Breast Cancer Research and Treatment

, Volume 128, Issue 2, pp 437–445

Epirubicin and paclitaxel with G-CSF support in first line metastatic breast cancer: a randomized phase II study of dose-dense and dose-escalated chemotherapy

  • R. I. Lalisang
  • F. L. G. Erdkamp
  • C. J. Rodenburg
  • C. T. A. M. Knibbeler-van Rossum
  • J. W. R. Nortier
  • A. van Bochove
  • P. H. Th. J. Slee
  • E. E. Voest
  • J. A. Wils
  • J. Wals
  • O. J. L. Loosveld
  • A. E. M. Smals
  • G. H. Blijham
  • V. C. G. Tjan-Heijnen
  • H. C. Schouten
Clinical trial

DOI: 10.1007/s10549-011-1558-3

Cite this article as:
Lalisang, R.I., Erdkamp, F.L.G., Rodenburg, C.J. et al. Breast Cancer Res Treat (2011) 128: 437. doi:10.1007/s10549-011-1558-3

Abstract

An increased dose-intensity can be achieved by either higher dose of chemotherapy per cycle (dose-escalation) or by shortening the interval between cycles (dose-dense). This multicenter randomized phase II study assessed the efficacy and safety of two different approaches: epirubicin 110 mg/m2 combined with paclitaxel 200 mg/m2 every 21 days and epirubicin 75 mg/m2 combined with paclitaxel 175 mg/m2 every 10 days, both supported with G-CSF. Patients with advanced breast cancer and without prior palliative chemotherapy were scheduled for 6 cycles. Evaluable for response were 101 patients and for toxicity 106 patients. Grade ≥3 toxicities occurred in 39% of patients in the dose-escalated arm and in 29% of the dose-dense arm, mainly febrile neutropenia, thrombocytopenia, neurotoxicity and (asymptomatic) cardiotoxicity. The median delivered cumulative doses for epirubicin/paclitaxel were 656/1194 and 448/1045 mg/m2, treatment durations were 126 and 61 days, and delivered dose intensities were 36/67 and 51/120 mg/m2/week for the dose-escalated and dose-dense arm, respectively. Response rates were 75 and 70%, the progression-free survival 6 and 7 months, respectively. Dose-dense chemotherapy with a lower cumulative dose, a halved treatment time, but a higher dose-intensity may be as effective and safe as dose-escalated chemotherapy. The value of dose-densification over standard scheduled chemotherapy regimes yet needs to be determined.

Keywords

Combination chemotherapy Breast neoplasm’s Dose-dense Dose-intensive Epirubicin Paclitaxel 

Supplementary material

10549_2011_1558_MOESM1_ESM.doc (37 kb)
Supplementary material 1 (DOC 37 kb)

Copyright information

© Springer Science+Business Media, LLC. 2011

Authors and Affiliations

  • R. I. Lalisang
    • 1
  • F. L. G. Erdkamp
    • 2
  • C. J. Rodenburg
    • 3
  • C. T. A. M. Knibbeler-van Rossum
    • 4
    • 14
  • J. W. R. Nortier
    • 5
    • 15
  • A. van Bochove
    • 6
  • P. H. Th. J. Slee
    • 7
  • E. E. Voest
    • 8
  • J. A. Wils
    • 9
  • J. Wals
    • 10
  • O. J. L. Loosveld
    • 11
  • A. E. M. Smals
    • 12
  • G. H. Blijham
    • 8
  • V. C. G. Tjan-Heijnen
    • 1
  • H. C. Schouten
    • 13
  1. 1.Division of Medical Oncology, Department of Internal Medicine, GROW-School of Oncology and Developmental BiologyMaastricht Universitair Medisch CentrumMaastrichtThe Netherlands
  2. 2.Orbis Medisch CentrumSittardThe Netherlands
  3. 3.Meander Medisch CentrumAmersfoortThe Netherlands
  4. 4.St. Elisabeth ZiekenhuisTilburgThe Netherlands
  5. 5.DiaconessenhuisUtrechtThe Netherlands
  6. 6.Zaans Medisch CentrumZaandamThe Netherlands
  7. 7.St. Antonius ZiekenhuisNieuwegeinThe Netherlands
  8. 8.Universitair Medisch Centrum UtrechtUtrechtThe Netherlands
  9. 9.Laurentius ZiekenhuisRoermondThe Netherlands
  10. 10.Atrium Medisch CentrumHeerlenThe Netherlands
  11. 11.Amphia ZiekenhuisBredaThe Netherlands
  12. 12.St. Anna ZiekenhuisGeldropThe Netherlands
  13. 13.Division of Hematology, Department of Internal Medicine, GROW-School of Oncology and Developmental BiologyMaastricht Universitair Medisch CentrumMaastrichtThe Netherlands
  14. 14.Jeroen Bosch ZiekenhuisDen BoschThe Netherlands
  15. 15.Leids Universitair Medisch CentrumLeidenThe Netherlands