Sexual Minority Men of Color Have Blunted Diurnal Cortisol Rhythms Compared to White Sexual Minority Men: A Case for Intersectionality [Meeting Abstract]
Young sexual minority men (YSMM) may experience disrupted hypothalamic-pituitary-adrenal (HPA)-axis functioning as compared to their heterosexual counterparts due to sexual minority stress. However, young men who identify as both sexual and racial minorities may experience additional minority stress based on the intersection of sexual orientation and racial/ethnic identity. Nevertheless, there is a dearth of research examining HPA-axis functioning among White YSMM versus YSMM of color. The current study examined diurnal cortisol rhythms among N=101 White YSMM (44.5%) and YSMM of color (55.5%). Data came from a larger daily diary project examining sexual minority stress and HPA-axis functioning among YSMM recruited from a Midwest (59.4%) and a Northeast (40.6%) location (Mage=22.7, SD=2.6). Participants completed a baseline survey ascertaining demographic information and other psychosocial constructs. Starting the next day, participants provided four saliva samples a day (upon awakening, 30-minutes after awakening, midday, and evening) for five consecutive days to measure diurnal cortisol. After the first three samples, participants were provided with a link to a brief survey to gather information pertinent to cortisol (e.g., caffeine consumption). After the evening sample, participants were provided with a link to a longer nightly survey ascertaining experiences at the day-level. Racial/ethnic differences in diurnal cortisol measures were examined using repeated-measures analysis of covariance (ANCOVA) controlling for mean awakening time (M=0930, SD=1.83). A significant time by group interaction effect was observed (F(2.5, 241.0)=8.3, p<.0001, eta2=.08). Post-hoc analyses found that YSMM of color had lower cortisol levels than White YSMM 30-minutes after awakening (p=.03) but higher cortisol levels than White YSMM in the evening (p=.02). Findings revealed a blunted diurnal cortisol curve among YSMM of color compared to White YSMM, with differences in cortisol 30-minutes after waking and in the evening (Fig. 1). Our findings provide evidence that stress experienced at the intersection of sexual orientation and racial/ethnic identity may have a negative influence on HPA-axis functioning among YSMM of color. Researchers and clinicians should adopt an intersectional perspective when seeking to understand HPA-axis functioning differences among sexual minorities
ENVISION, a phase 3 study to evaluate efficacy and safety of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1, in acute hepatic porphyria patients [Meeting Abstract]
Abstract GS-14 is under embargo until Saturday 13 April 2019, 07:00. This abstract has been selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials that will be made publicly available on the congress website at 07:00 (CET) on the day of their presentation at the congress. Industry must not issue press releases - even under embargo - covering the data contained in abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials until the individual embargo for each data set lifts. Media must not issue coverage of the data contained in abstracts selected to be highlighted during official EASL Press Office activities or in official EASL Press Office materials until the individual embargo for each data set lifts. Journalists, industry, investigators and/or study sponsors must abide by the embargo times set by EASL. Violation of the embargo will be taken seriously. Individuals and/or sponsors who violate EASL's embargo policy may face sanctions relating to current and future abstract submissions, presentations and visibility at EASL Congresses. The EASL Governing Board is at liberty to ban attendance and/or retract data. Copyright for abstracts (both oral and poster) on the website and as made available during The International CongressTM 2019 resides with the respective authors. No reproduction, re-use or transcription for any commercial purpose or use of the content is permitted without the written permission of the authors. Permission for re-use must be obtained directly from the authors.
First-line ribociclib plus endocrine therapy in hormone receptor-positive, HER2-negative advanced breast cancer: A pooled efficacy analysis [Meeting Abstract]
Ribociclib plus endocrine therapy in patients with hormone receptor-positive, HER2-negative advanced breast cancer presenting with visceral metastases: Subgroup analysis of phase III MONALEESA trials [Meeting Abstract]
Ribociclib plus endocrine therapy in hormone receptor-positive, HER2-negative advanced breast cancer: A pooled safety analysis [Meeting Abstract]
Pooled efficacy analysis of first-line ribociclib (RIB) plus endocrine therapy (ET) in HR+/HER2: Advanced breast cancer (ABC) [Meeting Abstract]
Assessment of endometrial safety during treatment of symptomatic uterine fibroids with ulipristal acetate: Venus II [Meeting Abstract]
Introduction: VENUS II was a phase 3, randomized, double-blind, placebo-controlled study of ulipristal acetate (UPA; Allergan plc), an oral selective progesterone receptor modulator (SPRM), in women with symptomatic uterine fibroids (UFs). SPRM-associated endometrial changes (PAECs) were characterized because they may be misdiagnosed as hyperplasia.
