Πέμπτη 29 Σεπτεμβρίου 2022

Long-term Locoregional Control With Unilateral Radiation for AJCC-7 T1-2N2b Tonsillar Cancer

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imageObjectives: Unilateral radiation to cervical nodes has been used as a de-escalation strategy in well-lateralized tonsil cancers. The efficacy of this approach with multiple ipsilateral nodes is not established. The study hypothesis was that unilateral radiation for American Joint Committee on Cancer (AJCC)-7 T1-2N2b tonsillar cancer results in a low rate of contralateral nodal failure. Materials and Methods: This study was a retrospective chart review of patients with AJCC-7 T1-2N2b tonsillar cancer from 2 academic institutions who were treated with unilateral radiation. The primary endpoint was the contralateral nodal failure rate. Locoregional control, overall survival, and the need for gastrostomy tube placement were additional endpoints. Results: The study cohort included 66 patients treated between 2005 and 2016. The median follow-up time was 80.9 months; contralateral nodal failure occurred in 2/66 (3.0%) patients at 4.1 and 20.9 months, respectively. Both patients underwent salvage treatment with long-term subsequent survival. Overall locoregional control at both 2 and 5 years was 93.9% and the median duration of control was not reached. Overall survival at 5 years was 92.4%. Conclusions: The use of unilateral radiation for AJCC-7 T1-2N2b tonsillar cancer resulted in low rates of contralateral nodal failure. This outcome demonstrates the safety of considering unilateral radiation treatment in patients with a relatively high ipsilateral nodal burden.
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A Novel Nomogram for Predicting Breast Cancer–specific Survival in Male Patients

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imageObjectives: To compare breast cancer–specific survival (BCSS) of nonmetastatic invasive breast cancer between male (MBC) and female (FBC) patients, define clinicopathologic variables related to BCSS in nonmetastatic invasive MBC patients, and establish a nomogram for individual risk prediction. Materials and Methods: On the basis of Surveillance, Epidemiology, and End Results database, 2094 MBC and 48,104 FBC cases underwent propensity score matching (PSM). We compared the prognosis of patients before and after PSM and developed a nomogram for BCSS of nonmetastatic invasive MBC patients. Internal validation was performed using the consistency index, calibration curves, and receiver operating characteristic curves. Simultaneously, data from 49 nonmetastatic invasive MBC patients diagnosed between January 2012 and May 2016 were collected for external validation. Results: Before PSM, overall survival and BCSS were significantly shorter in MBC than those in FBC patients. After PSM, MBC patients continued to have a shorter overall survival, but not BCSS, than FBC patients. Marital status, age, histologic grade, estrogen/progesterone receptor status, Tumor Lymph Node stage, and surgery were included in the prediction model. Conclusions: The nomogram developed in this study seems to be more accurate than conventional Tumor-nodal-metastasis staging staging to predict BCSS and may serve as an effective tool for assessing the prognosis of nonmetastatic invasive MBC.
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The French FRACTURE database: A way to improve knowledge on management of children with very rare tumors

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Abstract

Introduction

Very rare pediatric tumors (VRTs), defined by an annual incidence ≤2 per million inhabitants, represent a heterogeneous group of cancers. Due to their extremely low incidence, knowledge on these tumors is scant. Since 2012, the French Very Rare Tumors Committee (FRACTURE) database has recorded clinical data about VRTs in France. This study aims: (a) to describe the tumors registered in the FRACTURE database; and (b) to compare these data with those registered in the French National Registry of Childhood Cancer (RNCE).

Methods

Data recorded in the FRACTURE database between January 1, 2012 and December 31, 2018 were analyzed. In addition, these data were compared with those of the RNCE database between 2012 and 2015 to evaluate the completeness of the documentation and understand any discrepancies.

Results

A total of 477 patients with VRTs were registered in the FRACTURE database, representing 97 histological types. Of the 14 most common tumors registered in the RNCE (772 patients), only 19% were also registered in the FRACTURE database. Total 39% of children and adolescent VRTs registered in the RNCE and/or FRACTURE database (323 of a total of 828 patients) were not treated in or linked to a specialized pediatric oncology unit.

