Subpopulation Of Women Research Articles

Intersecting gender inequalities in non-communicable disease risk factors in Kerala: A primary study

Abstract Evidence globally and in India indicates intersecting gender inequalities in Non-Communicable Diseases (NCDs) risk factors. These are understudied in Kerala, which is at an advanced stage of an epidemiological transition. We estimated sex differences in self-reported prevalence and screening coverage of blood pressure (BP) and blood glucose (BG) grouped by the socio-economic status. A multistage cluster random sampling survey of 3398 women and 2982 men was conducted in 4 districts of Kerala from July to October 2019. Descriptive, Relative Concentration Index (RCI) for age, wealth and education and Population Attributed Fraction (PAF) for caste/tribal groups and religion were computed using Stata 12 and WHO's Health Equity Assessment Toolkit (HEAT) Plus. More women reported BP and BG screening than men (BP - W: 90.3%; 95%CI: (89.1, 91.4) vs M: 80.8%; 95%CI: (78.5, 82.9); BG- W: 86.2%; 95%CI: 84.9, 87.4 vs M: 78.3%; (95%CI: 75.9, 80.6)).BP prevalence was significantly higher among women than men (BP - W: 11.2%; 95%CI: (9.0, 13.9) vs M: 7.9%; 95%CI: (6.6, 9.6). BP screening was concentrated among less educated women (WRCI: -0.2: 95%CI: -0.2, -0.1), older (WRCI: 0.3: 95%CI: 0.2, 0.4; MRCI: 0.5: 95%CI: 0.4,0.7) and wealthier populations (WRCI: 0.1: 95%CI: 0.03, 0.2; MRCI: 0.3: 95%CI: 0.1, 0.4).High BP was concentrated among more educated women (WRCI: 0.9: 95%CI: 0.1, 1.6) and less educated men (MRCI: -1.6: 95%CI: -2.6, -0.6). High BG was concentrated among less educated women (WRCI: -1.6: 95%CI: -2.4, -0.8) and more educated men (MRCI: 0.9: 95%CI: -0.1, -1.6). Religion inequality in high BG among women was -19.1(95%CI:-28.0, -10.2).We found distinct patterns of sex related inequalities in NCD risk factors in Kerala. There is a need for greater screening among men but also sub populations of women who may be under-served by screening services. These patterns require further exploration to understand contexts and pathways to ensure program design leaves no one behind. Key messages Intersecting gender inequalities in prevalence and screening coverage of NCD risk factors in Kerala, India. NCD screening should reach all gender equitably despite of their social economic status.

Intimate Partner Violence, HIV Pre-Exposure Prophylaxis (PrEP) Acceptability, and Attitudes About Use: Perspectives of Women Seeking Care at a Family Planning Clinic.

Pre-exposure prophylaxis (PrEP) presents an opportunity to expand prevention options for women at risk for HIV infection. Yet, women's PrEP use remains low and relatively little is known about PrEP acceptability and attitudes among a sub-population of women at risk for HIV-those experiencing intimate partner violence (IPV). A cross-sectional survey included closed and open-ended questions to assess IPV, PrEP acceptability, and attitudes about PrEP use among women seeking care at an urban family planning clinic in Pittsburgh, Pennsylvania (N = 145). Approximately 70% of women reported being willing to use PrEP with the key reasons for potential use including previous STI diagnosis, inconsistent condom use, and lack of or dishonest conversations with partners. Among women reporting recent IPV (41%), potential barriers to PrEP included concerns around drug effects, access/affordability, and adherence. Over half of women reporting recent IPV reported concerns around partner reaction impacting potential PrEP use. Results from this mixed-methods study highlight the need for a woman-centered PrEP intervention that uniquely includes awareness raising and understanding of PrEP for women, as well as reflects the context of IPV in decision-making and care.

