Abstract
Introduction: Sorafenib is an oral multikinase inhibitor with anti-angiogenic and anti-proliferative activity that is indicated for use in hepatocellular and renal cell carcinomas. Sorafenib is being developed in a number of solid tumors, including breast cancer (BC). Areas covered: A series of four randomized, double-blind, placebo-controlled Phase IIb screening Trials were developed to Investigate the Efficacy of Sorafenib (TIES) when added to select chemotherapies for patients with HER2-negative advanced BC with a primary endpoint of progression-free survival (PFS). Results have been varied. SOLTI-0701 reported significant PFS benefit for sorafenib plus capecitabine as first- or second-line treatment, and AC01B07 reported a modest but significant PFS benefit when sorafenib was combined with gemcitabine or capecitabine for patients whose disease had progressed during or after bevacizumab. Sorafenib plus first-line paclitaxel did not significantly improve PFS (NU07B1 study), nor did its addition to first-line docetaxel and/or letrozole (FM-B07-01 study). A Phase III trial of sorafenib plus capecitabine has been initiated. Expert opinion: Phase IIb data indicate a potential role for sorafenib in combination with select chemotherapies for HER2-negative advanced BC, but Phase III confirmatory trials are necessary. The variability in results across studies with sorafenib may be related to the chemotherapy combination and/or patient population.
Original language | English (US) |
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Pages (from-to) | 1177-1191 |
Number of pages | 15 |
Journal | Expert Opinion on Investigational Drugs |
Volume | 21 |
Issue number | 8 |
DOIs | |
State | Published - Aug 2012 |
Funding
Development of this manuscript was supported by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, with writing and editorial assistance provided by Michael Raffin of Fishawack Communications. W Gradishar has received research funding from Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals; and has no other relevant conflicts to declare.
Keywords
- anti-angiogenic
- anti-proliferative
- metastatic breast cancer
- multikinase inhibitor
- sorafenib
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)