title: Dose-dense primary chemotherapy, as part of multidisciplinary treatment, for inoperable stage III B breast cancer--long-term results of a phase II trial.
abstract: BACKGROUND
  Primary chemotherapy as part of multidisciplinary approach is the established treatment for inoperable stage III B breast cancer. The primary endpoints were conversion to operable disease and feasibility of conservative surgery (breast-conserving therapy: BCT); secondary were clinical and pathological complete response rate, local and distant control and safety of the primary regimen.
  
  
  METHODS
  Between 1998 and 2001, 40 inoperable breast cancer patients < or =60 years, 72% T4abc and 28% T4d, received 6 cycles of primary PEV dose-dense regimen: cisplatin 50 mg/m2, epirubicin 100 mg/m2 and vinorelbine 25 mg/m2, i.v. (q 14). Modified radical mastectomy (MRM) or BCT was performed, followed by adjuvant chemotherapy, radiotherapy and hormone therapy.
  
  
  RESULTS
  All patients were converted to operable disease, and BCT was feasible in 24% of T4abc patients. After a median follow-up of 84 months (range 58-96), local and distant relapses were 7.5% (0% in BCT ) and 25% (25% in BCT), respectively. Clinical response was 80% (clinical complete response [cCR]: 20%); pathological complete response (pCR) was 40% in breast, 50% in axilla (pLN0); 32% both in breast and axilla. Neutropenia (G4, 30%), leukopenia (G4, 25%), alopecia (G2, 100%), nausea and vomiting (G4, 20%) were the most common toxicities.
  
  
  CONCLUSIONS
  The PEV dose-dense regimen seems to be highly effective in terms of resectability and pCR. Toxicity, mainly hematological, was acceptable. Successful BCT is feasible, in selected patients, without compromising local and distant control.
authors.affiliation: Department of Medical Oncology, Policlinico Universitario, Cagliari, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Massidda
authors.forename: Francesco
authors.initials: F
authors.lastname: Atzori
authors.forename: Antioco
authors.initials: A
authors.lastname: Scanu
authors.forename: Antonio
authors.initials: A
authors.lastname: Contu
authors.forename: Antonio
authors.initials: A
authors.lastname: Farris
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Catino
authors.forename: Sergio
authors.initials: S
authors.lastname: Palmeri
authors.forename: Luigi
authors.initials: L
authors.lastname: Minerba
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Ionta
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D015251:Epirubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008408:Mastectomy; D015412:Mastectomy, Segmental; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D005047:Etoposide; D002945:Cisplatin