title: Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer.
abstract: BACKGROUND
  Neoadjuvant treatment based on the combination of trastuzumab plus chemotherapy is the standard of care in patients with HER2-positive early or locally advanced breast cancer. The concurrent use of trastuzumab, anthracyclines and taxanes is frequently used in this setting despite the potential cardiotoxicity of both anthracyclines and trastuzumab. However, not much information is available about this chemotherapy scheme.
  
  
  OBJECTIVE
  We wanted to evaluate the efficacy and safety profile of the combination of trastuzumab, liposome-encapsulated doxorubicin and paclitaxel as neoadjuvant scheme. We also tried to establish predictive factors of pathologic complete response.
  
  
  METHODS
  The study was carried out in a tertiary University Hospital of Spain.
  
  
  METHODS
  This is a descriptive study of the clinical practice performed in our hospital.
  
  
  METHODS
  Efficacy was measured in terms of pathologic complete response, which was defined as the absence of invasive cancer cells in the breast and the axilla after neoadjuvant treatment.
  
  
  RESULTS
  Thirty patients were included, the median age was 48. Seventeen (56.7 %) were hormonal receptor (HR) positive, 14 (46.6 %) had IIIa-b clinical stage and one of them had inflammatory breast cancer. 12 patients (40 %) achieved pCR. Patients with HR-negative BC achieved a higher pCR rate than those ones with HR-positive BC (61.5 % and 23.5 %, respectively; p value = 0.035). 21 patients (70 %) underwent breast conservative surgery. The treatment was in general well tolerated, most frequent grade 3-4 adverse events were neutropenia (20 %), asthenia and liver enzyme alteration (10 %) and febrile neutropenia (6.7 %). No patient developed heart failure, but one (3.3 %) presented a 10 % asymptomatic absolute reduction in left ventricular fraction ejection.
  
  
  CONCLUSIONS
  The studied treatment for the neoadjuvant setting of HER2 positive breast cancer seems to be an effective therapeutic option. Despite the expected high rate of cardiotoxicity of this regimen, the study results shows that this treatment regimen appears to be safe. The combination of trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel should be considered for the treatment of HER2-overexpressing breast cancer.
authors.affiliation: Pharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain. muriarte215@gmail.com.
authors.forename: Moisés
authors.initials: M
authors.lastname: Uriarte-Pinto
authors.affiliation: Pharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
authors.forename: Ángel
authors.initials: Á
authors.lastname: Escolano-Pueyo
authors.affiliation: Pharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Gimeno-Ballester
authors.affiliation: Pharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
authors.forename: Oihana
authors.initials: O
authors.lastname: Pascual-Martínez
authors.affiliation: Pharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
authors.forename: María Reyes
authors.initials: MR
authors.lastname: Abad-Sazatornil
authors.affiliation: Pharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Agustín-Ferrández
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy / Q000235:genetics*; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008081:Liposomes; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*; D000068878:Trastuzumab / Q000008:administration & dosage*
chemical_list: D004317:Doxorubicin; D008081:Liposomes; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: Cardiotoxicity; Docetaxel; HER2-breast cancer; Liposomal doxorubicin; Trastuzumab