Cis-platinum in treatment of advanced or recurrent squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group.

Thirty-four patients with advanced or recurrent squamous cell carcinoma of the cervix no longer amenable to control with surgery and/or radiotherapy were treated with cis-platinum 50 mg/m2 intravenously every three weeks. Among 22 patients who had received no prior chemotherapy, three complete and eight partial responses were observed (response rate 50%), whereas only two partial responses were observed among 12 patients who had received prior chemotherapy (response rate 17%). The observed response rate was marginally significantly higher among those with no prior chemotherapy (p = 0.059). The overall frequency of response was 38% (13/34). Responses were observed in those with pelvic (7/20) as well as extrapelvic disease (6/14). Adverse effects included primarily leukopenia (11/34), thrombocytopenia (13/34), nausea and vomiting (29/34), and azotemia (17/34). Adverse effects were generally mild to moderate and hence tolerable. Cis-platinum thus appears to be a highly active agent in the treatment of squamous cell carcinoma of the cervix at the dose and schedule tested.