Tibolone and Breast Tissue: a Review.
Breast
Breast cancer
Breast density
Hormone replacement therapy
Menopause
Tibolone
Journal
Reproductive sciences (Thousand Oaks, Calif.)
ISSN: 1933-7205
Titre abrégé: Reprod Sci
Pays: United States
ID NLM: 101291249
Informations de publication
Date de publication:
12 2023
12 2023
Historique:
received:
23
02
2023
accepted:
09
07
2023
medline:
4
12
2023
pubmed:
14
7
2023
entrez:
14
7
2023
Statut:
ppublish
Résumé
The safety profile of hormone replacement therapy (HRT) on breast is still controversial. Tibolone is an option of treatment for climacteric syndrome of postmenopausal women. Its risk profile on breast is debated. This is an updated narrative review focusing on the impact of tibolone on breast. Particularly, we will report data from major preclinical and clinical studies regarding the effects of the use of this compound on breast tissue and breast density. Moreover, we will analyze and discuss the most relevant findings of the principal studies evaluating the relationship between tibolone and breast cancer risk. Our purpose is making all clinicians who are particularly involved in women's health more aware of the effects of this compound on breast and, thus, more experienced in the management of menopausal symptoms with this drug. According to the available literature, tibolone seems to be characterized by an interesting safety profile on breast tissue.
Identifiants
pubmed: 37450250
doi: 10.1007/s43032-023-01295-9
pii: 10.1007/s43032-023-01295-9
doi:
Substances chimiques
tibolone
FF9X0205V2
Estrogen Receptor Modulators
0
Norpregnenes
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
3403-3409Informations de copyright
© 2023. The Author(s), under exclusive licence to Society for Reproductive Investigation.
Références
Rossouw JE, Anderson GL, Prentice RL, AZ LC, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J, Writing Group for the Women’s Health Initiative Investigators.; Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288(3):321–33. https://doi.org/10.1001/jama.288.3.321 .
doi: 10.1001/jama.288.3.321
pubmed: 12117397
The NAMS. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24(7):728–53.
doi: 10.1097/GME.0000000000000921
Kloosterboer HJ. Tissue-selective effects of tibolone on the breast. Maturitas. 2004;49(1):S5–S15. https://doi.org/10.1016/j.maturitas.2004.06.022 .
doi: 10.1016/j.maturitas.2004.06.022
pubmed: 15351102
Kloosterboer HJ, Schoonen WG, Deckers GH, Klijn JG. Effects of progestagens and Org OD14 in in vitro and in vivo tumor models. J Steroid Biochem Mol Biol. 1994;49(4-6):311–8. https://doi.org/10.1016/0960-0760(94)90273-9 .
doi: 10.1016/0960-0760(94)90273-9
pubmed: 8043494
Gompel A, Chaouat M, Jacob D, Perrot JY, Kloosterboer HJ, Rostene W. In vitro studies of tibolone in breast cells. Fertil Steril. 2002;78(2):351–9. https://doi.org/10.1016/s0015-0282(02)03203-x .
doi: 10.1016/s0015-0282(02)03203-x
pubmed: 12137874
Pasqualini JR, Chetrite GS. Estrone sulfatase versus estrone sulfotransferase in human breast cancer: potential clinical applications. J Steroid Biochem Mol Biol. 1999;69(1-6):287–92. https://doi.org/10.1016/s0960-0760(99)00082-5 .
doi: 10.1016/s0960-0760(99)00082-5
pubmed: 10419004
de Gooyer ME, Kleyn GT, Smits KC, Ederveen AG, Verheul HA, Kloosterboer HJ. Tibolone: a compound with tissue specific inhibitory effects on sulfatase. Mol Cell Endocrinol. 2001;183(1-2):55–62. https://doi.org/10.1016/s0303-7207(01)00606-2 .
doi: 10.1016/s0303-7207(01)00606-2
pubmed: 11604225
Kandouz M, Lombet A, Perrot JY, Jacob D, Carvajal S, Kazem A, Rostene W, Therwath A, Gompel A. Proapoptotic effects of antiestrogens, progestins and androgen in breast cancer cells. J Steroid Biochem Mol Biol. 1999;69(1-6):463–71. https://doi.org/10.1016/s0960-0760(99)00069-2 .
