Gemcitabine and epirubicin in patients with metastatic breast cancer: a phase I/II study.
Fiche publication
Date publication
octobre 2006
Auteurs
Membres identifiés du Cancéropôle Est :
Pr FUMOLEAU Pierre, Pr PETIT Thierry
Tous les auteurs :
Campone M, Fumoleau P, Viens P, Dieras V, Pujade-Lauraine E, Serin D, Petit T, Espie M, Kayitalire L, Bozec L, Pouillart P
Lien Pubmed
Résumé
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.
Référence
Breast. 2006 Oct;15(5):601-9.