title: Paclitaxel and carboplatin as neoadjuvant chemotherapy in patients with locally advanced breast cancer: A phase II Trial of the Hellenic Cooperative Oncology Group.
abstract: OBJECTIVE
  This phase II study sought to evaluate the efficacy of the paclitaxel-carboplatin combination as neoadjuvant chemotherapy in patients with locally advanced breast cancer (LABC).
  
  
  METHODS
  A total of 46 patients with LABC and inflammatory breast cancer (IBC) received 6 cycles of paclitaxel 175 mg/m2, followed by carboplatin, at an area under the curve of 6, before mastectomy. The primary endpoint constituted response to chemotherapy. We studied ERCC1 protein, microtubule-associated protein-tau, estrogen receptor, progesterone receptor, epidermal growth factor receptor (EGFR), HER2, and Ki-67 immunohistochemically in tissue microarray and whole-tissue sections. In addition, EGFR and HER2 gene status was assessed by fluorescence in situ hybridization. Predictive and prognostic molecular markers were retrospectively investigated.
  
  
  RESULTS
  A total of 42 female patients were considered eligible. Forty percent had IBC. Twenty-five patients (60%) experienced a clinical response, and 4 patients (9.5%) experienced a pathologic complete response. Chemotherapy was well tolerated. After a median follow-up of 45 months (range, 8.8-64.8 months), the estimated 3-year progression-free survival (PFS) was 54%, and the 3-year overall survival (OS) was 66%. The overexpression of EGFR protein was associated with a lower response rate (0 vs. 67%; P = .023), whereas high Ki-67 expression, high-grade tumors, tumor stage T4, and triple-negative tumors were associated with poorer PFS. Only high-grade tumors were associated with a significantly shorter OS (P = .004).
  
  
  CONCLUSIONS
  The combination of paclitaxel and carboplatin is an effective and well-tolerated regimen in female patients with LABC.
authors.affiliation: First Department of Medicine, Laiko General Hospital, Athens, Greece. hgogas@hol.gr <hgogas@hol.gr>
authors.forename: Helen
authors.initials: H
authors.lastname: Gogas
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Pectasides
authors.forename: Ioannis
authors.initials: I
authors.lastname: Kostopoulos
authors.forename: Evangelos
authors.initials: E
authors.lastname: Lianos
authors.forename: Dimosthenis
authors.initials: D
authors.lastname: Skarlos
authors.forename: George
authors.initials: G
authors.lastname: Papaxoinis
authors.forename: Mattheos
authors.initials: M
authors.lastname: Bobos
authors.forename: Haralabos P
authors.initials: HP
authors.lastname: Kalofonos
authors.forename: Kalliopi
authors.initials: K
authors.lastname: Petraki
authors.forename: Kitty
authors.initials: K
authors.lastname: Pavlakis
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Bafaloukos
authors.forename: George
authors.initials: G
authors.lastname: Fountzilas
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D016190:Carboplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D004268:DNA-Binding Proteins / Q000378:metabolism; D018572:Disease-Free Survival; D004720:Endonucleases / Q000378:metabolism; D066246:ErbB Receptors / Q000378:metabolism; D005260:Female; D006801:Humans; D019394:Ki-67 Antigen / Q000378:metabolism; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D016875:tau Proteins / Q000378:metabolism
chemical_list: D014408:Biomarkers, Tumor; D016190:Carboplatin; D004268:DNA-Binding Proteins; D004720:Endonucleases; D066246:ErbB Receptors; D019394:Ki-67 Antigen; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D016875:tau Proteins; C512478:EGFR protein, human; C508053:ERBB2 protein, human; C071447:ERCC1 protein, human