Adjuvant treatment decisions for endometrial cancer (EC) are based on stage, the histological grade of differentiation, histological subtype, and few histopathological markers. The Proactive ...Molecular Risk Classifier for Endometrial Cancer (ProMisE) identified four risk groups of EC patients using a combination of immunohistochemistry and mutation analysis: Polymerase Epsilon exonuclease domain mutated (POLE EDM), mismatch repair deficient (MMRd), p53 wild-type/copy-number-low (p53 wt), and p53-mutated/copy-number-high (p53 abn). Patients allocated to the POLE or abnormal p53 expression subtype are faced with a significantly altered outcome possibly requiring a modified adjuvant treatment decision. Within this review, we summarize the development of ProMisE, characterize the four molecular subtypes, and finally discuss its value in terms of a patient-tailored therapy in order to prevent significant under or overtreatment.
Systematic pelvic and paraaortic lymphadenectomy has been widely used in the surgical treatment of patients with advanced ovarian cancer, although supporting evidence from randomized clinical trials ...has been limited.
We intraoperatively randomly assigned patients with newly diagnosed advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery to either undergo or not undergo lymphadenectomy. All centers had to qualify with regard to surgical skills before participation in the trial. The primary end point was overall survival.
A total of 647 patients underwent randomization from December 2008 through January 2012, were assigned to undergo lymphadenectomy (323 patients) or not undergo lymphadenectomy (324), and were included in the analysis. Among patients who underwent lymphadenectomy, the median number of removed nodes was 57 (35 pelvic and 22 paraaortic nodes). The median overall survival was 69.2 months in the no-lymphadenectomy group and 65.5 months in the lymphadenectomy group (hazard ratio for death in the lymphadenectomy group, 1.06; 95% confidence interval CI, 0.83 to 1.34; P = 0.65), and median progression-free survival was 25.5 months in both groups (hazard ratio for progression or death in the lymphadenectomy group, 1.11; 95% CI, 0.92 to 1.34; P = 0.29). Serious postoperative complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% P = 0.01; mortality within 60 days after surgery, 3.1% vs. 0.9% P = 0.049).
Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery was not associated with longer overall or progression-free survival than no lymphadenectomy and was associated with a higher incidence of postoperative complications. (Funded by Deutsche Forschungsgemeinschaft and the Austrian Science Fund; LION ClinicalTrials.gov number, NCT00712218.).
Cancer diagnosis and treatment in pregnant women is a challenging situation. A multidisciplinary network of specialists is required to guide both, the expecting mother and the unborn child through ...the diagnostic workup and the cytotoxic therapy, by balancing the respective risks and benefits. Tumor entity, stage, biology and gestational week at diagnosis determine the appropriate approach. As premature delivery emerged as one of the main risk factors for adverse long-term outcome of the progeny, it should be avoided, if reasonable from the oncological perspective. This article offers a comprehensive review with respect to the various aspects of cancer in pregnancy.
Aim
The gold standard to treat an apical pelvic organ prolapse is the abdominal route via a sacrocolpopexy, which is also reproduced by laparoscopic route. A laparoscopic sacrocolpopexy however, ...requires surgical expertise. Three‐dimensional (3D) laparoscopy has been developed to overcome the lack of depth perception, that is a known disadvantage of conventional two‐dimensional (2D) laparoscopy. This procedure can accelerate the learning curve and optimize the intra‐, peri‐, and postoperative outcomes. This study aims to compare 3D laparoscopy to traditional 2D laparoscopy for sacrocolpopexy.
Methods
Data from 132 patients who underwent a sacrocolpopexy with 2D or 3D laparoscopy in Department of Obstetrics and Gynecology, University Medical Center of the Johannes Gutenberg University, between June 2012 and September 2021, were collected retrospectively. Seventy‐one laparoscopic sacrocolpopexy operations in 2D (n = 23) and 3D (n = 48) group were reviewed and compared regarding the duration of surgery, blood loss and the length of hospital admission as primary objectives.
Results
There were no differences in the baseline demographics between the two groups. The estimated blood loss (1.0 (±0.6) g/dL vs 1.7 (±1.0) g/dL, p = 0.010), and duration of surgery (115.4 (±34.7) min. vs 134.7 (±26.2) min., p = 0.012) was significantly better in favor of 3D laparoscopy. The length of hospital stay was comparable in both groups (p = 0.833). Furthermore, no differences were observed between the groups regarding other surgical outcomes.
