Effects of Non-Ablative Solid-State Vaginal Laser (SSVL) for the Treatment of Vulvovaginal Atrophy in Breast Cancer Survivors after Adjuvant Aromatase Inhibitor Therapy: Preliminary Results.

BACKGROUND: One of the side effects of anti-estrogen treatments in breast cancer survivors (BCSs), especially with aromatase inhibitor (AI) treatment, is the frequent appearance of vulvo-vaginal atrophy (VVA). We aim to evaluate the efficacy, safety and feasibility of a new type of non-ablative Solid-State Vaginal Laser (SSVL) treatment in BCSs with VVA. METHODS: A total of 30 BCSs with a history of AI use and symptoms of VVA were treated with a non-ablative SSVL (LASEmaR 1500™-EUFOTON)in this non-randomized pilot study. The effects of the laser have been evaluated at baseline, 10 wk and 24 wk using a visual analogue scale (VAS), the Vaginal Health Index (VHI), the Vulvar Health Index (VuHI), the Female Sexual Function Index (FSFI), the EORTC QLQ-BR23, the Vaginal Maturation Index (VMI) and vaginal pH. RESULTS: At 10-week follow-up vs. baseline there were no statistically significant differences in FSFI, lubrication and EORTC QLQ-BR23. In all the subjective (dyspareunia, VHI, VuHI, FSFI, QLQ) and objective parameters (VMI and pH) there was a statistically significant improvement at the 6-month follow-up. Satisfaction was very high (4.7 out of 5), with 95.7% of patients being satisfied, more than or very satisfied. CONCLUSIONS: Preliminary results of SSVL treatment of VVA and dyspareunia in BCSs after AI treatment suggest clinical improvement, without relevant side effects and with a high degree of satisfaction.

Effect of a Multi-Ingredient Coriolus-versicolor-Based Vaginal Gel in Women with HPV-Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study.

Human papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a Coriolus-versicolor-based vaginal gel (Papilocare®) on HPV-dependent low-grade cervical lesion repair in a real-life scenario. HPV-positive women ≥ 25 years with ASCUS/LSIL cervical cytology results and concordant colposcopy images were included, receiving the vaginal gel one cannula/day for 21 days (first month) + one cannula/alternate days (five months). A 6-month second treatment cycle was prescribed when needed. Repair of the cervical low-grade lesions through cytology and colposcopy, HPV clearance, and level of satisfaction, and tolerability were evaluated. In total, 192 and 201 patients accounted for the total and safety analyses, respectively, and 77.1% repaired cervical lesions at 6 or 12 months (76.0% for high-risk HPV). Additionally, 71.6% achieved HPV clearance throughout the study's duration (70.6% for high-risk HPV). Satisfaction level was rated 7.9 and 7.5 out of 10 at 6 and 12 months, respectively. Only three mild-moderate product-related adverse events were reported, and all of them were resolved by the end of the study. In our study, we observed higher regression rates of low-grade cervical lesions in women treated with Papilocare® vaginal gel than spontaneous regression rates reported in the literature.

Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study.

BACKGROUND: Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16-26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27-45 versus 16-26 years of age. METHODS: This international, open-label study (NCT03158220) was conducted in women 16-45 years of age. Participants (16-26 years, n = 570 and 27-45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study. RESULTS: At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27-45 years were compared to those in women 16-26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27-45 years to 16-26 years) was 0.60-0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27-45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16-26 years, and 85.2% and 24.1% of women 27-45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study. CONCLUSIONS: The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27-45 years compared with women 16-26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16-26 years to women 27-45 years of age. Clinical trial registration NCT03158220.

Lack of correlation between first trimester maternal serum 25-hydroxyvitamin D levels and ultrasound measured crown-rump length and nuchal translucency.

