Safety of prasterone in breast cancer survivors treated with aromatase inhibitors: the VIBRA pilot study

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.

摘要

背景：由于对雌激素治疗乳腺癌幸存者（BCS）绝经期生殖泌尿系统综合征（GSM）安全性的担忧, 出现了一些新的选择, 如雄激素治疗, 因为这种治疗不会在接受芳香化酶抑制剂（AIs）的患者中转化出雌激素。

目的：这项初步研究的目的是评估接受AIs的BCS采用阴道普拉睾酮（脱氢表雄酮[DHEA]）治疗的安全性和有效性。

方法：这项开放的、前瞻性的初步研究纳入了10名接受AIs治疗的BCS。所有参与者都有严重的GSM主诉。DHEA作为阴道栓剂给药。参与者第一个月每晚使用一粒, 之后的五个月里每两晚使用一粒。在普拉睾酮的治疗开始后, 患者需参加连续随访, 评估症状、身体状况的改善情况和血清雌二醇水平。

结果：随访6个月后, 平均血清雌二醇水平保持在3.4至4.3pg/ml的低水平（p=0.9136）。性交困难的可视化评分由8.5分平均提高了0.4分（p=0.0178）。阴道健康指数（VHI）评分由9.75分提高到15.8分（p=0.0277）, 女性性功能指数由11.2分提高到20.6分（p=0.0277）。阴道pH值由基线8.1分最终改变为6.5分（p=0.0330）。

结论：与性行为和阴道健康相关的症状与体检结果有显著改善, 但血清雌二醇仍处于低水平。对于接受AIs的BCS, 普拉睾酮治疗GSM似乎是一种安全、有效的选择。

Keywords:

• Prasterone
• genitourinary syndrome of menopause
• breast cancer survivors
• aromatase inhibitors
• pilot study

Data availability statement

Data are available at: Castelo-Branco, Camil; Mension, Eduard; Anglès, Sònia; Alonso, Immaculada (2021), ‘Prasterone to treat Genitourinary Syndrome of Menopause in breast cancer survivors treated with aromatase inhibitors’, Mendeley Data, V1, doi: 10.17632/h4bvr4dk74.1.

Acknowledgements

The authors would like to express their gratitude to all of the participants of the study.

Potential conflict of interest

The authors have no conflicts of interest to declare.

Source of funding

No other funding sources have been used.