Docetaxel and gemcitabine in anthracycline-resistant advanced breast cancer: A Hellenic cooperative oncology group phase II study

A phase II study was conducted to evaluate the activity and toxicity profil e of the combination of docetaxel and gemcitabine in anthracycline-resistan t advanced breast cancer (ABC). Thirty-nine eligible patients with a median performance status of I (range, 0-2) M were enrolled in the study. Treatme nt consisted of docetaxel 75 mg/m(2) in a 1-hr infusion on day 1 preceded b y gemcitabine 1000 mg/m(2) over 30 min on days 1 and 8. One hundred eighty- one treatment cycles were administered, 113 (62.4%) of them at full dose. R elative dose intensity of gemcitabine and of docetaxel was 0.73 and 0.85, r espectively. More common grade 3-4 toxicities ineluded neutropenia (49%), a nemia (10%), fatigue (10%), nausea-vomiting (8%), and alopecia (77%). Seven patients were hospitalized for febrile neutropenia. Granulocyte colony-sti mulating factor (G-CSF) administration was required in 90% Of patients. Ove rall, 14 patients (36%) responded, 3 (7.5%) of them completely. Median dura tion of response was 10.3 months (range, 4.6-175+). Median time to progress ion was 7 months (range, 0.2-17.5+) and median survival 12.7 months (range, 2-20.5+). In conclusion, the combination of docetaxel and gemcitabine, as used in the present study, has moderate activity, in anthracycline-resistan t ABC. Future studies should incorporate prophylactic administration of G-C SF to reduce the incidence of febrile neutropenia and maintain close intens ity.