Τρίτη 7 Σεπτεμβρίου 2021

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany

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Abstract

Background

In the Phase-III clinical trial, CheckMate 141, nivolumab significantly improved survival versus standard of care in patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

Methods

This pooled analysis investigated the real-world effectiveness of nivolumab, following prior platinum-based therapy, in patients with R/M SCCHN from the United States (US) Flatiron Health database and German HANNA prospective observational study.

Results

Overall, 782 patients (56% US; 44% Germany) were included. Median overall survival (OS) was 8.71 months, and progression-free survival was 4.11 months. Eastern Cooperative Oncology Group Performance Status 0 or 1, platinum sensitivity, and older age were associated with longer OS, in which number of prior lines of therapy had no significant effect.

Conclusion

These findings demonstrate survival benefits of nivolumab in patients with R/M SCCHN in the real-world setting. The observed real-world effectiveness of nivolumab aligns with the efficacy of nivolumab in CheckMate 141.

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Endoscopic endonasal management of skull base defects in pediatric patients

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Int J Pediatr Otorhinolaryngol. 2021 Sep 1;150:110902. doi: 10.1016/j.ijporl.2021.110902. Online ahead of print.

ABSTRACT

PURPOSE: Skull base defects in children may be the result of congenital anomalies or trauma. They often present as cerebrospinal fluid (CSF) rhinorrhea, meningitis, brain abscess or nasal obstruction. Surgical intervention is predominantly the treatment of choice. Our goal is to assess the efficacy of endoscopic endonasal approach in treating skull base defects in pediatric patients.

MATERIAL AND METHODS: In this retrospective study we identified 38 patients (mean age 8.7 ± 5.6 years old, ranging 2 months-18 years) who underwent endoscopic endonasal repair of skull base defects, between March 2010 and February 2020. Patients who had skull base reconstruction after tumor resection, those who were lost to follow-up or did not sign the consent forms were excluded from the study.

RESULTS: The clinical indications for endoscopic endonasal repair were trauma (n = 24, 63.1%) and congenital defects (n = 14, 36.9%). Congenital skull base defects included basal meningoencephalocele (n = 5, 35.7%) and frontoethmoidal defects (n = 9, 64.3%). Mean follow up time was 32 ± 29.04 months, ranging 2-103 months. Fat graft (alone or in combination) was the most commonly used material to repair the skull base defects. Thirty-seven patients (97%) showed successful results after endoscopic endonasal surgery and were symptom free.

CONCLUSION: The endoscopic endonasal repair of CSF leak and skull base defects proved to be safe and feasible with 97% success rate.

PMID:34488041 | DOI:10.1016/j.ijporl.2021.110902

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Stratifying the Risk of Cardiovascular Disease in Obstructive Sleep Apnea Using Machine Learning

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Objectives/Hypothesis

Obstructive sleep apnea (OSA) is associated with higher risk of morbidity and mortality related to cardiovascular disease (CVD). Due to overlapping clinical risk factors, identifying high-risk patients with OSA who are likely to develop CVD remains challenging. We aimed to identify baseline clinical factors associated with the future development of CVD in patients with OSA.

Study Design

Retrospective analysis of prospectively collected data.

Methods

We performed a retrospective analysis of 967 adults aged 45 to 84 years and enrolled in the Multi-Ethnic Study of Atherosclerosis. Six machine learning models were created using baseline clinical factors initially identified by stepwise variable selection. The performance of these models for the prediction of additional risk of CVD in OSA was calculated. Additionally, these models were evaluated for interpretability using locally interpretable model-agnostic explanations.

Results

Of the 967 adults without baseline OSA or CVD, 116 were diagnosed with OSA and CVD and 851 with OSA alone 10 years after enrollment. The best performing models included random forest (sensitivity 84%, specificity 99%, balanced accuracy 91%) and bootstrap aggregation (sensitivity 84%, specificity 100%, balanced accuracy 92%). The strongest predictors of OSA and CVD versus OSA alone were fasting glucose >91 mg/dL, diastolic pressure >73 mm Hg, and age >59 years.

Conclusion

In the selected study population of adults without OSA or CVD at baseline, the strongest predictors of CVD in patients with OSA include fasting glucose, diastolic pressure, and age. These results may shape a strategy for cardiovascular risk stratification in patients with OSA and early intervention to mitigate CVD-related morbidity.

