno VincenziAffiliated withMedical Oncology Unit, “San Giovanni di Dio” HospitalMedical Oncology Campus Biomedico
    • , Antonietta SabiaAffiliated withMedical Oncology Unit, “San Giovanni di Dio” HospitalMedical Oncology Unit, “S. Maria della Pietà”
    • , Alberto D’AgostinoAffiliated withMedical Oncology Unit, “San Giovanni di Dio” HospitalSurgery Division Unit, “Loreto Mare”
    • , Vincenzo FaiolaAffiliated withMedical Oncology Unit, “San Giovanni di Dio” Hospital
    • , Raffaele AddeoAffiliated withMedical Oncology Unit, “San Giovanni di Dio” Hospital

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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.

Keywords

Sorafenib Long-acting octreotide Hepatocellular carcinoma