Deborah J. Goldfrank

Simple Strategies for Vaginal Health Promotion in Cancer Survivors

INTRODUCTION With the population of cancer survivors nearing 12 million, an ever-increasing number of women will face vaginal health issues related to their disease and/or treatment. Abrupt menopause triggered by cancer treatment, for example, can cause intense and prolonged estrogen deprivation symptoms, including vaginal dryness and discomfort. Simple strategies to promote vaginal health are available. AIMS To provide a comprehensive overview of vaginal health issues caused by estrogen deprivation in female cancer patients/survivors and provide recommendations to identify, treat, and promote vaginal health. METHODS We describe a treatment algorithm, based on scientific literature and supported by clinical experience, found to be effective in treating these patients at two major cancer centers. We also provide examples of handouts for patient education on vaginal health promotion. MAIN OUTCOME MEASURES Evidence-based medicine and psychosocial literature, in addition to clinical experience at two major cancer centers. RESULTS Simple, non-hormonal interventions for sexual dysfunction are often overlooked. Several studies show that education on vaginal lubricants, moisturizers, and dilator use (as needed) can decrease the morbidity of vaginal atrophy. These studies also provide support for our clinical treatment recommendations. Our goal in this article is to increase awareness of these strategies and to provide assistance to general gynecologists and oncologists caring for cancer patients and survivors. CONCLUSIONS Dedicating a small amount of time to educate female cancer survivors about methods to promote vaginal health can result in the reduction or elimination of vaginal discomfort. Non-hormonal vaginal health strategies often appear sufficient to remedy these issues. However, large randomized trials are needed, varying the format and components of the treatment program and exploring efficacy in various groups of female cancer survivors.

Effect of Mammography on Breast Cancer Risk in Women with Mutations in BRCA1 or BRCA2

Women who carry mutations in either the BRCA1 or BRCA2 genes are at risk for early-onset breast cancer and are recommended to begin screening mammography at age 25 to 30 years. Results of in vitro and animal studies suggest that BRCA1/BRCA2 mutation carriers are hypersensitive to ionizing radiation and possibly to radiation-induced breast cancer. This study was undertaken to investigate the association of low-dose radiation exposure from mammograms with breast cancer status in BRCA mutation carriers. One hundred sixty-two female mutation carriers provided information at time of genetic testing about exposure to mammograms before enrollment. Using unconditional logistic regression, breast cancer status was not associated with number of mammograms received before diagnosis (affected women) or ascertainment [unaffected women; adjusted odds ratio (OR), 0.94; P = not significant]. A larger group of 213 women provided information about lifetime number of mammograms. There was no association between mammogram exposure and risk in the group as a whole (adjusted OR, 1.04; P = not significant), although there was a modest association in BRCA1 carriers (adjusted OR, 1.08; P = 0.03). These findings indicate that screening mammography is unlikely to be associated with a large increase in breast cancer risk in this population. (Cancer Epidemiol Biomarkers Prev 2006;15(11):2311–3)

Hereditary ovarian cancer in Ashkenazi Jews.

Ovarian cancer is the fourth leading cause of cancer deaths among American women. While women in both the Ashkenazi and non-Ashkenazi populations have an estimated 1.7% lifetime risk of acquiring malignancy, the proportion of hereditary ovarian cancer is much higher in the Ashkenazim. Most of this increased proportion of hereditary ovarian cancer risk is accounted for by inherited mutations in the BRCA1 and BRCA2 genes. In the Ashkenazi Jewish population, 29 to 41% of ovarian cancer is believed to be secondary to inheriting one of three founder mutations in BRCA1 and BRCA2, while only 10% of ovarian cancer is attributed to mutations of these genes in non-Ashkenazim. In the US population in general, it is estimated that between 1 out of 345 and 1 out of 1000 individuals carries a BRCA mutation, compared with approximately 1 in 40 individuals of Ashkenazi Jewish descent. The ovarian cancer risk up to age 70 associated with BRCA mutation carriers has been reported to be as high as 66% for BRCA1 and 27% for BRCA2mutation carriers. Ovarian cancer in Ashkenazi kindreds has served as a model for the study of the histopathology of inherited ovarian cancers as well as for the study of risk reduction and screening among all women at inherited risk of ovarian cancer.

Abstract P4-11-04: Program evaluation of a female sexual medicine and women's health program

