Journal Article 026 Factors Influencing Sexual Function and Its Trajectory Throughout Treatment and Survivorship in Premenopausal Women with Breast Cancer Get access S. Goldfarb, S. Goldfarb Search for other works by this author on: Oxford Academic Google Scholar S. Kamer, S. Kamer Search for other works by this author on: Oxford Academic Google Scholar R. Baser, R. Baser Search for other works by this author on: Oxford Academic Google Scholar J. Quistorff, J. Quistorff Search for other works by this author on: Oxford Academic Google Scholar N. Mannino, N. Mannino Search for other works by this author on: Oxford Academic Google Scholar M. Gemignani, M. Gemignani Search for other works by this author on: Oxford Academic Google Scholar M. Dickler M. Dickler Search for other works by this author on: Oxford Academic Google Scholar The Journal of Sexual Medicine, Volume 15, Issue Supplement_2, June 2018, Page S108, https://doi.org/10.1016/j.jsxm.2018.03.037 Published: 01 June 2018

Abstract Background: There is evidence that many cancer survivors live with sexual dysfunction that impacts their quality of life. It is essential to identify factors that influence the development of sexual symptoms and understand their trajectory over time in order to guide potential interventions to treat sexual dysfunction. Most studies to date have been cross-sectional and longitudinal studies are needed to understand the change of sexual function over time. This study aims to investigate and describe the factors that impact sexual health and dysfunction in breast cancer patients during and after their cancer treatment. Methods: A longitudinal prospective trial is being conducted in premenopausal women 18-50 years of age with breast cancer being treated at MSKCC. Validated questionnaires on sexual health and function were administered to patients after they were diagnosed with breast cancer, but before they initiated cancer treatment and at one-year follow-up after initiation of primary breast cancer therapy. Demographic and treatment information was also collected. The female sexual function index (FSFI) total and individual domain scores were calculated. Baseline and 12-month scores were compared using paired t-tests. Multivariable linear regression was used to assess individual variable associations with 12-month FSFI total scores controlling for baseline scores. Results: 127 women were eligible for analysis at the time of this abstract and had a median age of 41. Eighty-nine percent of tumors were estrogen receptor positive and 24.4% were HER-2 overexpressing. Eighty-nine percent of patients received chemotherapy, 61.4% received Tamoxifen and 23% received a LHRH agonist in combination with an aromatase inhibitor. Mean FSFI total score was 20.4 at baseline and 21.2 at 12-months post diagnosis. More than half of women met FSFI criteria for sexual dysfunction (FSFI score<26) at baseline (57.5%) and 12-months (55.2%). Small increases in sexual activity were seen with 27.8% of patients inactive at baseline compared to 23.2% at 12 months. Similarly, women engaging in sexual activity more than once a week increased from 9.5% to 16.8%. Desire (libido) significantly improved (p = 0.023) from baseline to 12 months. Controlling for baseline score, younger age and treatment with tamoxifen were associated with better 12-month scores (p < 0.05). Conclusions: Mean FSFI scores in our patients with breast cancer before and after treatment are consistent with scores from other studies looking at cancer patients and are lower than those of healthy women. In the peri-diagnosis period patients had worse sexual function that showed signs of small improvements 12 months after initiation of treatment, especially in the desire domain. Patients are being followed to see if sexual function continues to improve over time, to better understand the factors causing sexual dysfunction in these patients and to determine the best time to intervene in order to improve symptoms. Citation Format: Goldfarb SB, Kamer S, Baser R, Quistorff J, Gemignani ML, Dickler M. Improvement in sexual function over time in premenopausal women with breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-12-12.

Abstract 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.

Abstract 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<0.001) as did the Vulvar (VuAS) symptoms (mean 0.78 to 0.57, p=0.007). Only 17% (15/19) had normal vaginal moisture at Visit 1, compared to 29% (26/90) at the last visit (p=0.04). Sixty-seven percent (59/88) reported performing pelvic floor exercises a few times per week to daily at their last visit. FSFI arousal mean scores improved from the first (mean=2.30) to last visit (mean=2.93) (p=0.003), and urinary incontinence rates declined from the first (58%, 32/55) to last visit (24%, 13/55). 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<0.001). Confidence about future sexual activity increased from 43% (34/79) at Visit 1 to 67% (53/79) at the last visit (p<0.001). Concerns about sexual/vaginal health (scale of 0-10) decreased over time, with 54% (43/80) rating their concern at 9 or 10 at the first visit and 28% (22/80) at the last visit (p<0.001). 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 women's 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.

