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Lancet Oncology, The

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Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an open-label, multicentre, phase II study - 11/08/11

Doi : 10.1016/S1470-2045(09)70171-8 
Sandrine Faivre, ProfMD a, ⁎ , Eric Raymond, ProfMD a, Eveline Boucher, MD b, Jean Douillard, ProfMD c, Ho Y Lim, MD d, Jun S Kim, MD e, Magaly Zappa, MD a, Silvana Lanzalone, MSc f, Xun Lin, PhD g, Samuel DePrimo, PhD g, Charles Harmon, PhD g, Ana Ruiz-Garcia, PhD g, Maria J Lechuga, MD f, Ann Lii Cheng, ProfMD h
a Beaujon University Hospital, Clichy, France 
b Centre Eugène Marquis, University Hospital, Rennes, France 
c Centre R Gauducheau, St-Herblain, France 
d Samsung Medical Center, Seoul, South Korea 
e Korea University Guro Hospital, Seoul, South Korea 
f Pfizer Oncology, Milan, Italy 
g Pfizer Oncology, La Jolla, CA, USA 
h Department of Internal Medicine and Oncology, National Taiwan University Hospital, Taipei, Taiwan 

* Correspondence to: Prof Sandrine Faivre, Department of Medical Oncology (INSERM U728–Paris 7), Beaujon University Hospital, Assistance Publique–Hôpitaux de Paris, 100 Boulevard du Général, Paris, France

Summary

Background

Hepatocellular carcinoma (HCC) tumour spread is partly dependent on neoangiogenesis. In this open-label, multicentre, phase II trial done in Europe and Asia, sunitinib, a multitargeted tyrosine-kinase inhibitor with anti-angiogenic properties, was assessed in patients with advanced unresectable HCC.

Methods

Between February and July, 2006, eligible patients were enrolled and treated with repeated cycles of oral sunitinib (50 mg/day for 4 weeks, followed by 2 weeks off treatment). The primary endpoint of this Simon two-stage phase II trial was objective response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, with an expected response rate of 15%. This trial is registered with ClinicalTrials.gov, number NCT00247676.

Findings

Of 37 patients enrolled, one (2·7%) patient experienced a confirmed partial response, giving an overall objective response rate of 2·7% (95% CI 0·1–14·2); on the basis of this, the trial did not proceed to the second stage. 13 (35%) of 37 patients achieved stable disease for over 3 months. Commonly observed grade 3 and 4 adverse events included thrombocytopenia (14 of 37; 37·8%), neutropenia (nine of 37; 24·3%), asthenia (five of 37; 13·5%), hand–foot syndrome (four of 37; 10·8%), and anaemia (four of 37; 10·8%). There were four deaths among the 37 patients (10·8%) that were possibly related to treatment.

Interpretation

Sunitinib showed pronounced toxicities at a dose of 50 mg/day in patients with unresectable HCC. The response rate was low, and the study did not meet the primary endpoint based on RECIST criteria.

Funding

Pfizer Oncology.

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© 2009  Elsevier Ltd. Tous droits réservés.
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Vol 10 - N° 8

P. 794-800 - août 2009 Retour au numéro
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