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, Ian E. Smith*, R. P. A'Hern, G. A. Coombes, T. F. Hickish, A. C. Robinson, R. W. Laing, M. E.R. O'Brien, S. R. Ebbs, A. Hong, A. Wardley, T. Mughal, M. Verrill, D. Dubois, J. M. Bliss, W. Allum, G. Gui, S. Dean, C. Trask, M. KissinF. McKinna, A. Goodman, T. Howell, T. Guilliford, A. Golding, M. McIllmurray, J. Barrett, C. Charlton, C. Price, T. Iveson, S. O'Reilley, T. Perren, N. Mithal, P. Ellis, R. Allerton, D. Bloomfield, R. Agrawal, P. Murray, W. Pratt, N. Davidson, J. Mansi, D. Rea

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

32 Citations (Scopus)

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: Pati ents 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 f or 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.

Original languageEnglish
Pages (from-to)1435-1441
Number of pages7
JournalAnnals of Oncology
Volume16
Issue number9
DOIs
Publication statusPublished - 1 Sep 2005

Keywords

  • Breast cancer
  • Chemotherapy
  • Epirubicin
  • Neoadjuvant
  • Phase III
  • Vinorelbine

ASJC Scopus subject areas

  • Hematology
  • Oncology

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