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The Effects of a 17 beta-estradiol, Softgel, Vaginal Insert on Vulvar and Vaginal Atrophy (VVA), Including Moderate to Severe Dyspareunia and Vaginal Dryness in Postmenopausal Women > 60 Years of Age [Meeting Abstract]

Goldstein, Steven R.; Archer, David F.; Graham, Shelli; Bernick, Brian; Mirkin, Sebastian
ISI:000594858400087
ISSN: 1072-3714
CID: 4729412

Abnormal Uterine Bleeding

Khafaga, Ashraf; Goldstein, Steven R
Abnormal uterine bleeding (AUB) is a common medical problem, with a direct influence on women's quality of life, utilization of health care resources, and costs. AUB in women older than 40 years and especially in postmenopausal women requires a prompt and efficient evaluation, mainly to exclude the presence of malignant or premalignant lesions of the endometrium. Cancer of the endometrium is the most common gynecologic malignancy, with an incidence in the United States of more than 60,000 cases and mortality estimated at 10,000 women annually. This article outlines the role of transvaginal ultrasonography in the evaluation of cases of AUB.
PMID: 31677744
ISSN: 1558-0474
CID: 4177982

O-RADS US Risk Stratification and Management System: A Consensus Guideline from the ACR Ovarian-Adnexal Reporting and Data System Committee

Andreotti, Rochelle F; Timmerman, Dirk; Strachowski, Lori M; Froyman, Wouter; Benacerraf, Beryl R; Bennett, Genevieve L; Bourne, Tom; Brown, Douglas L; Coleman, Beverly G; Frates, Mary C; Goldstein, Steven R; Hamper, Ulrike M; Horrow, Mindy M; Hernanz-Schulman, Marta; Reinhold, Caroline; Rose, Stephen L; Whitcomb, Brad P; Wolfman, Wendy L; Glanc, Phyllis
The Ovarian-Adnexal Reporting and Data System (O-RADS) US risk stratification and management system is designed to provide consistent interpretations, to decrease or eliminate ambiguity in US reports resulting in a higher probability of accuracy in assigning risk of malignancy to ovarian and other adnexal masses, and to provide a management recommendation for each risk category. It was developed by an international multidisciplinary committee sponsored by the American College of Radiology and applies the standardized reporting tool for US based on the 2018 published lexicon of the O-RADS US working group. For risk stratification, the O-RADS US system recommends six categories (O-RADS 0-5), incorporating the range of normal to high risk of malignancy. This unique system represents a collaboration between the pattern-based approach commonly used in North America and the widely used, European-based, algorithmic-style International Ovarian Tumor Analysis (IOTA) Assessment of Different Neoplasias in the Adnexa model system, a risk prediction model that has undergone successful prospective and external validation. The pattern approach relies on a subgroup of the most predictive descriptors in the lexicon based on a retrospective review of evidence prospectively obtained in the IOTA phase 1-3 prospective studies and other supporting studies that assist in differentiating management schemes in a variety of almost certainly benign lesions. With O-RADS US working group consensus, guidelines for management in the different risk categories are proposed. Both systems have been stratified to reach the same risk categories and management strategies regardless of which is initially used. At this time, O-RADS US is the only lexicon and classification system that encompasses all risk categories with their associated management schemes.
PMID: 31687921
ISSN: 1527-1315
CID: 4172482

Simple Adnexal Cysts: SRU Consensus Conference Update on Follow-up and Reporting

Levine, Deborah; Patel, Maitray D; Suh-Burgmann, Elizabeth J; Andreotti, Rochelle F; Benacerraf, Beryl R; Benson, Carol B; Brewster, Wendy R; Coleman, Beverly G; Doubilet, Peter M; Goldstein, Steven R; Hamper, Ulrike M; Hecht, Jonathan L; Horrow, Mindy M; Hur, Hye-Chun; Marnach, Mary L; Pavlik, Ed; Platt, Lawrence D; Puscheck, Elizabeth; Smith-Bindman, Rebecca; Brown, Douglas L
This multidisciplinary consensus update aligns prior Society of Radiologists in Ultrasound (SRU) guidelines on simple adnexal cysts with recent large studies showing exceptionally low risk of cancer associated with simple adnexal cysts. Most small simple cysts do not require follow-up. For larger simple cysts or less well-characterized cysts, follow-up or second opinion US help to ensure that solid elements are not missed and are also useful for assessing growth of benign tumors. In postmenopausal women, reporting of simple cysts greater than 1 cm should be done to document their presence in the medical record, but such findings are common and follow-up is recommended only for simple cysts greater than 3-5 cm, with the higher 5-cm threshold reserved for simple cysts with excellent imaging characterization and documentation. For simple cysts in premenopausal women, these thresholds are 3 cm for reporting and greater than 5-7 cm for follow-up imaging. If a cyst is at least 10%-15% smaller at any time, then further follow-up is unnecessary. Stable simple cysts at initial follow-up may benefit from a follow-up at 2 years due to measurement variability that could mask growth. Simple cysts that grow are likely cystadenomas. If a previously suspected simple cyst demonstrates papillary projections or solid areas at follow-up, then the cyst should be described by using standardized terminology. These updated SRU consensus recommendations apply to asymptomatic patients and to those whose symptoms are not clearly attributable to the cyst. These recommendations can reassure physicians and patients regarding the benign nature of simple adnexal cysts after a diagnostic-quality US examination that allows for confident diagnosis of a simple cyst. Patients will benefit from less costly follow-up, less anxiety related to these simple cysts, and less surgery for benign lesions.
PMID: 31549945
ISSN: 1527-1315
CID: 5111302

