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

H. C. Wagenaar, S. Pecorelli, C. Mangioni, M. E L Van der Burg, N. Rotmensz, A. Anastasopoulou, P. Zola, C. H N Veenhof, A. J. Lacave, J. P. Neijt, A. T. Van Oosterom, N. Einhorn, J. B. Vermorken

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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/m2 intravenously (i.v.), and cisplatin, 50 mg/m2 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.

Original languageEnglish
Pages (from-to)1624-1628
Number of pages5
JournalEuropean Journal of Cancer
Volume37
Issue number13
DOIs
Publication statusPublished - 2001

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Keywords

  • Cervical cancer
  • Cisplatin
  • Mitomycin-C
  • Phase II study

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology

Cite this

Wagenaar, H. C., Pecorelli, S., Mangioni, C., Van der Burg, M. E. L., Rotmensz, N., Anastasopoulou, A., Zola, P., Veenhof, C. H. N., Lacave, A. J., Neijt, J. P., Van Oosterom, A. T., Einhorn, N., & Vermorken, J. B. (2001). 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. European Journal of Cancer, 37(13), 1624-1628. https://doi.org/10.1016/S0959-8049(01)00178-2