Missing documentation in breast cancer survivors: genitourinary syndrome of menopause (2024)

Abstract

Introduction

Breast cancer survivors, particularly those who are postmenopausal, oftenexperience genitourinary syndrome of menopause (GSM), which adversely affects theirquality of life [1–4]. Broeckel et al. [5] found that breast cancer survivorstreated with adjuvant chemotherapy had decreased sexual function compared withage-matched women with no history of cancer. The study also revealed that vaginaldryness was one of the most important predictors of decreased sexual function inbreast cancer survivors. Breast cancer survivors receiving adjuvant aromataseinhibitor therapy also reported distressing GSM and sexual dysfunction[6,7]. In addition, women reporting vaginal dryness often had painwith gynecologic examinations [8].

Breast cancer survivors who experience atrophic vaginitis are usually givennonhormone therapies, although such therapies often offer inadequate symptom relief[9–10]. Although vaginally administered estrogen hasbeen shown to be an effective treatment for atrophic vaginitis [2–4, 11–12], there has been concern that vaginal estrogenmay be systemically absorbed, stimulate breast tissue, possibly leading torecurrence [10, 13–14]. However, Le Ray and Dell’Aniello [15] showed no increase in breast cancerrecurrence among patients using vaginal estrogen who were treated with tamoxifen.The American College of Obstetricians and Gynecologists [16] recommends that vaginal estrogen be offeredto those patients who are unresponsive to nonhormone remedies after an informeddecision-making and consent process about the potential risks and benefits of usingvaginal estrogen in collaboration with their oncologist.

Recently, several new therapies became available including thermo-ablativefractional CO2 laser therapy and newly FDA-approved intravaginaldehydroepiandrosterone (DHEA). Thermo-ablative fractional CO2 laser is a new,well-tolerated, and effective option currently used for treatment of vulvovaginalatrophy [17–18]. The long-term effectiveness of laser therapyis still being studied. Pieralli et al. [19] evaluated 50 breast cancer survivors after a course ofvaginal fractional CO2 laser treatment found that 52% were satisfied afterintermediate term follow-up (mean time 11 months). The recommended course of therapycosts thousands of U.S. dollars, involves three treatments spaced 6 weeks apart, andhas a recommended follow-up maintenance of about a year after completion of therapy.This procedure is neither approved nor cleared by the FDA for the specificindication of treating vulvovaginal atrophy [20].

Intravaginal DHEA, another new treatment, was approved by the FDA on November17, 2016, to treat moderate to severe dyspareunia [21–23]. Although studies have shown that the steroid concentrationsused in this treatment remain within normal postmenopausal values in women receivingdaily 0.5% intravaginal DHEA for 12 weeks, it is contraindicated in breastcancer survivors because there was a small increase in serum levels of estrogen[24]. Since intravaginalDHEA only recently received FDA approval, it is currently in the production phaseand net yet available for patient use.

Ospemifene is an estrogen agonist/antagonist with an FDA indication for thetreatment of moderate to severe dyspareunia. It has not been adequately studied inbreast cancer survivors and should not be used in this population.

Since the prevalence of distressing sexual dysfunction in breast cancersurvivors is very high, we sought to determine how often clinicians documented GSMand the percentages of patients with symptoms who received treatment in a very largebreast survivorship clinic at a comprehensive cancer center.

Materials and Methods

We conducted a descriptive study of female patients who were treated at theBreast Cancer Survivorship Clinic, housed in the Cancer Prevention Center at TheUniversity of Texas MD Anderson Cancer Center. In addition to breast oncologists,the health care providers in this clinic include two family doctors, one internist,and eight nurse practitioners, all specially trained in cancer prevention,screening, diagnosis, and survivorship care.

After Institutional Review Board approval, we reviewed the medical recordsof patients who completed treatment for invasive breast cancer at least 5 yearsbefore their visit to the survivorship clinic or who completed treatment for ductalcarcinoma in situ at least 6 months before their visit. Medical records weredesignated ineligible if the patient did not have a pathological diagnosis of breastcancer or was not examined in the Breast Cancer Survivorship Clinic, or if therecords were duplicate (only 1 record per patient was included).

Patient data were stored in databases designed and maintained byPatient-Reported Outcomes, Survey and Population Research (PROSPR), a sharedresource of the Cancer Center Support Grant at MD Anderson. The PROSPR group alsohelped prepare the datasets and conduct the analyses.

