title: Preoperative weekly cisplatin-epirubicin-paclitaxel with G-CSF support in triple-negative large operable breast cancer.
abstract: BACKGROUND
  Findings from our previously published phase II study showed a high pathologic complete remission (pCR) rate in patients with triple-negative large operable breast cancer after the administration of eight cisplatin-epirubicin-paclitaxel (PET) weekly cycles. The safety and efficacy data of the initial population were updated, with inclusion of additional experience with the same therapy.
  
  
  METHODS
  Patients with triple-negative large operable breast cancer (T2-T3 N0-1; T > 3 cm) received eight preoperative weekly cycles of cisplatin 30 mg/m2, epirubicin 50 mg/m2, paclitaxel (Taxol) 120 mg/m2, with granulocyte colony-stimulating factor (5 microg/kg days 3-5) support.
  
  
  RESULTS
  Overall 74 consecutive patients (T2/T3 = 35/39; N0/N+ = 26/48) were treated, from May 1999 to May 2008. At pathological assessment, 46 women (62%; 95% confidence interval 50-73) showed pCR in both breast and axilla. At a 41-month median follow-up (range 3-119), 13 events (nine distant metastases) had occurred, 5-year projected disease-free survival (DFS) and distant disease-free survival being 76% and 84%, respectively. Five-year DFS was 90% and 56% in pCRs and non-pCRs, respectively. Severe neutropenia and anemia occurred in 23 (31%) and eight (10.8%) patients, respectively. Severe non-hematological toxicity was recorded in <20% of patients. Peripheral neuropathy was quite frequent but never severe.
  
  
  CONCLUSIONS
  Eight weekly PET cycles are a highly effective primary treatment in women with triple-negative large operable breast cancer. This approach results in a very promising long-term DFS in this poor prognosis population. This triplet regimen is worthy of evaluation in phase III trials.
authors.affiliation: Department of Senology, Unit of Preoperative Treatments, National Cancer Institute of Naples, Naples, Italy. giuseppe.frasci@libero.it
authors.forename: G
authors.initials: G
authors.lastname: Frasci
authors.forename: P
authors.initials: P
authors.lastname: Comella
authors.forename: M
authors.initials: M
authors.lastname: Rinaldo
authors.forename: G
authors.initials: G
authors.lastname: Iodice
authors.forename: M
authors.initials: M
authors.lastname: Di Bonito
authors.forename: M
authors.initials: M
authors.lastname: D'Aiuto
authors.forename: A
authors.initials: A
authors.lastname: Petrillo
authors.forename: S
authors.initials: S
authors.lastname: Lastoria
authors.forename: C
authors.initials: C
authors.lastname: Siani
authors.forename: G
authors.initials: G
authors.lastname: Comella
authors.forename: G
authors.initials: G
authors.lastname: D'Aiuto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage; D011300:Preoperative Care; D016896:Treatment Outcome
chemical_list: C543033:PET regimen; D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D017239:Paclitaxel; D002945:Cisplatin