title: Neoadjuvant trastuzumab and docetaxel in breast cancer: preliminary results.
abstract: Trastuzumab/chemotherapy combinations have already shown superior results in metastatic breast cancer patients. The purpose of this study is to determine the clinical efficacy of neoadjuvant trastuzumab and docetaxel in women with locally advanced breast cancer, with or without metastatic disease. Treatment-naive women with HER2-overexpressing locally advanced breast cancer, with or without metastatic disease, were included. Patients received trastuzumab 4 mg/kg loading dose intravenously then 2 mg/kg weekly. On day 22, docetaxel 100 mg/m2 every 3 weeks for 4 cycles was added to weekly trastuzumab. Patients then underwent surgery and subsequent 4 cycles of AC (doxorubicin/cyclophosphamide; 60/600 mg/m2) without trastuzumab. Weekly trastuzumab was resumed 1 month after completion of AC and continued for a year. Preliminary results from the first 22 patients with median follow-up of 15.5 months (range, 2-38 months) are reported. Of these, 9 patients (40.9%) had inflammatory breast cancer, and 6 patients (27.3%) had stage IV breast cancer. Seventeen of 22 patients (77.3%) had objective clinical response, with a clinical complete response in 9 patients (40.9%). Two patients (9.1%) had decline in cardiac function and 7 patients (31.8%) experienced neutropenia, with 2 deaths (9.1%) from neutropenic sepsis. Eight patients (36.4%) have relapsed, 3 with local skin recurrence (13.6%) and 5 with distant recurrence, of whom 1 had liver metastasis (4.5%) and 4 had brain metastasis (18.2%). Combined neoadjuvant trastuzumab and docetaxel induced high clinical response rates for HER2-overexpressing breast cancer, in particular for inflammatory breast cancer. A high rate of brain metastasis was noted, particularly in patients with baseline metastatic disease.
authors.affiliation: Department of Surgery, Methodist Hospital, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA.
authors.forename: Andrea E
authors.initials: AE
authors.lastname: Van Pelt
authors.forename: Syed
authors.initials: S
authors.lastname: Mohsin
authors.forename: Richard M
authors.initials: RM
authors.lastname: Elledge
authors.forename: Susan G
authors.initials: SG
authors.lastname: Hilsenbeck
authors.forename: M Carolina
authors.initials: MC
authors.lastname: Gutierrez
authors.forename: Anthony
authors.initials: A
authors.lastname: Lucci
authors.forename: Mamta
authors.initials: M
authors.lastname: Kalidas
authors.forename: Thomas
authors.initials: T
authors.lastname: Granchi
authors.forename: Bradford G
authors.initials: BG
authors.lastname: Scott
authors.forename: D Craig
authors.initials: DC
authors.lastname: Allred
authors.forename: Jenny C
authors.initials: JC
authors.lastname: Chang
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology / Q000628:therapy; D000077143:Docetaxel; D005260:Female; D018734:Genes, erbB-2 / Q000235:genetics; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage*; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D000068878:Trastuzumab