A pilot phase II study of capecitabine plus cisplatin in the treatment of recurrent carcinoma of the uterine cervix

Oncology. 2007;72(1-2):33-8. doi: 10.1159/000111086. Epub 2007 Nov 12.

Abstract

Background: To assess the efficacy and tolerability of combination therapy with capecitabine and cisplatin in patients with recurrent carcinoma of the uterine cervix.

Methods: Sixteen patients were treated with oral capecitabine (1,000 mg/m2 twice daily, days 1-14) and intravenous cisplatin (50 mg/m(2) on day 1 every 3 weeks) for a maximum of six cycles.

Results: Their median age was 50 years (31-74 years). Ten patients (63%) had recurrent disease outside the radiation field. The overall response rate was 50% (95% confidence interval 26-75%); 4 patients had complete response (25%). The overall response rate was 33% in patients with recurrent disease within the previous irradiated field and 60% in patients with tumor outside the irradiated field. The median time to progression was 9 months, with a median overall survival of 23 months. The majority of adverse events were mild and there were no grade 4 adverse events. Hematological toxicity was the most frequent adverse event with grade 3 neutropenia in 19% of patients. Grade 2 and 3 hand-foot syndrome occurred in 38 and 6% of the patients, respectively. There were no chemotherapy-related deaths.

Conclusion: The combination of capecitabine plus cisplatin is a clinically active regimen with acceptable tolerability for patients with recurrent carcinoma of the uterine cervix.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Capecitabine
  • Carcinoma / drug therapy*
  • Cisplatin / administration & dosage
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / analogs & derivatives
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Uterine Cervical Neoplasms / drug therapy*

Substances

  • Deoxycytidine
  • Capecitabine
  • Cisplatin
  • Fluorouracil