Abstract
e14713 Background: Regorafenib (BAY 73-4506) is a potent oral multi-kinase inhibitor with targeted activity against (VEGFR) -1,-2, and -3, TIE-2, FGFR-1, PDGFR-α/β and ret, c-Kit, raf-1 kinases. Currently it is approved for treatment in previously treated patients with metastatic colorectal cancer (mCRC) and in locally advanced gastrointestinal stromal tumors (GIST), and is being explored in other cancers. We conducted a meta-analysis to ascertain the incidence and risk of HFSR, a commonly reported AE. Methods: Our search was performed on electronic databases (PubMed, Scopus, Web of Knowledge) and the ASCO website for presented abstracts. We searched for studies published until December 2012. Eligible Phase II-III clinical trials utilizing a 160mg dose of Regorafenib were included in the analysis. Relative risk (RR), and 95% confidence intervals (CI) were calculated using random-effects or fixed-effects models based on the heterogeneity of included studies. Results: In these trials, regorafenib was investigated in mCRC, gastrointestinal stromal tumor (GIST), and renal cell carcinoma (RCC). A total of 1,078 patients were analyzed. The overall incidence of all-grade and high-grade HFSR was 60.5% (95% CI: 48.3–71.6%) and 20.4% (95% CI: 15.4–26.6%), respectively. The relative risks of all-grade and high-grade HFSR to regorafenib monotherapy in comparison with controls were increased for all-grade (RR=5.40, 95% CI: 3.76-7.76, p<0.001) and high-grade (RR=41.99, 95% CI: 5.88–299.93, p<0.001) HFSR. The incidence of the HFSR based on tumor type was 62.9% (95% CI: 46.9–76.5%) for mCRC, 69.5% (95% CI: 29.7–92.5%) for GIST and 46.6% (95% CI: 42.3–51.0%) for RCC, which was not very significant (p=0.08) suggesting that tumor type does not seem to influence the incidence of HFSR in patients treated with regorafenib. Conclusions: The incidence and risk of developing HFSR is highest with regorafenib, when compared to other multikinase inhibitors (e.g. sorafenib, sunitinib, pazopanib, axitinib). This toxicity warrants further investigation and evidence-based management strategies, in order to ensure adherence and most favorable clinical outcome.
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