From February 24, 2020, a COVID‐19 obstetric task force was structured to deliver management recommendations for obstetric care. From March 1, 2020, six COVID‐19 hubs and their spokes were ...designated. An interim analysis of cases occurring in or transferred to these hubs was performed on March 20, 2020 and recommendations were released on March 24, 2020. The vision of this strict organization was to centralize patients in high‐risk maternity centers in order to concentrate human resources and personal protective equipment (PPE), dedicate protected areas of these major hospitals, and centralize clinical multidisciplinary experience with this disease. All maternity hospitals were informed to provide a protected labor and delivery room for nontransferable patients in advanced labor. A pre‐triage based on temperature and 14 other items was developed in order to screen suspected patients in all hospitals to be tested with nasopharyngeal swabs. Obstetric outpatient facilities were instructed to maintain scheduled pregnancy screening as per Italian guidelines, and to provide pre‐triage screening and surgical masks for personnel and patients for pre‐triage‐negative patients. Forty‐two cases were recorded in the first 20 days of hub and spoke organization. The clinical presentation was interstitial pneumonia in 20 women. Of these, seven required respiratory support and eventually recovered. Two premature labors occurred.
In Lombardy, criteria for the management of COVID‐19 pregnancies were established by a structured obstetrical task force from the beginning of the epidemic. Recommendations and preliminary data are reported here.
Hyperthermic intraperitoneal chemotherapy (HIPEC) has been proposed as a treatment in ovarian cancer. A recently published RCT demonstrated that HIPEC prolongs disease-free survival (DFS) and overall ...survival (OS) in ovarian cancer. The aim of the study was to investigate oncologic results of cytoreductive surgery+HIPEC compared with cytoreductive surgery alone in advanced primary ovarian cancer with a particular attention to the pattern of recurrence.
This is a retrospective case control study with a propensity score (PS) matching of the patients. All the patients treated for primary advanced ovarian cancer who underwent interval surgery with or without HIPEC were collected; a PS was calculated in order to match cases to controls.
Among 77 eligible patients 56 patients were included in the study. Preoperative patients' characteristics were homogeneous. No difference in morbidity and mortality after surgery were recorded. DFS was not different among the 2 groups (13.2 vs. 13.9 months, p=0.454) but OS was better in patients treated with HIPEC with no median reached vs. 35.5 months (p=0.048). Patients treated with cytoreductive surgery alone were more likely to have a peritoneal recurrence (43% vs. 14%).
HIPEC seems to affect the relapse pattern with lesser peritoneal recurrence. This difference in relapse pattern seems to affect the OS with better results in patients treated with HIPEC. Further studies are needed to confirm these findings.
Carboplatin/paclitaxel is the standard first-line chemotherapy for patients with advanced ovarian cancer. Multicentre Italian Trials in Ovarian Cancer-2 (MITO-2), an academic multicenter phase III ...trial, tested whether carboplatin/pegylated liposomal doxorubicin (PLD) was more effective than standard chemotherapy.
Chemotherapy-naive patients with stage IC to IV ovarian cancer (age ≤ 75 years; Eastern Cooperative Oncology Group performance status ≤ 2) were randomly assigned to carboplatin area under the curve (AUC) 5 plus paclitaxel 175 mg/m(2) or to carboplatin AUC 5 plus PLD 30 mg/m(2), every 3 weeks for six cycles. Primary end point was progression-free survival (PFS). With 632 events in 820 enrolled patients, the study would have 80% power to detect a 0.80 hazard ratio (HR) of PFS.
Eight hundred twenty patients were randomly assigned. Disease stages III and IV were prevalent. Occurrence of PFS events substantially slowed before obtaining the planned number. Therefore, in concert with the Independent Data Monitoring Committee, final analysis was performed with 556 events, after a median follow-up of 40 months. Median PFS times were 19.0 and 16.8 months with carboplatin/PLD and carboplatin/paclitaxel, respectively (HR, 0.95; 95% CI, 0.81 to 1.13; P = .58). Median overall survival times were 61.6 and 53.2 months with carboplatin/PLD and carboplatin/paclitaxel, respectively (HR, 0.89; 95% CI, 0.72 to 1.12; P = .32). Carboplatin/PLD produced a similar response rate but different toxicity (less neurotoxicity and alopecia but more hematologic adverse effects). There was no relevant difference in global quality of life after three and six cycles.
Carboplatin/PLD was not superior to carboplatin/paclitaxel, which remains the standard first-line chemotherapy for advanced ovarian cancer. However, given the observed CIs and the different toxicity, carboplatin/PLD could be considered an alternative to standard therapy.
'The Endometrial Cancer Conservative Treatment (E.C.Co.). A multicentre archive' is a worldwide project endorsed by the Gynecologic Cancer Inter-Group, aimed at registering conservatively treated ...endometrial cancer (EC) patients. This paper reports the oncological and reproductive outcomes of intramucous, G2, endometrioid EC patients from this archive.