doi: 10.1016/s0960-0760(99)00069-2
pubmed: 10419026
Chetrite G, Kloosterboer HJ, Pasqualini JR. Effect of tibolone (Org OD14) and its metabolites on estrone sulphatase activity in MCF-7 and T-47D mammary cancer cells. Anticancer Res. 1997;17(1A):135–40.
pubmed: 9066643
Biglia N, Maffei S, Lello S, Nappi RE. Tibolone in postmenopausal women: a review based on recent randomised controlled clinical trials. Gynecol Endocrinol. 2010;26(11):804–14. https://doi.org/10.3109/09513590.2010.495437 .
doi: 10.3109/09513590.2010.495437
pubmed: 20586550
Kloosterboer HJ. Tibolone: a steroid with a tissue-specific mode of action. J Steroid Biochem Mol Biol. 2001;76(1-5):231–8. https://doi.org/10.1016/s0960-0760(01)00044-9 .
doi: 10.1016/s0960-0760(01)00044-9
pubmed: 11384882
Cline JM, Register TC, Clarkson TB. Effects of tibolone and hormone replacement therapy on the breast of cynomolgus monkeys. Menopause. 2002;9(6):422–9. https://doi.org/10.1097/00042192-200211000-00007 .
doi: 10.1097/00042192-200211000-00007
pubmed: 12439101
Desreux J, Kloosterboer H, Noël A, Frankenne F, Lemaire M, Putman M, Foidart JM. Effects of tibolone on sulfatase pathway of estrogens metabolism and on growth of MCF-7 human breast tumors implanted in ovariectomized nude mice. Gynecol Obstet Invest. 2007;63(1):31–8. https://doi.org/10.1159/000094917 .
doi: 10.1159/000094917
pubmed: 16899995
Reed MJ, Kloosterboer HJ. Tibolone: a selective tissue estrogenic activity regulator (STEAR). Maturitas. 2004;48(Suppl 1):S4–6. https://doi.org/10.1016/j.maturitas.2004.02.013 .
doi: 10.1016/j.maturitas.2004.02.013
pubmed: 15337241
de Gooyer ME, Deckers GH, Schoonen WG, Verheul HA, Kloosterboer HJ. Receptor profiling and endocrine interactions of tibolone. Steroids. 2003;68(1):21–30. https://doi.org/10.1016/s0039-128x(02)00112-5 .
doi: 10.1016/s0039-128x(02)00112-5
pubmed: 12475720
Wolfe JN. Breast patterns as an index of risk for developing breast cancer. AJR Am J Roentgenol. 1976;126(6):1130–7. https://doi.org/10.2214/ajr.126.6.1130 .
doi: 10.2214/ajr.126.6.1130
pubmed: 179369
Boyd NF. Mammographic density and risk of breast cancer. Am Soc Clin Oncol Educ Book. 2013. https://doi.org/10.1200/EdBook_AM.2013.33.e57 .
Tice JA, Bissell MCS, Miglioretti DL, Gard CC, Rauscher GH, Dabbous FM, Kerlikowske K. Validation of the breast cancer surveillance consortium model of breast cancer risk. Breast Cancer Res Treat. 2019;175(2):519–23. https://doi.org/10.1007/s10549-019-05167-2 .
doi: 10.1007/s10549-019-05167-2
pubmed: 30796654
pmcid: 7138025
Tyrer J, Duffy SW, Cuzick J. A breast cancer prediction model incorporating familial and personal risk factors. Stat Med. 2004;23(7):1111–30. https://doi.org/10.1002/sim.1668 .
doi: 10.1002/sim.1668
pubmed: 15057881
McNicholas MM, Heneghan JP, Milner MH, Tunney T, Hourihane JB, MacErlaine DP. Pain and increased mammographic density in women receiving hormone replacement therapy: a prospective study. AJR Am J Roentgenol. 1994;163(2):311–5. https://doi.org/10.2214/ajr.163.2.8037021 .
