Phase I - II study of oral idarubicin, tegafur and levo-folinate in patients with pretreated advanced breast cancer

G. Cilenti, L. Tozzi, A. Suriano, A. Tartarone, Giorgio Lelli

Research output: Contribution to journalArticle

Abstract

Thirty patients with pretreated advanced breast cancer were enrolled in a study aimed to establish the maximum tolerated dose and to evaluate the efficacy of oral idarubicin (12 mg/m2/day for 3 days every 4 weeks) with tegafur and levo-folinate (200 mg/m2/day and 50 mg/day, respectively, for a minimum of 6 days, increasing the dose and duration according to a modified Fibonacci scheme). The maximum tolerated doses identified were 200 mg/m2 days 1-30 for tegafur and 50 mg days 1-30 for levo-folinate. We obtained 2 partial remissions (7%) and 12 stable disease (45%) in 27 objectively evaluable patients. The main toxicity was gastrointestinal, with no hematologic toxicity. Median time to progression was 4 months (range 2-14), median survival was 10 months (3-30). A median number of 4 cycles (1-13) was administered. The results seem to support the use of this combination in elderly and pretreated patients.

Original languageEnglish
Pages (from-to)402-406
Number of pages5
JournalJournal of Chemotherapy
Volume11
Issue number5
Publication statusPublished - 1999

Keywords

  • Advanced breast cancer
  • Breast cancer
  • Idarubicin
  • Levo-folinate
  • Tegafur

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Microbiology (medical)

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    Cilenti, G., Tozzi, L., Suriano, A., Tartarone, A., & Lelli, G. (1999). Phase I - II study of oral idarubicin, tegafur and levo-folinate in patients with pretreated advanced breast cancer. Journal of Chemotherapy, 11(5), 402-406.