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Annals of Oncology Advance Access originally published online on June 9, 2005
Annals of Oncology 2005 16(9):1435-1441; doi:10.1093/annonc/mdi276
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© 2005 European Society for Medical Oncology

Neoadjuvant vinorelbine/epirubicin (VE) versus standard adriamycin/cyclophosphamide (AC) in operable breast cancer: analysis of response and tolerability in a randomised phase III trial (TOPIC 2)

S. Chua1, I. E. Smith1,*, R. P. A'Hern1, G. A. Coombes2, T. F. Hickish3, A. C. Robinson4, R. W. Laing5, M. E. R. O'Brien6, S. R. Ebbs7, A. Hong8, A. Wardley9, T. Mughal10, M. Verrill11, D. Dubois12, J. M. Bliss2 and other members of the TOPIC Trial Group

1 Royal Marsden Hospital, London and Sutton 2 Institute of Cancer Research 3 Royal Bournemouth and Poole Hospitals 4 Southend Hospital 5 St Luke's Cancer Centre, Guildford, Surrey 6 Kent Oncology Centre 7 Mayday University Hospital, Croydon 8 Royal Devon and Exeter Hospital 9 Christie Hospital, Manchester 10 Royal Lancaster Infirmary 11 Northern Centre for Cancer Treatment 12 Portsmouth Oncology Centre, Portsmouth, UK

* Correspondence to: Dr I. E. Smith, The Royal Marsden Hospital, Fulham Road, London SW3 6JJ, UK. Tel: +44-207-808-2751; Fax: +44-207-352-5441; Email: ian.smith{at}rmh.nthames.nhs.uk

Background: Vinorelbine is active and well tolerated against advanced breast cancer but there are no published efficacy studies in early breast cancer. We have therefore carried out a randomised phase III neoadjuvant trial in operable breast cancer.

Patients and methods: Patients with ≥3 cm operable breast carcinoma were randomised to receive either vinorelbine 25 mg/m2 on days 1 and 8 and epirubicin 60 mg/m2 on day 1, 3 weekly for six cycles (VE) or doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 i.v. on day 1, 3 weekly for six cycles (AC), prior to standard local therapy, and adjuvant endocrine therapy as appropriate.

Results: A total of 451 patients were randomised. Results for AC and VE, respectively, were: overall clinical response 73% and 74%, complete clinical remission 20% and 24%, pathological complete remission 12% and 12%, mastectomy rate 52% and 55%. None of these differences were significant. Dose reduction was required in 8% for AC and 20% for VE (P <0.001) (GSCF support not used). Significantly more grade 3/4 toxicity for nausea, vomiting and alopecia (despite scalp cooling) was seen for AC compared with VE but significantly less grade 3/4 thrombophlebitis and neuropathy.

Conclusions: Neoadjuvant VE is as effective as AC in early breast cancer and was better tolerated except for thrombophlebitis and neuropathy.

Key words: breast cancer, chemotherapy, epirubicin, neoadjuvant, phase III, vinorelbine


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