Annals of Oncology Advance Access originally published online on April 7, 2005
Annals of Oncology 2005 16(5):726-734; doi:10.1093/annonc/mdi166
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© 2005 European Society for Medical Oncology
High dose chemotherapy and autologous stem cell transplantation as adjuvant therapy for primary breast cancer patients with four or more lymph nodes involved: long-term results of an international randomised trial
1 Cancer Research UK Department of Cancer Medicine, Imperial College London, Hammersmith Hospital, Du Cane Road, London; 2 Clinical Trials and Statistics Unit (ICR-CTSU), Institute of Cancer Research, Sutton, Surrey; 3 Cancer Research UK Department of Medical Oncology, Christie Hospital NHS Trust, Wilmslow Road, Manchester; 4 International Collaborative Cancer Group, Department of Medical Oncology, Division of Medicine, Imperial College London, Charing Cross Campus, Fulham Palace Road, London; 5 Department of Medical Oncology, St Bartholomew's Hospital, 1st Floor KGV Building, London UK; 6 University Hospital, Department of Oncology and Haematology, Division of Medical Oncology, Modena, Italy; 7 Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia Médica, Zaragoza, Spain; 8 Mount Vernon Hospital Cancer Centre, Rickmansworth Road, Northwood; 9 Department of Clinical Oncology, Guy's Hospital, London, UK
* Correspondence to: R. C. Coombes, CR UK, Department of Cancer Medicine, Imperial College London, Hammersmith Hospital, 6th Floor, MRC Cyclotron Building, Du Cane Road, London W12 0NN, UK. Tel: +44-20-8383-5828; Fax: +44-20-8383-5830; Email: c.coombes{at}imperial.ac.uk
Background:: The purpose of this study was to assess whether a short course of anthracycline containing chemotherapy followed by high dose therapy with autologous stem-cell support improves disease-free and overall survival as compared with conventional, anthracycline containing chemotherapy, in patients with primary breast cancer and four or more histologically involved lymph nodes.
Patients and methods:: Two hundred and eighty one patients entered into a randomised clinical trial were allocated to receive standard, conventional treatment (5-fluorouracil, epirubicin and cyclophosphamide–FEC for six cycles) or FEC for three cycles followed by high dose therapy consisting of cyclophosphamide, thiotepa and carboplatin and stem cell rescue (HDT). To be eligible, patients had to be free of overt metastatic disease and be 
60 years of age. Analyses were according to intention to treat.
Results:: At a median follow up of 68 months, 118 patients have experienced a relapse or death from breast cancer (62 in the FEC followed by HDT arm and 56 in the conventional FEC arm) and a total of 100 patients have died (54 in the FEC followed by HDT arm and 46 in the conventional FEC arm). No significant difference was observed in relapse-free survival [hazard ratio 1.06, 95% CI 0.74–1.52, p = 0.76] or overall survival [hazard ratio 1.18, 95% CI 0.80–1.75, p = 0.40]. Five patients died from treatment related causes, three as a consequence of HDT and two in the conventional FEC arm.
Conclusions:: At the present time, no benefit has been observed from replacing three cycles of conventional chemotherapy with the HDT regimen described here. Patients should continue to receive conventional chemotherapy as adjuvant therapy for breast cancer.
Key words: autologous stem cell transplantation, high dose chemotherapy, primary breast cancer
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