Cytoprotection/radioprotection with amifostine: potential role in cervical cancer and early findings in the Radiation Therapy Oncology Group C-0116 trial.

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.