Examining adherence barriers among women with HIV to tailor outreach for long-acting injectable antiretroviral therapy

BackgroundLong-acting (LA) injectable antiretroviral therapy (ART) has been found non-inferior to daily oral ART in Phase 3 trials. LA ART may address key barriers to oral ART adherence and be preferable to daily pills for some people living with HIV. To date, women have been less represented than men in LA ART research. Using longitudinal data from the Women’s Interagency HIV Study (WIHS) cohort of women living with HIV in the United States, we examined barriers and facilitators of daily oral ART adherence that may be related to or addressed by LA ART.MethodsWe conducted a secondary analysis of WIHS cohort data from 1998 to 2017 among participants seen for at least 4 visits since 1998 who reported using ART at least once (n = 2601). Two dichotomous outcomes, patient-reported daily oral ART adherence and viral suppression were fit using generalized linear models, examining the role of socio-demographic and structural factors.ResultsAt study enrollment, the median age was 40.5 years, 63% of participants were African American and 22% were Latina. The majority (82%) reported taking ART more than 75% of the time and 53% were virally suppressed. In multivariate analysis, several sub-groups of women had lower odds of reported adherence and viral suppression: 1) younger women (adherence aOR: 0.71; viral suppression aOR: 0.63); 2) women who inject drugs (adherence aOR: 0.38; viral suppression aOR: 0.50) and those with moderate (adherence aOR: 0.59; viral suppression aOR: 0.74) and heavy alcohol consumption (adherence aOR: 0.51; viral suppression aOR: 0.69); 3) those with depressive symptoms (adherence aOR: 0.61; viral suppression aOR: 0.76); and 4) those with a history of going on and off ART (adherence aOR: 0.62, viral suppression aOR: 0.38) or changing regimens (adherence aOR: 0.83, viral suppression aOR: 0.56).ConclusionsCurrent injectable contraceptive users (vs. non-users) had greater odds of oral ART adherence (aOR: 1.87) and viral suppression (aOR: 1.28). Findings identify profiles of women who may benefit from and be interested in LA ART. Further research is warranted focused on the uptake and utility of LA ART for such key subpopulations of women at high need for innovative approaches to achieve sustained viral suppression.

Association of Event-Free and Distant Recurrence–Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer

Pathologic complete response (pCR) is a known prognostic biomarker for long-term outcomes. The I-SPY2 trial evaluated if the strength of this clinical association persists in the context of a phase 2 neoadjuvant platform trial. To evaluate the association of pCR with event-free survival (EFS) and pCR with distant recurrence-free survival (DRFS) in subpopulations of women with high-risk operable breast cancer treated with standard therapy or one of several novel agents. Multicenter platform trial of women with operable clinical stage 2 or 3 breast cancer with no prior surgery or systemic therapy for breast cancer; primary tumors were 2.5 cm or larger. Women with tumors that were ERBB2 negative/hormone receptor (HR) positive with low 70-gene assay score were excluded. Participants were adaptively randomized to one of several different investigational regimens or control therapy within molecular subtypes from March 2010 through 2016. The analysis included participants with follow-up data available as of February 26, 2019. Standard-of-care neoadjuvant therapy consisting of taxane treatment with or without (as control) one of several investigational agents or combinations followed by doxorubicin and cyclophosphamide. Pathologic complete response and 3-year EFS and DRFS. Of the 950 participants (median [range] age, 49 [23-77] years), 330 (34.7%) achieved pCR. Three-year EFS and DRFS for patients who achieved pCR were both 95%. Hazard ratios for pCR vs non-pCR were 0.19 for EFS (95% CI, 0.12-0.31) and 0.21 for DRFS (95% CI, 0.13-0.34) and were similar across molecular subtypes, varying from 0.14 to 0.18 for EFS and 0.10 to 0.20 for DRFS. The 3-year outcomes from the I-SPY2 trial show that, regardless of subtype and/or treatment regimen, including 9 novel therapeutic combinations, achieving pCR after neoadjuvant therapy implies approximately an 80% reduction in recurrence rate. The goal of the I-SPY2 trial is to rapidly identify investigational therapies that may improve pCR when validated in a phase 3 confirmatory trial. Whether pCR is a validated surrogate in the sense that a therapy that improves pCR rate can be assumed to also improve long-term outcome requires further study. ClinicalTrials.gov Identifier: NCT01042379.