1829 Current State of Pelvic Ultrasound for Endometriosis: Results of an International Survey [Meeting Abstract]

Leonardi, M; Goldstein, S R; Benacceraf, B; Condous, G
Study Objective: Compare how obstetrician/gynecologists (OBGYNs) in four English-speaking regions (Australia/New Zealand (ANZ), Canada (CAN), United Kingdom (UK), and United States of America (USA)) think of and use transvaginal ultrasound (TVS) in the diagnosis and management of endometriosis.
Design(s): An online survey.
Setting(s): Between May and November 2018, the online survey was distributed in ANZ, CAN, UK and USA. Patients or Participants: Independently-practicing OBGYNs belonging to the Royal Australian New Zealand College of Obstetricians and Gynaecologists, Society of Obstetricians and Gynaecologists of Canada, American College of Obstetricians and Gynecologists and British Society for Gynaecological Endoscopy.
Intervention(s): Questions on the diagnosis and management of endometriosis, with particular emphasis on the utility of ultrasound.
Measurements and Main Results: Questions were designed by the study team and piloted. The formal invitation was distributed via email through the respective societies with a reminder at two weeks. Responses were analyzed quantitatively using descriptive and inferential statistics. Missing data were excluded from the analysis. 1140 OBGYNs responded. Regional respondent number and response rate are as follows: ANZ 449(20.4%), CAN 156(10.4%), UK: 95(14.2%), US: 440(1.4%). 65 respondents were disqualified based on practice composition. Differences in the utilization of the deep endometriosis (DE) TVS were noted, with ANZ members seemingly adopting the technology more readily. Similarly, ANZ respondents had the highest rates of expectation/belief in the utility of TVS for endometriosis. A high rate of disbelief of TVS utility exists broadly. Lastly, US members ranked endometriomas as the most important feature of endometriosis predict on imaging preoperatively, whereas UK members ranked rectovaginal septum and ANZ/CAN members ranked bowel DE as most important, respectively.
Conclusion(s): Regional differences were noted in the awareness of utility and adoption of TVS for diagnosis of endometriosis. This study should serve as an important stepping stone in raising awareness and introducing educational campaigns to improve the utility and adoption of this essential preoperative and diagnostic tool.
Copyright
EMBASE:2003345999
ISSN: 1553-4669
CID: 4137402

Ospemifene for the treatment of menopausal vaginal dryness, a symptom of the genitourinary syndrome of menopause

Archer, David F; Simon, James A; Portman, David J; Goldstein, Steven R; Goldstein, Irwin
Introduction: Vulvovaginal atrophy (VVA), a component of the genitourinary syndrome of menopause, is a progressive condition due to decline in estrogen leading to vaginal and vulvar epithelial changes. Accompanying symptoms of dryness, irritation, burning, dysuria, and/or dyspareunia have a negative impact on quality of life. Ospemifene is a selective estrogen receptor modulator (SERM) approved by the FDA for moderate to severe dyspareunia and vaginal dryness due to postmenopausal VVA. Areas covered: PubMed was searched from inception to March 2019 with keywords ospemifene and vulvar vaginal atrophy to review preclinical and clinical data describing the safety and efficacy of ospemifene for vaginal dryness and dyspareunia due to VVA. Covered topics include efficacy of ospemifene on vaginal cell populations, vaginal pH, and most bothersome VVA symptoms; imaging studies of vulvar and vaginal tissues; effects on sexual function; and safety of ospemifene on endometrium, cardiovascular system, and breast. Expert opinion: Ospemifene is significantly more effective than placebo in all efficacy analyses studied, working through estrogen receptors and possibly androgen receptors. Safety as assessed by adverse events was generally comparable to that with placebo and to other SERMs, and/or adverse events were not clinically meaningful. No cases of endometrial or breast cancer were reported.
PMID: 31526199
ISSN: 1744-8417
CID: 4097932

SERMs: past and present [Meeting Abstract]

Goldstein, S
SERMs are selective estrogen receptor modulators. Actually, clomiphene citrate was the first SERM, although for all practical purposes, tamoxifen, introduced in the late 1970's, is thought of as the first SERM. It results in increased survival and disease-free survival in women with breast cancer. It is the most widely prescribed anti-neoplastic drug worldwide. It has some untoward effects in the uterus and venous system. It is approved for breast cancer prevention as well. Raloxifene is approved for prevention and treatment of osteoporosis as well as breast cancer prevention. It is also thrombogenic in the venous system but does not cause pathologic changes like tamoxifen in the endometrium. TSEC (tissue specific estrogen complex)is a new concept of combining estrogen with a SERM instead of progestin for endometrial protection. Currently, the combination of conjugated estrogen and bazedoxifene is approved to treat vasomotor symptoms and prevent osteoporosis. Attempts to combine other estrogens with other SERMs have not been successful and such trials were halted because of an increase in endometrial hyperplasia.
EMBASE:2001868102
ISSN: 1873-4111
CID: 3900652

