Phase II study of mitomycin-C and cisplatin in disseminated, squamous cellcarcinoma of the uterine cervix. A European Organization for Research and Treatment of Cancer (EORTC) Gynecological Cancer Group study

The aim of this study was to investigate the tumour response rate and toxic ity of a combination chemotherapy consisting of mitomycin-C and cisplatin i n patients with disseminated squamous-cell carcinoma of the uterine cervix. Chemotherapy consisted of mitomycin, 6 mg/m(2) intravenously (i.v.), and c isplatin, 50 mg/m2 given i.v., both administered on day I of each cycle. Th e regimen was repeated at 4-weekly intervals. Mitomycin-C/cisplatin were us ed to treat 33 evaluable patients aged 29-67 years (median: 50 years). All patients except 1 had previously been treated with either surgery, radiatio n or both. At the initiation of chemotherapy, 8 patients had loco-regional and disseminated disease and 25 women had only distant metastases. The over all response rate was 42% (95% confidence interval (CI): 26-61 lo). Five co mplete and nine partial responses were observed with a median duration of r esponse of 7.9 months (95 % CI: 3.7-23.5 months). 9 patients had stable dis ease and 10 developed progressive disease during mitomycin-C/cisplatin-trea tment. World Health Organization (WHO) grade III/IV side-effects were docum ented in 15 women, of whom 10 had gastro-intestinal toxicity, 3 had haemato logical toxicity, 1 had alopecia and 1 developed an allergic reaction to ci splatin. There were neither drug-related deaths nor severe or irreversible renal or hepatic dysfunction or peripheral neuropathy. The median progressi on-free survival was 5.0 months (95 lo CI: 3.6-6.2 months) for all patients and 10.5 months (95% CI: 6.2-15.2 months) for the responders. The median o verall survival was 11.2 months (95% CI: 6.5-18.4 months). The mitomycin-C/ cisplatin combination showed antitumour activity in the treatment of advanc ed or recurrent squamous-cell carcinoma of the uterine cervix. The regimen was well tolerated and could be administered on an outpatient basis. (C) 20 01 Elsevier Science Ltd. All rights reserved.