A Non-Hormonal Approach to Preventing Vulvovaginal Atrophy from Aromatase Inhibitors (AIs)

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1 A Non-Hormonal Approach to Preventing Vulvovaginal Atrophy from Aromatase Inhibitors (AIs) Leslie R. Schover, PhD Department of Behavioral Science Funded by the Duncan Family Institute for Cancer Prevention & Risk Assessment

2 Nonadherence to AIs About half of women fail to take AIs for the full 5 years with >80% medication possession ratio Factors known to predict nonadherence: cost of medication, age over 65, more comorbidities; more patient-reported side effects, including myalgia, sexual dysfunction, hot flashes, fatigue SIDE EFFECTS ARE THE ONLY MODIFIABLE RISK FACTOR FOR NONADHERENCE

3 Sexual Dysfunction and AIs Publication N Months on AIs Assessment Questionnaire Low Sexual Desire Vaginal Dryness Dyspareunia Morales et al., 37 3 Item written for study 68% 50% 62% 2004 Cella et al., FACT-ES 34% 18% 17% Jones et al., Item written for study 58% 50% -- Oberguggenberger et al., 2011 Baumgart et al., 2011 Kyvernitakis et al., 2013 Aiello Bowles et al., 2012 Fallowfield et al., Unknown FACT-ES 51% 32% 16% 35 Unknown FACT-ES -- 42% 62% Item written for study 43%* 57% Unknown Item written for study 36% 36% FACT-ES 32% 17% 13%

4 Vulvovaginal atrophy and AIs Tamoxifen acts as weak estrogen in reproductive tract AIs prevent production of estrogen in tissues outside the ovary, exacerbating postmenopausal vaginal atrophy Over 50% of menopausal women without breast cancer have problems with vaginal dryness 59% enjoy sex less, 55% avoid sex

5 RETROSPECTIVE SURVEY Sent to 296 women from MD Anderson Breast Management System registry Started AI as first hormone TX for localized disease months ago 129 respondents (43.6% response rate) 81% non-hispanic white, mean age: 63.4 ± 8.7, 47% college degree, mean 26 months since cancer diagnosis, 73% married or in committed relationship

6 SEXUAL PROBLEMS 93% sexual dysfunction on FSFI, and 75% of these distressed about it 75% abnormal on MSIQ Only 52% sexually active when started AI, but 79% of them had new problems 24% discontinued having sex 52% took some action to solve a problem: 56% tried lubricant, 32% tried moisturizer, 39% asked doctor s advice

7 MEDICAL OPTIONS, N = 71 Option N % Stopped taking AI 1 1% Tried vaginal estrogen 4 6% Switched to another AI 4 6% Switched to tamoxifen 4 6%

8 TREATMENT ALGORITHM FOR VAGINAL LUBRICATION VAGINAL ATROPHY Use a vaginal moisturizer regularly 2-3 times a week Teach optimal lubricant techniques Find best option (silicone- vs. water-based) PELVIC MUSCLE CONTROL Teach Kegel exercises Use graduated vaginal dilators Transition with partner to vaginal penetration Use coital positions giving patient control CONSIDER ESTROGEN REPLACEMENT Choose lowest effective dose Ring or estradiol tablet vs. cream Check blood levels, especially if on aromatase inhibitors REFERRAL FOR SPECIALIZED SERVICES Pelvic floor biofeedback Intensive sex therapy Gynecological surgery Moisturizer options: Polycarbophil Hyaluronic Acid Prebiotic Lubricant options: Water-based Silicone-based Prebiotic Avoid perfumes, flavors, warming types, parabens, glycerin, high ph Carter J, Goldfrank D, Schover LR. J Sex Med. 2011;8:

9 SPECIFIC TECHNIQUES FOR SEXUAL PAIN Learn to control PC muscles: tense & relax Consider a set of graduated vaginal dilators Use coital positions that minimize deep penetration and give the woman control

10 Prospective, Randomized Trial Inclusion Criteria 168 women prescribed an AI for 1 st time in last 4 weeks before study consent Localized breast cancer, have a sexual partner, tried sex at least 1/ 6 months Literate in English, internet access Recruitment sites: Breast Medical Oncology clinic Radiation oncology (end of treatment) Surgical oncology (at referral to BMO)

11 DESIGN OF RANDOMIZED TRIAL: RECRUIT WEEK 0-4 OF FIRST AI 3 groups: Usual care plus handout on coping with AI side effects (myalgia, hot flashes, fatigue, bone density, vaginal dryness) Handout plus Tendrils web site and 4.5 hrs. phone counseling over 6 months), Supply of vaginal moisturizer, lubricant, vaginal dilator Tendrils group randomized to prebiotic vs. hyaluronic acid vaginal moisturizer

12 HANDOUT Importance of taking AIs regularly for full time period Coping with myalgias Coping with hot flashes Coping with fatigue Preventing loss of bone density Preventing vaginal dryness and pain

13 Primary and Secondary Endpoints for Randomized Trial Assessment points: Baseline, 6 months, 12 months Primary endpoint: Change in FSFI across time Secondary endpoints: Adherence to AIs, MSIQ, Distress about sexual problems, Satisfaction with sexual intervention, Menopause symptom ratings (21 items), daily exercise, vaginal ph from home kit

14 WILL VAGINAL REHAB WORK? Penile rehab after radical prostatectomy: promoting oxygenated blood flow may prevent atrophy and keep endothelial cells healthy Same neurotransmitters are involved in the vagina and vulva as in penis Expansion/lubrication is analogue of erection, but estrogen deprivation may limit benefits of sexual activity