title: Preoperative therapy with epidoxorubicin and docetaxel plus trastuzumab in patients with primary breast cancer: a pilot study.
abstract: OBJECTIVE
  Combining anthracyclines and taxanes are to date the most active cytotoxic treatment option in the neoadjuvant and palliative therapy of breast cancer patients. Adding trastuzumab to these cytotoxic agents can improve outcome for women with human epidermal growth factor receptor 2 (HER2)-overexpressing advanced breast cancer. We conducted a pilot study of preoperative epidoxorubicin and docetaxel plus trastuzumab in outpatient patients suffering from breast cancer.
  
  
  METHODS
  Fourteen consecutive patients were enrolled in this prospective clinical pilot trial. Preoperative treatment consisted of weekly trastuzumab (4 mg/kg body-weight loading dose, 2 mg/kg/week maintenance dose), in combination with weekly epidoxorubicin (30 mg/m2 body surface area [BSA]) and docetaxel (35 mg/m2 BSA) once a week for 6 weeks followed by 1 week off therapy.
  
  
  RESULTS
  Patients received a total of 30 cycles (median: 2 cycles, range: 2-3 cycles) of this therapeutic regimen. Outpatient epidoxorubicin and docetaxel plus trastuzumab were well tolerated. A major response to this preoperative therapy regimen could be demonstrated in 12 of 14 patients (86%) leading to breast-conserving surgery in 11 of 14 patients (79%).
  
  
  CONCLUSIONS
  We conclude that outpatient epidoxorubicin and docetaxel plus trastuzumab are safe in the neoadjuvant treatment of patients suffering from breast cancer, based on a favorable side-effect and activity profile. Thus, this regimen can be considered for further clinical trials.
authors.affiliation: Department of Internal Medicine I, Division of Oncology, University Hospital of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.
authors.forename: Catharina
authors.initials: C
authors.lastname: Wenzel
authors.forename: Dagmar
authors.initials: D
authors.lastname: Hussian
authors.forename: Rupert
authors.initials: R
authors.lastname: Bartsch
authors.forename: Ursula
authors.initials: U
authors.lastname: Pluschnig
authors.forename: Gottfried J
authors.initials: GJ
authors.lastname: Locker
authors.forename: Margarethe
authors.initials: M
authors.lastname: Rudas
authors.forename: Michael F
authors.initials: MF
authors.lastname: Gnant
authors.forename: Raimund
authors.initials: R
authors.lastname: Jakesz
authors.forename: Christoph C
authors.initials: CC
authors.lastname: Zielinkski
authors.forename: Guenther G
authors.initials: GG
authors.lastname: Steger
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D017567:Karnofsky Performance Status; D015412:Mastectomy, Segmental; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D010865:Pilot Projects; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077143:Docetaxel; D004317:Doxorubicin; D015251:Epirubicin; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab