Interview with Ezra Cohen, MD
Associate Professor of Medicine
University of Chicago Medical Center
01.10.2011
Q. What clinical trials are currently underway for afatinib* in head and
neck cancer?
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.