The is a summary of a study published as a preprint on ResearchSquare.com. It has not yet been peer reviewed.
Key Takeaways
Adjuvant endocrine therapy for early breast cancer is associated with sexual dysfunction, particularly in women who have had a mastectomy and are experiencing worsening physical and endocrine disorder symptoms, such as fatigue, weakness, changes in blood glucose levels, weight fluctuations, and mood swings, finds a new study published as a preprint on ResearchSquare.com.
Routinely assessing women for sexual dysfunction symptoms may improve quality of life.
Why This Matters
Adjuvant endocrine therapies for hormone receptor-positive (HR+) breast cancer, including aromatase inhibitors (AI), tamoxifen, and ovarian function suppression or ablation, can lead to vaginal dryness, dyspareunia, trouble reaching climax, and loss of libido. Plus, radiation can adversely affect response to sensation.
Negative effects of treatment, along with body image issues associated with breast cancer surgery, can lead to sexual dysfunction.
Routinely assessing women with early breast cancer for worsening endocrine symptoms and worsening physical function is necessary and may lead to earlier interventions to improve sexual function.
Study Design
A secondary analysis from a prospective clinic-based cohort of 300 women initiating adjuvant endocrine therapy from March 2012 to December 2016 for stage 0-III breast cancer was done.
Patient-reported outcomes across a broad range of symptoms common during endocrine therapy at 3, 6, 12, 24, 36, 48, and 60 months were completed by participants. Sexual function was evaluated by the Medical Outcomes Study Sexual Problems (MOS-SP) measure.
A distribution-based method to identify the minimal important difference (MID) — or the smallest change in patient-reported outcomes — that patients would perceive as beneficial or harmful on MOS-SP was used with a change of eight points representing clinically significant worsening of sexual function. Distribution methods for changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) score and Functional Assessment of Cancer Therapy–Endocrine Symptom (FACT-ES) score were also used.
Patients were excluded if they had incomplete MOS-SP scores or had baseline MOS-SP scores greater than 92.
Key Results
Of the 300 participants, the mean age was 62 years, and 84.3% had stage I-II breast cancer.
Prior to adjuvant endocrine therapy, 44% had a mastectomy, 28.2% received chemotherapy, and 66.3% received radiation.
Among treatments initiated, 55% received an AI only, 39.7% received tamoxifen only, 5% received tamoxifen plus ovarian function suppression (OFS), and one patient received an AI plus OFS. Five patients switched between types of their endocrine therapy and the remainder did not switch.
Compared with baseline, 45.7% experienced more than an eight-point worsening of MOS-SP at any time point.
Worsening endocrine symptoms (odds ratio [OR], 1.34; P < .001), worsening physical function (OR, 1.08; P = .06), and prior mastectomy (OR, 1.45; P = .09) were associated with worsening sexual function during adjuvant endocrine therapy.
Limitations
Few participants received ovarian function suppression treatment, which limited generalizability of results to this population.
The study cohort was predominantly of White participants of high socioeconomic status.
The study did not account for patients receiving other medications like selective serotonin reuptake inhibitors (SSRI), and specific concomitant medications taken by participants were not considered.
The number of participants who completed patient-reported outcomes questionnaires declined over time.
Sexual activity status was not measured on the MOS-SP measure.
Disclosures
The study was funded by the Susan G. Komen Foundation and the National Institutes of Health. Corresponding author Karen Lisa Smith, MD, PhD, has received research support from Pfizer. Vered Stearns, MD, has received research grants from Abbvie, Biocept, Pfizer, Puma Biotechnology, and Novartis, and is on a Data Safety Monitoring Board for Immunomedics, Inc. and AstraZeneca. Claire Snyder, PhD, MHS, has research funding from Pfizer and Genentech and has received personal consulting fees from Janssen. Elissa Thorner has received research support from Pfizer.
This is a summary of a preprint research study, “Factors Associated with Worsening Sexual Function During Adjuvant Endocrine Therapy in a Prospective Clinic-Based Cohort of Women with Early Stage Breast Cancer,” led by Karen Lisa Smith, MD, PhD, Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer Center. This study has not yet been peer reviewed. The full text of the study can be found on ResearchSquare.com.
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