Abstract B46: Trends in stage at diagnosis for ovarian, fallopian tube, and serous primary peritoneal cancers, 2004–2015

Abstract Introduction: Timely diagnosis is key to reducing distant stage ovarian cancer. The purpose of this study was to examine trends in the proportion of women diagnosed with ovarian cancer by stage and predictors of distant stage diagnosis, comparing two time periods: 2004–2009 and 2010–2015. Methods: We analyzed newly diagnosed malignant ovarian, fallopian tube, and serous primary peritoneal cancers reported to population-based central cancer registries funded by CDC’s National Program of Cancer Registries (NPCR) or the NCI’s Surveillance, Epidemiology, and End Results Program (SEER). We conducted a descriptive analysis examining demographic and clinical characteristics by SEER summary stage at diagnosis (localized, regional, distant, unstaged). We compared women diagnosed between 2004–2009 and 2010–2015 by stage, histology, race/ethnicity, and stage. We built a logistic regression model to examine predictors of a distant stage diagnosis. Results: In 2004, 18% of women were diagnosed at regional stage, which increased to 23% in 2015. There was a slight increase in local stage tumors (14% to 15%). Unstaged tumors declined from 10% to 7% over the same time period, and distant stage tumors declined from 58% to 56%. Only American Indian/Alaska Native (AI/AN) women did not experience a statistically significant decline in distant stage tumors over the two time periods. A greater proportion of serous tumors were diagnosed in the 2010–2015 time period compared to the first (53.2% vs. 50.5%). Predictors of distant stage diagnosis included being diagnosed between 2004–2009, older age (those over age 65), residence in the southern and western U.S., black race, serous histology, and residence in high-poverty census tracts. Conclusion: In the 2010–2015 time period, a smaller proportion of ovarian cancers were distant or unstaged at diagnosis compared to 2004–2009, and most subpopulations of women experienced a decline in distant ovarian cancer. More efforts are needed to increase timely diagnosis and access to specialized care in the southern and western US, high-poverty areas, and among black women. Citation Format: Julie S. Townsend, Mary C. Puckett, Sherri L. Stewart. Trends in stage at diagnosis for ovarian, fallopian tube, and serous primary peritoneal cancers, 2004–2015 [abstract]. In: Proceedings of the AACR Special Conference on Advances in Ovarian Cancer Research; 2019 Sep 13-16, 2019; Atlanta, GA. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(13_Suppl):Abstract nr B46.

Estimates of female genital mutilation/cutting in the Netherlands: a comparison between a nationwide survey in midwifery practices and extrapolation-model

BackgroundOwing to migration, female genital mutilation or cutting (FGM/C) has become a growing concern in host countries in which FGM/C is not familiar. There is a need for reliable estimates of FGM/C prevalence to inform medical and public health policy. We aimed to advance methodology for estimating the prevalence of FGM/C in diaspora by determining the prevalence of FGM/C among women giving birth in the Netherlands.MethodsTwo methods were applied to estimate the prevalence of FGM/C in women giving birth: (I) direct estimation of FGM/C was performed through a nationwide survey of all midwifery practices in the Netherlands and (II) the extrapolation model was adopted for indirect estimation of FGM/C, by applying population-based-survey data on FGM/C in country of origin to migrant women who gave birth in 2018 in the Netherlands.ResultsA nationwide survey among primary care midwifery practices that provided care for 57.5% of all deliveries in 2018 in the Netherlands, reported 523 cases of FGM/C, constituting FGM/C prevalence of 0.54%. The indirect estimation of FGM/C in an extrapolation-model resulted in an estimated prevalence of 1.55%. Possible reasons for the difference in FGM/C prevalence between direct- and indirect estimation include that the midwives were not being able to recognize, record or classify FGM/C, referral to an obstetrician before assessing FGM/C status of women and selective responding to the survey. Also, migrants might differ from people in their country of origin in terms of acculturation toward discontinuation of the practice. This may have contributed to the higher indirect-estimation of FGM/C compared to direct estimation of FGM/C.ConclusionsThe current study has provided insight into direct estimation of FGM/C through a survey of midwifery practices in the Netherlands. Evidence based on midwifery practices data can be regarded as a minimum benchmark for actual prevalence among the subpopulation of women who gave birth in a given year.

Age Moderates the Association Between Microfinance Membership and Physical Abuse, Relationship Power, and Transactional Sex in Haitian Women.

Microfinance interventions may have differential effects on relationship dynamics among subpopulations of women. We estimated the association between microfinance participation duration and physical abuse, relationship power, and transactional sex in a sample of Haitian women (n = 304). Furthermore, we tested for moderation by age. In older women, microfinance tended to be associated with reduced risk of violence, low relationship power, and transactional sex. These associations were not observed for younger women. Thus, older Haitian women may benefit from microfinance in ways that younger women do not. Future studies should examine whether additional training and resources could improve outcomes in younger women.