doi: 10.2214/ajr.163.2.8037021
pubmed: 8037021
Leung W, Goldberg F, Zee B, Sterns E. Mammographic density in women on postmenopausal hormone replacement therapy. Surgery. 1997;122(4):669–73; discussion 673-4. https://doi.org/10.1016/s0039-6060(97)90072-6 .
doi: 10.1016/s0039-6060(97)90072-6
pubmed: 9347841
Rutter CM, Mandelson MT, Laya MB, Seger DJ, Taplin S. Changes in breast density associated with initiation, discontinuation, and continuing use of hormone replacement therapy. JAMA. 2001;285(2):171–6. https://doi.org/10.1001/jama.285.2.171 .
doi: 10.1001/jama.285.2.171
pubmed: 11176809
Freer PE. Mammographic breast density: impact on breast cancer risk and implications for screening. Radiographics. 2015;35(2):302–15. https://doi.org/10.1148/rg.352140106 .
doi: 10.1148/rg.352140106
pubmed: 25763718
Fajardo LL, Hillman BJ, Frey C. Correlation between breast parenchymal patterns and mammographers’ certainty of diagnosis. Invest Radiol. 1988;23(7):505–8. https://doi.org/10.1097/00004424-198807000-00004 .
doi: 10.1097/00004424-198807000-00004
pubmed: 3170137
Kerlikowske K, Grady D, Barclay J, Frankel SD, Ominsky SH, Sickles EA, Ernster V. Variability and accuracy in mammographic interpretation using the American College of Radiology Breast Imaging Reporting and Data System. J Natl Cancer Inst. 1998;90(23):1801–9. https://doi.org/10.1093/jnci/90.23.1801 .
doi: 10.1093/jnci/90.23.1801
pubmed: 9839520
Kloosterboer HJ. Tissue-selectivity: the mechanism of action of tibolone. Maturitas. 2004;48(Suppl 1):S30–40. https://doi.org/10.1016/j.maturitas.2004.02.012 .
doi: 10.1016/j.maturitas.2004.02.012
pubmed: 15337246
Erel CT, Elter K, Akman C, Ersavasti G, Altug A, Seyisoglu H, Ertungealp E. Mammographic changes in women receiving tibolone therapy. Fertil Steril. 1998;69(5):870–5. https://doi.org/10.1016/s0015-0282(98)00051-x .
doi: 10.1016/s0015-0282(98)00051-x
pubmed: 9591495
Ozdemir A, Konuş O, Nas T, Erbaş G, Coşar S, Işik S. Mammographic and ultrasonographic study of changes in the breast related to HRT. Int J Gynaecol Obstet. 1999;67(1):23–32. https://doi.org/10.1016/s0020-7292(99)00102-2 .
doi: 10.1016/s0020-7292(99)00102-2
pubmed: 10576236
Valdivia I, Ortega D. Mammographic density in postmenopausal women treated with tibolone, estriol or conventional hormone replacement therapy. Clin Drug Investig. 2000;20(2):101–7. https://doi.org/10.2165/00044011-200020020-00005 .
doi: 10.2165/00044011-200020020-00005
pubmed: 23315352
Wolfe JN. Risk for breast cancer development determined by mammographic parenchymal pattern. Cancer. 1976;37(5):2486–92.
doi: 10.1002/1097-0142(197605)37:5<2486::AID-CNCR2820370542>3.0.CO;2-8
pubmed: 1260729
Colacurci N, Fornaro F, De Franciscis P, Palermo M, del Vecchio W. Effects of different types of hormone replacement therapy on mammographic density. Maturitas. 2001;40(2):159–64. https://doi.org/10.1016/s0378-5122(01)00232-8 .
doi: 10.1016/s0378-5122(01)00232-8
pubmed: 11716994
Lundström E, Christow A, Kersemaekers W, Svane G, Azavedo E, Söderqvist G, Mol-Arts M, Barkfeldt J, von Schoultz B. Effects of tibolone and continuous combined hormone replacement therapy on mammographic breast density. Am J Obstet Gynecol. 2002;186(4):717–22. https://doi.org/10.1067/mob.2002.121896 .
