Administrative delays of temporary recommendation for use: Impact on access to innovation in melanoma

xlomafota13 shared this article with you from Inoreader Administrative delays of temporary recommendation for use: Impact on access to innovation in melanoma Via Association française pour l'étude du cancer Bull Cancer. 2021 Dec 28:S0007-4551(21)00514-2. doi: 10.1016/j.bulcan.2021.11.007. Online ahead of print. ABSTRACT INTRODUCTION: Melanoma has benefited in recent years from therapeutic innovations, which have improved overall survival of patients. France has developed a regulatory arsenal allowing faster access to innovative drugs before marketing authorization: temporary authorization for use (ATU) and temporary recommendation for use (RTU). METHOD: We describe here the decision-making processes that led to the non-publication of the decree on the funding of three RTU in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib, and we analyse the fate of these drugs in order to quantify the potential loss of chance. RESULTS: On 03AUG2018, the French National Agency for Medicines and Health Product Safety (ANSM) published 3 RTU in order to give rapid access to major innovations in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib. These drugs have respectively demonstrated reductions in the risk of recurrence by 35 %, 43% and 55% for target populations of 2200, 1900 and 650 patients per year. Despite a favourable opinion on reimbursement from the French National Authority for Health (HAS), the decrees on reimbursement will never be published, prohibiting the use of these products before the marketing authorisation, and depriving many patients of a potential cure. CONCLUSION: Despite a favourable opinion from scientists and health agencies for the rapid availability of a drug, the French public health code does not systematically imply access to a therapeutic innovation. The reform of access to innovation implemented on 01JUL2021 may help tackle this issue. PMID:34972538 | DOI:10.1016/j.bulcan.2021.11.007 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Establishment and Characterization of FusionRed Stable Transfected Canine Prostate Adenocarcinoma and Transitional Cell Carcinoma Cells

xlomafota13 shared this article with you from Inoreader Establishment and Characterization of FusionRed Stable Transfected Canine Prostate Adenocarcinoma and Transitional Cell Carcinoma Cells Via In vivo (Athens, Greece) In Vivo. 2022 Jan-Feb;36(1):170-179. doi: 10.21873/invivo.12688. ABSTRACT BACKGROUND/AIM: Cancer cell inoculation is routinely used to evaluate novel therapeutic approaches in vivo. However, without reporter genes enabling deep tissue imaging, study of early tumor progression and therapeutic responses is often limited. We describe the establishment and characterization of two canine cancer cell lines stably expressing red fluorescence proteins as tools for later in vivo imaging. MATERIALS AND METHODS: Two red fluorescence cell lines were generated by plasmid transfection. Fluorescence protein expression was confirmed by flow cytometry and microscopy. Deep tissue imaging was demonstrated in mice using a NightOWL LB 983. Gene expression changes after transfection were analyzed by RNAseq. RESULTS: Both cell lines were detectable in vivo by subcutaneous injection of 1×106 cells. RNAseq revealed up to 2005 transfection-induced differentially expressed genes but no significant changes in cellular key pathways. CONCLUSION: The fluorescent cell lines provide a solid basis for future in vivo studies on canine cancer. PMID:34972712 | DOI:10.21873/invivo.12688 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Framework for Indirect Spatial Calibration of the Horizontal Plane of Endoscopic Laryngeal Images

xlomafota13 shared this article with you from Inoreader Framework for Indirect Spatial Calibration of the Horizontal Plane of Endoscopic Laryngeal Images Via Journal of Voice Calibrated horizontal-plane measurements from laryngeal images could contribute significantly to refining evidence-based practice and developing patient-specific models and precision-medicine approaches. Laser-projection endoscopes can address the need for direct calibrated measures; however, these systems are not widely available. This study presents the framework for an alternative indirect horizontal-plane calibration approach. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Postoperative Inhaled Steroids Following Glottic Airway Surgery Reduces Granulation Tissue Formation

