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Uterine and quality of life changes in postmenopausal women with an asymptomatic tamoxifen-thickened endometrium randomized to continuation of tamoxifen or switching to anastrozole

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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.
Keywords
BREAST-CANCER PATIENTS, 3RD-GENERATION AROMATASE INHIBITORS, Uterine volume, Endometrial thickness, Quality of life, INTERGROUP EXEMESTANE, MENOPAUSAL SYMPTOMS, HYPERPLASIA, Endocrine treatment, CONTROLLED-TRIAL, Breast cancer, Postmenopausal, THERAPY

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MLA
Van Calster, Ben, Johan Van Ginderachter, Jos Vlasselaer, et al. “Uterine and Quality of Life Changes in Postmenopausal Women with an Asymptomatic Tamoxifen-thickened Endometrium Randomized to Continuation of Tamoxifen or Switching to Anastrozole.” MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY 18.2 (2011): 224–229. Print.
APA
Van Calster, B., Van Ginderachter, J., Vlasselaer, J., Van de Putte, G., Berteloot, P., Timmerman, D., Depypere, H., et al. (2011). Uterine and quality of life changes in postmenopausal women with an asymptomatic tamoxifen-thickened endometrium randomized to continuation of tamoxifen or switching to anastrozole. MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY, 18(2), 224–229.
Chicago author-date
Van Calster, Ben, Johan Van Ginderachter, Jos Vlasselaer, Gregg Van de Putte, Patrick Berteloot, Dirk Timmerman, Herman Depypere, et al. 2011. “Uterine and Quality of Life Changes in Postmenopausal Women with an Asymptomatic Tamoxifen-thickened Endometrium Randomized to Continuation of Tamoxifen or Switching to Anastrozole.” Menopause-the Journal of the North American Menopause Society 18 (2): 224–229.
Chicago author-date (all authors)
Van Calster, Ben, Johan Van Ginderachter, Jos Vlasselaer, Gregg Van de Putte, Patrick Berteloot, Dirk Timmerman, Herman Depypere, Chantal Blomme, Geert Vlaemynck, Eric De Jonge, Rudy Van den Broecke, Ignace Vergote, Frederic Amant, Sabine Van Huffel, and Patrick Neven. 2011. “Uterine and Quality of Life Changes in Postmenopausal Women with an Asymptomatic Tamoxifen-thickened Endometrium Randomized to Continuation of Tamoxifen or Switching to Anastrozole.” Menopause-the Journal of the North American Menopause Society 18 (2): 224–229.
Vancouver
1.
Van Calster B, Van Ginderachter J, Vlasselaer J, Van de Putte G, Berteloot P, Timmerman D, et al. Uterine and quality of life changes in postmenopausal women with an asymptomatic tamoxifen-thickened endometrium randomized to continuation of tamoxifen or switching to anastrozole. MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY. 2011;18(2):224–9.
IEEE
[1]
B. Van Calster et al., “Uterine and quality of life changes in postmenopausal women with an asymptomatic tamoxifen-thickened endometrium randomized to continuation of tamoxifen or switching to anastrozole,” MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY, vol. 18, no. 2, pp. 224–229, 2011.
@article{1178427,
  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.},
  author       = {Van Calster, Ben and Van Ginderachter, Johan and Vlasselaer, Jos and Van de Putte, Gregg and Berteloot, Patrick and Timmerman, Dirk and Depypere, Herman and Blomme, Chantal and Vlaemynck, Geert and De Jonge, Eric and Van den Broecke, Rudy and Vergote, Ignace and Amant, Frederic and Van Huffel, Sabine and Neven, Patrick},
  issn         = {1072-3714},
  journal      = {MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY},
  keywords     = {BREAST-CANCER PATIENTS,3RD-GENERATION AROMATASE INHIBITORS,Uterine volume,Endometrial thickness,Quality of life,INTERGROUP EXEMESTANE,MENOPAUSAL SYMPTOMS,HYPERPLASIA,Endocrine treatment,CONTROLLED-TRIAL,Breast cancer,Postmenopausal,THERAPY},
  language     = {eng},
  number       = {2},
  pages        = {224--229},
  title        = {Uterine and quality of life changes in postmenopausal women with an asymptomatic tamoxifen-thickened endometrium randomized to continuation of tamoxifen or switching to anastrozole},
  url          = {http://dx.doi.org/10.1097/gme.0b013e3181eb9f14},
  volume       = {18},
  year         = {2011},
}

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