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Safety of prasterone in breast cancer survivors treated with aromatase inhibitors: the VIBRA pilot study.
Climacteric. 2022 Mar 28 [Online ahead of print]C

Abstract

BACKGROUND

Due to safety concerns on estrogen-based treatments for genitourinary syndrome of menopause (GSM) in breast cancer survivors (BCS), new options are appearing, such as androgen-based treatments, which according to proprieties would not be transformed systemically to estrogens in patients receiving aromatase inhibitors (AIs).

OBJECTIVE

The aim of this pilot study is to assess the security and efficacy of vaginal prasterone (dehydroepiandrostenedione [DHEA]) in BCS treated with AIs.

METHODS

This open, prospective, pilot study included 10 BCS treated with AIs. All participants complained of severe GSM. DHEA was administrated as a vaginal ovule. Participants were instructed to use one ovule every night during the first month, and one ovule every two nights for the entire five remaining months. The patients were requested to attend seriated visits after the beginning of the prasterone treatment to evaluate symptoms, physical improvement and serum estradiol.

RESULTS

Mean serum estradiol remained low from 3.4 pg/ml to 4.3 pg/ml (p = 0.9136) after 6 months of follow-up. The visual analog scale of dyspareunia improved from 8.5 to mean values after treatment of 0.4 (p = 0.0178). The Vaginal Health Index (VHI) scale and Female Sexual Function Index improved from 9.75 to 15.8 (p = 0.0277) and from an initial score of 11.2 to 20.6 (p = 0.0277), respectively. Vaginal pH changed from basal 8.1 to final 6.5 (p = 0.0330).

CONCLUSION

Symptoms and physical examination regarding sexuality and vaginal health improved significantly, while serum estradiol remained at low levels. Prasterone seems a safe and effective option to treat GSM in BCS receiving AIs.

Authors+Show Affiliations

Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Department of Pathology, Biomedical Diagnostic Center, Hospital Clinic of Barcelona, Barcelona, Spain.Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

35343852

Citation

Mension, E, et al. "Safety of Prasterone in Breast Cancer Survivors Treated With Aromatase Inhibitors: the VIBRA Pilot Study." Climacteric : the Journal of the International Menopause Society, 2022, pp. 1-7.
Mension E, Alonso I, Cebrecos I, et al. Safety of prasterone in breast cancer survivors treated with aromatase inhibitors: the VIBRA pilot study. Climacteric. 2022.
Mension, E., Alonso, I., Cebrecos, I., Castrejon, N., Tortajada, M., Matas, I., Gómez, S., Ribera, L., Anglès-Acedo, S., & Castelo-Branco, C. (2022). Safety of prasterone in breast cancer survivors treated with aromatase inhibitors: the VIBRA pilot study. Climacteric : the Journal of the International Menopause Society, 1-7. https://doi.org/10.1080/13697137.2022.2050208
Mension E, et al. Safety of Prasterone in Breast Cancer Survivors Treated With Aromatase Inhibitors: the VIBRA Pilot Study. Climacteric. 2022 Mar 28;1-7. PubMed PMID: 35343852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of prasterone in breast cancer survivors treated with aromatase inhibitors: the VIBRA pilot study. AU - Mension,E, AU - Alonso,I, AU - Cebrecos,I, AU - Castrejon,N, AU - Tortajada,M, AU - Matas,I, AU - Gómez,S, AU - Ribera,L, AU - Anglès-Acedo,S, AU - Castelo-Branco,C, Y1 - 2022/03/28/ PY - 2022/3/28/entrez PY - 2022/3/29/pubmed PY - 2022/3/29/medline KW - Prasterone KW - aromatase inhibitors KW - breast cancer survivors KW - genitourinary syndrome of menopause KW - pilot study SP - 1 EP - 7 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric N2 - BACKGROUND: Due to safety concerns on estrogen-based treatments for genitourinary syndrome of menopause (GSM) in breast cancer survivors (BCS), new options are appearing, such as androgen-based treatments, which according to proprieties would not be transformed systemically to estrogens in patients receiving aromatase inhibitors (AIs). OBJECTIVE: The aim of this pilot study is to assess the security and efficacy of vaginal prasterone (dehydroepiandrostenedione [DHEA]) in BCS treated with AIs. METHODS: This open, prospective, pilot study included 10 BCS treated with AIs. All participants complained of severe GSM. DHEA was administrated as a vaginal ovule. Participants were instructed to use one ovule every night during the first month, and one ovule every two nights for the entire five remaining months. The patients were requested to attend seriated visits after the beginning of the prasterone treatment to evaluate symptoms, physical improvement and serum estradiol. RESULTS: Mean serum estradiol remained low from 3.4 pg/ml to 4.3 pg/ml (p = 0.9136) after 6 months of follow-up. The visual analog scale of dyspareunia improved from 8.5 to mean values after treatment of 0.4 (p = 0.0178). The Vaginal Health Index (VHI) scale and Female Sexual Function Index improved from 9.75 to 15.8 (p = 0.0277) and from an initial score of 11.2 to 20.6 (p = 0.0277), respectively. Vaginal pH changed from basal 8.1 to final 6.5 (p = 0.0330). CONCLUSION: Symptoms and physical examination regarding sexuality and vaginal health improved significantly, while serum estradiol remained at low levels. Prasterone seems a safe and effective option to treat GSM in BCS receiving AIs. SN - 1473-0804 UR - https://www.unboundmedicine.com/medline/citation/35343852/Safety_of_prasterone_in_breast_cancer_survivors_treated_with_aromatase_inhibitors:_the_VIBRA_pilot_study. DB - PRIME DP - Unbound Medicine ER -
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