xlomafota13 shared this article with you from Inoreader Postoperative Inhaled Steroids Following Glottic Airway Surgery Reduces Granulation Tissue Formation Via otol rhinol Ann Otol Rhinol Laryngol. 2021 Dec 30:34894211065805. doi: 10.1177/00034894211065805. Online ahead of print. ABSTRACT OBJECTIVES: Transoral laser surgery for glottic stenosis (transverse cordotomy and anteromedial arytenoidectomy (TCAMA)) is often complicated by granulation tissue (GT) formation. GT can cause dyspnea and may require surgical removal to alleviate airway obstruction. Inhaled corticosteroids (ICS) have been shown to reduce benign vocal fold granulomas, however its use to prevent GT formation has not been described. We aimed to analyze the effect of immediate postoperative ICS on GT formation in patients undergoing transoral laser surgery for glottic stenosis. METHODS: A retrospective analysis of patients that had transoral laser surgery for glottic stenosis from 2000 to 2019 was conducted. Surgical instances were grouped into those that received postoperative ICS and those that did not. Demographics, diagnosis, comorbidities, intraoperative adjuvant therapy, and perioperative medications were collected. Differences in GT formation and need for surgical removal were compared between groups. A multivariate exact logistic regression model was performed. RESULTS: Forty-four patients were included; 16 required 2 glottic airway surgeries (60 surgical instances). Of the 23 instances where patients received immediate postoperative ICS, 0 patients developed GT; and of the 37 instances that did not receive postoperative ICS, 15 (40.5%) developed GT (P < .0001). Eight (53.3%) of these cases returned to the OR for GT removal. ICS use was solely associated with the absence of GT formation (P = .042) in the multivariate analysis. CONCLUSIONS: Immediate postoperative use of ICS seems to be a safe and effective method to prevent granulation tissue formation and subsequent surgery in patients following transoral laser airway surgery for glottic stenosis. PMID:34965742 | DOI:10.1177/00034894211065805 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Efficacy of Han-uvulopalatopharyngoplasty (HUPPP) combined with radiofrequency ablation of tongue base or HUPPP with traction of tongue base on moderate to severe patients with obstructive sleep apnea hypopnea syndrome (OSAHS):a multicenter randomized controlled trial

xlomafota13 shared this article with you from Inoreader Efficacy of Han-uvulopalatopharyngoplasty (HUPPP) combined with radiofrequency ablation of tongue base or HUPPP with traction of tongue base on moderate to severe patients with obstructive sleep apnea hypopnea syndrome (OSAHS):a multicenter randomized controlled trial Via Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2021 Dec 7;56(12):1248-1255. doi: 10.3760/cma.j.cn115330-20210429-00237. ABSTRACT Objective: To compare the therapeutic efficacy of Han-uvulopalatopharyngoplasty (HUPPP) combined with radiofrequency ablation of tongue base or HUPPP with traction of tongue base on moderate to severe patients with obstructive sleep apnea hypopnea syndrome (OSAHS). Methods: This is a multicenter randomized controlled trial. From March 2017 to July 2019, moderate to severe OSAHS patients from three clinical center in Shanghai who were intolerant to continuous positive airway pressure (CPAP) and with velopharyngeal and glossopharyngeal plane obstruction were enrolled in this study. According to the surgical type, they were 1∶1 randomized to HUPPP plus radiofrequency ablation of tongue base group (Ablation group) or HUPPP plus traction of tongue base group (Traction group). All patients completed over-night standard Polysomnography (PSG), upper-airway assessment (Friedman classification, Müller test, CT and cephalometric examination), preoperative routine examination, Epworth Sleepiness Scale (ESS) and Quebec sleep questionnaire (QSQ). Six to 12 months after operation, all the above-mentioned examinations were repeatedly performed. Changes of aforementioned variables before and after operation were assessed. Results: A total of 43 patients with moderate to severe OSAHS were enrolled in this study. One patient lost to follow-up, the remaining 21 were allocated to Ablation group and 21 were allocated to Traction group. The total therapeutic efficacy of all patients was 69.05% (61.90% in Ablation group and 76.19% in Traction group), but there was no statistical significance between the two groups (P= 0.317). The value of sleep scale score (ESS and QSQ), objective sleep variables (apnea-hypopnea index, oxygen saturation, percentage of time with blood oxygen less than 90% in total sleep time, oxygen desaturation index and micro-arousals) and upper airway cross-sectional area (palatopharyngeal and retrolingual area) of the two groups were improved (P<0.05), but the differences between the two groups were not statistically significant (P>0.05). Conclusion: For moderate to severe OSAHS who had glossopharyngeal plane obstruction, both HUPPP plus radiofrequency ablation of tongue base or HUPPP plus traction of tongue base are effective treatment for OSAHS, and the curative effect is similar. The choice of surgical type could be selected according to patient's or surgical conditions. PMID:34963211 | DOI:10.3760/cma.j.cn115330-20210429-00237 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

The imaging characteristics and prognosis of patients with cochlear implants whose cochlear nerves are not shown on MRI