Data were extracted from the patients’, clinic notes, medicationlists, and review of systems sections of the medical records. The review of systems“Genitourinary” section of the clinic note only listed urinarysymptoms as listed in Table 1. We collectedand recorded demographic information, the status of ovarian function, the presenceof pelvic pain, current vaginal infections or vaginal discharge, and symptomssuggestive of vaginal atrophy including vaginal dryness, pruritus, and/or vaginalbleeding. Symptoms related to atrophy of the lower urinary tract, including urinaryburning, frequency, hematuria, dribbling, and incontinence, were also recorded. Ifavailable, the date of the patient’s last menstrual period, sexual activitystatus (sexually active or not), and the results of the most recent Papanicolaoutest and pelvic examination were also noted, including whether the test revealedvaginal atrophy. Use of hormonal and anti-hormonal therapy (estrogen, progesterone,testosterone, raloxifene, tamoxifen, anastrozole, letrozole, and/or exemestane) wasalso recorded.

Attempts were made to sample all age groups for a total of 800 patientmedical records. This sample size was based on the resources available, includingone medical student for chart review and data collection. The sample size for eachof 10 separate age range groups (>21, 21–40, 41–45,46–50, 51–55, 56–59, 60–65, 66–70,71–75, >75) was determined by the number of available MD Anderson medicalrecords in each age group. We sorted the medical record in ascending order for eachage group. Sampling began with the lowest medical record number in each age groupand ended either when we reached the group sample size or when no more records wereavailable. All eligible medical records for women younger than 45 years wereincluded because of the small number of available records in these age groups.Ineligible and duplicate patient records were not included in the analyses.

Descriptive statistics were used to summarize the data. The Pearsonchi-square test was used to assess the relationship between sexual activity(sexually active vs. sexually inactive) and the prevalence of symptoms of urogenitalatrophy. The Fisher exact test was used when any of the cells had values <5. Byconvention, a P value of <0.05 indicated statistical significance. P values werecalculated based on the chi square and fisher exact tests. Odds ratios are reportedfor significant findings and were calculated using the 2×2 tables, nologistic regression models were run. All statistical analyses were carried out SAS(SAS Institute Inc., Cary, NC).

Results

Approximately 4,000 total electronic medical records were available for thestudy period, with the majority for patients older than 60 years. We evaluated 800unique patient records in this study including all of the 10 separate age rangegroups. Patient demographic information is summarized in Table 2.

There were 624 (78.00%) postmenopausal patients and 153(19.13%) premenopausal patients, leaving 23 (2.88%) patients withunknown status of ovarian function.

Treatment with vaginal estrogen and vaginal lubricants/moisturizers includednone versus two of the 24 patients using tamoxifen, one versus one of the 11patients on raloxifene, and two versus four of the 18 patients on aromataseinhibitors, respectively.

Of the 800 patients studied, 279 (34.9%) had documented symptomssuggestive of atrophic vaginitis (Table 3).The most common symptom reported was vaginal dryness (n = 181;22.6%), followed by vaginal bleeding (n = 37; 4.6%). Sexualactivity status was documented for only 152 patients (19%).

The number of patients with documented symptoms suggestive of lower urinarytract atrophy was much smaller (n = 71; 8.88%; Table 4). The most common urinary symptom documented wasincreased frequency (n = 23; 2.9%), followed by dribbling (n= 22; 2.8%).

Of the 403 patients with documented results from a recent Papanicolaou testand pelvic examination, 214 (53.1%) had documented vaginal atrophy accordingto one or both of these tests. The documented symptom of vaginal dryness occurredsignificantly more often among patients with documented vaginal atrophy than amongpatients without documented vaginal atrophy on the recent Papanicolaou test orpelvic examination (64/214 [29.9%] vs. 35/189[18.5%]; OR = 1.615 (1.023, 2.548); P =0.0023). No statistically significant differences in urinary symptoms were observedbetween women with vaginal atrophy and those without vaginal atrophy on a recentPapanicolaou test or pelvic examination.

Of the 279 patients with documented symptoms of vaginal atrophy, only 111(39.8%) had documentation that they received some form of treatment orreferral to a health care specialist. Of the 71 patients with documented symptoms oflower urinary tract atrophy, only 24 (33.8%) had documentation that theyreceived some form of treatment or referral.

Discussion

Our results revealed a troubling lack of documentation of ascertainment ofGSM in this population of breast cancer survivors. Also, for the small minority withdocumented symptoms, there is a woeful lack of treatment plans. These resultsdemonstrate a need to improve the current practice of evaluation and management ofGSM in breast cancer survivors. Even if GSM were elicited and treated but notdocumented, this results in an incomplete medical record and also negatively affectsfollow-up care. These results are consistent with many surveys that reveal thatpatients want to have discussions about GSM during their oncology visits but suchdiscussions rarely occur [25–27].

