DURHAM, NC--Use of amifostine (Ethyol) significantly reduces the
incidence of chronic as well as acute xerostomia and associated
symptoms in patients undergoing radiotherapy for the treatment of
head and neck cancer, David Brizel, MD, associate professor of
radiation oncology, Duke University Medical Center, said at the ASCO meeting.
In this phase III study, 315 patients were randomized to receive
daily radiotherapy alone or with 200 mg/m² of amifostine, given
30 minutes before treatment. Radiation toxicities were measured using
the RTOG Radiation Morbidity Scoring Criteria as well as a patient
The data showed that 78% of patients treated with radiotherapy alone
experienced moderate to severe xerostomia during and up to 1 month
after radiotherapy. This was reduced to 50% in patients who received
amifostine (P = .0001).
Importantly, Dr. Brizel said, this benefit was maintained. At 1 year
after radiotherapy, data available on about half of the study group
showed that 60% of those who received radiotherapy alone had moderate
to severe xerostomia vs 34% of patients who were pretreated with
amifostine (P = .0042).
The results of the patient benefit questionnaire correlated with the
physicians assessments, he said. One year after treatment,
patients treated with amifostine reported significantly less mouth
dryness and need for fluid supplementation and oral comfort aids than
patients treated with radiotherapy alone.
At a median follow-up of 13 months for all patients, there was no
difference between the treatment arms with respect to disease-free or
"It is important to ensure that in the process of attempting to
cure our patients, we also try to preserve the quality of their
lives," Dr. Brizel said. "This trial is significant in
showing that Ethyol can reduce the incidence of xerostomia."