Regorafenib was shown to increase overall survival in patients with colorectal cancer

Article by Katewinslet


Colorectal cancer is a malignancy of unrestrained cell growth in the colon, rectum, or appendix. Colon cancer affects roughly 1 million people per year and is the third most typical cancer worldwide, nonetheless it is a lot more typical in developed nations due to way of life risk aspects such as diet regime.

The symptoms of colorectal cancer are extremely dependent on the location of the tumor within the bowel and whether or not it has metastasized. The most widespread symptoms at presentation include constipation, blood in the stool, weight loss, fever, loss of appetite, nausea, and vomiting, particularly in a individual over 50.


Definitive diagnosis of colorectal cancer is through tumor biopsy, immediately after which CT scans are generally used to figure out the extent of the illness. Therapy of colorectal cancer is dependent upon how advanced it is. When caught early, surgery can be significantly efficient and curative. Nonetheless, as soon as metastases are present treatment is frequently directed far more at extending and improving good quality of life. According to the American Cancer Society, more than 20% of patients present with metastatic colorectal cancer at the time of diagnosis and the five-year survival rate is less than 60%. Consequently, this deadly disease nonetheless proves extremely challenging to treat following it has progressed past the very early stages.


Researchers have struggled to determine compounds that may prove successful in treating colorectal cancer. In truth, it has been half a decade because the final successful therapy was introduced. Nonetheless, in 2011 a new drug, Regorafenib, emerged from relative obscurity to grow to be a novel therapeutic with unprecedented effectiveness for colorectal cancer. Regorafenib is a multi-targeted tyrosine kinase inhibitor that is currently becoming investigated in various tumor sorts.

Regorafenib inhibits vascular endothelial growth element receptor (VEGFR) as well as a number of other tumor cell signaling kinases such as RET, KIT, PDGFR, and Raf, which subsequently inhibits tumor angiogenesis and cell proliferation. The drug was granted orphan drug status by the FDA for use in gastrointestinal stromal tumors (GISTs) in order to fast track its improvement for use in patients with metastatic, unresectable GISTs, which have progressed in spite of remedy with imatinib and sunitinib. Following the approval of orphan drug status, investigators started to evaluate whether or not it may possibly be effective in treating other cancers. 1 of the resulting research was the Right trial. The Appropriate trial was a multicenter, randomized, double-blind, placebo-controlled study that was carried out internationally with internet sites in North America, Europe, Australia, China, and Japan. The trial enrolled 760 individuals with metastatic colorectal cancer whose illness had progressed following approved standard treatments and were randomly assigned to either get regorafenib or placebo. The initial study endpoint was overall survival. Even so, secondary endpoints included disease control rate, objective tumor response rate, and progression totally free survival.

As of October 2011, the Correct trial was halted. The choice to cease the trail came right after a significant improvement in overall survival was noticed. These findings were the result of a pre-planned interim evaluation conducted by an independent Data Monitoring Committee (DMC). As per the recommendation of the DMC the study has now been unblinded, and all patients who were in the placebo group have been supplied the drug. Simply because of these results, regorafenib has been rapidly-tracked by the FDA for treatment of metastatic colorectal cancer that has progressed following intial therapy.


Colorectal cancer is a relatively frequent malignancy which has remained difficult to treat due to lack of effective chemotherapeutic agents. In 2011, a new tyrosine kinase inhibitor identified as regorafenib was shown to enhance general survival in patients with colorectal cancer that had progressed even in the face of heavy therapy. Regorafenib is currently on the quick track by way of the FDA approval process for treating colorectal cancer as there remains an excellent, albeit unmet, need in this area.


1. Cunningham, D Atkin, W, Lenz, HJ, Lynch, HT, Minsky, B, Nordlinger, B, Starling, N (2010 Mar 20). “Colorectal cancer.”. Lancet 375 (9719): 1030-47. 2. Stein, A Atanackovic, D, Bokemeyer, C (2011 Sep). “Present standards and new trends in the principal therapy of colorectal cancer.”. European journal of cancer (Oxford, England : 1990) 47 Suppl 3: S312-four. three. S. Hedbom et al. Meeting (2007) ASCO Annual Meeting.Citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Component I. 25(18S):3593 four. Wilhelm SM et al. (2010) Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer. 129(1):245-55

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