Guideline No. 398: Progesterone for Prevention of Spontaneous Preterm Birth.

To assess the benefits and risks of progesterone therapy for women at increased risk of spontaneous preterm birth (SPB) and to make recommendations for the use of progesterone to reduce the risk of SPB and improve postnatal outcomes. To administer or withhold progesterone therapy for women deemed to be at high risk of SPB. Preterm birth, neonatal morbidity and mortality, and postnatal outcomes including neurodevelopmental outcomes. Maternity care providers, including midwives, family physicians, and obstetricians. Pregnant women at increased risk of SPB. Medline, PubMed, EMBASE, and the Cochrane Library were searched from inception to October 2018 for medical subject heading (MeSH) terms and keywords related to pregnancy, preterm birth, previous preterm birth, short cervix, uterine anomalies, cervical conization, neonatal morbidity and mortality, and postnatal outcomes. This document represents an abstraction of the evidence rather than a methodological review. This guideline was reviewed by the Maternal-Fetal Medicine Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) and approved by the SOGC Board of Directors. Therapy with progesterone significantly reduces the risk of SPB in a subpopulation of women at increased risk. Although this therapy entails a cost to the woman in addition to the discomfort associated with its use, no other adverse effects to the mother or the baby have been identified. RECOMMENDATIONS (GRADE RATINGS IN PARENTHESES).

A Research Note on the Convergence of Childlessness Rates Between Women with Secondary and Tertiary Education in the United States.

A gap in childlessness rates between women with and without tertiary education in low-fertility settings has been well documented by scholars. However, in the United States, high rates of childlessness are declining for women with tertiary education. Will this current trend lead to a closing of the gap in childlessness across educational subgroups in this country? We answer this question using data from the Current Population Survey from 1976 through 2018. We present population-level trends in permanent childlessness by level of education and estimate the differences in the prevalence of childlessness across educational subgroups. Our findings indicate that the rates of childlessness for women aged 40-44 with tertiary education in the United States are the lowest they have been in over three decades and that rates of childlessness are converging among women with secondary and tertiary education. The declines in childlessness rates and the convergence in childlessness rates between women with secondary and tertiary education are observed for all of the three largest race/ethnicity sub-populations of American women: non-Hispanic white, non-Hispanic black, and Hispanic women. This report contributes to the emerging literature on the convergence of childlessness rates across sub-populations of women with different levels of educational attainment, which questions the well-established observation that there is a positive relationship between education and childlessness.

Elevated plasma homocysteine and cysteine are associated with endothelial dysfunction across menopausal stages in healthy women.

Hyperhomocysteinemia is associated with endothelial dysfunction and increased cardiovascular disease (CVD). We determined whether elevated homocysteine (Hcy) and markers of Hcy metabolism were associated with the previously reported endothelial dysfunction across stages of the menopause transition. Brachial artery flow-mediated dilation (FMD) and plasma concentrations of Hcy, cysteine, and methionine were measured in healthy women (n = 128) 22-70 yr of age categorized as premenopausal (n = 35), perimenopausal (early: n = 16; late: n = 21), and postmenopausal (early: n = 21; late: n = 35). Dietary intake of micronutrients involved in Hcy metabolism (e.g., vitamins B6, B12, folate) was assessed in a subpopulation of women. Hcy and cysteine concentrations were progressively higher, and methionine was progressively lower across menopausal stages (all P < 0.005). The higher Hcy and cysteine concentrations correlated with lower circulating estradiol levels (r = -0.49 and -0.50, respectively, both P < 0.001). FMD was inversely correlated with Hcy (r = -0.25, P = 0.004) and cysteine (r = -0.39, P < 0.001) and positively correlated with methionine concentrations (r = 0.25, P = 0.005). Dietary intake of vitamins B6 and B12 (both P < 0.05) were lower in postmenopausal women. Vitamin B12 intake correlated with FMD (r = 0.22, P = 0.006). These data suggest that declines in estradiol across stages of the menopause transition may lead to elevations in Hcy and cysteine that may contribute to endothelial dysfunction in postmenopausal women. Future studies should examine whether targeting Hcy metabolism during the perimenopausal to early postmenopausal period with interventions, including diet, attenuates or reverses the decline in endothelial function in women. NEW & NOTEWORTHY Declines in circulating estradiol across the stages of the menopausal transition may lead to elevations in Hcy and cysteine concentrations that may contribute to endothelial dysfunction. Abnormalities in the Hcy metabolic pathways, possibly related to dietary deficiencies of vitamins B12 and B6 and folate, may contribute to elevations in Hcy and cysteine concentrations. Findings also suggest that higher cysteine levels may be more damaging to the vascular endothelium than Hcy.