doi: 10.1067/mob.2002.121896
pubmed: 11967497
Bruce D, Robinson J, McWilliams S, Reddy M, Fentiman I, Rymer J. Long-term effects of tibolone on mammographic density. Fertil Steril. 2004;82(5):1343–7. https://doi.org/10.1016/j.fertnstert.2004.03.063 .
doi: 10.1016/j.fertnstert.2004.03.063
pubmed: 15533357
Beral V, Million Women Study Collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. Lancet. 2003;362(9382):419–27. https://doi.org/10.1016/s0140-6736(03)14065-2 .
doi: 10.1016/s0140-6736(03)14065-2
pubmed: 12927427
Whitehead M, Farmer R. The million women study: a critique. Endocrine. 2004;24(3):187–93. https://doi.org/10.1385/ENDO:24:3:187 .
doi: 10.1385/ENDO:24:3:187
pubmed: 15542884
Velthuis-Te Wierik EJ, Hendricks PT, Martinez C. Preferential prescribing of tibolone and combined estrogen plus progestogen therapy in postmenopausal women. Menopause. 2007;14(3 Pt 1):518–27. https://doi.org/10.1097/01.gme.0000247012.54468.75 .
doi: 10.1097/01.gme.0000247012.54468.75
pubmed: 17224856
Suissa S, Opatrny L. Commentary on ‘Hormone replacement therapy use and variations in the risk of breast cancer’. BJOG. 2008;115(7):918. https://doi.org/10.1111/j.1471-0528.2008.01733.x .
doi: 10.1111/j.1471-0528.2008.01733.x
pubmed: 18485173
Opatrny L, Dell’Aniello S, Assouline S, Suissa S. Hormone replacement therapy use and variations in the risk of breast cancer. BJOG. 2008;115(2):169–75; discussion 175. https://doi.org/10.1111/j.1471-0528.2007.01520.x .
doi: 10.1111/j.1471-0528.2007.01520.x
pubmed: 18081598
Sismondi P, Kimmig R, Kubista E, Biglia N, Egberts J, Mulder R, Planellas J, Moggio G, Mol-Arts M, Kenemans P. Effects of tibolone on climacteric symptoms and quality of life in breast cancer patients—data from LIBERATE trial. Maturitas. 2011;70(4):365–72. https://doi.org/10.1016/j.maturitas.2011.09.003 .
doi: 10.1016/j.maturitas.2011.09.003
pubmed: 22030384
Formoso G, Perrone E, Maltoni S, Balduzzi S, Wilkinson J, Basevi V, Marata AM, Magrini N, D’Amico R, Bassi C, Maestri E. Short-term and long-term effects of tibolone in postmenopausal women. Cochrane Database Syst Rev. 2016;10(10):CD008536. https://doi.org/10.1002/14651858.CD008536.pub3 .
doi: 10.1002/14651858.CD008536.pub3
pubmed: 27733017
Collaborative Group on Hormonal Factors in Breast Cancer. Type and timing of menopausal hormone therapy and breast cancer risk: individual participant meta-analysis of the worldwide epidemiological evidence. Lancet. 2019;394:1159–68.
doi: 10.1016/S0140-6736(19)31709-X
pmcid: 6891893
International Menopause Society. Comment on: Type and timing of menopausal hormone therapy and breast cancer risk: individual participant metaanalysis of the worldwide epidemiological evidence [Internet]. 2019. [cited 2020 Mar 22]. Available from: https://www.imsociety.org/manage/images/pdf/5054afeb9b1bc763032333443f1c0bed.pdf .
Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of breast cancer: nested case-control studies using the QResearch and CPRD databases. BMJ. 2020;371:m3873. https://doi.org/10.1136/bmj.m3873 .
doi: 10.1136/bmj.m3873
pubmed: 33115755
pmcid: 7592147
Baek JK, Kim HI, Kang MJ, Seon KE, Kim EH, Seo SK. Relationship between the type of hormone replacement therapy and incidence of breast cancer in Korea. Climacteric. 2022;25(5):516–22. https://doi.org/10.1080/13697137.2022.2077096 .
doi: 10.1080/13697137.2022.2077096
pubmed: 35674251