Modern evaluation of abnormal uterine bleeding [Meeting Abstract]

Goldstein, S
Abnormal uterine bleeding in women older than age 40 years, and certainly in menopausal patients, mandates evaluation, mainly to exclude cancer and hyperplasia, but also to better diagnose the source of the bleeding to appropriately manage the patient. In the past, dilation and curettage was the mainstay of diagnosis. This gave way to in-office suction pump-generated biopsies. Most recently, disposable biopsy instruments with their own internal piston to generate suction have become the standard of care. Rarely has such a technique received such widespread acceptance with such limited validation. Transvaginal ultrasonography, when technically feasible, is a noninvasive way to image the endometrial cavity. Saline-infusion sonohysterography is a subset of transvaginal ultrasonography reserved for patients in whom an adequate endometrial echo is not seen or when an endometrial echo is seen but not sufficiently thin. Appropriate understanding and use of transvaginal ultrasonography and addition of sonohysterography when necessary can allow a clinical algorithm that can triage patients with abnormal uterine bleeding to (1)no anatomic pathology best treated expectantly; (2)a global endometrial process, in which case random blind endometrial sampling is appropriate; or (3)a focal endometrial abnormality in which case endometrial sampling should be done with the visualization offered by hysteroscopy. Newer disposable office hysteroscopes finally allow office hysteroscopy to be done as a truly "point-of-care option." Finally, the incidence of thick endometrial echo found incidentally in postmenopausal women with no bleeding is extremely high (10-17%)and should not trigger automatic invasive endometrial evaluation.
EMBASE:2001868140
ISSN: 1873-4111
CID: 3900642

Increased Incidence of Endometrial Cancer Following the Women's Health Initiative: An Assessment of Risk Factors

Constantine, Ginger D; Kessler, Grant; Graham, Shelli; Goldstein, Steven R
BACKGROUND:The Surveillance, Epidemiology, and End Result (SEER) database shows a variable increase in endometrial cancer incidence over time. The objective of this review was to examine published endometrial cancer rates and potential etiologies. METHODS:Endometrial cancer incidence was obtained from the SEER Program database from 1975 through 2014, and a test for trend in incidence was calculated. Changes in risk factors thought to be associated with endometrial cancer, including age, obesity, diabetes, diet and exercise, reproductive factors, and medications (hormone therapy [HT] including Food and Drug Administration [FDA]-approved and non-FDA-approved [compounded] estrogens and progestogens, tamoxifen, and hormonal contraceptives) were found through PubMed searches. Temporal trends of risk factors were compared with endometrial cancer trends from SEER. RESULTS:Although endometrial cancer rates were constant from 1992 to 2002 (women 50-74 years of age), they increased 2.5% annually with a 10% increase from 2006 to 2012 (trend test 0.82). Use of approved prescription estrogen-progestogen combination products decreased after the publication of the Women's Health Initiative (WHI) data, whereas other risk factors either remained constant or decreased during the same time; however, compounded bioidentical HT (CBHT) use increased coincident with the endometrial cancer increase. CONCLUSION/CONCLUSIONS:Endometrial cancer rate increases after the first publication of WHI data in 2002 may be associated with the decreased use of approved estrogen-progestogen therapy, the increase in CBHT use, and the prevalence of obesity and diabetes; potential relationships require further evaluation.
PMID: 30484734
ISSN: 1931-843x
CID: 3689902

Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial

Archer, David F; Goldstein, Steven R; Simon, James A; Waldbaum, Arthur S; Sussman, Steven A; Altomare, Corrado; Zhu, Julie; Yoshida, Yuki; Schaffer, Sam; Soulban, Graziella
OBJECTIVE:To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA). METHODS:This 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VVA and moderate to severe vaginal dryness as their most bothersome symptom to daily oral ospemifene 60 mg or placebo. Coprimary efficacy endpoints included changes from baseline to week 12 in percentages of vaginal parabasal and superficial cells, vaginal pH, and vaginal dryness severity with ospemifene versus placebo; other secondary endpoints were evaluated (weeks 4, 8, and 12). Safety was assessed by treatment-emergent adverse events (TEAEs) and endometrial biopsies. RESULTS:Women (n = 631; ospemifene [n = 316], placebo [n = 315]) had a mean age of 59.8 years, a mean body mass index of 27.2 kg/m, and most were white. Ospemifene significantly improved (P < 0.0001) the percentages of parabasal and superficial cells, vaginal pH, and severity of vaginal dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia (P < 0.001), maturation value (P < 0.0001), and the Female Sexual Function Index (P < 0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; P < 0.0001) or were satisfied (49.2% vs 33.8%; P = 0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed. CONCLUSIONS:Ospemifene was effective and well tolerated for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.
PMID: 30694917
ISSN: 1530-0374
CID: 3626612