Cisplatin, radiation and amifostine in carcinoma of the uterine cervix

A pilot, open, comparative study was performed on patients with locally adv anced cervical cancer to investigate the efficacy and safety of amifostine. Twenty patients with a histologic diagnosis of squamous cervical cancer we re treated with radiotherapy and randomized in two groups. Group A received cisplatin at 20 mg/m(2) for five days in two cycles during intracavitary r adiotherapy and 100 mg/m(2) x 2 cycles during external radiotherapy, and am ifostine 825 mg/m(2) 15 min before the cisplatin infusion. Patients in grou p B received cisplatin in the same doses without amifostine. All patients h ad complete responses during a median follow-up of 20 months. Grade three n eutropenia was present in two patients in group A and in four of the contro l group, P = 0.31; grade 2 neurologic toxicity was seen in four patients in group B and in one of the patients in group A, P = 0.15. One patient neede d temporary interruption of amifostine due to hypotension. Eight of 10 pati ents in group A developed hypocalcemia during the treatment with amifostine . Our findings indicate that amifostine was well tolerated. In this series a mild neurologic and hematologic protection was found in patients that recei ved amifostine, although this was not statistically significant. No differe nces in disease-free survival response and overall survival was seen betwee n the two groups.