This extensive review summarizes clinical evidence on immunotherapy and targeted therapy currently available for endometrial cancer (EC) and reports the results of the clinical trials and ongoing ...studies. The research was carried out collecting preclinical and clinical findings using keywords such as immune environment, tumor infiltrating lymphocytes, programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) expression, immune checkpoint inhibitors, anti-PD-1/PD-L1 antibodies and others' on PubMed. Finally, we looked for the ongoing immunotherapy trials on ClinicalTrials.gov. EC is the fourth most common malignancy in women in developed countries. Despite medical and surgical treatments, survival has not improved in the last decade and death rates have increased for uterine cancer in women. Therefore, identification of clinically significant prognostic risk factors and formulation of new rational therapeutic regimens have great significance for enhancing the survival rate and improving the outcome in patients with advanced or metastatic disease. The identification of genetic alterations, including somatic mutations and microsatellite instability, and the definition of intracellular signaling pathways alterations that have a major role in in tumorigenesis is leading to the development of new therapeutic options for immunotherapy and targeted therapy.
Objective
To evaluate the predictive value of obesity, comorbidities, and fragility on overall and severe complication rate and survival among patients surgically treated for endometrial cancer.
...Methods
Consecutive patients with endometrial cancer treated at the Royal Infirmary Hospital of Edinburgh from June 1, 2015, to June 30, 2017, were retrospectively enrolled in an observational study. Considering pre‐existing medical conditions, comorbidities, and complications, modified fragility index (mFI) was calculated. Logistic regression was used to evaluate predicting variables of overall (G1–G4) and severe (G3–G4) complication rate.
Results
One hundred patients were surgically treated for endometrial cancer. Elevated mFI >3 was related to a statistically higher access rate to the high dependency unit (HDU) or intensive care unit (ITU) (33.3% vs 6.6%, P=0.013). Overall, 31 women had postoperative complications. Using multivariate analysis, it was shown that undergoing laparotomy (odds ratio OR 7.06, 95% confidence interval CI 2.52–19.71; P<0.001) and having an mFI >3 (OR 7.19, 95% CI 1.43–36.25; P=0.021) were independent predictors of overall complications (G1–G4). Moreover, only smoking (OR 5.01, 95% CI 1.15–21.75; P=0.031) and mFI >3 (OR 5.16, 95% CI 1.07–24.94; P=0.047) were independent factors for severe complications (G3–G4).
Conclusion
Modified fragility index was an important predictor of complications among patients treated for endometrial cancer and could be a useful tool for assisting clinicians in perioperative management.
Modified fragility index >3 is an important predictor of overall and severe complications among patients treated for endometrial cancer.
The aim of the study was to demonstrate the efficacy of sequential combined treatment with transobturator tape (TOT) followed by posterior tibial nerve stimulation (PTNS) in patients with mixed ...urinary incontinence (MUI); quality of life and patients' satisfaction was also assessed.
Retrospective analysis on women affected by MUI with prevalent Stress Urinary Incontinence (SUI) component. Women, divided in 2 groups, underwent different treatments, TOT vs. TOT+PTNS. Population was assessed by medical history, previous pelvic surgery, clinical exam, urodynamic exams, pelvic ultrasound examination, and questionnaires (The International Consultation on Incontinence Questionnaire Short Form, Overactive Bladder Questionnaire, Health Related Quality of Life) comparing them before and after 12 weeks after treatment.
One hundred twelve women were enrolled in the study. The mean age was 57.96±7.34 in the first group (N.=60) and 58.29±6.14 in the second group (N.=52). Peak flow (mL/s) statistically improved after treatment, 22.23±4.29 (TOT) vs. 24.81±5.8 (TOT+PTNS). First voiding desire (mL) improved significantly between the two groups 108.72±19.24 vs. 142.43±19.98. Maximum cystometric capacity (mL) in the TOT group at 12-weeks was 328.76±82.44 vs. TOT+PTNS group of 396.26±91.21. Detrusor pressure at peak flow(cmH2O) showed a greater improvement in TOT+PTNS than TOT alone 14.45±6.10 vs. 11.89±54.49. At 12-week, urinary diary and quality of life improved in terms of urgent urination events, mean number of voids, urge symptoms and nocturia events. The Patient Impression of Global Improvement (PGI-I) after 3 months was better in combined group.
Combined and sequential TOT+PTNS is more effective compared to TOT alone in MUI patients with prevalent SUI component.
The aim of this study was to demonstrate that the implementation of remote medical care in the management of patients suffering from specific urogynecological diseases can be a valid alternative to ...outpatient visits leading to a huge saving of resources which can be used for real emergencies. Therefore, the primary aim of this study was to demonstrate that patients treated with telehealth had the same improvement in symptoms and Quality of Life as those treated with outpatient visits.
