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Treatment of Advanced Breast Cancer with Docetaxel and Gemcitabine with and without Human Granulocyte Colony-stimulating Factor¹

Department of Internal Medicine I, Division of Oncology, Vienna University Medical School, Waehringer Guertel 18-20, A-1090 Vienna [G. V. K., M. R., B. S., W. S.]; Department of Surgery, Wr. Neustadt General Hospital, Corvinusring 3-5, A-2700 Wr. Neustadt [K. H., W. K., T. P., D. D.]; Department of Surgery, Baden General Hospital, Wimmergasse 29, A-2500 Baden [E. K.]; and Department of Surgery, Neunkirchen General Hospital, Peischingerstrasse 19, A-2620 Neunkirchen [F. L.], Austria

Purpose: A multicenter Phase II trial was performed to investigate the efficacy and tolerance of combined docetaxel and gemcitabine ± recombinant human granulocyte colony-stimulating factor (G-CSF) in patients with metastatic breast cancer.

Patients and Methods: Fifty-two patients participated in this trial, 51 of whom are evaluable for response. Thirty-eight patients received this combination as first-line chemotherapy, and 14 patients received this combination as second-line chemotherapy, including 10 patients who had failed anthracyclines. Therapy consisted of 1500 mg/m² gemcitabine and 50 mg/m² docetaxel, both administered on days 1 and 15 every 4 weeks. Depending on the absolute neutrophil counts on the day of scheduled chemotherapeutic drug administration, a 5-day course of 5 µg/kg G-CSF was given.

Results: The overall response rate was 60.5% (95% confidence interval, 43.4–75.9%) in patients receiving docetaxel plus gemcitabine as first-line chemotherapy, including 4 complete responses (10.5%) and 19 partial remissions (50%); 9 patients (24%) had disease stabilization, and only 5 (13%) progressed. Second-line treatment with this regimen resulted in 6 of 14 (43%) objective responses, 5 had stable disease, and 3 progressive disease. The median time to progression was 8.5 months in the first-line setting and 6.6 months in the second-line setting, respectively. After a median follow-up time of 15 months, 36 patients (69%) are still alive with metastatic disease. Myelosuppression was commonly observed; WHO grade 3 or 4 neutropenia, however, occurred in only 15 (29%) patients and was complicated by septicemia in 2 cases; grade 3 anemia was seen in 1 patient (2%). Severe (grade 3) nonhematological toxicity except for alopecia was rarely observed and included nausea/vomiting in 3 (6%), stomatitis in 2 (4%), anaphylaxis in 2, and peripheral neuropathy, skin toxicity, and increase of liver enzymes each in one patient.

Conclusion: Our data suggest that docetaxel and gemcitabine with and without G-CSF is an effective and fairly well-tolerated regimen for the treatment of advanced breast cancer. It might be particularly useful in patients exposed previously to adjuvant or palliative anthracyclines and/or alkylating agents.

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