A GYNECOLOGIC-ONCOLOGY-GROUP PHASE-II STUDY OF AMONAFIDE (SC NUMBER-308847) IN SQUAMOUS-CELL CARCINOMA OF THE CERVIX

Twenty evaluable patients with squamous cell carcinoma of the cervix, who had previously received a cisplatin-containing regimen, were treated with amonafide 300 mg/m2 over 1 hour for 5 consecutive days every 3 weeks. One partial response (5%) was seen. Hematologic toxicity was substantial with severe or life-threatening events occurring as follows: leukopenia, 5 patients (25%); thrombocytopenia, 4 patients (20%); granulocytopenia, 2 patients (10%). One patient experienced acute bilateral open-angle glaucoma immediately after treatment, and other developed gastric ulceration with life-threatening gastrointestinal bleeding. In view of the low response rate and high toxicity, amonafide does not warrant further investigation as second-line chemotherapy in squamous cell carcinoma of the cervix.