Journal article
A Phase 2 Study of a Fixed Combination of Uracil and Ftorafur and Leucovorin Given Orally in a Twice-Daily Regimen to Treat Patients With Recurrent Metastatic Breast Cancer
Cancer, Vol.116(10), pp.2301-2306
05/15/2010
DOI: 10.1002/cncr.25042
PMID: 20225231
Abstract
BACKGROUND: UFT, a combination of uracil and ftorafur, was developed to combine the cytotoxic effects of 5-fluorouracil (5-FU) with convenient oral dosing Leucovorin is combined with UFT to further potentiate the effect of 5-FU on tumor cells Orally administered UFT and leucovorin provide higher peak plasma concentrations of 5-FU and prolonged therapeutic 5-FU concentrations compared with continuous infusion of 5-FU METHODS: Ninety-four patients with metastatic breast cancer who had been previously treated with anthracyclines and/or taxanes were treated with UFT and leucovorin, given orally, for the first 28 days of a 35-day cycle The total daily dose of UFT was 300 mg/m(2), which was given in 2 divided doses every 12 hours The primary endpoint was time to disease progression (TTP) Secondary objectives included overall tumor response rate (OR = complete response [CR] + partial response [PR]) and overall survival (OS) RESULTS: Of the 94 patients enrolled, 68 were evaluable for efficacy Although no CRs were observed, 9 patients achieved PRs, for an OR of 13 2% in the evaluable population The median TIP for the evaluable population was 10 3 weeks, and the proportion of patients free of disease progression at 6 months was 17% The median OS was 61 6 weeks for all patients enrolled. The most common drug-related >= grade 3 adverse events (graded using the National Cancer Institute Common Toxicity Criteria version 2) were diarrhea, asthenia, nausea, and dehydration CONCLUSIONS: The combination of UFT and leucovorin administered orally in a twice-daily regimen was found to have modest activity Grade 3 toxicities were manageable with appropriate dose adjustments in patients with metastatic breast cancer previously treated with anthracyclines and/or taxanes Cancer 2010;116:2301-6. (C) 2010 American Cancer Society
Details
- Title: Subtitle
- A Phase 2 Study of a Fixed Combination of Uracil and Ftorafur and Leucovorin Given Orally in a Twice-Daily Regimen to Treat Patients With Recurrent Metastatic Breast Cancer
- Creators
- Gabriel N. Hortobagyi - The University of Texas MD Anderson Cancer CenterRobyn R. Young - Ctr Canc & Blood, Ft Worth, TX USAMark Karwal - Univ Iowa, Dept Internal Med, Carver Coll Med, Iowa City, IA 52242 USANuhad K. Ibrahim - MD Anderson Cancer Center MadridRobert Hermann - MD Anderson Cancer Center MadridJames L. Murray - MD Anderson Cancer Center MadridStanley P. Watkins - NW Georgia Oncol Ctr, Marietta, GA USAIra Gore - MD Anderson Cancer Center Madrid
- Resource Type
- Journal article
- Publication Details
- Cancer, Vol.116(10), pp.2301-2306
- Publisher
- Wiley
- DOI
- 10.1002/cncr.25042
- PMID
- 20225231
- ISSN
- 0008-543X
- eISSN
- 1097-0142
- Number of pages
- 6
- Grant note
- Novartis Honoraria Bristol Myers Squibb Company, Princeton, New Jersey; Bristol-Myers Squibb
- Language
- English
- Date published
- 05/15/2010
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984360050202771
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