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Sorafenib tosylate (brand name Nexavar)
Sorafenib (formerly called BAY 43-9006, now brand-named Nexavar) is an oral multikinase inhibitor that blocks the RAF kinase and VEGF receptors 2 and 3 to target tumor cell growth and angiogenesis, as well as PDGFR-B, KIT, FLT-3, and RET. During 2005 it was in clinical trials for kidney cancer and melanoma. Nexavar was approved by the FDA for use against kidney cancer in December 2005. You can view the prescribing information for Nexavar, with side-effects and safety data, at the FDA Medwatch site.
Because sorafenib (Nexavar) is FDA-appoved for other diseases, it may be prescribed off-label for GIST patients. The NCCN Soft Tissue Sarcoma Guidelines version 2.2009 section "SARC-E page, Generally Accepted Systemic Therapy Agents and Regimens" (which is on page 35 of the 69-page pdf) now includes sorafenib. This inclusion may help patients secure insurance coverage for off-label use. You can access this guide by going to the NCCN website, completing a free registrration and log-in, then clicking on Soft Tissue Sarcoma under the tab for NCCN Clinical Practice Guidelines in Oncology.
Help from Bayer:
The Bayer REACH program for financial assistance with sorafenib will accept GIST patients' applications even though soraenib is not yet approved for GIST. Contact a REACH Program Counselor by calling 1.866.NEXAVAR or 1.87.REACH.4.IT (1.877.322.4448) Monday through Friday from 9 AM to 8 PM EST. For questions about taking Nexavar, contact the Bayer program called NexConnect. It's a 24 hour 7 day a week hotline staffed by oncology nurses. The number is 1-866-Nexavar ( 1 866-639-2827).
LINK HERE for Bayer Nexavar assistance information.
Results for sorafenib (Nexavar) against GIST
The latest report on sorafenib effectiveness comes from a collection of 32 patients treated in various institutions in Europe (not a trial) and presented at the 2009 ASCO meeting by Dr. Peter Reichardt. Quoting the paper abstract:
"All pts had failed IM, SU, NI. 19 % of pts achieved partial remission and 44% disease stabilization. Approximately half of the pts had an improvement of symptoms and/or performance. Half of the pts were on treatment longer than 4 months (actuarial data) and 41% of pts continue to receive sorafenib."
You can link to read the full abstract:
Sorafenib fourth-line treatment in imatinib-, sunitinib-, and nilotinib-resistant metastatic GIST: A retrospective analysis. Author(s): P. Reichardt, M. Montemurro, H. Gelderblom, J. Blay, P. Rutkowski, B. Bui, J. T. Hartmann, D. Pink, S. Leyvraz, J. Schütte; Citation: J Clin Oncol 27:15s, 2009 (suppl; abstr 10564)
Sorafenib trial
A GIST trial for sorafenib began in January 2006 at the University of Chicago under the direction of Dr. Hedy Kindler, principal investigator. The title is “A Phase II Study of BAY 43-9006 for Patients with Imatinib-Resistant Malignant Gastrointestinal Stromal Tumor.” After approval of sunitinib for GIST the criteria were changed to require that patients have become resistant to both imatinib and sunitinib. This trial has now finished.
January 2008 First Report on Trial
The first report about this trial was presented at the January 2008 ASCO GI Cancers Symposium, where a paper reported some positive results in GIST patients who had previously experienced progression either on imatinib or on both imatinib and sunitinib. Link below for the abstract of this paper and associated slides:
Activity of sorafenib (SOR) in patients (pts) with imatinib (IM) and sunitinib (SU)-resistant (RES) gastrointestinal tumors (GIST): A phase II trial of the University of Chicago Phase II Consortium
Authors: H. S. Nimeiri, R. G. Maki, K. Kasza, D. D'Adamo, W. Chow, P. Dy, B. Polite, J. Jin, E. E. Vokes, H. L. Kindler
June 2008 ASCO Update
A further update about this sorafenib trial was given at the June 2008 ASCO meeting. You can link to the abstract and then click an icon below the abstract to see the slides without hearing the talk or to hear the webcast and see the slides.
Activity of sorafenib (SOR) in patients (pts) with imatinib (IM) and sunitinib (SU)-resistant (RES) gastrointestinal stromal tumors (GIST): A phase II trial of the University of Chicago Phase II Consortium.
Presenter: Lauren Wiebe, MD Meeting: 2008 ASCO Annual Meeting Session: Emerging Targets for Sarcoma Therapy (Clinical Science Symposium)
January 2011 Final Report on Trial
A presentation at the GI Cancers Symposium gave final results. You can click the title below for the full abstract. The efficacy results in the abstract were:
"Partial response (PR): 13% (1 IM-RES, 4 IM/SU-RES);
Stable disease (SD): 55% (3 IM-RES, 18 IM/SU-RES).
Disease control rate (PR + SD): 68%.
Median progression-free survival: 5.2 mo (95% CI: 3.4, 7.4).
Median overall survival 11.6 mo (95% CI: 8.8, 18.0);
1-year survival 50%; 2-year survival 29%.
Three pts remain on trial receiving study drug (1 PR at 34 mo; 2 SD at 18 and 37 mo)."
Final results of a University of Chicago phase II consortium trial of sorafenib (SOR) in patients (pts) with imatinib (IM)- and sunitinib (SU)-resistant (RES) gastrointestinal stromal tumors (GIST).
J Clin Oncol 29: 2011 (suppl 4; abstr 4)
Manufacturer Information
Development of sorafenib (Nexavar) is co-sponsored by two different pharmaceutical firms: Bayer and Onyx.
LINKS to relevant information:
- http://www.nexavar.com
- manufacturer information about this drug
- More about BAY 43-9009 clinical trials pertaining to GIST
- Medical papers pertaining to this drug (not with respect to GIST)
- 2004 powerpoint presentation about this drug by Dr. Eisen.