A Pilot Study of the Creighton Model System of Natural Family Planning in a Subpopulation of Women in Enugu, South-East Nigeria

A Pilot Study of the Creighton Model System of Natural Family Planning in a Subpopulation of Women in Enugu, South-East Nigeria

“Invincible Black Women”: Group Therapy for Black College Women

Black college women present to counseling with an array of culturally distinct mental health concerns. There is also a subpopulation of women who may be hesitant to seek services, despite their need. These facts substantiate the necessity for culturally responsive outreach and intervention targeted at this demographic. The authors present the outreach and intervention techniques associated with “Invincible Black Women,” a culturally relevant interpersonal process group implemented with Black women attending a predominately White institution. Based on counselor experience and group member feedback, the authors offer suggestions regarding the format, topics, and facilitation style useful in promoting Black college women’s mental wellness.

A Study of Completed Suicide Among Women in the Reproductive Age Group From Coastal Karnataka

Introduction: Though in absolute numbers more men commit suicide than women, there are various complexities associated with female suicides. The studies on suicides among women based on whether or not they are in the reproductive age group may lead to greater understanding of specific factors attributable to this particular sub-population of women. Materials and Methods: Women in the reproductive age group who died as a result of fatal deliberate self-harm were autopsied at the Department of Forensic Medicine, Kasturba Medical College, Manipal during January 2010 and September 2011. Results: 44 women suicides were included. Thirty-one of the victims (70%) were aged above 19 years (adults) and 13 (30%) were adolescents. In 11 cases (25%) the motive was either not mentioned or could not be ascertained. Out of the remaining 33 victims, the most common reason for committing suicide was health related issues (n=16). Among the suicide methods, poisoning was the most common, seen in 28 of the victims (64%). In 41 cases (93%) the place of occurrence of the incident was indoors. Thirty of the victims (68%) were hospitalised after the suicide attempt. Conclusion:It is recommended that psychiatric assessment should be considered for women with chronic and vague symptoms of ill health not responding to treatment, as a possible manifestation of the underlying psychiatric disease, which then turns into the primary motive for suicide for women in the reproductive age group.

Abstract AP26: SMAC–MIMETIC TREATMENT ENHANCES ANTITUMOR EFFECT OF STANDARD CHEMOTHERAPY IN OVARIAN CANCERS EXPRESSING LOW CASPASE 8 IN VITRO AND IN VIVO

Abstract Ovarian cancer is the most lethal gynecological cancer in the US. Standard treatment consists of surgery followed by chemotherapies relying on apoptotic tumor cell death. Most women with advanced stage disease will relapse, suggesting that this disease is characterized by primary and acquired resistance to chemotherapy, and targeted approaches to treatment are greatly needed. We recently demonstrated that low Caspase 8 expression levels in ovarian cancers correlated with resistance to chemotherapy, and a subpopulation of ovarian cancer patients with low Caspase 8 levels exhibits poorer overall survival after standard of care treatment. We hypothesized that the loss of Caspase 8 function reduces the cancer cells' ability to undergo apoptosis when exposed to standard chemotherapy. Here we show that combination treatment with Smac-mimetics targets tumor cells with low Caspase 8 and induces necroptotic cell death. We investigated the in vitro sequential effect of Smac-mimetic added to carboplatin + paclitaxel treatment of ovarian cancer cells expressing wild type, low and mutant Caspase 8 levels, which resulted in a 2-4fold enhancement of cell death. In vivo treatment of mice bearing subcutaneous or intraperitoneal ovarian xenografts showed greater aggressiveness of Caspase 8 deficient vs wild-type tumors; combined treatment with chemotherapy and Smac-mimetic resulted in over 50% decrease in low-Caspase 8 xenograft growth, as well as enhanced overall survival of the mice. Subpopulations of women with low Caspase 8 ovarian cancers that resist apoptosis could benefit from treatments which promote non-apoptotic forms of cell death, such as Smac-mimetic induced necroptosis. Clinical validation of such approaches are needed to increase the effectiveness of current standard ovarian cancer treatment. Citation Format: Lídia Hernandez and Christina M. Annunziata. SMAC–MIMETIC TREATMENT ENHANCES ANTITUMOR EFFECT OF STANDARD CHEMOTHERAPY IN OVARIAN CANCERS EXPRESSING LOW CASPASE 8 IN VITRO AND IN VIVO [abstract]. In: Proceedings of the 11th Biennial Ovarian Cancer Research Symposium; Sep 12-13, 2016; Seattle, WA. Philadelphia (PA): AACR; Clin Cancer Res 2017;23(11 Suppl):Abstract nr AP26.

