Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06).

Details

Serval ID
serval:BIB_14A0D26A55E6
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06).
Journal
Oncologist
Author(s)
Koeberle Dieter, Montemurro Michael, Samaras Panagiotis, Majno Pietro, Simcock Mathew, Limacher Andreas, Lerch Stefanie, Kovacs Katalin, Inauen Roman, Hess Vivianne, Saletti Piercarlo, Borner Markus, Roth Arnaud, Bodoky Gyoergy
ISSN
1549-490X[electronic], 1083-7159[linking]
Publication state
Published
Issued date
2010
Volume
15
Number
3
Pages
285-292
Language
english
Abstract
BACKGROUND: Sunitinib (SU) is a multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activity. The objective of this trial was to demonstrate antitumor activity of continuous SU treatment in patients with hepatocellular carcinoma (HCC). PATIENTS AND METHODS: Key eligibility criteria included unresectable or metastatic HCC, no prior systemic anticancer treatment, measurable disease, and Child-Pugh class A or mild Child-Pugh class B liver dysfunction. Patients received 37.5 mg SU daily until progression or unacceptable toxicity. The primary endpoint was progression-free survival at 12 weeks (PFS12). RESULTS: Forty-five patients were enrolled. The median age was 63 years; 89% had Child-Pugh class A disease and 47% had distant metastases. PFS12 was rated successful in 15 patients (33%; 95% confidence interval, 20%-47%). Over the whole trial period, one complete response and a 40% rate of stable disease as the best response were achieved. The median PFS duration, disease stabilization duration, time to progression, and overall survival time were 1.5, 2.9, 1.5, and 9.3 months, respectively. Grade 3 and 4 adverse events were infrequent. None of the 33 deaths were considered drug related. CONCLUSION: Continuous SU treatment with 37.5 mg daily is feasible and has moderate activity in patients with advanced HCC and mild to moderately impaired liver dysfunction. Under this trial design (>13 PFS12 successes), the therapy is considered promising. This is the first trial describing the clinical effects of continuous dosing of SU in HCC patients on a schedule that is used in an ongoing, randomized, phase III trial in comparison with the current treatment standard, sorafenib (ClinicalTrials.gov identifier, NCT00699374).
Keywords
Hepatocellular Carcinoma, Sunitinib, Tyrosine Kinase Inhibitor, RECIST, Efficacy, Sorafenib, Inhibitor, Therapy, Design, Safety
Pubmed
Web of science
Open Access
Yes
Create date
13/04/2010 9:55
Last modification date
20/08/2019 12:43
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