Twenty-three patients (Stage IA, G2, endometrioid EC) were enrolled between January 2004 and March 2019. Primary and secondary endpoints were, respectively, complete regression (CR) and recurrence rates, and pregnancy and live birth rates.
A median follow-up of 35 months (9-148) was achieved. Hysteroscopic resection (HR) plus progestin was adopted in 74% (17/23) of cases. Seventeen patients showed CR (median time to CR, 6 months; 3-13). Among the 6 non-responders, one showed persistence and 5 progressed, all submitted to definitive surgery, with an unfavorauble outcome in one. The recurrence rate was 41.1%. Ten (58.8%) complete responders attempted to conceive, of whom 3 achieved at least one pregnancy with a live-birth. Two out of the 11 candidate patients underwent definitive surgery, while the remaining 9 have so far refused. To date, 22 patients show no evidence of disease, and one is still alive with disease.
Fertility-sparing treatment seems to be feasible even in G2 EC, although caution should be kept considering the potential pathological undergrading or non-endometrioid histology misdiagnosis. The low rate of attempt to conceive and of compliance to definitive surgery underline the need for a 'global' counselling extended to the follow-up period.
The aim of the study was to assess the predictive value of dyspareunia, general chronic pain, and metacognitive beliefs to sexual distress in a sample of women with endometriosis. Ninety-six women ...(mean age = 34.60 ± 6.44 years) with a diagnosis of endometriosis took part to this cross-sectional study. Sociodemographic and clinical data were collected by means of a structured ad hoc questionnaire. Metacognitive beliefs and sexual distress were assessed by means of the Metacognitions Questionnaire (MCQ30) and the Female Sexual Distress Scale-R (FSDS-r). General chronic pain intensity was collected by means of a Numeric Rating Scale. Data were subjected to Hierarchical logistic regression. We found high percentages of dyspareunia and sexual distress (i.e., 66% and 76%). Findings suggested that dyspareunia and chronic pain did not predict sexual distress, while negative beliefs about worries predicted sexual distress over and above them (
p
= .040, odd ratio 1.159). In the target population, metacognitive beliefs may have more influence on sexual distress than pain symptomatology.
Prophylactic Bilateral Salpingo-Oophorectomy (PBSO) reduces the risk of developing ovarian cancer. However, the psychological mechanisms that may affect post-surgery Quality of Life (QoL) among ...patients who underwent PBSO are still largely unknown. Thus, this study aimed at exploring the direct and indirect associations of satisfaction with medical communication and cancer anxiety on post-surgery QoL among women at high risk of developing ovarian cancer.
Fifty-nine women (mean age: 50.64 ± 6.7 years) who underwent PBSO took part in this cross-sectional study, filling out a sociodemographic and clinical questionnaire, a battery of validated psychological measures and an
developed scale for the assessment of cancer anxiety. We first examined the correlations among all variables of interest, and then tested if cancer anxiety mediated the association between satisfaction with medical communication and post-surgery psychological QoL, controlling both for time from surgery and education.
Post-surgery psychological QoL was unrelated from any sociodemographic or clinical variable. Cancer anxiety had a significant direct negative effect on psychological QoL, while satisfaction with medical communication had a significant positive direct effect on it. Finally, cancer anxiety significantly mediated the association between satisfaction with medical communication and post-surgery psychological QoL.
Results suggest that post-surgery psychological QoL of patients who underwent PBSO may be increased with interventions, delivered in a genetic counselling setting, targeting quality of medical communication and cancer anxiety.
Objective
To analyze the effects of pregnancy and early events in the newborn on the risk of subsequent atopic dermatitis (AD) during the first year of life.
Patients and Methods
This is a ...prospective multicenter cohort study of newborns during the first year of life. Newborns identified on random days in three obstetrics departments in the area of Bergamo, Lombardy, Northern Italy, were eligible. At baseline, the mothers were interviewed by medical staff during their stay in hospital after delivery. At 6 and 12 months after delivery, a postal questionnaire was sent to the parents. Relative risks were calculated with and without adjustment by multiple regression analysis.
Results
A total of 1081 newborns entered the study: 796 (74%) parents answered the 12‐month questionnaire. Hundred and thirty‐eight (17%) reported a diagnosis of AD at 6 months and 222 (28%) at 12 months. Parental history of AD and/or asthma was associated with an increased risk of AD (RR 1.5, 95%CI 1.1–2.0). Birth weight was slightly associated with an increased risk of AD: RR 1.04, 95%CI 1.001–1.08 (continuous variable, increment of 100 grams). No association emerged between breast feeding, smoking, and risk of AD.
Conclusions
This study in an Italian offspring cohort points to family history of atopic diseases and body weight at birth as relevant risk factors. The study was unable to document associations with other perinatal factors particularly breast feeding and parental smoking in the perinatal period.
