Breast Cancer Research and Treatment

, Volume 55, Issue 3, pp 203–211

Treatment of advanced breast cancer with gemcitabine and vinorelbine plus human granulocyte colony‐stimulating factor

Authors

  • Karin Haider
    • Department of SurgeryWr. Neustadt General Hospital
  • Gabriela V. Kornek
    • Division of Oncology, Department of Internal Medicine 1, ViennaUniversity Medical School
  • Werner Kwasny
    • Department of SurgeryWr. Neustadt General Hospital
  • Georg Weinländer
    • Division of Oncology, Department of Internal Medicine 1, ViennaUniversity Medical School
  • Julia Valencak
    • Division of Oncology, Department of Internal Medicine 1, ViennaUniversity Medical School
  • Friedrich Lang
    • Department of SurgeryNeunkirchen General Hospital
  • F. Püribauer
    • Department of SurgeryNeunkirchen General Hospital
  • Erwin Kovats
    • Department of SurgeryBaden General Hospital
  • Dieter Depisch
    • Department of SurgeryWr. Neustadt General Hospital
  • Werner Scheithauer
    • Division of Oncology, Department of Internal Medicine 1, ViennaUniversity Medical School
Article

DOI: 10.1023/A:1006136112585

Cite this article as:
Haider, K., Kornek, G.V., Kwasny, W. et al. Breast Cancer Res Treat (1999) 55: 203. doi:10.1023/A:1006136112585

Abstract

Purpose. A phase II trial was performed to investigate the efficacy and tolerance of gemcitabine, vinorelbine, and recombinant human granulocyte colony‐stimulating factor (G‐CSF) in advanced breast cancer.

Patients and methods. Between April 96 and August 97, 60 patients entered this trial. Forty‐five patients were previously untreated and 15 patients had failed previous palliative chemotherapy with (n = 10) or without anthracyclines (n = 5). Therapy consisted of gemcitabine 1000 mg/m2 on days 1 + 15 + 21 and vinorelbine 40 mg/m2 on days 1 + 21, both diluted in 250 ml saline and infused over 30 min. G‐CSF was administered at 5 μg/kg/day subcutaneously from days 2–6 and 22–26. Courses were repeated every 5 weeks. Treatment was continued in case of response or stable disease until a total of six courses.

Results. The overall response rate was 55.5% for patients who had not received prior palliative chemotherapy (95% confidence interval, 40%–70.3%), including 5 CR (11.1%) and 20 PR (44.4%) 12 patients (27%) had stable disease (SD), and 8 (18%) progressed. Second‐line treatment with this regimen resulted in 6/15 (40%) objective remissions, 5 had SD, and 4 PD. The median time to progression was 9.5 months (range, 1.5–28) in previously untreated patients, and 7.0 months (range, 2–23) in those who had failed prior chemotherapy. After a median follow‐up time of 15 months, 44 patients (73%) are still alive with metastatic disease. Myelosuppression was commonly observed, though WHO 3 and 4 neutropenia occured in only 9 (l5%) and 2 patients (3%), and was never complicated by septicaemia; grade 3 anemia was noted in 2 patients. Severe (WHO grade 3) nonhematologic toxicity was rarely observed, and included nausea/emesis in 3 and constipation in 2 patients.

Conclusions. Our data suggest that gemcitabine and vinorelbine plus G‐CSF is an effective and tolerable first‐ as well as second‐line combination regimen for treatment of advanced breast cancer.

advanced breast cancerchemotherapygemcitabinevinorelbine
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Copyright information

© Kluwer Academic Publishers 1999