BACKGROUND: Vitamin D regulates the human genome and it is thought to influence the fetal growth and development, but its relation to early ultrasound fetal measures is still unknown. OBJECTIVE: To assess first trimester 25-hydroxyvitamin D [25(OH)D] maternal serum status and correlate with ultrasound crown-rump length (CRL) and nuchal translucency (NT) measurements. METHOD: In this cross-sectional study, women with singleton pregnancies undergoing the first trimester standard two-dimensional ultrasound scan for fetal anomalies were included: CRL (n = 498) and NT (n = 487). Concomitantly, maternal serum 25(OH)D levels were also measured. RESULTS: Median serum 25(OH)D levels for the entire sample (n = 498) was 27.4 ng/mL (interquartile range 20.9-32.7). Serum 25(OH)D was adequate (≥ 30 ng/mL) in only 36.1% of gravids, whereas levels were found to be insufficient (20-29.99 ng/mL) in 41.2% and deficient (< 20 ng/mL) in 22.7%. No significant correlation was found between the serum 25(OH)D levels and the measured ultrasound parameters. CONCLUSION: First trimester 25(OH)D levels did not correlate to fetal ultrasound measurements.

First trimester serum levels of 25-hydroxyvitamin D, free ß-human chorionic gonadotropin, and pregnancy-associated plasma protein A in Spanish women.

BACKGROUND: Vitamin D has been implicated in embryo/placental development and growth; however information in this regard is limited or unavailable. OBJECTIVE: To assess 25-hydroxyvitamin D (25(OH)D), free ß-human chorionic gonadotropin (ß-hCG) and pregnancy associated plasma protein A (PAPP-A) status during pregnancy. METHODS: Serum 25(OH)D, ß-hCG, and PAPP-A levels were measured in the first trimester of otherwise healthy Spanish pregnant women (n=488). Rho Spearman coefficients were calculated to determine correlations between analytes. RESULTS: Median serum 25(OH)D levels for the entire sample was 27.4 ng/ml (interquartile range=12.1). 25(OH)D levels were insufficient (20-29.99 ng/ml) and deficient (<20 ng/ml) in 40.6% and 23.2%, respectively, in relation to ethnics, body mass index values, tobacco use, and season/gestational age at blood sampling. ß-hCG and PAPP-A levels significantly correlated (r²=0.47) yet neither of them with 25(OH)D levels. Despite this, the three analytes significantly correlated with gestational age at sampling. CONCLUSION: First trimester 25(OH)D, ß-hCG, and PAPP-A levels increase with gestational age; however, placental peptides do not correlate with vitamin D levels, suggesting a non-placental 25(OH)D production. More research is required in this regard.

First trimester serum 25-hydroxyvitamin D status and factors related to lower levels in gravids living in the Spanish Mediterranean coast.

OBJECTIVE: To assess first trimester serum 25-hydroxyvitamin D [25(OH)D] status and factors related to deficient levels in pregnant Spanish women. METHODS: This cross-sectional study was carried out among 502 gravids (11 to 14 weeks) living in the Spanish Mediterranean sea coast (near Almería at latitude 36° N, longitude 2° W) to whom serum 25(OH)D levels were measured by electrochemiluminescence immunoassay. Logistic and multiple linear regression analysis were performed to assess the influence of ethnicity, immigration status, season of the year at blood sampling, body mass index (BMI), parity and smoking habit over 25(OH)D levels. RESULTS: The median (interquartile range, IQR) serum 25(OH)D levels for the entire sample was 27.4 ng/mL (IQR = 20.9-32.8). Only 35.9% of participants had adequate serum 25(OH)D levels (≥30 ng/mL) whereas in 41.4% and 22.7% these levels were found to be insufficient (20-29.9 ng/mL) and deficient (<20 ng/mL), respectively. Vitamin D status was found to be significantly lower in Arab women as compared to Caucasian women. 25(OH)D levels were positively correlated with gestational age at sampling and inversely with BMI values (univariate analysis). Logistic regression analysis determined that non-Caucasian ethnicity, season at sampling (autumn/winter), and nulliparity were factors related to deficient 25(OH)D levels. Multiple linear regression found a similar model yet also including maternal weight inversely correlating with 25(OH)D levels. CONCLUSION: Despite living in one of the sunniest, warmest, and driest climates of Europe, gravids displayed a high prevalence of first trimester insufficient/deficient serum 25(OH)D levels related to season at sampling, nulliparity, maternal weight, and non-Caucasian ethnicity.