title: 5-year results of cisplatin-epirubicin-vinorelbine (PEV) combination as primary chemotherapy in T2-3, N0-2 breast cancer patients: a multicentre phase II study.
abstract: The aim this study was to assess the efficacy of cisplatin-epirubicin-vinorelbine, as primary chemotherapy, in reducing the tumour burden in T2-3 N0-2 breast carcinomas. Breast conservative surgery (BCS) rate, clinical and pathological complete response (pCR), toxicity and 5-year disease-free survival (DFS) and overall survival (OS) were evaluated.
  
  
  METHODS
  Eighty-eight women with tumours > or =2.5 cm were treated with cisplatin (P) 50 mg/m2, epirubicin (E) 100 mg/m2 and vinorelbine (V) 25 mg/m2, every 3 weeks.
  
  
  RESULTS
  Fifty-six out of the 88 patients (63.6%) underwent BCS, notably including 12/23 patients with initial tumours >5 cm. The overall clinical response was 72.8% (cCR=11.4%), pCR 20.5% and pTO+pNO 17%. No cardiac toxicity was observed. Grade 3/4 adverse events were leukopenia (9.4%), neutropenia (7.9%), nausea and vomiting (7.3%). After a median follow-up of 5 years, 24 patients (27.3%) had developed local or distant metastases. The mean DFS and OS were 51.7 (SE 2.38) and 57.02 (SE 1.98) months, respectively, and were significantly higher in pCR patients in comparison to the others (63.05 vs. 48.76, p<0.01 and 64.59 vs. 55.04, p<0.05, respectively).
  
  
  CONCLUSIONS
  The PEV regimen was highly effective in reducing the tumour burden, especially for large tumours. The rate of pCR was similar to that obtained by other, including taxane-based regimens, and was well-tolerated. The study demonstrated the feasibility of such a regimen even in small centres, and being of low cost this combination could be of value in the application of primary therapy.
authors: Medical Oncology, Treviglio Hospital, P.le Ospedale 1, 24047 Treviglio (BG), Italy. sandro.barni@ospedale.treviglio.bg.it
authors: S
authors: S
authors: Barni
authors: M
authors: M
authors: Visini
authors: E
authors: E
authors: Piazza
authors: M T
authors: MT
authors: Ionta
authors: A
authors: A
authors: Ardizzoia
authors: E
authors: E
authors: Arnoldi
authors: S
authors: S
authors: Fava
authors: G
authors: G
authors: Pinotti
authors: F
authors: F
authors: Torretta
authors: G
authors: G
authors: Corradini
authors: S
authors: S
authors: Villa
authors: A M
authors: AM
authors: Nosenzo
authors: B
authors: B
authors: Massidda
authors: M E
authors: ME
authors: Cazzaniga
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D015251:Epirubicin; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine