Molecular diagnosis of endometrial cancer from uterine aspirates.

Rapid and reliable diagnosis of endometrial cancer (EC) in uterine aspirates is highly desirable. Current sensitivity and failure rate of histological diagnosis limit the success of this method and subsequent hysteroscopy is often necessary. Using quantitative reverse transcriptase-polymerase chain reaction on RNA from uterine aspirates samples, we measured the expression level of 20 previously identified genes involved in EC pathology, created five algorithms based on combinations of five genes and evaluated their ability to diagnose EC. The algorithms were tested in a prospective, double-blind, multicenter study. We enlisted 514 patients who presented with abnormal uterine bleeding. EC was diagnosed in 60 of the 514 patients (12%). Molecular analysis was performed on the remnants of aspirates and results were compared to the final histological diagnoses obtained through biopsies acquired by aspiration or guided by hysteroscopy, or from the specimens resected by hysterectomy. Algorithm 5 was the best performing molecular diagnostic classifier in the case-control and validation study. The molecular test had a sensitivity of 81%, specificity of 96%, positive predictive value (PPV) of 75% and negative predictive value (NPV) of 97%. A combination of the molecular and histological diagnosis had a sensitivity of 91%, specificity of 97%, PPV of 79% and NPV of 99% and the cases that could be diagnosed on uterine aspirate rose from 76 to 93% when combined with the molecular test. Incorporation of the molecular diagnosis increases the reliability of a negative diagnosis, reduces the need for hysteroscopies and helps to identify additional cases.

The impact of genitourinary syndrome of menopause on well-being, functioning, and quality of life in postmenopausal women.

OBJECTIVE: Symptoms of genitourinary syndrome of menopause (GSM) are bothersome to middle-aged and older women, and affect their quality of life (QoL), sexuality, and daily activities. The objective of the study was to evaluate the impact of vaginal symptoms and GSM on the well-being, functioning, and QoL of postmenopausal women from Spain. METHODS: This study involved 423 postmenopausal women participating in the GENISSE study (a multicenter, cross-sectional, descriptive, observational study) who presented at least 1 vaginal symptom. All women completed the "day-to-day impact of vaginal aging" (DIVA) questionnaire. Analysis of total scores and subdomains of the questionnaire were performed in women diagnosed with GSM and those without the condition. RESULTS: In these women, the highest mean scores on the DIVA questionnaire were found in the sexual functioning domain long version (mean 1.8; SD 1.0), followed by the sexual functioning domain short version (mean 1.7; SD 1.1), self-perception and body image (mean 1.4; SD 1.1), activities of daily living (mean 0.7; SD 0.8), and emotional well-being (mean 0.7; SD 0.8) scales. A total of 299 women (70.7%) had vaginal symptoms with a diagnosis of GSM, whereas 124 (29.3%) had no GSM diagnosis. Scores on the DIVA questionnaire were significantly higher in women with a diagnosis of GSM than in those without this condition. CONCLUSIONS: Vaginal symptoms impact the well-being, functioning, and QoL of postmenopausal women, especially sexual function, self-perception, and body image. This impact is significantly higher in women with GSM. Identifying and treating patients affected by vaginal symptoms and GSM may be beneficial for improving their QoL.

The therapeutic effect of a new ultra low concentration estriol gel formulation (0.005% estriol vaginal gel) on symptoms and signs of postmenopausal vaginal atrophy: results from a pivotal phase III study.

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of a new low-concentration estriol formulation (0.005% estriol vaginal gel), providing an ultra low dose of estriol per application (50 µg), for the local treatment of postmenopausal vaginal atrophy. METHODS: Postmenopausal women with symptoms and signs of vaginal atrophy were enrolled in a prospective, double-blind, placebo-controlled study. Women received either 1 g of vaginal gel containing 50 µg of estriol or placebo gel, daily for 3 weeks and then twice weekly up to 12 weeks. A cytological vaginal study, evaluation of vaginal pH, and assessment of symptoms and signs of vaginal atrophy were performed, and changes between baseline and weeks 3 and 12 were assessed. Adverse events were recorded. RESULTS: A total of 167 women were included (114 received estriol and 53 received placebo). After 12 weeks of therapy, a superiority of estriol compared with placebo gel was shown in the change in maturation value and vaginal pH (P < 0.001 and P < 0.001, respectively). The superiority of estriol was well demonstrated in improvement of vaginal dryness (P = 0.001) and the Global Symptom Score (P = 0.018). Estriol gel proved also superior in the improvement of several of the most outstanding vaginal signs of vaginal atrophy evaluated. After 3 weeks, estriol gel also showed a superiority over the placebo gel in most symptoms and signs evaluated. Treatment-related adverse events were similar among groups. CONCLUSIONS: 0.005% Estriol vaginal gel, a new formulation providing an ultra low dose of estriol per application, was shown to be safe and effective in the treatment of postmenopausal vaginal atrophy.