In a nutshell
The present study evaluated the efficacy of a new drug, Regorafenib, for the treatment of refractory (progressing despite several lines of treatment) metastatic colorectal cancer (mCRC).
Some background
Many of the patients with colorectal cancer do not present any symptoms in the early stages of the disease so the cancer spreads to the surrounding or distant organs of the body (metastasizes). In this advanced stage usually the cancer cannot be removed completely with surgery. Standard treatment for these patients includes chemotherapy and biological therapy which target proteins that allow the cancer to grow, thus shrinking the cancer or stopping its growth. However, in some patients the cancer continues to grow despite all these therapies. For these patients new medications are being researched in order to prolong survival and stop the disease from progressing. Regorafenib (Stivarga) is a newly FDA approved drug for the treatment of patients with mCRC after failure of previous therapies. It is a type of biological therapy, which acts by perturbing the tumors' blood supply.
Methods & findings
The study included overall 760 patients with mCRC. 505 patients were treated with Regorafenib and 255 received placebo (a substance that has no medical effect, used as a control in testing new drugs). Parameters measured included overall survival (the percentage of patients who have survived for a defined period of time), progression-free survival, or PFS (the percentage of patients who have survived for a defined period of time, without progression of their cancer) as well as complication rate and quality of life.
The bottom line
In summary, Regorafenib showed survival benefits, and delayed disease progression to some degree in patients with mCRC after failure of previous therapies. However, treatment involved higer frequency of side effects.
The fine print
The results of this study served as grounds for the approval of Regorafenib by the US FDA.
Published By :
The Lancet
Date :
Nov 22, 2012