Level of Evidence

3 Laryngoscope, 2021

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Efficacy of Superior Laryngeal Nerve Block for the Treatment of Neurogenic Cough: a Retrospective Review

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Abstract

Chronic cough may be multifactorial. A subset of patients may have a neurogenic cough, secondary to irritation of the superior laryngeal nerve. Superior laryngeal nerve blocks may be an efficacious treatment for neurogenic cough. Neuromodulating medications may be used in the treatment of chronic cough, but may have side effects. There are no reported serious adverse effects from superior laryngeal nerve blocks. Prospective, placebo-controlled studies are needed to confirm the efficacy of superior laryngeal nerve blocks for the treatment of chronic cough.

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Comparison of outcomes of endoscopic ear surgery with microsurgery for cholesteatoma; a prospective study of 91 cases with three year follow up

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Abstract

Trans-canal endoscopic ear surgery (TEES) is a relatively new concept, but endoscopes have been used previously as an adjunct to microsurgery (MEES) in patients with cholesteatoma (1). TEES has the added benefit of reduced morbidity and increased likelihood that the patients will tolerate the procedure as a day-case, but this can variate according to local practise and protocols. It also allows for close inspection of "hidden" areas such as sinus tympani with angled scopes.

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Application of different imaging methods for the localization of cerebrospinal fluid rhinorrhea: a comparative study

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Ann Palliat Med. 2021 Aug;10(8):8797-8807. doi: 10.21037/apm-21-1994.

ABSTRACT

BACKGROUND: CSF rhinorrhea is a type of CSF leakage caused by an aseptic abnormal passage between the subarachnoid space and the adjacent sinus and nasal cavity due to a cranial dural defect. At present, the value of computed tomography cisternography (CTC) in locating CSF rhinorrhea has been widely recognized, and magnetic resonance hydrography (MRH), as a heavy T2-weighted water imaging, plays a pivotal role in showing the location of the leak. In this paper, we retrospectively summarize the imaging manifestations seen at our hospital of patients with clinically confirmed CSF rhinorrhea at the skull base and evaluate the diagnostic value of different imaging methods in the localization of CSF rhinorrhea by means of preoperative imaging analysis using CTC and MRH.

METHODS: Fifty-five patients with CSF rhinorrhea admitted to our department from October 2016 t o January 2021 were retrospectively analyzed. The patients' conventional CT, CTC, and MRH imaging data were compared, and the location of the leak determined preoperatively matched the location of the leak found during surgery. Moreover, there was no recurrence during the follow-up period of 4 months to 3 years.

RESULTS: There were statistically significant differences between the diagnostic positivity rate of CTC and spiral CT (χ2=16.755, P<0.00), and between the diagnostic positivity rate of cranial MRH and spiral CT (χ2=6.338, 6.338=0.01), and no statistically significant difference between the diagnostic positivity rate of CTC and cranial MRH (χ2=2.625, P=0.1).

CONCLUSIONS: The combined use of imaging techniques has important practical significance for the proper treatment and prognostic evaluation of CSF rhinorrhea. CTC has the highest positive rate for the diagnosis of CSF rhinorrhea, followed by MRH, while spiral CT is safer. CTC and MRH can promote the diag nostic rate in determining the location of CSF rhinorrhea, and selective combined application can be an important guide to surgery.

PMID:34488368 | DOI:10.21037/apm-21-1994

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Lateralized Readiness Potentials Recorded with Near-Threshold Auditory Stimuli in Subjects Simulating Hearing Loss

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Audiol Neurootol. 2021 Sep 6:1-9. doi: 10.1159/000517451. Online ahead of print.

ABSTRACT

INTRODUCTION: Preparatory motor cortical responses like the lateralized readiness potential (LRP) may be useful in revealing persistent attempts to feign hearing loss. Previous studies suggest only a marginal effect of stimulus intensity on the amplitude of the LRP. However, this has not been investigated using low-intensity auditory stimuli to cue NoGo trials. We address this in an experiment where subjects were instructed not to give a manual response to low-instensity stimuli, a situation that is akin to simulating hearing loss.

METHODS: The LRP was recorded from normal hearing listeners (N = 10) with 500 and 4,000-Hz pure tones and trains of 4,000 Hz (2-1-2) tonebursts. Electrophysiologic data underwent processing to (i) analyze the effect of the stimulus type on the LRP, (ii) classify results according to manual response with both logistic reg ression and linear support vector machine (SVM) models, and (iii) derive auditory brainstem responses (ABRs) from the tonebursts.