This study focused on how often clinicians documented GSM and thepercentages of patients with symptoms who received treatment in a very large breastsurvivorship clinic at a comprehensive cancer center, and the lack of documentationwas worrisome. Bradford et al. [28] studied the effect of a brief intervention to increase routinescreening for sexual problems in this same breast survivorship clinic by giving aseminar for clinic nurses and adding several screening items on sexuality in thereview of systems form. Sexual problems were documented in 5.2% of 233records before implementation and in 7.6% of 236 records afterimplementation (p = 0.278). There was much less documentation ofinterventions for sexual problems, with 2.6% of records beforeimplementation and 3.0% of records after implementation (p = 0.803).Although 88.1% of survivors completed the screening items and 22.6%of the respondents listed one or more sexual problems, only 23.4% of thoselisting sexual problems had a documented intervention. This study showed thatscreening by self-report alone is insufficient to change clinical practice toimprove care for breast cancer survivors with sexual problems.

Substantial progress has been made by members of the Scientific Network onFemale Sexual Health and Cancer who developed a Sexual Symptom Checklist for Womenafter Cancer for use in the clinic to assess female oncology patients. They alsodeveloped patient handouts, including Vulvovaginal Dryness, Vulvovaginal Health, andLoss of Desire after Cancer Treatment. Finally, this Network provides information onhow to expand a referral network of specialized providers to address GSM[29]. Zhou et al.[30] provided tips andstrategies for primary care physicians to improve the management of sexual healthproblems in men and women; Boswell and Dizon [31] provided additional strategies for themanagement of sexual health problems for breast cancer survivors.

There is a need to provide continued medical education to disseminate thesestrategies that address the genitourinary health of postmenopausal cancer survivors.Health care professionals should be educated about current nonhormone treatments forGSM and when and how to initiate vaginal estrogens if needed. Studies should beconducted for intravaginal DHEA, ospemifene, and other upcoming therapies forvaginal atrophy suitable for breast cancer survivors. Advances in these areas withmore treatment options may increase the likelihood that genitourinary concerns willbe adequately addressed.

The volume of breast cancer survivorship clinic visit records that wereeligible for evaluation is a major strength of the study. Unfortunately, evaluationof these records revealed sparse documentation of GSM and treatment plans. Ourresults also showed that even when these symptoms were documented, health careprofessionals addressed them in fewer than 40% of patients. These findingsare consistent with previous findings of Chin et al. [32], which revealed that less than one-third ofpostmenopausal breast cancer survivors receiving endocrine therapy who reported GSMreceived some form of treatment for these symptoms. Ganz et al. [33] showed that treating GSM cangreatly reduce pain, improve sexual desire or pleasure, and ultimately improvequality of life for breast cancer survivors.

Since these results are from a single clinic, albeit a very large clinic,generalizability of the results is limited. However, these results are consistentwith other studies detailing the need for more assessments and treatments forgenitourinary problems in breast cancer patients [7, 34].Another possible limitation to our study is that some women with documented vaginalatrophy on examination were not troubled by the atrophy and did not report symptoms.It is very probable that some women with documented vaginal atrophy on examinationwere not sexually active. More than 50% of American women older than age 50years do not have a functional male sexual partner and tend to be less distressedabout GSM [7]. Anotherlimitation in this study is the lack of correlation between the status of ovarianfunction and the symptoms documented in the medical record. Determination of sexualactivity was listed for only 19% of patients, very little additionalinformation can be reliably learned from this variable.

Conclusion

Significant progress has been made with the development of GSM assessmenttools, patient handouts, and new treatments. Since most breast cancer survivorstoday live long, cancer-free lives, it is imperative to disseminate the progressmade in these areas for integration into the practices of providers who care forbreast cancer survivors. We must all screen for GSM, perform a proper evaluationwith a treatment plan and document this process for every patient.

Acknowledgments

Funding: This research was supported in part by a cancer preventionfellowship for Elena Sutherland; by National Cancer Institute grant R25E CA6452 forShine Chang, PhD, Principal Investigator; by the NIH/NCI under award numberR25 CA056452 and used the Cancer Prevention Research Training Program and thePatient-Reported Outcomes, Survey & Population Research (PROSPR) SharedResource; and by The University of Texas MD Anderson Cancer Center’s DuncanFamily Institute for Cancer Prevention and Risk Assessment, Clinical CancerPrevention Research Core.

We thank John Yick, Programmer Analyst II; W. Denise Rahming-Foster, Senior ResearchCoordinator; Elenita Tamez, Research Assistant; Carol Rosenblum, MPH, Core Manager,PROSPR, Department of Behavioral Science; and Debra Kelly, RN, OCN, Research Nurse,Department of Clinical Cancer Prevention at MD Anderson.

Footnotes

References