title: Phase II study of mitomycin-C and cisplatin in disseminated, squamous cell carcinoma of the uterine cervix. A European Organization for Research and Treatment of Cancer (EORTC) Gynecological Cancer Group study.
abstract: The aim of this study was to investigate the tumour response rate and toxicity of a combination chemotherapy consisting of mitomycin-C and cisplatin in patients with disseminated squamous-cell carcinoma of the uterine cervix. Chemotherapy consisted of mitomycin, 6 mg/m(2) intravenously (i.v.), and cisplatin, 50 mg/m(2) given i.v., both administered on day 1 of each cycle. The regimen was repeated at 4-weekly intervals. Mitomycin-C/cisplatin were used to treat 33 evaluable patients aged 29-67 years (median: 50 years). All patients except 1 had previously been treated with either surgery, radiation or both. At the initiation of chemotherapy, 8 patients had loco-regional and disseminated disease and 25 women had only distant metastases. The overall response rate was 42% (95% confidence interval (CI): 26-61%). Five complete and nine partial responses were observed with a median duration of response of 7.9 months (95% CI: 3.7-23.5 months). 9 patients had stable disease and 10 developed progressive disease during mitomycin-C/cisplatin-treatment. World Health Organization (WHO) grade III/IV side-effects were documented in 15 women, of whom 10 had gastro-intestinal toxicity, 3 had haematological toxicity, 1 had alopecia and 1 developed an allergic reaction to cisplatin. There were neither drug-related deaths nor severe or irreversible renal or hepatic dysfunction or peripheral neuropathy. The median progression-free survival was 5.0 months (95% 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 overall survival was 11.2 months (95% CI: 6.5-18.4 months).The mitomycin-C/cisplatin combination showed antitumour activity in the treatment of advanced or recurrent squamous-cell carcinoma of the uterine cervix. The regimen was well tolerated and could be administered on an outpatient basis.
authors.affiliation: Department of Gynaecology, Leiden University Medical Center, Department of Gynaecology, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. wagenaari@hotmail.com
authors.forename: H C
authors.initials: HC
authors.lastname: Wagenaar
authors.forename: S
authors.initials: S
authors.lastname: Pecorelli
authors.forename: C
authors.initials: C
authors.lastname: Mangioni
authors.forename: M E
authors.initials: ME
authors.lastname: van der Burg
authors.forename: N
authors.initials: N
authors.lastname: Rotmensz
authors.forename: A
authors.initials: A
authors.lastname: Anastasopoulou
authors.forename: P
authors.initials: P
authors.lastname: Zola
authors.forename: C H
authors.initials: CH
authors.lastname: Veenhof
authors.forename: A J
authors.initials: AJ
authors.lastname: Lacave
authors.forename: J P
authors.initials: JP
authors.lastname: Neijt
authors.forename: A T
authors.initials: AT
authors.lastname: van Oosterom
authors.forename: N
authors.initials: N
authors.lastname: Einhorn
authors.forename: J B
authors.initials: JB
authors.lastname: Vermorken
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D016685:Mitomycin; D002945:Cisplatin