Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally ...invasive surgery is inferior to laparotomy with regards to disease-free and overall survival.
To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy.
Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes.
Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden.
Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years.
Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer.
The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1-β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients.
Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter.
The trial is registered at ClinicalTrials.gov (NCT03719547).
A Mg isotope study of sugar maple (Acer saccharum Marsh.) in a field site in southern Québec, Canada, and seedlings grown in sterile soil substrate in the laboratory, both demonstrate per mil level ...within-tree Mg isotope fractionation. However, only sugar maple seedlings grown in the laboratory fractionate Mg isotopes during uptake into fine roots, favoring heavy isotope enrichment in the plant compared to the growth medium. Absence of uptake-related Mg isotope fractionation in field stands of sugar maple is tentatively attributed to the activities of the arbuscular mycorrhizal fungi that colonize fine roots of the trees in the field, but were absent from the laboratory grown specimens. The fungi facilitate nutrient uptake for the tree, while the tree provides valuable carbohydrates to the fungi. Without the symbiotic fungi, pot-grown trees in the laboratory are visibly stressed and often die. The mechanisms responsible for Mg isotopic fractionation in stressed trees remain to be elucidated. Rivers are isotopically light compared to bedrock weathering sources of Mg, and this has bearing on the δ26Mg value of the continental weathering flux of Mg to the oceans, which is an important parameter in studies of ocean Mg cycling in the geological past. If uptake-related fractionation is negligible in many other naturally growing tree species, as it is in sugar maple, then forest growth will exert little or no influence on the δ26Mg value of the export flux of Mg to first-order streams and rivers, and in turn the ocean Mg cycle. Above the tree line, preferential retention of heavy Mg isotopes in clay minerals formed during silicate weathering has been linked to the low δ26Mg values in rivers. In the forested catchment of this study there is no clear evidence for these effects. The 1 N HNO3 leach of the Bf-BC and C mineral soils, which are often used to identify minerals that may be releasing Mg and other base cations to plant-available pools, have the same average δ26Mg value (−0.66‰, n = 2) as the litter layer and exchangeable leach of the forest floor, all soil solutions, and the stream (−0.63 ± 0.17‰ 2σ, n = 23). More revealing is the molar Mg/Ca ratio of the 1 N HNO3 treatment (0.17), which is nearly identical to the bulk Mg/Ca ratio of the aboveground biomass (0.14). We conclude that the 1 N HNO3 leach in this setting releases Mg from secondary minerals, such as vermiculite, other clays, and amorphous phases, which have taken up plant-recycled Mg and Ca that has filtered down through the soil from the litter layer of the forest floor. A single mineral, chlorite, with an estimated δ26Mg value of −0.78‰, appears to be responsible for supplying most of the Mg that is circulating between the forest and soils in this setting, which is weathered and cached over timescales of thousands of years.
The angiogenic factors sFlt-1 and PlGF play an established role in the detection of preeclampsia (PE). Recent data suggest that sEng might contribute to the pathogenesis of PE. However, only a few ...studies so far have addressed its role.
This monocentric cross-sectional study of high-risk pregnancies aims to compare the levels of sFlt-1/PlGF ratio and sEng depending on different placental-related adverse pregnancy outcomes. The statistical analysis takes into account Pearson's correlation coefficient between angiogenic factors, the area under the curve estimates (AUCs) for detection, and adjusted odds ratios (aOR) with 95% confidence intervals (95%-CIs). The analysis included 206 patients: 60 controls, 90 PE (59 EOPE, 35 LOPE), 94 FGR, and 35 HELLP cases. Some outcomes overlapped because FGR commonly complicated PE and HELLP syndrome. Serum levels of sFlt-1/PlGF and sEng correlated with each other. Higher levels were observed in HELLP syndrome and EOPE cases. AUCs for sFlt-1/PlGF ratio and sEng were, respectively, 0.915 (95%-Cl 0.87-0.96) and 0.872 (95%-Cl 0.81-0.93) in PE, 0.895 (95%-Cl 0.83-0.96) and 0.878 (95%-Cl 0.81-0.95) in HELLP syndrome, 0.891 (95%-Cl 0.84-0.94), and 0.856 (95%-Cl 0.79-0.92) in FGR.aORsfor sFlt-1/PlGF ratio and sEng were, respectively: 2.69 (95%-Cl 1.86-3.9) and 2.33 (95%-Cl 1.59-3.48) in PE, 2.38 (95%-Cl 1.64-3.44) and 2.28 (95%-Cl 1.55-3.4) in FGR, and 2.10 (95%-Cl 1.45-3.05) and 1.88 (95%-Cl 1.31-2.69) in HELLP syndrome. In addition, the aORs between sFlt-1/PlGF and sEng were very similar but higher for PE and FGR than HELLP syndrome.In conclusion,sEng performed similarly to sFlt-1/PlGF to detect placental dysfunctions.
