Abstract
BackgroundOn the basis of clinical activity of capecitabine and gemcitabine for metastatic breast cancer, we carried out a multicenter phase II clinical trial on the combination of these two agents in advanced anthracycline-pretreated breast cancer patients. Main objectives were to assess its efficacy and safety profile. Patients and methodsSeventy-six anthracycline-pretreated breast cancer patients were evaluated and were stratified according to previous treatment of advanced disease (group-1: not previously treated and group-2: previously treated). Study treatment consisted of gemcitabine 1000 mg/m2, i.v., as 30 min-infusion, days 1 and 8 every 21 days, plus oral capecitabine 830 mg/m2 b.i.d., days 1–14 every 21 days. ResultsOverall response rate was 61% for group-1, 48.5% for group-2 and 55.2% for the whole population. Clinical benefit rate was 73% for group-1, 80% for patients in group-2 and 76% for all patients. Median time to progression was 13.0 months for group-1, 8.2 months for group-2 and 11.1 months for the whole population. Most frequent grade 3–4 observed toxic effects per patient were neutropenia (60%), asymptomatic liver toxicity (13.5%), asthenia (14%) and hand–foot syndrome (16%). Only one patient presented febrile neutropenia. No treatment-related deaths occurred. ConclusionCombination of gemcitabine and capecitabine is an active and safe regimen in anthracycline-pretreated breast cancer patients.
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