Conclusion

VRTs represent many different heterogenous entities, which nevertheless account for 10% of all pediatric cancers diagnosed each year. Sustainability in the collection of these rare tumor cases is therefore important, and a regular systematic collaboration between the FRACTURE database and the RNCE register helps to provide a more exhaustive picture of these VRTs and allow research completeness for some peculiar groups of patients.

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Controlling Nutritional Status (CONUT) score is a prognostic marker for laryngeal cancer patients with curative resection

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Abstract

Background

To investigate the prognostic value of pre-treatment Controlling Nutritional Status (CONUT) score in laryngeal cancer.

Methods

Preoperative CONUT score was retrospectively calculated in 154 laryngeal cancer patients who underwent curative resection in our hospital from 2013 to 2016. The associations of CONUT with clinicopathological factors and survival were evaluated. The efficacy of CONUT score to predict prognosis was evaluated.

Results

The CONUT score was associated with body mass index (p = 0.033), neutrophil (p = 0.011), tumor size (p = 0.017), pTNM stage (p = 0.001), adjuvant radiotherapy (p < 0.001), negative pathologic factors (p < 0.001), and larynx preservation (p < 0.001). Patients with a higher CONUT score had worse overall survival (hazard ratio: 1.94, 95% confidence interval [CI]: 1.13–3.72, p = 0.039) and disease-free survival (hazard ratio: 2.16, 95% CI: 1.19–3.90, p = 0.011). The area under the curve of CONUT score (0.728) was higher than Preoperative Nutritional Index (0.72), platelet-to-lymphocyte ratio (0.675), and neutrophil-to-lymphocyte ratio (0.687).

Conclusion

The CONUT score can be useful for predicting survival in laryngeal cancer patients after curative resection.

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Risk of adverse neonatal outcomes among pregnant women with disabilities

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Abstract
Background
To compare risk of neonatal morbidities between women with and without documented disability and to evaluate mediation of these associations by pre-term birth and caesarean delivery.
Methods
Using data from the Consortium on Safe Labor (2002–2008; n = 223 385), we evaluated risk of 22 neonatal outcomes among singleton deliveries using ICD-9 codes to define physical (n = 1733), sensory (n = 250) and intellectual disability (n = 91). Adjusted relative risk (aRR) was estimated for each outcome among each category of disability, and among women with any disability using Poisson regression models with robust variance. Causal mediation methods evaluated pre-term birth and caesarean delivery as mediators.
Results
Compared with no disabili ty, neonates of women with any disability had higher risk of nearly all neonatal outcomes, including pre-term birth (aRR = 1.77; 95% CI 1.62–1.94), small for gestational age (SGA) (aRR = 1.25; CI 1.11–1.41), neonatal intensive care unit (NICU) admission (aRR = 1.70; CI 1.54–1.87), seizures (aRR = 2.81; CI 1.54–5.14), cardiomyopathy (aRR = 4.92; CI 1.15–20.95), respiratory morbidities (aRR ranged from 1.33–2.08) and death (aRR = 2.31; CI 1.38–3.87). Women with disabilities were more likely to have a maternal indication for pre-term delivery, including pre-pregnancy diabetes (aRR = 3.80; CI 2.84–5.08), chronic hypertension (aRR = 1.46; CI 0.95–2.25) and severe pre-eclampsia/eclampsia (aRR = 1.47; CI 1.19–1.81). Increased risk varied but was generally consistent across all disability categories. Most outcomes were partially mediated by pre-term birth, except SGA, and heightened risk remained for NICU admissions, respiratory distre ss syndrome, anaemia and a composite of any adverse outcome (aRR = 1.21; CI 1.10–1.32).
Conclusion
Neonates of women with disabilities were at higher risk of a broad range of adverse neonatal outcomes, including death. Risks were not fully explained by pre-term birth.
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Transmission of Carbapenem-resistant Klebsiella pneumoniae in US hospitals

