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(Drug information on 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 amifostine.
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 allowed.
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.