Trends in Postpartum Depressive Symptoms — 27 States, 2004, 2008, and 2012

Postpartum depression is common and associated with adverse infant and maternal outcomes (e.g., lower breastfeeding initiation and duration and poor maternal and infant bonding) (1-3). A developmental Healthy People 2020 objective is to decrease the proportion of women delivering a live birth who experience postpartum depressive symptoms (PDS).* To provide a baseline for this objective, CDC sought to describe self-reported PDS overall, by reporting state, and by selected sociodemographic factors, using 2004, 2008, and 2012 data from the Pregnancy Risk Assessment Monitoring System (PRAMS). A decline in the prevalence of PDS was observed from 2004 (14.8%) to 2012 (9.8%) among 13 states with data for all three periods (p<0.01). Statistically significant (p<0.05) declines in PDS prevalence were observed for eight states, and no significant changes were observed for five states. In 2012, the overall PDS prevalence was 11.5% for 27 states and ranged from 8.0% (Georgia) to 20.1% (Arkansas). By selected characteristics, PDS prevalence was highest among new mothers who 1) were aged ≤19 years or 20-24 years, 2) were of American Indian/Alaska Native or Asian/Pacific Islander race/ethnicity, 3) had ≤12 years of education, 4) were unmarried, 5) were postpartum smokers, 6) had three or more stressful life events in the year before birth, 7) gave birth to term, low-birthweight infants, and 8) had infants requiring neonatal intensive care unit admission at birth. Although the study did not investigate reasons for the decline, better recognition of risk factors for depression and improved screening and treatment before and during pregnancy, including increased use of antidepressants, might have contributed to the decline. However, more efforts are needed to reduce PDS prevalence in certain states and subpopulations of women. Ongoing surveillance and activities to promote appropriate screening, referral, and treatment are needed to reduce PDS among U.S. women.

CE/BZA effects on bone and quality of life in European postmenopausal women: a pooled analysis

Objectives: To evaluate the efficacy of conjugated estrogens/bazedoxifene (CE/BZA) on bone mineral density (BMD), bone turnover markers (BTM), and menopause-specific quality of life (MENQOL) in European women.Methods: Data through 12 months were pooled from two double-blind, randomized, controlled trials in non-hysterectomized postmenopausal women who received CE/BZA or placebo. Women from European study sites with evaluable BMD (n = 60), BTM (n = 56), and MENQOL questionnaire (n = 236) data were included and compared with 1523 women from US study sites (n = 730 with evaluable data for bone outcomes).Results: At month 12, CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg, respectively, significantly improved BMD (adjusted difference vs. placebo) in lumbar spine (2.5%, 2.9%; both p ≤ 0.011) and total hip (1.7%, 2.2%, both p ≤ 0.002), significantly improved serum BTMs (osteocalcin: –31.1%, –33.1%; C-telopeptide: –48.5%, –36.8%) vs. placebo (osteocalcin: 6.7%, C-telopeptide: 4.2%; all p < 0.001), and significantly improved MENQOL vasomotor function scores (–2.1, –2.2) vs. placebo (–0.7; both p < 0.001). No significant treatment × subpopulation interactions were observed for any of the outcomes.Conclusions: Twelve-month CE/BZA treatment prevented bone loss and improved vasomotor function in European postmenopausal women. Findings were similar to those in the subpopulation of women enrolled at US study sites.

Bacterial vaginosis: a critical analysis of current knowledge.

Improved diagnosis of bacterial vaginosis is needed to accurately determine its role in pathology.

