title: Neoadjuvant dose-dense gemcitabine plus docetaxel and vinorelbine plus epirubicin for operable breast cancer: improved prognosis in triple-negative tumors.
abstract: BACKGROUND
  Neoadjuvant anti-tumor activity of an alternating taxane- and anthracycline-based dose-dense regimen in patients with operable, non-inflammatory large breast cancer was investigated.
  
  
  OBJECTIVE
  The objective is to study the rate of pathological complete response in patients with breast cancer receiving dose-dense chemotherapy sequentially with gemcitabine plus docetaxel and vinorelbine plus epirubicin.
  
  
  METHODS
  Women (n = 74) with clinical stage II or III breast cancer were enrolled in this open-label, multicenter study to receive six 2-weekly courses of gemcitabine 1000 mg/m2 plus docetaxel 75 mg/m2 on days 1 and 15, and vinorelbine 25 mg/m2 plus epirubicin 100 mg/m2 on days 29 and 43. Patients with an objective response on day 56 then received another cycle of gemcitabine/docetaxel on day 57 and of vinorelbine/epirubicin on day 71. Conservative surgery was scheduled for all patients.
  
  
  RESULTS
  Of the patients enrolled, 30% had triple-negative breast cancer (TNBC). The pathologic complete response (pCR) rate was 22% overall, but was higher in TNBC than patients without TNBC (40.9% vs 14.0%; p = 0.028). Among patients with a pCR, patients with TNBC had similar recurrence-free survival (RFS) and overall survival (OS) to patients without TNBC. Among those without a pCR, RFS rates for patients with TNBC were significantly lower than for patients without TNBC (p = 0.04). The most common severe hematologic toxicity was neutropenia.
  
  
  CONCLUSIONS
  Administering four drugs in a dose-dense alternating sequence gave a high pCR in patients with operable, invasive breast cancer. Patients with TNBC with a pCR had similar OS to patients without TNBC, whereas patients with TNBC without a pCR had poorer survival rate than their non-TNBC counterparts.
authors.affiliation: Department of Medical Oncology, Georges Pompidou European Hospital, Paris, France. jacques.medioni@egp.aphp.fr
authors.forename: Jacques
authors.initials: J
authors.lastname: Medioni
authors.forename: Cyrille
authors.initials: C
authors.lastname: Huchon
authors.forename: Marie-Aude
authors.initials: MA
authors.lastname: Le Frere-Belda
authors.forename: Henri
authors.initials: H
authors.lastname: Hofmann
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Bats
authors.forename: Denise
authors.initials: D
authors.lastname: Eme
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Andrieu
authors.forename: Stéphane
authors.initials: S
authors.lastname: Oudard
authors.forename: Fabrice
authors.initials: F
authors.lastname: Lecuru
authors.forename: Eric
authors.initials: E
authors.lastname: Levy
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis / Q000175:diagnosis; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis / Q000175:diagnosis; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D011960:Receptors, Estrogen / Q000235:genetics; D011980:Receptors, Progesterone / Q000235:genetics; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D043823:Taxoids; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine; C508053:ERBB2 protein, human