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2006: Campone Mario; Fumoleau Pierre; Viens Patrice; Diéras Véronique; Pujade-Lauraine Eric; Serin Daniel; Petit Thierry; Espié Marc; Kayitalire Louis; Bozec Laurence; Pouillart Pierre
Gemcitabine and epirubicin in patients with metastatic breast cancer: a phase I/II study.
Breast (Edinburgh, Scotland) 2006;15(5):601-9.
Gemcitabine and epirubicin were evaluated in metastatic breast cancer (MBC) patients to determine the maximum tolerated dose (MTD), efficacy, and toxicity of the combination. Patients initially received 800 mg/m(2) of gemcitabine (days 1 and 8) and 50 mg/m(2) of epirubicin (day 1) every 21 days. Each dose level had three to eight patients. Phase II used the dose level preceding the MTD. Forty-eight patients enrolled without reaching MTD; therefore, phase II used the highest dose level (1500 mg/m(2) of gemcitabine, 90 mg/m(2) of epirubicin). After 23 patients (group A) experienced hematologic toxicities and frequent dose reductions, 15 received 1250 mg/m(2) gemcitabine (days 1 and 4) and 90 mg/m(2) epirubicin (day 1) every 21 days (group B). Out of 38 patients, 46% responded (group A 32%, group B 67%). Median response duration was 8.5 months; median time to progression 8.4 months; and median time to treatment failure 4.8 months. Gemcitabine and epirubicin are well tolerated and active in MBC patients, and the group B regimen warrants further investigation.

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