Hematopoietic stem cell transplantation (HSCT) is an efficacious treatment for many hematologic malignancies. However, the conditioning regimen of high-dose (HD) chemotherapy with or without total body irradiation (TBI) can be associated with neurotoxicity. In this prospective study, we used quantitative neuroimaging techniques to examine regional gray matter and ventricular volumes, and standardized neuropsychological tests to assess cognitive function before and 1 year after HSCT in 28 patients with hematologic malignancies and in ten healthy controls evaluated at similar intervals. Nineteen patients received conditioning treatment with HD chemotherapy alone and nine had both TBI and HD chemotherapy. There was a significant reduction in gray matter volume in the middle frontal gyrus bilaterally and in the left caudate nucleus in the patient group (all patients combined) but not among healthy controls over the 1-year follow-up period. There was a significant increase in left lateral ventricle volume and in total ventricle volume in the patient group, relative to healthy controls. Similar brain structural changes were seen for patients treated with HD chemotherapy alone. The neuropsychological results showed that 21 % of patients could be classified as impaired at baseline. The Reliable Change Index suggested no significantly different rates of cognitive decline between patients and healthy controls. The findings suggest that HSCT patients may be at an increased risk for developing regional brain volume loss, and that subgroups may experience cognitive dysfunction prior to and 1 year following the transplant.

Background: Genomic testing for common genetic variants associated with skin cancer risk could enable personalized risk feedback to motivate skin cancer screening and sun protection. Methods: In a cross-sectional study, we investigated whether skin cancer cognitions and behavioral factors, sociodemographics, family factors, and health information-seeking were related to perceived importance of learning about how (a) genes and (b) health habits affect personal health risks using classification and regression trees (CART). Results: The sample (n = 1,772) was collected in a large health maintenance organization as part of the Multiplex Initiative, ranged in age from 25–40, was 53% female, 41% Caucasian, and 59% African-American. Most reported that they placed somewhat to very high importance on learning about how genes (79%) and health habits (88%) affect their health risks. Social influence actors were associated with information-seeking about genes and health habits. Awareness of family history was associated with importance of health habit, but not genetic, information-seeking. Conclusions: The investment of family and friends in health promotion may be a primary motivator for prioritizing information-seeking about how genes and health habits affect personal health risks and may contribute to the personal value, or personal utility, of risk information. Individuals who seek such risk information may be receptive to interventions aimed to maximize the social implications of healthy lifestyle change to reduce their health risks.

11 Background: The risk of dying of cancer is highest in the first two years after a curative resection for gastric cancer. Therefore, the prognosis of patients who did not recur in the first two years is improved because they survived this critical period, a phenomenon called conditional survival. The US-derived gastric cancer nomogram predicts disease-specific survival (DSS) based on pathological variables. However, a disease-free interval after surgery, which improves the prognosis, is not captured by the nomogram. Therefore, it has only been used directly after surgery and not in the follow-up setting. The purposes of this study were to develop a conditional survival nomogram for 1, 2 and 3-year survivors (step 1) and to test if the introduction of follow-up variables would improve predictive accuracy of the nomogram in the follow-up setting (step 2).METHODSIn a combined US-Dutch population of 1642 patients who underwent an R0 resection for gastric cancer and for whom the old nomogram variables were available, a conditional survival nomogram based on the original variables was developed for one (N=1147), two (N=879) and three (N=721) year survivors (step 1). To improve predictive accuracy in the follow-up setting, weight loss, performance status (PS), hemoglobin (HGB), and albumin (ALB) at one year after resection were retrospectively collected and added to the baseline variables in a new nomogram (step 2).RESULTSThe conditional survival nomograms for 1, 2 and 3-year survivors (step 1) showed a high predictive accuracy in the calibration plots. Surviving one, two and three years shows a median improvement of 5-year DSS of 4%, 9% and 14% respectively. The introduction of weight loss, PS, HGB, and ALB at one year after surgery (step 2) did not improve this nomogram, but availability of these variables was limited.CONCLUSIONSA strongly predictive conditional survival nomogram was developed, giving an improved prognosis for 1, 2 and 3-year survivors of gastric cancer. Introduction of variables available at one year after resection did not further improve this nomogram. This might be caused by the limited availability of follow-up data, as well as the strong predictive accuracy of the original variables. No significant financial relationships to disclose.