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)
Authors: Chua, S., Hickish, T.F. et al.
Journal: Annals of Oncology
Volume: 16
Issue: 9
Pages: 1435-1441
ISSN: 0923-7534
DOI: 10.1093/annonc/mdi276
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. © 2005 European Society for Medical Oncology.
Source: Scopus