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    Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study.

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    Authors
    Kaufman, Bella
    Mackey, John R
    Clemens, Michael R
    Bapsy, Poonamalle P
    Vaid, Ashok
    Wardley, Andrew M
    Tjulandin, Sergei
    Jahn, Michaela
    Lehle, Michaela
    Feyereislova, Andrea
    Révil, Cédric
    Jones, Alison
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    Affiliation
    Chaim Sheba Medical Center, Tel Hashomer, Israel. bella.kaufman@sheba.health.gov.il
    Issue Date
    2009-11-20
    
    Metadata
    Show full item record
    Abstract
    PURPOSE: TAnDEM is the first randomized phase III study to combine a hormonal agent and trastuzumab without chemotherapy as treatment for human epidermal growth factor receptor 2 (HER2)/hormone receptor-copositive metastatic breast cancer (MBC). PATIENTS AND METHODS: Postmenopausal women with HER2/hormone receptor-copositive MBC were randomly assigned to anastrozole (1 mg/d orally) with or without trastuzumab (4 mg/kg intravenous infusion on day 1, then 2 mg/kg every week) until progression. The primary end point was progression-free survival (PFS) in the intent-to-treat population. Results Overall, 103 patients received trastuzumab plus anastrozole; 104 received anastrozole alone. Patients in the trastuzumab plus anastrozole arm experienced significant improvements in PFS compared with patients receiving anastrozole alone (hazard ratio = 0.63; 95% CI, 0.47 to 0.84; median PFS, 4.8 v 2.4 months; log-rank P = .0016). In patients with centrally confirmed hormone receptor positivity (n = 150), median PFS was 5.6 and 3.8 months in the trastuzumab plus anastrozole and anastrozole alone arms, respectively (log-rank P = .006). Overall survival in the overall and centrally confirmed hormone receptor-positive populations showed no statistically significant treatment difference; however, 70% of patients in the anastrozole alone arm crossed over to receive trastuzumab after progression on anastrozole alone. Incidence of grade 3 and 4 adverse events was 23% and 5%, respectively, in the trastuzumab plus anastrozole arm, and 15% and 1%, respectively, in the anastrozole alone arm; one patient in the combination arm experienced New York Heart Association class II congestive heart failure. CONCLUSION: Trastuzumab plus anastrozole improves outcomes for patients with HER2/hormone receptor-copositive MBC compared with anastrozole alone, although adverse events and serious adverse events were more frequent with the combination.
    Citation
    Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. 2009, 27 (33):5529-37 J. Clin. Oncol.
    Journal
    Journal of Clinical Oncology
    URI
    http://hdl.handle.net/10541/109237
    DOI
    10.1200/JCO.2008.20.6847
    PubMed ID
    19786670
    Type
    Article
    Language
    en
    ISSN
    1527-7755
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.2008.20.6847
    Scopus Count
    Collections
    All Christie Publications
    Medical Oncology

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