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ABSTRACT
Background
Carbapenem-resistant Klebsiella pneumoniae (CRKp) is the most prevalent carbapenem-resistant Enterobacterales in the United States. We evaluated clustering of CRKp in hospitalized patients in US hospitals.
Methods
From April 2016 to August 2017, 350 patients with clonal group 258 were included as part of the Consortium on Re sistance Against Carbapenems in Klebsiella and other Enterobacteriaceae (CRACKLE-2), a prospective, multicenter, cohort study. A maximum-likelihood tree was constructed using RAxML. Static clusters shared ≤21 single nucleotide polymorphisms (SNP) and a most recent common ancestor. Dynamic clusters incorporated SNP distance, culture timing, and rates of SNP accumulation and transmission using the R program TransCluster.
Results
Most patients were admitted from home (n = 150, 43%) or a long-term care facility (n = 115, 33%). Urine (n = 149, 43%) was the most common site of isolation. In total, 55 static and 47 dynamics clusters were identified involving 210/350 (60%) and 194/350 (55%) patients, respectively. About half of static clusters were identical to dynamic clusters. Static clusters consisted of 33 (60%) intra-system and 22 (40%) inter-system clusters. Dynamic clusters consiste d of 32 (68%) intra-system and 15 (32%) inter-system clusters and had fewer SNP differences compared to static clusters (8 versus 9, P= 0.045, 95% CI: [-4, 0]). Dynamic inter-system clusters contained more patients than dynamic intra-system clusters (median [IQR]: 4 [2, 7] vs 2 [2, 2], P= 0.007, 95% CI: [-3, 0]).
Conclusions
Widespread intra-system and inter-system transmission of CRKp was identified in hospitalized US patients. Employing different methods for assessing genetic similarity resulted in only minor differences in interpretation.
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Τετάρτη 28 Σεπτεμβρίου 2022

Evaluation of an Opt-Out Protocol for Antibiotic De-escalation in Patients with Suspected Sepsis: a multicenter randomized controlled trial

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Abstract
Background
Sepsis guidelines recommend daily review to de-escalate or stop antibiotics in appropriate patients. This randomized controlled trial evaluated an opt-out protocol to decrease unnecessary antibiotics in patients with suspected sepsis.
Methods
We evaluated non-ICU adults on broad-spectrum antibiotics despite negative blood cultures at ten U.S. hospitals from September 2018 through May 2020. A 23-item safety check excluded patients with ongoing signs of systemic infection, concerning or inadequate microbiologic data, or high-risk conditions. Eligible patients were randomized to the opt-out protocol vs. usual care. The primary outcome was 30-day post-enrollment antibacterial days of therapy (DOT). Clinicians caring for intervention patients were contacted to encourage antibiotic discontinuation using opt-out language. If antibiotics were continued, clinicians discussed rationale for continuing antibiotics and de-escalation plans. To evaluate those with zero post-enrollment DOT, hurdle models provided two measures: 1) the odds ratio of antibiotic continuation and 2) ratio of mean DOT among those who continued antibiotics.
Results
Among 9606 patients screened, 767 (8%) were enrolled. Intervention patients had 32% lower odds of antibiotic continuation (79% vs. 84%, OR 0.68, 95% confidence interval (CI) [0.47, 0.98]). DOT among those who continued antibiotics were similar (ratio of means 1.06, 95% CI [0.88-1.26]). Few er intervention patients were exposed to extended-spectrum antibiotics (36% v. 44%. Common reasons for continuing antibiotics were treatment of localized infection (76%) and belief that stopping antibiotics was unsafe (31%). Thirty-day safety events were similar.
Conclusions
An antibiotic opt-out protocol targeting patients with suspected sepsis resulted in more antibiotic discontinuations, similar DOT when antibiotics were continued, and no evidence of harm.
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The effect of adjuvant radiotherapy on clinical outcomes in early major salivary gland cancer

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Abstract

Background

This study investigated the effects of adjuvant radiotherapy on outcomes in early-stage major salivary gland cancers.

Methods

A total of 655 patients were identified, including 355 (54.2%) received adjuvant radiotherapy and 300 (45.8%) had surgery alone. The effect of adjuvant radiotherapy on 5-year locoregional recurrence and disease-specific survival (DSS) was calculated using the Kaplan–Meier method, Wilcoxon rank sum test, and Cox proportional hazards model.

Results

There were no significant differences in locoregional recurrence and DSS between patients receiving adjuvant radiotherapy and those not in both univariate and multivariable analysis. Although patients with positive margin status had a higher locoregional recurrence and those with moderate/poor differentiation had a worse DSS, stratified analysis still indicated there were no protective effects from the use of adjuvant radiotherapy.

Conclusions

The use of adjuvant radiation therapy was not associated with improved locoregional recurrence and DSS, even for those with high-risk histopathological factors.

