Interview with Ezra Cohen, MD
Associate Professor of Medicine
University of Chicago Medical Center
Q. What clinical trials are currently underway for afatinib* in head and
A. For afatinib* itself there are two randomised studies that are ongoing and they target an aspect of this disease, or two aspects of the disease, that I think ErbB blockers may be quite relevant and quite effective. The first is adjuvant therapy and what we mean by that is patients who are treated with curative intent, they are rendered essentially disease-free by chemotherapy and radiation. But we know that they are still at significant risk for the cancer coming back. In fact, we can define a group of patients based on stage, human papillomavirus status, primary tumour site and other factors that have likely a 50% chance or more of the cancer recurring. And so these are patients that, obviously, if we could do something to prevent that recurrence, we should. Unfortunately, right now, there is nothing that is effective in this arena. But we do know that many of these tumours may be responsive to ErbB inhibition and at least from other preliminary studies, we are beginning to realise that inhibition of the ErbB Family members may actually be effective in this setting. And so one of the randomised trials does exactly that. It randomises patients who are at high risk for recurrence, who have been rendered disease free after therapy but who may need therapy down the road, and so randomises these patients to either receive afatinib* or placebo for 18 months or as long as the subject can stay on the study. The other randomised trial is in, let's say a more traditional setting, where the ErbB Family blockers have been used, and that is patients with a recurrent metastatic disease. Patients with a recurrent metastatic disease are not treated for cure. These are patients who we can offer palliative chemotherapy to or palliative agents, but we know that we are not going to be able to cure the disease. We do know that EGFR inhibitors, for instance cetuximab, are effective in this disease and we hope that we can improve on that efficacy with ErbB blockers. So, with that in mind, the current Phase III study randomises patients to afatinib* versus a commonly used chemotherapy drug called methotrexate.
*Afatinib is an investigational compound. Its safety and efficacy has not yet been fully established.