Journal article
Sorafenib in combination with local microtherapy guided by gadolinium-EOB-DTPA enhanced MRI in patients with inoperable hepatocellular carcinoma (HCC) (SORAMIC).
- Ricke, Jens Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
- Schuette, Kerstin Otto-von-Guericke-University, Magdeburg, Germany
- Rosmorduc, Olivier Hôpital Saint Antoine, Paris, France
- Jakob, Augustinus University Hospital Basel, Basel, Switzerland
- Verslype, Chris Digestive Oncology, University Hospitals Gasthuisberg, Leuven, Belgium
- Sangro, Bruno Liver Unit, Clinica Universitaria and CIBEREHD, Pamplona, Spain
- Walecki, Jerzy Centralny Szpital Kliniczny, MSWiA, Warszawa, Poland
- Klumpen, Heinz-Josef Academisch Medisch Centrum Universiteit van Amsterdam, Amsterdam, Netherlands
- Peynircioglu, Bora Haceteppe University of Medicine, Ankara, Turkey
- Yalcin, Bulent Ankara University School of Medicine, Ankara, Turkey
- Bartolozzi, Carlo University of Pisa, Pisa, Italy
- Amthauer, Holger Otto-von-Guericke-University Magdeburg, Magdeburg, Germany
- Malfertheiner, Peter Otto-von-Guericke-University of Magdeburg, Magdeburg, Germany
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2012, vol. 30, no. 15_suppl, p. TPS4148-TPS4148
English
TPS4148 Background: HCC is a leading cause of cancer-related mortality in both men and women. It represents the fifth most common cancer worldwide with an increasing incidence. For the individual patient tumor stage at diagnosis (number and size of nodules, presence or absence of vascular invasion, presence or absence of extrahepatic spread), liver function and general health status are the principal prognostic factors. The clinical management of HCC requires a comprehensive, multidisciplinary approach. In early HCC curative treatment can be achieved by local ablation, resection or liver transplantation. In intermediate stages patients (pts) are offered locoregional treatment with palliative intent (transarterial chemoembolisation (TACE), Yttrium-90-radioembolisation (SIRT)). In advanced disease systemic therapy with sorafenib (sor) has the potential to prolong survival of pts and is standard of care in pts with preserved liver function. Studies on the combined use of locoregional and systemic therapy with their potential of a beneficial synergism are few and conducted in a small number of pts. Methods: This phase II-study is composed of three substudies with the following primary objectives: 1. In pts in whom local ablation is appropriate to determine if sor in combination with RFA prolongs the time-to-recurrence in comparison with RFA plus placebo. Primary endpoint (PEP): time to recurrence, n = 290 pts 2. In pts in whom RFA is not appropriate (palliative treatment group) to determine if the combination of SIRT and sor improves the overall survival in comparison to sor alone. PEP: overall survival, n = 375 pts 3. To confirm in a 2-step procedure that Gd-EOB-DTPA enhanced MRI is non-inferior or superior compared with contrast-enhanced multislice CT for stratification of pts to a palliative or a local ablation treatment strategy. PEP: correct stratification of pts to a palliative versus local ablation treatment strategy; n = 830 pts The trial has started in December 2010 as a multinational and multicentric study. 90 pts have been enrolled until January 31st 2012 with 51 pts randomized in the palliative arm and 14 pts treated in the curative arm.
- Language
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- English
- Open access status
- closed
- Identifiers
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- DOI 10.1200/jco.2012.30.15_suppl.tps4148
- ISSN 0732-183X
- Persistent URL
- https://sonar.ch/global/documents/207474
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