title: Efficacy and safety of neoadjuvant chemotherapy with concurrent liposomal-encapsulated doxorubicin, paclitaxel and trastuzumab for human epidermal growth factor receptor 2-positive breast cancer in clinical practice.
abstract: BACKGROUND
  Based on previous results obtained with non-pegylated liposomal-encapsulated doxorubicin (TLC-D99) together with paclitaxel and trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer (BC), a similar regimen was evaluated in the neoadjuvant setting in a prospectively selected series of consecutive patients with clinical stage II-III BC. Primary and secondary objectives included the rate of pathologic complete response (pCR), safety, and predictive factors of pCR.
  
  
  METHODS
  Patients received six cycles of TLC-D99 (50 mg/m(2) every 3 weeks), paclitaxel (80 mg/m(2) weekly) and trastuzumab (4 mg/kg initial dose and 2 mg/kg weekly). All patients underwent surgery after treatment. pCR was defined as the absence of invasive cancer cells in the breast and the axilla.
  
  
  RESULTS
  Sixty-two patients with a median age of 46.6 years were analyzed. Stage IIIA was diagnosed in 43.5% of patients and 14.5% had inflammatory BC. Conservative surgery was performed in 46.8% of the patients and pCR was achieved in 63% (95% CI 50.5-75.5). Patients with estrogen receptor (ER)-negative tumors presented a significantly higher pCR rate than patients with ER-positive tumors (74.4 vs 43.5%; P = 0.028). Forty-five patients (72.6%) completed study treatment and 80.6% received at least five treatment cycles. No patients developed congestive heart failure and 14.5% of patients showed a ≥ 10 % decrease in the left ventricular ejection fraction.
  
  
  CONCLUSIONS
  The triple combination therapy assessed is effective and safe, offering a high pCR rate in patients with HER2-positive BC.
authors.affiliation: Medical Oncology Service, Fundación Instituto Valenciano de Oncología, C/Gregorio Gea, 31, 46009, Valencia, Spain, jogagre@hotmail.com.
authors.forename: Joaquín
authors.initials: J
authors.lastname: Gavilá
authors.forename: Ángel
authors.initials: Á
authors.lastname: Guerrero
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Climent
authors.forename: Aranzazu
authors.initials: A
authors.lastname: Fernández
authors.forename: Francisco
authors.initials: F
authors.lastname: Gozalbo
authors.forename: María
authors.initials: M
authors.lastname: Carrascosa
authors.forename: Josefina
authors.initials: J
authors.lastname: Camps
authors.forename: Vicente
authors.initials: V
authors.lastname: Guillem
authors.forename: Amparo
authors.initials: A
authors.lastname: Ruiz
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000378:metabolism; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D012074:Remission Induction; D000068878:Trastuzumab / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004317:Doxorubicin; D017239:Paclitaxel; D011092:Polyethylene Glycols; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C506643:liposomal doxorubicin; C508053:ERBB2 protein, human