Method(s): Premenopausal women (18-50 years) with >=1 UF and abnormal uterine bleeding were randomized to two 12-week treatment courses (TCs) of once-daily UPA or placebo, separated by a drug-free interval (two menses), with 12-week drug-free follow-up. Randomization was in a 1:1:2:1:2:1 ratio, with TC1/TC2 dosing of placebo/ UPA 5 mg, placebo/UPA 10 mg, UPA 5 mg/5 mg, UPA 5 mg/placebo, UPA 10 mg/10 mg, or UPA 10 mg/ placebo. Endometrial thickness (ET) and pipelle biopsies were assessed at baseline, 10 to 18 days after first menses following TC1 (visit [V] 3), 10 to 18 days after first menses following TC2 (V6), and end of follow-up. Biopsies were assessed independently by three pathologists.
Result(s): Safety population: placebo/UPA 5 mg (n = 56), placebo/ UPA 10 mg (n = 57), UPA 5 mg/5 mg (n = 107), UPA 5 mg/placebo (n = 54), UPA 10 mg/10 mg (n = 110), UPA 10 mg/placebo (n = 45). No significant differences in ET mean change from baseline with UPA vs placebo were observed at V3 (least squares [LS] mean difference vs placebo: UPA 5 mg 0.53, P = .39; UPA 10 mg 0.52, P = .41) or V6 (LS mean difference vs pooled placebo in TC2 after UPA treatment in TC1: UPA 5 mg/5 mg 0.42, P = .58; UPA 10 mg/10 mg -0.95, P = .23). Biopsies revealed no evidence of malignancy/atypia. Isolated cases of hyperplasia without atypia were transient and occurred across all arms. Incidences of PAECs assessed by two or more pathologists at baseline and V3, respectively, were UPA 5 mg, 11.3%, 13.5%; UPA 10 mg, 12.3%, 14.4%; and placebo, 15.5%, 6.8%. At end of follow-up, incidences were placebo/UPA 5 mg, 16.1%; placebo/UPA 10 mg, 10.0%; UPA 5 mg/5 mg, 9.1%; UPA 5 mg/placebo, 12.5%; UPA 10 mg/10 mg, 15.9%; and UPA 10 mg/placebo, 4.3%.
Conclusion(s): Two UPA therapy courses demonstrated favorable endometrial safety
Benign endometrial changes by race and BMI with ulipristal acetate treatment [Meeting Abstract]
Objectives: Ulipristal acetate (UPA) is an oral selective progesterone-receptor modulator (SPRM). VENUS I (NCT02147197) was a phase 3, randomized, double-blind, placebo-controlled study assessing UPA for treatment of uterine fibroids (UF), which included a large proportion of black (self-identified) and obese (BMI >=30 kg/m2) patients. Methods: This study included a screening period, one 12-week treatment course, and a 12-week drug-free follow-up period. During treatment, premenopausal women (18-50 years) with >=1 UF and cyclic excessive bleeding were randomized to receive once-daily UPA 5 mg, UPA 10 mg, or placebo. Endometrial thickness was assessed via transvaginal ultrasound. Endometrial biopsies were evaluated at baseline, mid treatment, and by the end of the follow-up period for malignancy and SPRM-associated endometrial changes (PAEC), defined as non-physiologic epithelial changes, extensive cysts, or vascular changes as assessed by three independent pathologists. Results: Of 157 patients randomized, 68.8% were black, and 50.3% were obese. Mean endometrial thickness (mm) at end of treatment (EoT) was similar for black (n = 75) vs non-black (n = 35) patients: UPA 5 mg (11.6 for both), UPA 10 mg (13.0 vs 12.2), placebo (11.0 vs 13.2); and for obese (n = 53) vs non-obese (n = 57) patients: 5 mg (11.9 vs 11.4), 10 mg (13.6 vs 11.9), placebo (10.7 vs 12.4). No evidence of malignancy was observed in endometrial biopsies. One case of hyperplasia without atypia was seen at EoT (black, obese patient; 10 mg), which resolved by end of follow-up. The overall number of patients with PAEC did not increase from baseline to EoT in any treatment group by race or by BMI. Conclusion: In this first US-based phase 3 study of UPA, there was no increase in patients with PAEC in any group (race, BMI). Acknowledging the small subgroup sample sizes, UPA was shown to be a safe treatment option for UF, regardless of race and BMI
Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib plus fulvestrant: Results from MONALEESA-3 [Meeting Abstract]
Treatment of Symptomatic Uterine Fibroids with Ulipristal Acetate: Endometrial Safety [Meeting Abstract]