DURHAM, NC--Use of amifostine(Drug information on 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 benefit questionnaire.
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 overall survival.
"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."
