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  1. Article: Tamoxifen Metabolism and Efficacy in Breast Cancer: A Prospective Multicenter Trial.

    Neven, Patrick / Jongen, Lynn / Lintermans, Anneleen / Van Asten, Kathleen / Blomme, Chantal / Lambrechts, Diether / Poppe, An / Wildiers, Hans / Dieudonné, Anne-Sophie / Brouckaert, Olivier / Decloedt, Jan / Berteloot, Patrick / Verhoeven, Didier / Joerger, Markus / Vuylsteke, Peter / Wynendaele, Wim / Casteels, Minne / Van Huffel, Sabine / Lybaert, Willem /
    Van Ginderachter, Johan / Paridaens, Robert / Vergote, Ignace / Dezentjé, Vincent Olaf / Van Calster, Ben / Guchelaar, Henk-Jan

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2018  Volume 24, Issue 10, Page(s) 2312–2318

    Abstract: Purpose: ...

    Abstract Purpose:
    MeSH term(s) Aged ; Aged, 80 and over ; Antineoplastic Agents, Hormonal/adverse effects ; Antineoplastic Agents, Hormonal/pharmacokinetics ; Breast Neoplasms/diagnosis ; Breast Neoplasms/drug therapy ; Breast Neoplasms/metabolism ; Breast Neoplasms/mortality ; Drug Monitoring ; Female ; Humans ; Middle Aged ; Postmenopause ; Receptors, Estrogen/metabolism ; Selective Estrogen Receptor Modulators/adverse effects ; Selective Estrogen Receptor Modulators/pharmacokinetics ; Tamoxifen/adverse effects ; Tamoxifen/pharmacokinetics ; Treatment Outcome
    Chemical Substances Antineoplastic Agents, Hormonal ; Receptors, Estrogen ; Selective Estrogen Receptor Modulators ; Tamoxifen (094ZI81Y45)
    Language English
    Publishing date 2018-02-19
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-17-3028
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Uterine and quality of life changes in postmenopausal women with an asymptomatic tamoxifen-thickened endometrium randomized to continuation of tamoxifen or switching to anastrozole.

    Van Calster, Ben / Van Ginderachter, Johan / Vlasselaer, Jos / Van de Putte, Gregg / Berteloot, Patrick / Timmerman, Dirk / Depypere, Herman / Blomme, Chantal / Vlaemynck, Geert / De Jonge, Eric / Van den Broecke, Rudy / Vergote, Ignace / Amant, Frédéric / Van Huffel, Sabine / Neven, Patrick

    Menopause (New York, N.Y.)

    2011  Volume 18, Issue 2, Page(s) 224–229

    Abstract: Objective: Before the knowledge that 5 years of adjuvant tamoxifen is less efficacious than 2 to 3 years of tamoxifen followed by 2 to 3 years of anastrozole/exemestane, we designed a multicenter double-blind randomized controlled trial in women taking ... ...

    Abstract Objective: Before the knowledge that 5 years of adjuvant tamoxifen is less efficacious than 2 to 3 years of tamoxifen followed by 2 to 3 years of anastrozole/exemestane, we designed a multicenter double-blind randomized controlled trial in women taking tamoxifen with a thickened endometrium to compare uterine and quality-of-life parameters between those switching to anastrozole and those continuing tamoxifen.
    Methods: Asymptomatic postmenopausal women who took adjuvant tamoxifen for 2 to 3 years for operable breast cancer with a double endometrial thickness greater than 7 mm were randomized to 20 mg tamoxifen or 1 mg anastrozole for the remaining duration, totaling 5 years. Tablets were unrecognizable for drug assignment. The primary endpoints were the differences in double endometrial thickness and uterine volume after 1 year. Uterine and quality-of-life data were analyzed using regression methods, and missing values were handled using multiple imputation.
    Results: Seventy-two women (median age, 60 y) were randomized in five hospitals. Relative to women continuing tamoxifen, women switching to anastrozole experienced a decrease of 53% (95% CI, 41%-63%) in double endometrial thickness and a decrease of 51% (95% CI, 39%-60%) in uterine volume. Vaginal dryness (b = 0.064; 95% CI, 0.016-0.112) and sexual problems (b = 0.054; 95% CI, 0.007-0.102) increased in women taking anastrozole compared with women taking tamoxifen. Treatment arms did not differ regarding withdrawal rate and the experience of (serious) adverse events.
    Conclusions: Despite premature trial closure, our data provided valuable insights. Switching to anastrozole strongly decreased the endometrial thickness and uterine volume but increased sexual disturbances. Safe and effective interventions are needed to alleviate sexual dysfunction.
    MeSH term(s) Aged ; Antineoplastic Agents, Hormonal/adverse effects ; Antineoplastic Agents, Hormonal/therapeutic use ; Aromatase Inhibitors/therapeutic use ; Breast Neoplasms/drug therapy ; Breast Neoplasms/surgery ; Double-Blind Method ; Female ; Humans ; Middle Aged ; Nitriles/adverse effects ; Nitriles/therapeutic use ; Postmenopause/drug effects ; Quality of Life ; Sexual Dysfunction, Physiological/chemically induced ; Tamoxifen/adverse effects ; Tamoxifen/therapeutic use ; Treatment Outcome ; Triazoles/adverse effects ; Triazoles/therapeutic use ; Uterus/drug effects
    Chemical Substances Antineoplastic Agents, Hormonal ; Aromatase Inhibitors ; Nitriles ; Triazoles ; Tamoxifen (094ZI81Y45) ; anastrozole (2Z07MYW1AZ)
    Language English
    Publishing date 2011-02
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1205262-0
    ISSN 1530-0374 ; 1072-3714
    ISSN (online) 1530-0374
    ISSN 1072-3714
    DOI 10.1097/gme.0b013e3181eb9f14
    Database MEDical Literature Analysis and Retrieval System OnLINE

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