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Annals of Oncology Advance Access published online on June 9, 2005
Annals of Oncology, doi:10.1093/annonc/mdi276
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© 2005 European Society for Medical Oncology
Received March 10, 2005
Accepted April 29, 2005

Original article

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. Chua 1, I. E. Smith 1*, R. P. A'Hern 1, G. A. Coombes 2, T. F. Hickish 3, A. C. Robinson 4, R. W. Laing 5, M. E. R. O'Brien 6, S. R. Ebbs 7, A. Hong 8, A. Wardley 9, T. Mughal 10, M. Verrill 11, D. Dubois 12, J. M. Bliss 2, and and other members of the TOPIC Trial Group

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

* To whom correspondence should be addressed.
I. E. Smith, E-mail: ian.smith{at}rmh.nthames.nhs.uk


  Abstract

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.

Keywords: breast cancer; chemotherapy; epirubicin; neoadjuvant; phase III; vinorelbine.
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