Cisplatin, radiation, and amifostine in carcinoma of the uterine cervix.
A pilot, open, comparative study was performed on patients with locally advanced cervical cancer to investigate the efficacy and safety of amifostine. Twenty patients with a histologic diagnosis of squamous cervical cancer were treated with radiotherapy and randomized in two groups. Group A received cisplatin at 20 mg/m2 for five days in two cycles during intracavitary radiotherapy and 100 mg/m2 x 2 cycles during external radiotherapy, and amifostine 825 mg/m2 15 min before the cisplatin infusion. Patients in group B received cisplatin in the same doses without amifostine. All patients had complete responses during a median follow-up of 20 months. Grade three neutropenia was present in two patients in group A and in four of the control 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 needed temporary interruption of amifostine due to hypotension. Eight of 10 patients 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 received amifostine, although this was not statistically significant. No differences in disease-free survival response and overall survival was seen between the two groups.
Department of Medical Oncology, National Cancer Institute and Biomedical Investigations Institute, UNAM, Tlalpan, Mexico; Department of Radiotherapy, National Cancer Institute and Biomedical Investigations Institute, UNAM, Tlalpan, Mexico; Department of Gynecology, National Cancer Institute and Biomedical Investigations Institute, UNAM, Tlalpan, Mexico; Division of Clinical Research, National Cancer Institute and Biomedical Investigations Institute, UNAM, Tlalpan, Mexico.
D.
D
Gallardo
A.
A
Mohar
G.
G
Calderillo
A.
A
Mota
G.
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Solorza
A.
A
Lozano
P.
P
Solano
J.
J
De La Garza