ACTIVITY OF PACLITAXEL IN ADVANCED OR RECURRENT SQUAMOUS-CELL CANCER OF THE CERVIX

Twenty-six patients with squamous cell cancer of the cervix were treat ed with i,v, paclitaxel, 250 mg/m(2) over 3 h every 21 days, They rece ived steroid, H-1 and H-2 blocker premedications, and granulocyte-colo ny-stimulating factor (G-CSF) support (5 mu g/kg/day). No prior chemot herapy, except as a radiation sensitizer, was allowed, The median age was 50 (range, 36-81) years, and performance status Zubrod was 1 (rang e, 0-2), Eight (33%) patients had prior surgery, and 22 (92%) had prio r radiation therapy, Twenty-four patients were evaluable for response; 2 were later found to be ineligible, Five patients had partial respon ses (21%; 95% confidence interval, 6-40%), and 14 (58%; 95% confidence interval, 35-78%) had stable disease, The median duration of response was 10 (range, 3-27+) weeks, The responses were within the radiation port (four responses) and outside of it (one response), The median int erval from the start of irradiation to the start of paclitaxel in resp onding patients was 94 weeks, whereas in patients with stable disease it was 68 weeks, and in patients whose disease progressed it was 46 we eks, Eighty-eight percent of the 105 cycles of paclitaxel were adminis tered at a dose of 250 mg/m(2) or higher, Granulocytopenia was brief a nd noncumulative, with grades 3 and 4 experienced by 5 and 3 patients, respectively, G-CF was used for a median of 7 (range, 2-14) days/cycl e, Anemia was mild, with G(3) noted in 3 patients, and thrombocytopeni a was not significant, Infections and musculoskeletal pain were mild a nd infrequent, Sensory (14 patients G(1) or G(2) and 2 patients G(3)) and motor (4 patients G(1) or G(2) and 1 patient G(3)) neurotoxicity w as noted, There was no significant cardiovascular toxicity, Paclitaxel is active in patients with squamous cell cancer of the cervix and is well tolerated at this dose schedule with G-CSF support.