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Annals of Oncology Advance Access originally published online on January 30, 2006
Annals of Oncology 2006 17(4):588-596; doi:10.1093/annonc/mdl001
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© 2006 European Society for Medical Oncology

Efficacy of high-dose alkylating chemotherapy in HER2/neu-negative breast cancer

S. Rodenhuis1,*, M. Bontenbal4, Q. G. C. M. van Hoesel5, W. M. Smit6, M. A. Nooij7, E. E. Voest8, E. van der Wall9, P. Hupperets10, H. van Tinteren3, J. L. Peterse2, M. J. van de Vijver2, E. G. E. de Vries11 for the Netherlands Working Party on Autologous Transplantation in Solid Tumours

1 Department of Medical Oncology, 2 Department of Pathology, 3 Biometrics Department, The Netherlands Cancer Institute, Amsterdam; 4 Department of Medical Oncology, The Erasmus Medical Center/Daniel den Hoed Cancer Center, Rotterdam; 5 Department of Medical Oncology, University Medical Center St. Radboud, Nijmegen; 6 Department of Medical Oncology, Medical Hospital Twente, Enschede; 7 Department of Medical Oncology, University Medical Center Leiden, Leiden; 8 Department of Medical Oncology, University Medical Center Utrecht, Utrecht; 9 Department of Medical Oncology, Free University Hospital Amsterdam, Amsterdam (present address: University Medical Center Utrecht); 10 Department of Medical Oncology, University Hospital Maastricht, Maastricht; 11 Department of Medical Oncology, University Medical Center Groningen, Groningen, The Netherlands

* Correspondence to: Prof. S. Rodenhuis, Department of Medical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands. Tel: +31-20-512 2870; Fax +31-20-512 2858; E-mail: sroden{at}nki.nl

Background: High-dose chemotherapy in the adjuvant treatment of breast cancer has been abandoned by many.

Patients and methods: 885 patients with stage III primary breast cancer and four or more axillary lymph node metastases were randomised to receive either five courses of FEC (fluorouracil, epirubicin and cyclophosphamide) followed by radiation therapy and tamoxifen, or the same treatment but with high-dose alkylating chemotherapy (cyclophosphamide, thiotepa and carboplatin) replacing the fifth course of FEC. Of these patients, 621 had HER2/neu-negative disease, as determined by immunohistochemistry and chromogenic in situ hybridisation.

Results: At a median follow-up of 84 months, a trend for a better relapse-free survival was observed in the high-dose arm: (hazard ratio (HR) 0.84, P = 0.076, two-sided). The 621 patients with HER2/neu-negative disease benefited from high-dose therapy, while patients with HER2/neu-positive disease did not (test for interaction, P = 0.006). There was a marked relapse-free survival benefit for patients with HER2/neu-negative disease (71.5% versus 59.1%, 5 years after randomisation; HR 0.68, P = 0.002) and also a survival benefit (78.2% versus 71.0% at 5 years; HR 0.72, P = 0.02).

Conclusions: The findings from this subgroup analysis provide additional evidence that HER2/neu-positive breast cancer is relatively resistant to alkylating agents. For HER2/neu-negative tumours, however, high-dose chemotherapy should remain the subject of clinical studies.

Key words: breast cancer, alkylating agents, high-dose chemotherapy, peripheral blood progenitor cell transplant, adjuvant chemotherapy


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