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Efficacy of bismuth for antibiotic‐resistant Helicobacter pylori strains eradication: A systematic review and meta‐analysis

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Abstract

Background & Aims

Antibiotic resistance of Helicobacter pylori (H. pylori) is increasing worldwide, and bismuth quadruple therapy has been recommended as a first-line regimen in many areas. This study aimed to investigate whether bismuth would improve the eradication rate (ER) of clarithromycin-/metronidazole-/levofloxacin-resistant H. pylori strains and how much additional efficacy bismuth could achieve.

Methods

PubMed, EMBASE, Web of Science, and Cochrane Central databases for randomized controlled trials were systematically searched by two independent reviewers until 15 January 2022. Pooled ERs of clarithromycin-/metronidazole-/levofloxacin-resistant H. pylori strains were compared between bismuth-containing and non-bismuth therapies. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using a random-effects model.

Results

Eight studies enrolling 340 individuals were included. The RRs of pooled ERs compared between bismuth-containing and non-bismuth therapies were 1.83 for clarithromycin-resistant strains (95% CI 1.16–2.89, pooled ER: 76.9% vs. 36.6%, p = .009, I2 = 0%), 1.39 for metronidazole-resistant strains (95% CI 1.09–1.78, pooled ER: 86.8% vs. 60.9%, p = .008, I2 = 37%), 2.75 for dual clarithromycin/metronidazole-resistant strains (95% CI 1.01–7.52, pooled ER: 76.9% vs. 18.2%, p = .05, I2 = 0%), and 1.04 for levofloxacin-resistant strains (95% CI 0.56–1.93, pooled ER: 63.4% vs. 54.3%, p = .90; I2 = 60%). Bismuth significantly increased the ERs of clarithromycin-, metronidazole-, and dual-resistant strains by 40%, 26%, and 59%, respectively. Subgroup analysis of treatment duration showed that the significantly higher eradication rate fo r antibiotic-resistant strains in bismuth-containing therapy than non-bismuth therapy was only observed in 14-day treatment regimens and not in 7-day regimens (p = .02 and .17, respectively).

Conclusions

Bismuth was most effective in improving the ERs of dual-resistant H. pylori strains, followed by clarithromycin- and metronidazole-resistant strains. Prolonged treatment duration might effectively improve the efficacy of bismuth in overcoming antibiotic resistance.

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Reconstruction of the Obliterated Eustachian Tube: A Pilot Case Series

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Reconstruction of the Obliterated Eustachian Tube: A Pilot Case Series

Complete occlusion of the cartilaginous ET can be associated with intractable mucoid effusion; endoscopic examination should be considered in such cases. In this pilot study, ET reconstruction was done and found to be a safe and possibly effective procedure in patients with total obliteration of the ET from various etiologies.


Objective

To investigate the safety and early efficacy of a procedure for reconstruction of the obliterated Eustachian tube (ET).

Study Design

Retrospective case series.

Methods

Patients with total obliteration of the cartilaginous ET, with intractable mucoid effusion causing repeated occlusion of tympanostomy tubes were included. Patients underwent endoscopic transnasal/transoral reconstruction of the obliterated ET using transtympanic illuminated guidewire guidance. A temporary stent (angiocatheter filled with bonewax) was placed to maintain patency while healing. In four cases an additional steroid-eluting propel stent was placed in the ET orifice. Main outcome measures were otomicroscopy results, absence of middle ear effusion, and nasopharyngoscopy showing patency of the ET orifice.

Results

Nine ETs (seven patients), ages 17–68 years (mean 37.9) underwent ET reconstruction. Follow-up ranged from 4 to 56 months (mean 30.9 months). 89% of operated ears had no effusion at last follow-up. Two patients (three Eustachian tubes) underwent successful reoperation. There were no complications directly related to the procedure. Etiologies of obliteration included scarring after sinus surgery, obstruction after maxillo-mandibular advancement surgery (two patients), bullous pemphigus, gunshot trauma, and previous patulous obliteration (two patients).

Conclusions

Complete occlusion of the cartilaginous ET can be associated with intractable mucoid effusion; endoscopic examination should be considered in such cases. In this pilot study, ET reconstruction was found to be a safe and possibly effective procedure in patients with total obliteration of the ET from various etiologies. Larger studies with long term follow up are indicated.

Level of Evidence

4 Laryngoscope, 2022

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