xlomafota13 shared this article with you from Inoreader The imaging characteristics and prognosis of patients with cochlear implants whose cochlear nerves are not shown on MRI Via Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2021 Dec 7;56(12):1283-1291. doi: 10.3760/cma.j.cn115330-20210126-00038. ABSTRACT Objective: To analyze the temporal bone CT and inner ear magnetic resonance imaging characteristics of cochlear implant patients with no cochlear nerve display in the inner auditory canal under MRI. To retrospectively analyze the long-term hearing and speech rehabilitation effects of such patients after cochlear implant. And to analyze the correlation between the results of imaging examinations and the postoperative effects of cochlear implant patients with this type of cochlear nerve deficiency. Methods: A total of 88 children with cochlear nerve deficiency, who underwent cochlear implantation in Shandong Provincial ENT Hospital from May 2014 to October 2018, were enrolled. Patients with cochlear malformations were excluded,only the patients with cochlear nerve deficiency whose cochlear structu re was normal and no cochlear nerve displayed in inner auditory canal under MRI were enrolled. There were 64 patients, including 4 bilaterally implanted, 68 ears in total, with an average age of (2.8±1.7) years (range 1-6 years) at the time of implantation. The implanted product was Cochlear, including 24RECA and 512 models. All patients underwent inner ear magnetic resonance imaging and temporal bone CT scan before operation. Auditory speech function assessments were performed at 12 months, 24 months, and 36 months after surgery, including categories of auditory performance (CAP), speech intelligibility rating (SIR) and hearing aid threshold test. The imaging evaluation content included the width of the cochlear nerve canal of temporal bone CT, the width of the internal auditory canal, the width of the auditory nerve at the cerebellopontine angle of the inner ear MRI, and the ratio of the facial nerve to the width of the auditory nerve at the cerebellopontine angle. The correlatio ns between the results of postoperative hearing aid hearing threshold, CAP, SIR and imaging results were analyzed. Results: Among the 64 cases of cochlear nerve not shown under MRI, 56 ears with CT data showed that the width of the cochlear nerve canal in temporal bone CT was (0.72±0.30) mm (mean±standard deviation, the same below), and the width of the internal auditory canal was (4.07±1.10) mm; 66 ears with MRI data showed that the diameter of the auditory nerve at the cerebellopontine angle of the inner ear MRI was (1.58±0.27) mm, the diameter of the facial nerve was (1.57±0.27) mm, and the ratio of the diameter of the facial nerve to the auditory nerve was (1.02±0.23). The average hearing thresholds at 12, 24, and 36 months after surgery were (46.8±2.5) dB HL, (40.7±0.8) dB HL, and (36.8±1.5) dB HL, respectively. The preoperative and postoperative CAP scores at 12, 24 and 36 months were (1.0±1.0), (3.8±1.4), (4.5±1.4) and (5.1±0.7) points, respectively. The p reoperative and postoperative SIR scores at 12, 24, and 36 months were (1.1±0.3), (1.9±0.9), (2.5±0.9), and (2.9±0.6) points, respectively. The hearing threshold at 24 months after surgery was negatively correlated with the width of the internal auditory canal of temporal bone CT (r=-0.349, P=0.037), and the hearing threshold at 36 months after surgery was positively correlated with the ratio of the diameter of the facial nerve to the auditory nerve at the cerebellopontine angle of the inner ear MRI (r=0.740, P=0.001). Conclusions: Children with cochlear implants whose cochlear nerves are not shown on MRI can benefit from cochlear implantation, and their speech and auditory functions can improve significantly after surgery. The width of the internal auditory canal in the temporal bone CT and the ratio of the diameter of the facial nerve to the auditory nerve at the cerebellopontine angle of the inner ear MRI may be related to the long-term hear ing threshold after surgery. PMID:34963216 | DOI:10.3760/cma.j.cn115330-20210126-00038 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Neutrophil extracellular traps in the pathogenesis of chronic rhinosinusitis

xlomafota13 shared this article with you from Inoreader Neutrophil extracellular traps in the pathogenesis of chronic rhinosinusitis Via Vestnik otorinolaringologii Vestn Otorinolaringol. 2021;86(6):105-112. doi: 10.17116/otorino202186061105. ABSTRACT The review presents the current understanding of the pathogenesis of chronic rhinosinusitis. The causes of damage to the mucous membrane of the paranasal sinuses are most often the result of a combination of immunological, infectious and anatomical factors. This indicates the need for a multidisciplinary approach to the study of the pathogenesis of this pathology. There is no single universally recognized classification of chronic rhinosinusitis, which takes into account histological and immunological changes in the mucous membrane of the paranasal sinuses. The discovery of the mechanism of completion of the life cycle of neutrophils - the formation of a neutrophil extracellular trap or NETosis, different from necrosis and apoptosis, opened up new prospects in the study of the pathogenesis of inflammatory processes, including rhinosinusitis. Neutroph il extracellular traps reduce the permeability of the epithelial barrier in the mucous membrane of the paranasal sinuses. This determines their possible role in the etiopathogenesis of rhinosinusitis. In recent years, more and more attention has been paid to the feasibility, effectiveness and safety of therapy that affects the immune component of the inflammatory process, including NETosis. The data obtained in the study of extracellular traps can be used in clinical practice. It is neutrophil extracellular traps that can become a potential target in the treatment of patients with chronic rhinosinusitis. PMID:34964339 | DOI:10.17116/otorino202186061105 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.