title: Phase II clinical trial of liposomal-encapsulated doxorubicin citrate and docetaxel, associated with trastuzumab, as neoadjuvant treatment in stages II and IIIA HER2-overexpressing breast cancer patients. GEICAM 2003-03 study.
abstract: BACKGROUND
  we previously reported a phase I trial of liposome-encapsulated doxorubicin citrate (LD), docetaxel and trastuzumab as neoadjuvant in stages II and IIIA human epidermal growth factor receptor 2-overexpressing breast cancer patients. This study evaluates the efficacy of this regimen in a phase II trial.
  
  
  METHODS
  patients were treated with LD 50 mg/m(2) and docetaxel 60 mg/m(2) every 21days associated with standard trastuzumab dose and pegfilgrastim support.
  
  
  RESULTS
  fifty-nine patients were enrolled; median age: 48 years (range 24-71 years); premenopausal patients: 36 (61%); 19 patients (32%) presented stage IIIA disease and 40 patients (67%) stage II; histological grades 2-3 tumors: 50 patients (84%) and estrogen receptor-progesterone receptor negative: 28 patients (47%). In all, 27% achieved a pathological complete response in breast and axilla (grade 5-Miller and Payne classification); 15% of patients achieved grade 4. Clinical and radiological response rates were 86% and 81%, respectively. Forty-two patients (71%) underwent breast-conserving surgery. The main grades 3-4 toxic effects were non-febrile neutropenia (29%) and fatigue (8%). Grade 2 left ventricular ejection fraction decline was observed in nine patients. No congestive heart failure was observed.
  
  
  CONCLUSIONS
  LD plus docetaxel combination associated with trastuzumab as neoadjuvant is active in breast cancer and entails a favorable cardiotoxicity profile. This regimen is a new treatment option in these patients.
authors.affiliation: Oncology Department, Hospital Universitario Miguel Servet, Zaragoza. Electronic address: aantont@gmail.com.
authors.forename: A
authors.initials: A
authors.lastname: Antón
authors.affiliation: Oncology Department, Instituto Valenciano de Oncología, Valencia.
authors.forename: A
authors.initials: A
authors.lastname: Ruiz
authors.affiliation: Oncology Department, Onkologikoa, San Sebastián.
authors.forename: A
authors.initials: A
authors.lastname: Plazaola
authors.affiliation: Oncology Department, Complejo Hospitalario Universitario de A Coruña, A Coruña.
authors.forename: L
authors.initials: L
authors.lastname: Calvo
authors.affiliation: Oncology Department, Consorci Sanitari Parc Taulí, Sabadell.
authors.forename: M A
authors.initials: MA
authors.lastname: Seguí
authors.affiliation: Oncology Department, Hospital Universitario La Fe, Valencia.
authors.forename: A
authors.initials: A
authors.lastname: Santaballa
authors.affiliation: Oncology Department, Hospital Clínic i Provincial, Barcelona.
authors.forename: M
authors.initials: M
authors.lastname: Muñoz
authors.affiliation: Oncology Department, Complejo Hospitalario de Jaén, Jaén.
authors.forename: P
authors.initials: P
authors.lastname: Sánchez
authors.affiliation: Oncology Department, Althaia-Xarxa Assistencial de Manresa, Manresa.
authors.forename: A
authors.initials: A
authors.lastname: Miguel
authors.affiliation: Staff members of GEICAM, Madrid, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Carrasco
authors.affiliation: Oncology Department, Hospital Universitario Miguel Servet, Zaragoza.
authors.forename: J
authors.initials: J
authors.lastname: Lao
authors.affiliation: Oncology Department, Instituto Valenciano de Oncología, Valencia.
authors.forename: J
authors.initials: J
authors.lastname: Camps
authors.affiliation: Oncology Department, Onkologikoa, San Sebastián.
authors.forename: J
authors.initials: J
authors.lastname: Alfaro
authors.affiliation: Oncology Department, Complejo Hospitalario Universitario de A Coruña, A Coruña.
authors.forename: S
authors.initials: S
authors.lastname: Antolín
authors.affiliation: Staff members of GEICAM, Madrid, Spain.
authors.forename: M C
authors.initials: MC
authors.lastname: Cámara
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011092:Polyethylene Glycols; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000037:antagonists & inhibitors / Q000096:biosynthesis*; D011994:Recombinant Proteins; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000068878:Trastuzumab; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077143:Docetaxel; D004317:Doxorubicin; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor; D011092:Polyethylene Glycols; D018719:Erb-b2 Receptor Tyrosine Kinases; D011994:Recombinant Proteins; D043823:Taxoids; D000068878:Trastuzumab; C455861:pegfilgrastim