PIREAUS, GreeceIn advanced-stage lung cancer, radiation therapy
provides effective local-regional control but requires irradiation of large
tissue volumes and high total tumor doses. "Bolus tumor doses higher
than 60 Gy produce better local tumor control but more toxicity," Dosia
Antonadou, MD, explained.
"Patients with lung cancer have compromised lung tissue and they can
have many symptoms during or after radiation therapy or during
radiochemotherapy," she continued. "We undertook a phase III
randomized, multicenter trial to investigate whether daily pretreatment with
amifostine (Ethyol) could safely reduce the incidence of esophagitis and
pneumonitis in patients with lung cancer undergoing definitive conventional
radiotherapy." Dr. Antonadou is consultant in the Radiation Oncology
Department, Metaxas Cancer Hospital, Pireaus, Greece.
Patients were randomized to either 340 mg/m² IV amifostine, given daily
15 to 20 minutes before radiation, followed by radiation at 2 Gy/day, 5 days
per week, to a total dose of 55 to 60 Gy, or to the same regimen without
The primary study endpoints were the incidence of grade 2 or worse
esophagitis, the incidence of grade 2 or worse acute lung toxicity, and the
incidence of pneumonitis and/or fibrosis. Secondary endpoints were response
rates. "This was to address the concern that amifostine might
compromise the efficacy of the treatment," Dr. Antonadou said.
Patients entered into this study had histologically or cytologically
proven lung cancer with a performance status of 2 or better and disease
confined to the primary sites and regional lymph nodes. Patients with
pleural effusion were excluded from the study. No previous radiotherapy was
Dr. Antonadou reported that 146 patients were randomized, that median
follow up was 5 months, and that the treatment arms were evenly balanced.
"The majority of our patients were stage IIIB," she said.