• Prescrire Int. 2014 Jan 1;23(145):8-11.

AbstractPatients with metastatic colorectal cancer who have exhausted their therapeutic options have a life expectancy of only a few months. Treatment is then based on tailored supportive care, without cytotoxic drugs. Regorafenib, an inhibitor of multiple protein kinases, has been authorised in the European Union for the treatment of patients with metastatic colorectal cancer who have no other therapeutic options. Clinical evaluation is based on a double-blind, randomised, placebo-controlled trial in patients who had already received multiple lines of cytotoxic chemotherapy but who remained in good overall condition. Adding regorafenib to best supportive care led to median overall survival, albeit of only a few weeks (6.4 months with regorafenib versus 5 months with placebo). Regorafenib has many adverse effects, including hepatic, cardiovascular, cutaneous, gastrointestinal, thyroid, neurological and haematological disorders, as well as infections and bleeding. These adverse effects are severe in about 40% of patients. Some patients died from these adverse effects, notably liver damage and bleeding. In practice, according to the only available trial, regorafenib appears to prolong overall survival by a few weeks in some cases, but at a cost of serious adverse effects in about 40% of patients, including premature death. Pending further evaluation, it is preferable to recommend best supportive care.

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