Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 794-800 |
| Number of pages | 7 |
| Journal | The Lancet Oncology |
| Volume | 10 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 2009 Aug 1 |
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ASJC Scopus subject areas
- Oncology
Cite this
Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma : an open-label, multicentre, phase II study. / Faivre, Sandrine; Raymond, Eric; Boucher, Eveline; Douillard, Jean; Lim, Ho Y.; Kim, Jun Suk; Zappa, Magaly; Lanzalone, Silvana; Lin, Xun; DePrimo, Samuel; Harmon, Charles; Ruiz-Garcia, Ana; Lechuga, Maria J.; Cheng, Ann Lii.
In: The Lancet Oncology, Vol. 10, No. 8, 01.08.2009, p. 794-800.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma
T2 - an open-label, multicentre, phase II study
AU - Faivre, Sandrine
AU - Raymond, Eric
AU - Boucher, Eveline
AU - Douillard, Jean
AU - Lim, Ho Y.
AU - Kim, Jun Suk
AU - Zappa, Magaly
AU - Lanzalone, Silvana
AU - Lin, Xun
AU - DePrimo, Samuel
AU - Harmon, Charles
AU - Ruiz-Garcia, Ana
AU - Lechuga, Maria J.
AU - Cheng, Ann Lii
PY - 2009/8/1
Y1 - 2009/8/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=67651165187&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=67651165187&partnerID=8YFLogxK
U2 - 10.1016/S1470-2045(09)70171-8
DO - 10.1016/S1470-2045(09)70171-8
M3 - Article
C2 - 19586800
AN - SCOPUS:67651165187
VL - 10
SP - 794
EP - 800
JO - The Lancet Oncology
JF - The Lancet Oncology
SN - 1470-2045
IS - 8
ER -