Conclusion
3D laparoscopy shows a significant benefit in terms of estimated blood loss and surgery duration among complex urogynecological surgeries compared to traditional 2D laparoscopy.
We estimate (1) sexual activity and sexual desire in women living with and without a partner across the age range in Germany and (2) changes over 11 years. A representative survey of 1345 (response ...rate: 65%) women between 18 and 99 years from 2016 was compared to a survey of 1314 women age 18–91 from 2005 (response rate: 53%). Sexual activity was assessed as having been physically intimate with someone in the past year; frequency of sexual desire was rated for the past 4 weeks. In 2016, the great majority of women living with a partner were sexually active and indicated sexual desire until the age of 60, which decreased thereafter. Compared to 2005, fewer women cohabited with a partner. Across the age range, women living without a partner reported considerably less sexual activity and desire. The overall proportion of women reporting partnered sexual activity decreased from 67% to 62% in 2016, and absent sexual desire increased from 24% to 26%. Declines of sexual activity and desire affected mostly young and middle-aged women. The decline of sexual activity and desire seems to be due to a reduced proportion of women living with a partner. There was also a generation effect with younger and middle-aged women without a partner becoming less sexually active and experiencing less desire compared to the previous survey. While surveys were methodologically comparable, interpretations are limited by the absence of longitudinal data.
We assessed the tolerability and antitumor activity of solitomab, a bispecific T-cell engager (BiTE®) antibody construct targeting epithelial cell adhesion molecule (EpCAM). Patients with ...relapsed/refractory solid tumors not amenable to standard therapy received solitomab as continuous IV infusion in a phase 1 dose-escalation study with six different dosing schedules. The primary endpoint was frequency and severity of adverse events (AEs). Secondary endpoints included pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. Sixty-five patients received solitomab at doses between 1 and 96 µg/day for ≥28 days. Fifteen patients had dose-limiting toxicities (DLTs): eight had transient abnormal liver parameters shortly after infusion start or dose escalation (grade 3, n = 4; grade 4, n = 4), and one had supraventricular tachycardia (grade 3); all events resolved with solitomab discontinuation. Six patients had a DLT of diarrhea: four events resolved (grade 3, n = 3; grade 4, n = 1), one (grade 3) was ongoing at the time of treatment-unrelated death, and one (grade 3) progressed to grade 5 after solitomab discontinuation. The maximum tolerated dose was 24 µg/day. Overall, 95% of patients had grade ≥3 treatment-related AEs, primarily diarrhea, elevated liver parameters, and elevated lipase. Solitomab half-life was 4.5 hours; serum levels plateaued within 24 hours. One unconfirmed partial response was observed. In this study of a BiTE® antibody construct targeting solid tumors, treatment of relapsed/refractory EpCAM-positive solid tumors with solitomab was associated with DLTs, including severe diarrhea and increased liver enzymes, which precluded dose escalation to potentially therapeutic levels.
Background: Intermittent fasting (IF) is defined as an eating pattern without calorie restrictions, alternating between periods of fasting and eating. In the past decades IF has not only become a ...popular weight-reducing diet but is thought to improve Quality of Life (QoL) and fatigue. However, very little evidence exists for the general population. Thus, we aimed to assess the impact of a 16-h fasting period per day over a three-month study period on QoL and especially fatigue in healthy people. Methods: We conducted a prospective cohort study including healthy subjects. All participants fasted 16 h for at least five days a week while maintaining their normal lifestyle. In the study, we analysed blood samples as well as QoL through standardized questionnaires (WHO-5 questionnaire, Short Form Health 36). Furthermore, we measured the degree of fatigue with the Fatigue Assessment Scale (FAS) and Fatigue Severity Scale (FSS) as well as compliance, activity records, and weight alterations. All endpoints were evaluated at baseline, after two weeks, four weeks, and three months of IF. Results: A total of 30 participants fasted for the entire study period. The results of the WHO-5 questionnaire (15.6 ± 4.6 vs. 18 ± 3.6, p < 0.0019) demonstrated a significant increase in QoL. For long-term QoL six out of eight domains measured by the Short Form Health 36 (SF-36) significantly improved (e.g., physical health: 92.3 ± 11.6 vs. 96.5 ± 6.3, p = 0.015; mental health: 75.5 ± 12.0 vs. 81.7 ± 9.0; p < 0.001 and body pain: 74.1 ± 31.8 vs. 89.5 ± 14.9; p = 0.008) after three months. Fatigue significantly decreased from 10.3 ± 3.2 to 8.4 ± 2.5; p = 0.002 for mental fatigue and from 12.6 ± 3.8 to 10.7 ± 3.3; p = 0.002 measured by the FAS. The mean FSS-Score at baseline was 3.5 ± 1.2 compared to 2.9 ± 1.1 (scale 1−7) after three months (p < 0.001). Notably, the proliferation marker IGF-1 was significantly reduced. No clinically significant changes in laboratory parameters were observed that would have endangered a participant’s safety. Conclusions: IF according to the 16:8 regime over a fasting period of three months significantly improved several aspects of the QoL and decreased fatigue in healthy people, while maintaining a good safety profile. The practicability of this diet was also demonstrated for shift workers and people with a high percentage of active labour. Apart from the improvement in QoL and fatigue, the significant reduction in IGF-1, which can act as an accelerator of tumour development and progression, might be an indicator of the potential benefits of IF for patients with cancer.
