Clinical study of radioprotective effects of amifostine (YM-08310, WR-2721) on long-term outcome for patients with cervical cancer.

PURPOSE: A retrospective analysis was performed to investigate the radioprotective effects of amifostine on the long-term outcome of radiation therapy for the patients with carcinoma of the uterine cervix.

METHODS AND MATERIALS: Eighty-three patients with histologically proven epidermoid carcinoma (Stage II-IVA disease) of the uterine cervix were treated with definitive radiation therapy between January 1978 and December 1984. Forty-six patients treated with radiation alone, whereas 37 patients treated with radiation plus amifostine. Amifostine was given intravenously 30 min prior to every radiation. Most patients received 75 mg/m2 of amifostine daily from the initiation of the course of radiation therapy. The median total dose of amifostine given was 1300 mg/m2, with a range of 280 mg/m2 to 3700 mg/m2.

RESULTS: The 5-year overall actuarial survival for the patients treated with radiation alone and with radiation plus amifostine were: 72% and 88% in Stage II disease (p = 0.45); 52% and 50% in Stage III disease (p = 0.68); and 40% and 43% in Stage IVA disease (p = 0.51), respectively. The 5-year intra-pelvic recurrence rates in the patients treated with amifostine were almost the same as those observed in the patients treated without amifostine (0% vs. 6% in Stage II disease; 15% vs. 10% in Stage III disease; 25% vs. 40% in Stage IVA disease). There was also no statistically significant difference of the chronic rectal or bladder complication rate between the groups treated by each regimen.

CONCLUSION: We concluded that any radioprotective effects of amifostine on tumor tissue and any beneficial effects of amifostine against chronic radiation injury were not observed in the patients with cervical cancer followed up for more than 5 years after radiation therapy.