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    Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years

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    Author
    Goss, Paul E.
    Ingle, James N.
    Pritchard, Kathleen I.
    Robert, Nicholas J.
    Muss, Hyman
    Gralow, Julie
    Gelmon, Karen
    Whelan, Tim
    Strasser-Weippl, Kathrin
    Rubin, Sheldon
    Sturtz, Keren
    Wolff, Antonio C.
    Winer, Eric
    Hudis, Clifford
    Stopeck, Alison
    Beck, J. Thaddeus
    Kaur, Judith S.
    Whelan, Kate
    Tu, Dongsheng
    Parulekar, Wendy R.
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    Affiliation
    Univ Arizona
    Issue Date
    2016-07-21
    
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    Publisher
    MASSACHUSETTS MEDICAL SOC
    Citation
    Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years 2016, 375 (3):209 New England Journal of Medicine
    Journal
    New England Journal of Medicine
    Rights
    Copyright © 2016 Massachusetts Medical Society.
    Collection Information
    This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu.
    Abstract
    BACKGROUND Treatment with an aromatase inhibitor for 5 years as up-front monotherapy or after tamoxifen therapy is the treatment of choice for hormone-receptor-positive early breast cancer in postmenopausal women. Extending treatment with an aromatase inhibitor to 10 years may further reduce the risk of breast-cancer recurrence. METHODS We conducted a double-blind, placebo-controlled trial to assess the effect of the extended use of letrozole for an additional 5 years. Our primary end point was disease-free survival. RESULTS We enrolled 1918 women. After a median follow-up of 6.3 years, there were 165 events involving disease recurrence or the occurrence of contralateral breast cancer (67 with letrozole and 98 with placebo) and 200 deaths (100 in each group). The 5-year disease-free survival rate was 95% (95% confidence interval [CI], 93 to 96) with letrozole and 91% (95% CI; 89 to 93) with placebo (hazard ratio for disease recurrence or the occurrence of contralateral breast cancer, 0.66; P = 0.01 by a two-sided log-rank test stratified according to nodal status, prior adjuvant chemotherapy, the interval from the last dose of aromatase-inhibitor therapy, and the duration of treatment with tamoxifen). The rate of 5-year overall survival was 93% (95% CI, 92 to 95) with letrozole and 94% (95% CI, 92 to 95) with placebo (hazard ratio, 0.97; P = 0.83). The annual incidence rate of contralateral breast cancer in the letrozole group was 0.21% (95% CI, 0.10 to 0.32), and the rate in the placebo group was 0.49% (95% CI, 0.32 to 0.67) (hazard ratio, 0.42; P = 0.007). Bone-related toxic effects occurred more frequently among patients receiving letrozole than among those receiving placebo, including a higher incidence of bone pain, bone fractures, and new-onset osteoporosis. No significant differences between letrozole and placebo were observed in scores on most subscales measuring quality of life. CONCLUSIONS The extension of treatment with an adjuvant aromatase inhibitor to 10 years resulted in significantly higher rates of disease-free survival and a lower incidence of contralateral breast cancer than those with placebo, but the rate of overall survival was not higher with the aromatase inhibitor than with placebo. ( Funded by the Canadian Cancer Society and others;)
    Note
    July 21, 2016. 6 Month Embargo.
    ISSN
    0028-4793
    1533-4406
    PubMed ID
    27264120
    DOI
    10.1056/NEJMoa1604700
    Version
    Final published version
    Sponsors
    Canadian Cancer Society Research Institute [021039, 015469]; National Cancer Institute [CA180888, CA189953, CA180828, CA13612, CA37981, CA077202, CA180863, CA67753, CA189805, CA16116, CA180802]; Canadian Cancer Trials Group [CA077202, CA180863]; ECOG-ACRIN Cancer Research Group [CA180820, CA21115]; Novartis Pharmaceuticals; Avon Foundation; AstraZeneca; Pfizer; Roche; Amgen; Novartis; Glaxo-SmithKline; Eisai; Genomic Health; NanoString; Genentech; BioMarin
    Additional Links
    http://www.nejm.org/doi/10.1056/NEJMoa1604700
    ae974a485f413a2113503eed53cd6c53
    10.1056/NEJMoa1604700
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