Treatment of Advanced Breast Cancer (ABC) with Docetaxel and Gemcitabine + Human Granulocyte Colony-Stimulating Factor (G-CSF).

Background: In order to investigate the efficacy and tolerance of docetaxel in combination with gemcitabine + G-CSF in ABC we initiated a multicenter phase II trial. Methods: Fifty-two patients received a combination regimen consisting of docetaxel (50 mg/m², days 1+15) and gemcitabine (1500 mg/m², days 1+15) + G-CSF (5 mcg/kg/d, s.c.) depending on the nadir granulocyte counts. Treatment courses were repeated every 4 weeks. Results: Patients and Methods: Forty-one pts are presently evaluable for response and toxicity assessment. Twelve were pre- and 29 pts were postmenopausal. Their median age was 61 (44-75) years, and the median WHO performance status 1 (0-2). Predominant sites were visceral in 29, bone in 6 and soft-tissue in 6 pts, respectively. Eleven pts were refractory to previous 1st-line chemotherapy, all others were previously untreated. After a median of 6 (2-6) treatment courses an overall response rate of 56% including 4 CR, and 19 PR was observed. Specifically, 19/30 (63%) previously untreated pts, and 4/11 (36%) chemotherapeutically pretreated pts responded. Eleven additional pts had SD (27%) and only 7 PD (17%). The median time to response was only 2.5 (2-4.5) months. The median duration of response (>6 months), time to progression (>8 months) and survival (>13 months) with 31 pts (76%) currently alive have not been reached yet. WHO grade 3 or 4 neutropenia occurred in 6 (17%) pts each, and was complicated by septicaemia in 3 (7%). Non-hematologic side effects were generally mild to moderate, and included alopecia (68%). nausea/vomiting (63%), peripheral neuropathy (34%). tearing (31%), fatigue (47%), stomatitis (32%), peripheral edema (36%). diarrhea (24%), skin/nail reactions (36%), constipation (15%) and pathologically raised liver enzymes (27%). Conclusions: We conclude that docetaxel and gemcitabine + G-CSF is an effective and fairly well tolerated regimen for the treatment of ABC. [ABSTRACT FROM AUTHOR]