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Factors associated with worsening sexual function during adjuvant endocrine therapy in a prospective clinic-based cohort of women with early-stage breast cancer

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Abstract

Purpose

Sexual function problems are common but under-reported among women receiving adjuvant endocrine therapy for breast cancer. Worsening scores on patient-reported outcomes (PROs) may identify those at risk for sexual function problems during treatment. We performed a secondary analysis of prospectively collected PROs in women receiving adjuvant endocrine therapy to identify factors associated with worsening sexual function.

Methods

Women with stage 0–III breast cancer initiating adjuvant endocrine therapy participating in a prospective cohort completed PROs at baseline, 3, 6, 12, 24, 36, 48, and 60 months. Sexual function was evaluated by the MOS-SP measure. Other measures included PROMIS pain interference, fatigue, depression, anxiety, physical function, and sleep disturbance and the Endocrine Symptom Subscale of the FACT-ES. We evaluated associations between score worsening of at least the minimal important difference (MID) in PROMIS T-scores (4 points) and FACT-ES scores (5 points) with score worsening of at least the MID in MOS-SP scores (8 points) using logistic regression.

Results

Among 300 participants, 45.7% experienced ≥ 8-point worsening of MOS-SP score at any time point compared to baseline. Worsening endocrine symptoms (OR 1.34, 95% CI 1.22–1.49, p < 0.001), worsening physical function (OR 1.09, 95% CI 1.00–1.18, p = 0.06), and prior mastectomy (OR 1.45, 95% CI 0.94–2.23, p = 0.09) were associated with MOS-SP score worsening by at least the MID.

Conclusion

Worsening endocrine symptoms and physical function identified on PROs are associated with worsening sexual function during adjuvant endocrine therapy. Routine assessment of these domains with PROs may identify women at risk for sexual function problems.

Trial registration number

NCT01937052; Date of Registration: 09/09/2013.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

This work was supported by funding from the Susan G. Komen Foundation and the National Institutes of Health [P30 CA006973].

Author information

Authors and Affiliations

Authors

Contributions

Conceptualization: KLS, NV, and VS. Data Curation: JL. Formal Analysis: ALB. Funding Acquisition: VS. Methodology: KLS, ALB, VS, and CS. Resources: VS, JL, and CS. Software: not applicable. Supervision: KLS and VS. Writing of the original draft: NV and KLS. Writing, reviewing, and editing of the manuscript: All authors.

Corresponding author

Correspondence to Karen Lisa Smith.

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Karen Lisa Smith has received research support (to institution) from Pfizer. Karen Lisa Smith’s spouse has stock ownership in ABT Labs and Abbvie. Vered Stearns has received research grants (to institution) from Abbvie, Biocept, Pfizer, Puma Biotechnology, and Novartis. Vered Stearns has been on an advisory board for Novartis (10/25/21). Vered Stearns is a Data Safety Monitoring Board member for Immunomedics, Inc. and for AstraZeneca. Vered Stearns has received non-financial support from Foundation Medicine for Study Assays. Claire Snyder has research funding (to institution) from Pfizer and Genentech and has received personal consulting fees from Janssen via Health Outcomes Solutions. Elissa Thorner has received research support (to institution) from Pfizer. The following authors declare that they have no conflicts of interest related to the work presented in this manuscript: Neha Verma, Amanda Blackford, and Jennifer Lehman.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. We obtained approval from the Johns Hopkins (JH) Institutional Review Board (IRB) to conduct this prospective study. All participants signed written informed consent.

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Verma, N., Blackford, A.L., Thorner, E. et al. Factors associated with worsening sexual function during adjuvant endocrine therapy in a prospective clinic-based cohort of women with early-stage breast cancer. Breast Cancer Res Treat 196, 535–547 (2022). https://doi.org/10.1007/s10549-022-06750-w

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