Abstract OT2-01-01: Endocrine therapy alone as primary treatment for elderly patients with clinical stage I to III estrogen receptor positive breast cancer with low recurrence score

Abstract Background: Approximately 20% of breast cancers are diagnosed in women 75 years of age or older. Elderly patients with breast cancer are at a higher risk for over- or under-treatment. In general, older patients are more likely to die from comorbidities than from their breast cancer. The 21-gene Recurrence Score (RS) predicts 10-year distant recurrence rate in the adjuvant setting in women with early stage ER+ breast cancer. In elderly patients, a large percentage of the cancers diagnosed are ER+. It is likely that a subpopulation of elderly women with good prognosis ER+ tumors can be identified who may benefit from endocrine therapy alone, without surgery, to treat their cancer without compromising clinical outcome. We hypothesize that endocrine therapy alone will provide adequate local and systemic control of breast cancer in the subpopulation of women 75 or older with ER+ breast cancer and low RS. Trial Design: This is a single arm phase II trial in pts with newly diagnosed early stage ER+ breast cancer, age 75 or greater. RS will be obtained on core biopsies collected at the time of diagnosis. Patients whose scores are &amp;lt; 18 will be enrolled into the trial and receive endocrine therapy only. Patients whose scores are ≥ 18 will receive standard of care (SOC) treatment. Tumor assessment will occur every 6 months. Patient can continue on endocrine therapy for up to 10 years. If there is progression of disease, then an alternative endocrine agent may be prescribed or the patient can opt for SOC treatment. Objectives: Primary: To determine the rate of loco-regional progression in women with early-stage ER+ breast cancer, 75 years or older with low RS who are treated with endocrine therapy alone. Secondary: To determine the breast cancer-specific survival and overall survival of women with early-stage ER+ breast cancer who are 75 years or older treated with endocrine therapy alone. To correlate response to treatment with RS. Eligibility: Newly diagnosed invasive breast cancer defined as cT1 or T2, N0-1, M0, age 75 years of age or older and ECOG performance status ≤ 2. Disease must be ER+ (Allred score ≥ 5) and HER2- and measurable defined as lesions that can be accurately measured in at least one dimension by ultrasound or mammogram. Statistical Methods: A Kaplan-Meier model will be used to estimate the 5-year local or systemic progression rate with a Brookmeyer-Crowley confidence interval. If the true 5-year progression rate is 10%, a sample size of 50 will provide power = .90 at a one-sided .05 significance level to demonstrate that the rate is less than 25.5%. A point estimate of the cumulative incidence of local progression at 5 years will be calculated using a Kaplan-Meier model or, if covariate adjustment is desired, a Cox proportional hazards model. The upper bound of a 95% confidence interval will be used to determine whether the rate may plausibly fall above 25.5%. Accrual: Target 50 patients with an RS score &amp;lt; 18 will be enrolled. Anticipated opening is July 2015. Citation Format: Aft R, Trinkaus K, Ma C. Endocrine therapy alone as primary treatment for elderly patients with clinical stage I to III estrogen receptor positive breast cancer with low recurrence score. [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 OT2-01-01.

Antiviral therapy for hepatitis C: Has anything changed for pregnant/lactating women?

Hepatitis C virus (HCV) affects about 3% of the world's population, with the highest prevalence in individuals under 40. The prevalence in pregnant women varies with geographical distribution (highest in developing countries). Prevalence also increases in sub-populations of women at high risk for blood-transmitted infections. HCV infection in pregnancy represents a non-negligible problem. However, most of the past antiviral regimens cannot be routinely offered to pregnant or breastfeeding women because of their side effects. We briefly reviewed the issue of treatment of HCV infection in pregnant/breastfeeding women focusing on the effects of the new direct-acting antivirals on fertility, pregnancy and lactation in animal studies and on the potential risk for humans based on the pharmacokinetic properties of each drug. Currently, all new therapy regimens are contraindicated in this setting because of lack of sufficient safety information and adequate measures of contraception are still routinely recommended for female patients of childbearing potential.

591: Maternal total cell free DNA in preeclampsia and IUGR: evidence for differences in maternal and fetal response for abnormal implantation

591: Maternal total cell free DNA in preeclampsia and IUGR: evidence for differences in maternal and fetal response for abnormal implantation