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*, Frans 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, Olaf J. L. Loosveld, A. E. M. Smals, G.H. Blijham, V. C. G. Tjan-Heijnen, H. C. Schouten

*Corresponding author for this work

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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/m(2) combined with paclitaxel 200 mg/m(2) every 21 days and epirubicin 75 mg/m(2) combined with paclitaxel 175 mg/m(2) 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 a parts per thousand yen3 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/m(2), treatment durations were 126 and 61 days, and delivered dose intensities were 36/67 and 51/120 mg/m(2)/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.
Original languageEnglish
Pages (from-to)437-445
JournalBreast Cancer Research and Treatment
Issue number2
Publication statusPublished - Jul 2011


  • Combination chemotherapy
  • Breast neoplasm's
  • Dose-dense
  • Dose-intensive
  • Epirubicin
  • Paclitaxel

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