An experimental drug for advanced colorectal cancer that available treatments have failed to halt, has shown promisein a clinical trial, says Bayer HealthCare, the company that makesit. The results of the phase III trial show that compared toplacebo, regorafenib slowed tumor growth and extended survival. In a statement released yesterday, Bayer announced that the PhaseIII CORRECT (Colorectal cancer treated with regorafenib or placeboafter failure of standard therapy) trial “met its primary endpoint,showing statistically significant improvement in overall survival… in patients with metastatic colorectal cancer (mCRC) whosedisease had progressed after approved standard therapies”. The statement goes on to add that the trial also shows thatregorafenib showed statistically significant improvement inprogression-free survival and improvement in disease control ratein the patients who received the drug compared to those whoreceived placebo.
The trial results show that more of the side effects commonly oroccasionally seen with chemotherapy occurred with the drug thanwith placebo, including fatigue , hand-foot skin reaction, diarrhea , anorexia , high blood pressure , oral mucositis (inflammation of the lining of the mouth) andrash/skin peeling. The trial was “unblinded” late in 2011 after an independent datamonitoring committee said the drug was showing significantimprovement in overall survival and patients receiving placeboshould be offered the option to take it. It was conducted in North America, Europe, China, Japan andAustralia and enrolled 760 patients. Bayer said they will be seeking Food and Drug Administration (FDA)approval for regorafenib within the next 12 months. s.
If approved, itwill be the first new treatment for colorectal cancer in over fiveyears. Dr Axel Grothey, MD, Professor of Oncology at the Mayo Clinic is aco-principal investigator on the trial. He is presenting the trial results at the 2012 Gastrointestinal Cancers Symposium of the American Society ofClinical Oncology (ASCO-GI) , in San Francisco later this week. The oral abstract presentation (LBA number 385) is set to takeplace at 14:30 h PT on 21 January in the Level 3 Ballroom, MosconeCenter West.
Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in the US, in both menand women. About half of patients diagnosed with the disease have the advancedform (metastases, usually to the liver), either at the time ofdiagnosis or due to recurrent disease. Written by Catharine Paddock PhD Copyright: Medical News Today Not to be reproduced without permission of Medical News Today Additional References Citations.
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