A phase II trial of UFT and leucovorin in women 65 years and older with advanced breast cancer

Supriya Gupta, Ann M. Mauer, Christopher W. Ryan, David A. Taber, Brian L. Samuels, Gini F. Fleming

    Research output: Contribution to journalArticlepeer-review

    7 Scopus citations


    The incidence of breast cancer increases with age. This trial evaluated the efficacy and safety of oral UFT (ftorafur plus uracil) plus leucovorin in elderly patients with advanced breast cancer. Eligibility criteria included age ≥65 years, locally advanced or metastatic breast cancer, ≤ 1 prior chemotherapy regimens in the setting of metastatic disease, performance status 0-2, and adequate end-organ function. UFT at 300 mg/m2 per day as 2 divided doses and 30 mg leucovorin with each dose were administered orally daily for 21 days, followed by a 7-day rest period. Ten patients were accrued. Six patients received treatment in their first relapse and 3 in their second. One patient was chemotherapy-naive. The dose-limiting toxicity was diarrhea with grade 3 or 4 diarrhea occurring more often in the oldest patients (1 of 6 patients between 65 and 69 vs. 3 of 4 patients ≥70 years old). Protocol treatment was discontinued in 2 patients (ages 78 and 83) secondary to severe gastrointestinal toxicity. One patient achieved a partial response. Although UFT/leucovorin had efficacy in 1 patient, toxicity in the patients over 70 years of age was increased. Careful evaluation of anticancer drug toxicity in very elderly patients is important as our population ages.

    Original languageEnglish (US)
    Pages (from-to)65-69
    Number of pages5
    JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
    Issue number1
    StatePublished - Feb 2005


    • Breast cancer
    • Elderly
    • Phase II
    • Toxicity
    • UFT

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

    Fingerprint Dive into the research topics of 'A phase II trial of UFT and leucovorin in women 65 years and older with advanced breast cancer'. Together they form a unique fingerprint.

    Cite this