Observational analysis on women with urogynecological diseases was performed during restrictive measures period. One group of patients was assessed in the clinic and one group by video consultations. The population answered Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), the Overactive Bladder Questionnaire Symptoms and Health-Related Quality of Life Short-Form Symptoms (OAB-Q), Prolapse Quality of Life Questionnaire (P-QoL), the Pelvic Pain and Urinary/Frequency Patient Symptom Scale (PUF) scores, the Short Form Health Survey questionnaires (SF-36) during the first visit and after 12 weeks. The primary endpoint was to evaluate the change in symptoms after the outpatient and telemedicine visit. The secondary endpoint was the evaluation of the telemedicine impact on the Quality of Life and sexual function.
One hundred twenty-five patients were considered. Symptoms of overactive bladder, genitourinary syndrome, and recurrent urinary infections improved significantly in both groups with no significant differences. Sexual activity increased significantly in both groups with a significant change in FSFI and FSDS values. The SF-36 showed a significant change 12 weeks after the visit in both groups.
Telemedicine is equally useful and effective as the outpatient visits in patients suffering from urogynecological diseases.
The aim of this study was to compare the efficacy and tolerability of solifenacin and mirabegron in patients with overactive bladder (OAB) syndrome.
We carried out a retrospective analysis in 342 ...women affected by OAB syndrome; 168 were treated with solifenacin 5 mg/daily and 174 with mirabegron 50 mg/daily. A clinical evaluation, 3-day voiding diary, and urodynamic testing was performed. Patients completed the Overactive Bladder Questionnaire - Short Form, the King's Health Questionnaire, and the Patient Global Impression of Improvement questionnaire. The adverse effects were evaluated. The two groups were compared at baseline and at 12 weeks.
After 12 weeks, a significant reduction in the mean number/24 h of voids and urgent micturition episodes/24 h was observed in both groups. Detrusor overactivity decreased from 58.3% to 13.1% in the solifenacin group and from 58% to 11% in the mirabegron group. Twenty (12%) and 18 (10.7%) patients taking solifenacin reported constipation and dry mouth, respectively, versus four (2.3%) and five (2.9%) patients taking mirabegron, respectively, but there was no difference between the groups in the change in vital signs. The Overactive Bladder Questionnaire - Short Form and King's Health Questionnaire scores did not demonstrate significant differences and the abandonment rates in the solifenacin and mirabegron groups were 25.5% and 20%, respectively.
Solifenacin and mirabegron showed the same efficacy in the treatment of OAB but solifenacin had more adverse effects.
Uterine fibroids are the most common benign tumor in women. According to literature, submucosal myomas have a negative effect on reproductive outcomes in women undergoing assisted reproductive ...techniques (ART) but there are fewer data concerning intramural fibroids. During last years, ulipristal acetate (UPA) 5 mg was widely used as medical option of fibroid's treatment, but from 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) has revoked the marketing authorization after some cases of liver toxicity.
In this observational, retrospective study we collected data from a sample of 23 women affected by symptomatic uterine fibroids (from type 1 to type 7 according FIGO classification) followed in our center for assisted reproduction from 2016-2019. All patients received 5 mg/day UPA for three months, followed by two months of wash-out therapy. A group of 13 women treated with UPA, with intramural fibroid not distorting the uterine cavity, after wash-out therapy, affected by tubal or idiopathic factors of infertility too, underwent ART. We also evaluated a control group of women, not affected by fibroids, randomly selected from a general group of our ART patients, similar by age, BMI, and cause of infertility only idiopathic or tubal factors. We evaluated the impact of UPA on reduction of fibroid volume, symptomatology and distortion of the cavity in all the women treated, and the IVF (in-vitro fertilization) outcome between the fibroid group of women affected by intramural fibroids who underwent ART, and the control group.
In all the women treated with UPA the overall median fibroid volume pretreatment was 45.168±35.360 mm
, that decreased to a mean value of 22.592±22.116 mm3 post one cycle of UPA, with an overall mean decrease of -22.586 mm
(of 49%) statistically significant (P=0.00001). After treatment, the distortion of the uterine cavity reduced in high percentage of cases: 85,71% (type 1-2), χ
difference in respect to the value pretreatment of 0.3941, and 86.96% of patients subjectively referred an improvement in the symptomatology. In the group of 13 women that undergone ART, after one IVF cycle for each patient, we obtained 61% of positivity of dosage of beta human chorionic gonadotropin (hCG) after UPA treatment, and we obtained a similar value in the control group.