Objectives
To assess the value of new magnetic resonance imaging (MRI) techniques in cervical cancer.
Methods
We searched PubMed and MEDLINE and reviewed articles published from 1990 to 2016 to ...identify studies that used MRI techniques, such as diffusion weighted imaging (DWI), intravoxel incoherent motion (IVIM) and dynamic contrast enhancement (DCE) MRI, to assess parametric invasion, to detect lymph node metastases, tumour subtype and grading, and to detect and predict tumour recurrence.
Results
Seventy-nine studies were included. The additional use of DWI improved the accuracy and sensitivity of the evaluation of parametrial extension. Most studies reported improved detection of nodal metastases. Functional MRI techniques have the potential to assess tumour subtypes and tumour grade differentiation, and they showed additional value in detecting and predicting treatment response. Limitations included a lack of technical standardisation, which limits reproducibility.
Conclusions
New advanced MRI techniques allow improved analysis of tumour biology and the tumour microenvironment. They can improve TNM staging and show promise for tumour classification and for assessing the risk of tumour recurrence. They may be helpful for developing optimised and personalised therapy for patients with cervical cancer.
Teaching points
• Conventional MRI plays a key role in the evaluation of cervical cancer.
• DWI improves tumour delineation and detection of nodal metastases in cervical cancer.
• Advanced MRI techniques show promise regarding histological grading and subtype differentiation.
• Tumour ADC is a potential biomarker for response to treatment.
Objectives
Small-for-gestational-age (SGA) pregnancy is a condition often leading to labor induction due to concerns about the possibility of an increased risk for fetal morbidity and mortality. In ...this retrospective cohort study, we try to evaluate the safety of oral misoprostol for labor induction in near-term and term pregnancies in SGA fetuses compared to dinoprostone as well as to planned primary cesarean section.
Materials and methods
Retrospective analysis of labor indution and primary cesarean section in SGA pregnancies 37 weeks and beyond in a tertiary care centre. In total, 284 consecutive patients with SGA fetuses were included. 80 recieved oral misoprostol, 85 dinoprostone as vaginal Gel and 119 were delivered by means of primary cesarean section. Primary endpoints were umbilical aterial pH and APGAR 5′. Secondary endpoints were APGAR 1′ and 10′, rates of relevant acidosis with a pH < 7.11 and depressed children, NICU admissions and vaginal operative deliveries as well as cesarean sections after labor induction.
Results
No significant differences were found concerning the umbilical arterial pH. No significant differences were found concerning APGAR 5′ after labor induction; however, APGAR 5′ was significantly lower after primary cesarean section. Similar results were found concerning APGAR 1′, 10-min APGAR values were not significantly different. Rates of relevant acidosis and depressed children did not differ; no significant differences were found concerning NICU admissions between all groups and vaginal operative deliveries and CS rates after labor induciton.
Conclusion
Oral misoprosol is a safe method for labor induction in SGA near-term and term pregnancies and, concerning the neonatal outcome, comparable with other methods of labor induction or primary CS. Our study showed no adverse neonatal outcomes related to the use of oral misoprostol.
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