RESULTS: The amplitude of the LRP did not differ between the 3 stimuli used to elicit the response. Single-trial electrode data from Go and NoGo trials were submitted to supervised binary classification, and the logistic regression model gave a mean accuracy of close to 0.7. The Jewett wave V latencies of the resultant ABRs from some subjects were found to increase between the high (Go) and low (NoGo) intensity tonebursts.

CONCLUSION: This study shows that auditory stimulus type does not affect the amplitude of the LRP and that the response can be recorded with stimuli that are near the auditory threshold. It can also be recorded with transient stimuli, and this allows for the possibility of simultaneously recording other confirmatory measurements, like ABR.

PMID:34488217 | DOI:10.1159/000517451

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Prognostic Significance of a Scoring System Combining p16, Smoking, and Drinking Status in a Series of 131 Patients with Oropharyngeal Cancers

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Background. Tobacco and alcohol are two main risk factors associated with head and neck squamous cell carcinoma (HNSCC). Studies showed that human papillomavirus (HPV) plays a role in the etiology of this cancer. HPV-positive oropharyngeal squamous cell carcinoma (OSCC) patients present in general a better response to conventional therapy and better overall survival (OS). However, OSCC is a heterogeneous disease regarding treatment. This study aimed to identify more effective prognostic factors associated with a poor clinical outcome for OSCC patients to improve treatment selection. Materials and Methods. OSCC patients diagnosed between 2007 and 2017, in two Belgian hospitals, were included. Demographic and clinicopathologic data were extracted from medical records. HPV status was determine d through p16 immunohistochemistry. Univariable and multivariable Cox proportional hazard regression analyses allowed to identify variables prognostic for OS and recurrence-free survival (RFS). Kaplan–Meier survival curves have been assessed for survival. Results. The study included 131 patients. Statistics showed that monotherapies were significantly associated with a shorter OS; p16 overexpression was significantly associated with a weak consumption of tobacco or alcohol, and a high p16 expression was significantly associated with both longer RFS and OS. The study validated that tobacco and alcohol consumption were significantly correlated with poorer RFS and poorer OS. Only p16 expression trended to be significant for RFS when compared to smoking and drinking habits, while p16 upregulation and alcohol use were both vital for OS indicating that p16 is an independent and significant prognostic factor in OSCC patients. Finally, a scoring system combining p16, tobacco, and alcohol status was defined and was significantly associated with longer RFS and longer OS for nonsmoker and nondrinker p16-positive OSCC patients. Conclusions. This study confirmed that the overexpression of the p16 protein could be viewed as a factor of good prognosis for RFS and OS of OSCC patients. The prognostic significance of a scoring system combining p16 expression, smoking, and drinking status was evaluated and concluded to be a more effective tool to determine therapeutic orientations based on the risk factors for better treatment relevance and survival.
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Vagus Nerve Stimulation as a Potential Adjuvant to Rehabilitation for Post-stroke Motor Speech Disorders

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Front Neurosci. 2021 Aug 19;15:715928. doi: 10.3389/fnins.2021.715928. eCollection 2021.

ABSTRACT

Stroke often leaves lasting impairments affecting orofacial function. While speech therapy is able to enhance function after stroke, many patients see only modest improvements after treatment. This partial restoration of function after rehabilitation suggests that there is a need for further intervention. Rehabilitative strategies that augment the effects of traditional speech therapy hold promise to yield greater efficacy and reduce disability associated with motor speech disorders. Recent studies demonstrate that brief bursts of vagus nerve stimulation (VNS) can facilitate the benefits of rehabilitative interventions. VNS paired with upper limb rehabilitation enhances recovery of upper limb function in patients with chronic stroke. Animal studies reveal that these improvements are driven by VNS-dependent synaptic plasticity in motor networks. M oreover, preclinical evidence demonstrates that a similar strategy of pairing VNS can promote synaptic reorganization in orofacial networks. Building on these findings, we postulate that VNS-directed orofacial plasticity could target post-stroke motor speech disorders. Here, we outline the rationale for pairing VNS with traditional speech therapy to enhance recovery in the context of stroke of speech motor function. We also explore similar treatments that aim to enhance synaptic plasticity during speech therapy, and how VNS differs from these existing therapeutic strategies. Based on this evidence, we posit that VNS-paired speech therapy shows promise as a means of enhancing recovery after post-stroke motor speech disorders. Continued development is necessary to comprehensively establish and optimize this approach, which has the potential to increase quality of life for the many individuals suffering with these common impairments.

