Uterine and quality of life changes in postmenopausal women with an asymptomatic tamoxifen-thickened endometrium randomized to continuation of tamoxifen or switching to anastrozole
| Autor: | J. Vlasselaer, Eric de Jonge, Johan Van Ginderachter, Ignace Vergote, Gregg Van de Putte, Chantal Blomme, Herman Depypere, Dirk Timmerman, Ben Van Calster, Sabine Van Huffel, Rudy Van den Broecke, G Vlaemynck, Patrick Berteloot, Patrick Neven, Frédéric Amant |
|---|---|
| Přispěvatelé: | Other departments |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
Antineoplastic Agents Hormonal Urology Anastrozole Breast Neoplasms Endometrium Asymptomatic law.invention chemistry.chemical_compound Breast cancer Randomized controlled trial Exemestane Double-Blind Method law Nitriles Medicine Humans Adverse effect Aged Gynecology business.industry Aromatase Inhibitors Uterus Obstetrics and Gynecology Middle Aged Triazoles medicine.disease Postmenopause Sexual Dysfunction Physiological Tamoxifen medicine.anatomical_structure Treatment Outcome chemistry Quality of Life Female medicine.symptom business medicine.drug |
| Zdroj: | Menopause (New York, N.Y.), 18(2), 224-229. Lippincott Williams and Wilkins |
| ISSN: | 1072-3714 |
| DOI: | 10.1097/gme.0b013e3181eb9f14 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|