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) have been recently reported with favorable oncological outcomes as treatment of advanced epithelial ovarian cancer ...(EOC). The aim of this study was to demonstrate the feasibility of CRS+HIPEC with cisplatin and paclitaxel for the treatment of advanced EOC.
This is a prospective observational study of 54 patients, from April 2007 to October 2013, with primary or recurrent peritoneal carcinomatosis due to EOC. The mean age was 54.51±9.34. Thirty patients (59%) had primary EOC, and 24 patients (41%) had recurrent disease.
Mean peritoneal cancer index was 10.11 (range, 0 to 28), complete cytoreduction (CC0) was achieved for 47 patients (87%), CC1 for seven patients (13%). Patients with suboptimal cytoreduction (CC2 and CC3) were not included in the study. The mean stay in intensive care unit was 4.73±5.51 days and the mean hospitalization time was 24.0±10.03 days. We did not observe any intraoperative death. Seven patients (13%) required additional operations. Three patients (5.6%) died within 30 days from the procedure. Severe complications were seen in 19 patients (35.2%). During the follow-up period, disease recurred in 33 patients (61.1%); the median disease-free survival time was 12.46 months and the median overall survival time was 32.91 months.
CRS+HIPEC with cisplatin and paclitaxel for advanced EOC is feasible with acceptable morbidity and mortality. Additional follow-up and further studies are needed to determine the effects of HIPEC on long term survival.
To investigate survival outcomes in endometrioid endometrial cancer (EEC) patients with single vs. multiple positive pelvic lymph nodes.
We performed a retrospective evaluation of all consecutive ...patients with histologically proven International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1 EEC who underwent primary surgical treatment between 2004 and 2014 at seven Italian gynecologic oncology referral centers. Patients with pre- or intra-operative evidence of extra-uterine disease (including the presence of bulky nodes) and patients with stage IIIC2 disease were excluded, in order to obtain a homogeneous population.
Overall 140 patients met the inclusion criteria. The presence of >1 metastatic pelvic node was significantly associated with an increased risk of recurrence and mortality, compared to only 1 metastatic node, at both univariate (recurrence: hazard ratio HR=2.19; 95% confidence interval CI=1.2-3.99; p=0.01; mortality: HR=2.8; 95% CI=1.24-6.29; p=0.01) and multivariable analysis (recurrence: HR=1.91; 95% CI=1.02-3.56; p=0.04; mortality: HR=2.62; 95% CI=1.13-6.05; p=0.02) and it was the only independent predictor of prognosis in this subset of patients. Disease-free survival (DFS) and disease-specific survival (DSS) were significantly longer in patients with only 1 metastatic node compared to those with more than 1 metastatic node (p=0.008 and 0.009, respectively).
The presence of multiple metastatic nodes in stage IIIC1 EEC represents an independent predictor of worse survival, compared to only one positive node. Our data suggest that EEC patients may be categorized according to the number of positive nodes.
Objective
To report mode of delivery and immediate neonatal outcome in women infected with COVID‐19.
Design
Retrospective study.
Setting
Twelve hospitals in northern Italy.
Participants
Pregnant ...women with COVID‐19‐confirmed infection who delivered.
Exposure
COVID 19 infection in pregnancy.
Methods
SARS‐CoV‐2‐infected women who were admitted and delivered from 1 to 20 March 2020 were eligible. Data were collected from the clinical records using a standardised questionnaire on maternal general characteristics, any medical or obstetric co‐morbidity, course of pregnancy, clinical signs and symptoms, treatment of COVID 19 infection, mode of delivery, neonatal data and breastfeeding.
Main outcome and measures
Data on mode of delivery and neonatal outcome.
Results
In all, 42 women with COVID‐19 delivered at the participating centres; 24 (57.1%, 95% CI 41.0–72.3) delivered vaginally. An elective caesarean section was performed in 18/42 (42.9%, 95% CI 27.7–59.0) cases: in eight cases the indication was unrelated to COVID‐19 infection. Pneumonia was diagnosed in 19/42 (45.2%, 95% CI 29.8–61.3) cases: of these, 7/19 (36.8%, 95% CI 16.3–61.6) required oxygen support and 4/19 (21.1%, 95% CI 6.1–45.6) were admitted to a critical care unit. Two women with COVID‐19 breastfed without a mask because infection was diagnosed in the postpartum period: their newborns tested positive for SARS‐Cov‐2 infection. In one case, a newborn had a positive test after a vaginal operative delivery.
Conclusions
Although postpartum infection cannot be excluded with 100% certainty, these findings suggest that vaginal delivery is associated with a low risk of intrapartum SARS‐Cov‐2 transmission to the newborn.
Tweetable
This study suggests that vaginal delivery may be associated with a low risk of intrapartum SARS‐Cov‐2 transmission to the newborn.
Tweetable
This study suggests that vaginal delivery may be associated with a low risk of intrapartum SARS‐Cov‐2 transmission to the newborn.
This article includes Author Insights, a video available at https://vimeo.com/rcog/authorinsights16278
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