Phase I - II Study of Oral Idarubicin, Tegafur and Levo-Folinate in Patients with Pretreated Advanced Breast Cancer

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/m 2 /day for 3 days every 4 weeks) with tegafur and levo-folinate (200 mg/m 2 /day and 50 mg/day, respectively, for a m...

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Bibliographic Details
Published in:Journal of chemotherapy (Florence) 1999-10, Vol.11 (5), p.402-406
Main Authors: Cilenti, G., Tozzi, L., Suriano, A., Tartarone, A., Lelli, G.
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Biological and medical sciences
Breast Neoplasms - drug therapy
Breast Neoplasms - pathology
Chemotherapy
Humans
Idarubicin - administration & dosage
Idarubicin - adverse effects
Leucovorin - administration & dosage
Leucovorin - adverse effects
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Tegafur - administration & dosage
Tegafur - adverse effects
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Summary: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/m 2 /day for 3 days every 4 weeks) with tegafur and levo-folinate (200 mg/m 2 /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/m 2 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.
ISSN:1120-009X
1973-9478
DOI:10.1179/joc.1999.11.5.402