Purpose
The study aimed to assess the course of the soluble Fms-like tyrosine kinase 1 (sFlt-1)/placental growth factor (PlGF) ratio in pregnant women with fetal growth restriction (FGR) and to ...evaluate potential associations between the sFlt-1/PlGF ratio and feto-maternal Doppler parameters, fetal biometric measurements and the time between study inclusion and birth (“time to delivery”).
Methods
This was a retrospective longitudinal single center study including 52 FGR cases. The serum levels of sFlt-1 and PlGF were measured by using the BRAHMS Kryptor Compact PLUS. Fetal biometric and Doppler parameters, as well as the sFlt-1/PlGF ratio, were obtained both upon study inclusion and upon birth.
Results
Various associations between the levels of the biomarkers in maternal blood upon study inclusion and upon birth and sonographic parameters were observed in FGR cases: umbilical artery (
p
< 0.01), uterine arteries (
p
< 0.01), ductus venosus (
p
< 0.05), cerebroplacental ratio (CPR) (
p
< 0.01), femur length (
p
< 0.01) and birth weight (
p
< 0.01). The higher the sFlt-1/PlGF ratio upon study inclusion, the shorter the “time to delivery” (
p
< 0.01). The multivariate regression analysis showed that the greater the daily percentage increase of the angiogenic markers, the shorter the “time to delivery” (
p
< 0.01).
Conclusion
The fetal well-being, as measured by feto-maternal Doppler parameters such as CPR and the severity of the placental dysfunction, as measured by the urgency of birth and birth weight, is reflected by the level of the sFlt-1/PlGF ratio in the maternal serum. A rapid daily increase of the sFlt-1/PlGF ratio is significantly associated with the clinical progression of the disease.
Purpose
The aims of this study were (1) to evaluate FDG PET/CT and CT for the detection of axillary lymph node metastases in breast cancer (BC) patients and (2) to evaluate FDG PET/CT as a pre-test ...for the triage to sentinel lymph node biopsy (SLNB) versus axillary lymph node dissection (ALND).
Methods
The sensitivity, specificity, positive and negative predictive value (PPV, NPV), and accuracy of FDG PET/CT and CT for axillary lymph node metastases were determined in 61 patients (gold standard: histopathology). According to the equation “NPV = specificity ∙ (1-prevalence) / specificity ∙ (1-prevalence) + (1-sensitivity) ∙ prevalence” FDG PET/CT was evaluated as a triage tool for SLNB versus ALND.
Results
The sensitivity, specificity, PPV, NPV and accuracy of FDG PET/CT was 58, 92, 82, 77 and 79% and of CT 46, 89, 72, 71 and 72%, respectively. Patients with an up to ~60% risk for axillary lymph node metastases appear to be candidates for SLNB provided that the axilla is unremarkable on FDG PET/CT.
Conclusion
FDG PET/CT cannot replace invasive approaches for axillary staging but may extend the indication for SLNB.
Zusammenfassung
Hintergrund
Die minimal-invasive Chirurgie ist durch die technische Evolution und die vorliegenden Studiendaten zum Standard in der gynäkologisch-onkologischen Chirurgie geworden und ...ist dabei, die offene Chirurgie in weiten Teilen abzulösen.
Stand der Entwicklung
Neue Konzepte, die auf der ontogenetischen Determination von Tumor- und Wirtsgewebe basieren, führen die Möglichkeiten der Tumorchirurgie in neue Dimensionen. Der rasante Fortschritt der modernen Bildgebung sowie der funktionell-anatomischen Diagnostik ermöglichen die Entwicklung individuell angepasster Operationsstrategien.
Fazit
Die Synthese der bereits heute zur Verfügung stehenden Möglichkeiten wird die minimal-invasive Onkochirurgie revolutionieren.
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