In our little sample we have observed that UPA represented a valid non-invasive medical treatment strategy for fibroids in women candidate for (IVF, not only in women affected by sub-mucosal, but also by intramural fibroids not distorting uterine cavity. After a single, three months course of treatment, we obtained good results in terms of reduction of fibroid's volume and improvement of symptomatology, without side effects, preparing a more favorable environment for ART.
The aim of this study was to evaluate the efficacy of ospemifene in the Vaginal Health Index (VHI), in the vulvovaginal vascular perfusion, and to assess its impact on quality of life and sexual ...function.
Among 52 eligible patients, 43 consecutive postmenopausal patients affected by vulvo-vaginal atrophy (VVA), or genitourinary syndrome (GSM) were evaluated. VVA evaluation and ultrasound of the vulvo-vaginal vascularization by sampling the Pulsatility Index (PI) of clitoris dorsal artery were performed before and after 3 months-treatment with ospemifene. The 36-Item Short Form Survey (SF-36) for the quality-of-life assessment before and after 3 months were available for all women; instead, Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) questionnaires for the sexual function evaluation were performed for sexually active women in the study. The Patient Impression of Global Improvement (PGI-I) after 3 months of treatment was also calculated.
The number of sexually active women significantly increased after 3 months (26 60.46% vs. 35 81.39%; P=0.01). The mean number of intercourses during the treatment increased (12.87±3.43 vs. 15.79±3.12, P=0.03). The PI of clitoris dorsal artery has significantly changed before and after treatment respectively (PI 1.69±0.42 vs. 1.28±0.45, P=0.001 RI 0.74±0.11 vs. 0.54±0.15, P=0.001). The FSFI, FSDS and SF-36 Questionnaires scores showed a significant improvement after 3 months. VHI and PI were the independent factors of a lower FSFI after 3 months of treatment at multivariate analysis.
Ospemifene improve the VHI and vulvovaginal vascular perfusion demonstrating a positive impact on sexual function and quality of life.
This extensive review summarizes clinical evidence on immunotherapy and targeted therapy currently available for endometrial cancer (EC) and reports the results of the clinical trials and ongoing ...studies. The research was carried out collecting preclinical and clinical findings using keywords such as immune environment, tumor infiltrating lymphocytes, programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) expression, immune checkpoint inhibitors, anti-PD-1/PD-L1 antibodies and others' on PubMed. Finally, we looked for the ongoing immunotherapy trials on ClinicalTrials.gov. EC is the fourth most common malignancy in women in developed countries. Despite medical and surgical treatments, survival has not improved in the last decade and death rates have increased for uterine cancer in women. Therefore, identification of clinically significant prognostic risk factors and formulation of new rational therapeutic regimens have great significance for enhancing the survival rate and improving the outcome in patients with advanced or metastatic disease. The identification of genetic alterations, including somatic mutations and microsatellite instability, and the definition of intracellular signaling pathways alterations that have a major role in in tumorigenesis is leading to the development of new therapeutic options for immunotherapy and targeted therapy.
The ever-increasing wave of immigration in Italy has posed demanding challenges in the management of the new multiethnic obstetric population. The aim of this study was to compare pregnancy and ...perinatal outcomes between immigrants and the native population in an Italian public hospital.
Singleton pregnant women (≥ 24 weeks of gestation) who delivered during a 3-year period in an Italian free care hospital were included. Long-term (≥ 2 years of residence) immigrant patients were divided into 4 groups according to their ethnic origin: Europeans, Asians, Latin Americans, and Africans. Perinatal indicators of obstetric outcomes were collected and compared between immigrants and Italians.
Of the 3556 patients included, 1092 were immigrants and 2464 Italians. The immigrant cohort experienced a higher rate of macrosomia (1.8% vs 0.6%; p = 0.001), very low birth weight (1.3% vs 0.6%; p = 0.048), very early preterm delivery (1.4% vs 0.4%; p = 0.048), and gestational diabetes mellitus (1.8% vs 0.5%; p = 003) compared with the native population. The overall rate of cesarean sections was greater among Italians (56% vs 45.8%; p < 0.001). Among ethnic groups, Europeans and Latin Americans reported a higher rate of preterm delivery (20.2% and 19%, respectively; p < 0.001). Latin Americans carried also a greater risk of fetal macrosomia (3.6%; p < 0.008), while the rate of very low birth weight was higher among Europeans and Africans (2% and 1.8%, respectively; p < 0.04).
Obstetricians should pay special attention to the potential disparities in pregnancy outcomes between immigrants and the native population. Future efforts should focus on reducing preterm delivery and glucose dysmetabolism among pregnant immigrants.
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