PMID:34489632 | PMC:PMC8417469 | DOI:10.3389/fnins.2021.715928

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Long-term aesthetics, patient-reported outcomes, and auricular sensitivity after microtia reconstruction: A systematic review

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J Plast Reconstr Aesthet Surg. 2021 Aug 19:S1748-6815(21)00379-X. doi: 10.1016/j.bjps.2021.08.004. Online ahead of print.

ABSTRACT

BACKGROUND: Auricular reconstruction for microtia is most frequently performed using autologous costal cartilage (ACC) or porous polyethylene (PPE) implants. Short-term results are generally promising, but long-term results remain unclear. Long-term outcomes were explored in this systematic review, and minimal reporting criteria were suggested for future original data studies.

METHODS: A systematic literature search was conducted in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from inception through October 14, 2020. Articles on auricular reconstruction in patients with microtia using ACC or PPE were included if postsurgical follow-up was at least 1 year. Outcome reporting was split into separate publications, and results on complications were reported previously. This publi cation focused on long-term aesthetic, patient-reported, and sensitivity outcomes.

RESULTS: Forty-one publications reported on these outcomes. Both materials led to aesthetically pleasing results and high rates of patient satisfaction. ACC frameworks grew similarly to contralateral ears, and the anterior surface of auricles regained sensitivity. Furthermore, postoperative health-related quality of life (HRQoL) outcomes were generally good. Data synthesis was limited due to considerable variability between studies and poor study quality. No conclusions could be drawn on the superiority of either method due to the lack of comparative analyses.

CONCLUSION: Future studies should minimally report (1) surgical efficacy measured using the tool provided in the UK Care Standards for the Management of Patients with Microtia and Atresia; (2) complications including framework extrusion or exposure, graft loss, framework resorption, wire exposure and scalp/auricular scar complication s and (3) HRQoL before and after treatment using the EAR-Q patient-reported outcome measure (PROM).

PMID:34489212 | DOI:10.1016/j.bjps.2021.08.004

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Effect of TSH stimulation protocols on adequacy of low-iodine diet for radioiodine administration

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PLoS One. 2021 Sep 7;16(9):e0256727. doi: 10.1371/journal.pone.0256727. eCollection 2021.

ABSTRACT

Low-iodine diet (LID) is a crucial preparation for radioactive iodine (RAI) treatment or scan in thyroid cancer. The aim of this study is to analyze the influence of thyroid stimulating hormone (TSH) stimulation protocols and other clinical factors on LID adequacy. Thyroid cancer patients who underwent LID for RAI scan or treatment were retrospectively analyzed. Patients were guided t o have LID for 2 weeks before RAI administration and urine iodine/creatinine ratio (UICR, μg/g Cr) was measured. TSH stimulation was conducted using either thyroid hormone withdrawal (THW) or recombinant human TSH (rhTSH) injection. Adequacy of LID was classified by UICR as 'excellent (< 50)', 'adequate (50-100)', 'inadequate (101-250)' and 'poor (> 250)'. A total of 1715 UICR measurements from 1054 patients were analyzed. UICR was significantly higher in case of rhTSH use than THW (72.4 ± 48.1 vs. 29.9 ± 45.8 μg/g Cr, P < 0.001). In patients who underwent LID twice using both TSH stimulation protocols alternately, UICR was higher in case of rhTSH than THW regardless of the order of method. Among clinical factors, female, old-age, and the first LID were significant factors to show higher UICR. Although the adequacy of LID was 'adequate' or 'excellent' in most patients, multivariate analysis demonstrated that THW method, male, young age, and prior LID-experience were sig nificant determinants for achieving 'excellent' adequacy of LID. In conclusion, UICR was higher and the proportion of 'excellent' LID adequacy was lower with rhTSH than with THW. UICR was higher also in women, old-age, and LID-naïve patients. Further researches are required to suggest effective methods to reduce body iodine pool in case of rhTSH use and to validate the efficacy of such methods on outcomes of RAI treatment.

PMID:34492048 | DOI:10.1371/journal.pone.0256727

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