Objectives: To evaluate the effectiveness of simple sexual/vaginal health treatment strategies in breast cancer patients/survivors seeking treatment at a female sexual medicine program, and to evaluate compliance and clinical outcomes. Methods: Demographics, medical information, and clinical assessments from 94 new visits with at least 1 follow-up from 09/12–10/14 were analyzed. The assessment form consists of a clinician evaluation with the Vaginal Assessment Scale (VAS) and Vulvar Assessment Scale (VuAS), and patient-reported outcomes (PROs) including the Sexual Activity Questionnaire (SAQ), Female Sexual Function Index (FSFI), and exploratory items. Compliance with treatment recommendations at the last visit were summarized. Changes from the first to last visit were compared with regard to clinical outcomes (e.g., vaginal pH, moisture), the VAS and VuAS, and the PROs (FSFI, SAQ, and confidence about future sexual activity). Results: The mean number of visits was 3 (range, 2-7). Mean age was 55.2 years (range, 29-48), 67% (n=63) were married or in an intimate relationship, and 94% (n=88) were menopausal. Seventy-seven percent (n=72) were on some form of active treatment, such as endocrine therapy (89%, 64/72). Only 15% (11/72) reported any hormonal supplementation (e.g., Vagifem). Treatment strategies included the use of vaginal moisturizers, lubricants with sexual activity, pelvic floor exercises, and dilator therapy. At last visit, 94% (80/85) of the women had complied with the clinical recommendation to moisturize 2 to 5+ times per week. Vaginal pH scores >6.5 declined from 31% (29/93) at Visit 1 to 20% (19/93) at the last visit (p=0.049). Vaginal (VAS) symptoms improved from the first to last visit (mean 1.2 to 0.59, p At Visit 1, 51% (43/85) of the women reported current sexual activity with a partner, and sexual activity rates increased over time—61% at last visit (52/85, p=0.049). FSFI total scores significantly improved from the first (mean=12.91) to last visit (mean=17.44) (p Conclusions: Breast cancer patients/survivors attending our female sexual medicine program reported improvement of vaginal and vulvar symptoms, sexual function and activity, and had clinical improvement over time on vaginal pH and moisture. Preliminary findings suggest that simple strategies, education, and support can improve vaginal/sexual health concerns in cancer survivorship. Citation Format: Carter J, Seidel B, Stabile C, Baser R, Eaton A, Goldfarb S, Goldfrank D. Program evaluation of a female sexual medicine and women9s health program. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-11-04.

Abstract P4-11-06: Feasibility of a non-hormonal vaginal moisturizer in postmenopausal cancer survivors

Objectives: This is a single-arm prospective longitudinal clinical trial investigating the feasibility of using a non-hormonal hyaluronic acid (HLA) vaginal gel (Hydeal-D) to improve estrogen deprivation vaginal health symptoms in postmenopausal women with a history of hormone receptor-positive cancer. Methods: Preliminary data from an ongoing clinical trial were examined. Demographics, medical information, and clinical assessment from breast cancer patients enrolled on study at baseline (n=23) and at 4-6 weeks (n=18) are presented. Eligible participants included those with a history of breast cancer receiving treatment with an aromatase inhibitor (AI) at the time of enrollment. Furthermore, participants could not have evidence of disease and had to have completed treatment for at least 3 months and no longer than 5 years (excluding AIs). Study participants were instructed to use HLA daily for 2 weeks, then 3 times per week for 12-14 weeks. Study outcomes include: pelvic exam results as recorded on a clinician evaluation form with the Vaginal Assessment Scale (VAS); patient-reported outcomes (PROs) of the Sexual Activity Questionnaire (SAQ), Sexual Self-Schema Scale, and Female Sexual Function Index (FSFI); PROMIS sexual function items; and exploratory items. Results: The mean age was 56 years (range, 42-75). Seventy-four percent (17/23) were married or living with a partner. Fifty-seven percent (13/23) reported sexual activity with a partner at baseline, which was 72% (13/18) at 4-6 weeks. On the VAS, 65% (15/23) reported symptoms of severe dryness at baseline and 61% (14/23) reported severe dyspareunia; these reported symptoms decreased to 6% (1/18) and 6% (1/18), respectively, at 4-6 weeks. Vaginal pH scores were greater than 6.5 in 30% (7/23) at baseline; by 4-6 weeks, only 22% (4/18) had a pH in this elevated range. At baseline, 78% (18/23) had minimal moisture and 22% (5/23) had no vaginal moisture seen on exam; by 4-6 weeks, 11% (2/18) had normal moisture and 89% (16/18) had minimal moisture. Pain with pelvic exams declined over time—87% (20/23) had pain at baseline, with 22% (5/23) rating it as severe, and 78% (14/18) had pain at 4-6 weeks, with none of the women rating their pain as severe. Forty-eight percent (11/23) indicated confidence about future sexual activity at baseline, which was 56% (10/18) at 4-6 weeks. Level of concern about sexual/vaginal health was measured on a scale of 0-10, with greatest concern rated as a 9 or 10. Sixty-one percent (14/23) of the women fell into this range at baseline; the percentage decreased to 28% (5/18) at 4-6 weeks. Conclusions: Preliminary findings suggest that an HLA vaginal gel may improve vaginal/sexual health issues and concerns of breast cancer survivors both in their perceived symptoms and on clinical exam; however, further study is needed to examine if these promising trends continue over time and to determine the ideal frequency of product administration. Citation Format: Carter J, Seidel B, Stabile C, Dickler M, Goldfrank D, Baser R, Goldfarb S. Feasibility of a non-hormonal vaginal moisturizer in postmenopausal cancer survivors. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-11-06.

Baseline characteristics and concerns of cancer patients/survivors seeking treatment at a female sexual medicine program

Purpose The purpose of this study is to characterize patients seeking treatment at a Female Sexual Medicine and Women’s Health Program and examine their sexual/vaginal health issues.