Although there is limited phase II evidence for Sutent in HCC, it relates only for first line therpay and the responses are minor. This would be use as 2nd line therapy, off-label. Unlike Nexavar, Sutent is lags in research studies. Whereas Nexavar is in phase III studies, that is not the case for Sutent. Clinical data demonstrated that treatment with Nexavar® (sorafenib) tablets has significantly extended overall survival (OS) of the HCC patient population. An independent data monitoring committee (DMC) that reviewed the clinical data has attested to the safety and efficacy of the product and therefore recommended early conclusion of the said study. As a result of this recommendation, Bayer and Onyx will stop the trial and allow all patients enrolled in this trial access to Nexavar. Given that there are limited approved systemic therapies for this disease, the companies will continue discussions with health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and European health authorities regarding the next steps in filing for approval for the treatment of HCC.
What Nexavar, Iressa, Tarceva, Sutent and Tykerb have in common is that they are small molecule drugs. However, they are not interchangeable and there is not sufficient credible data to consider off-label use of Sutent in 2nd line as other than investigtional.
Usha Dutta (2000) Treatment of hepatocellular carcinoma Journal of Gastroenterology and Hepatology 15 (8), 822–824.
A. X. Zhu, D. Sahani, A. Norden-Zfoni, N. S. Holalkere, L. Blaszkowsky, D. P. Ryan, J. W. Clark, K. Taylor, J. V. Heymach, K. Stuart Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005: 4120, updated as
Abstract No: 4637
Citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 4637
Author(s): A. X. Zhu, D. V. Sahani, E. di Tomaso, D. Duda, V. Sindhwani, S. S. Yoon, L. S. Blaszkowsky, J. W. Clark, D. P. Ryan, R. K. Jain