Concurrent
cisplatin-based chemoradiation
therapy is now considered the standard treatment for locally advanced cervical
carcinoma. Available data also suggest that
combined-modality therapy improves outcome compared with
radiation therapy alone in disease with positive para-aortic lymph nodes. However,
radiation therapy alone is associated with significant toxicity in
cervical cancer, and toxicity is increased with chemoradiation
therapy. The cytoprotectant/radioprotectant agent
amifostine (
Ethyol; MedImmune, Inc, Gaithersburg, MD) has been found to reduce toxicities associated with
cisplatin, radiation, and combined modality approaches in the treatment of several
tumor types. The limited available data on the use of
amifostine in patients with cervical or
pelvic cancers indicate a benefit in reducing chemoradiation toxicity, although
cisplatin regimens used in the early investigations in
cervical cancer are no longer considered optimal. In the
Radiation Therapy Oncology Group C-0116 phase I/II trial, patients with
cervical cancer with positive para-aortic or high common iliac nodes are to receive extended-field radiation and intracavitary
brachytherapy plus weekly
cisplatin in the first part of the study; in the second part of the trial, patients are also to receive
amifostine. The trial should provide important information on the potential for adjunctive
amifostine use in chemoradiation
therapy for
cervical cancer.