Πέμπτη 14 Ιανουαρίου 2021

Efficacy of Pembrolizumab Monotherapy for Advanced Gastric/Gastroesophageal Junction Cancer with Programmed Death Ligand 1 Combined Positive Score {greater than or equal to}10

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Purpose: Pembrolizumab demonstrated efficacy in PD-L1-positive (combined positive score [CPS] {greater than or equal to}1) advanced gastric/gastroesophageal junction (G/GEJ) cancer in the first-, second-, and third-line setting in KEYNOTE-062, KEYNOTE-061, and KEYNOTE-059, respectively. To better delineate the specificity of CPS as a predictor of clinical outcomes, we analyzed pembrolizumab efficacy in patients with CPS{greater than or equal to}10 in these trials. Experimental Design: Included were patients with CPS{greater than or equal to}10 tumors from KEYNOTE-059 cohort 1 (pembrolizumab, n=46; post hoc), KEYNOTE-061 (pembrolizumab, n=53; chemotherapy, n=55; post hoc), and KEYNOTE-062 (pembrolizumab, n=92; chemotherapy, n=90; primary). Efficacy outcomes were OS, PFS, ORR, and DOR. Results: In KEYNOTE-059 median follow-up was 6 months, median OS was 8 months (95% CI, 5.8-11.1), ORR was 17%, and median (range) DOR was 21 months (3+-35+). In KEYNOTE-061 me dian follow-up was 9 months, median OS (pembrolizumab vs chemotherapy) was 10 versus 8 months (HR, 0.64; 95% CI, 0.41-1.02), median PFS was 3 months versus 3 months (HR, 0.86; 95% CI, 0.56-1.33), ORR was 25% versus 9%, and median (range) DOR was not reached (4-26+ months) versus 7 months (3-7). In KEYNOTE-062, median follow-up was 11 months, median OS (pembrolizumab vs chemotherapy) was 17 months versus 11 months (HR, 0.69; 95% CI, 0.49-0.97), median PFS was 3 months versus 6 months (HR, 1.09, 95% CI; 0.79-1.49), ORR was 25% versus 38%, and median (range) DOR was 19 months (1+-34+) versus 7 months (2+-30+). Conclusions: This comprehensive analysis showed consistent improvements toward more favorable clinical outcomes with pembrolizumab across lines of therapy in patients with CPS{greater than or equal to}10 G/GEJ cancer.

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72-h diurnal RNA-seq analysis of fully expanded third leaves from maize, sorghum, and foxtail millet at 3-h resolution

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The purpose of this data set is to capture the complete diurnal (i.e., daily) transcriptome of fully expanded third leaves from the C4 panacoid grasses sorghum (Sorghum bicolor), maize (Zea mays), and foxtail mil...
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The Effects of Intervening With Synonasal Changes on Headaches in Migraine Patients Using Endonasal Surgery

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Objective: Some anatomical changes might trigger headaches in people who have migraine, and that surgical applications eliminating the structural problems in treatment-resistant migraine patients are effective in pain treatment. Methods: A total of 36 patients, who did not respond to different treatment options without aura migraine and chronic migraine that were showing synonasal and anatomical changes in synonasal nasal endoscopy and/or paranasal sinus CT screening, responding insufficiently and/or approximately one year period also did not respond to different treatment options, were included in this study between June 2016 and September 2019. Results: The relation between migraine episodes and synonasal symptoms was found to be statistically significant. A significant difference was detected between nasal congestion and obstruction, postnasal discharge, and runny nose in patients with attacks compared to patients without attacks. The difference between mean pain severity values was statistically significant when compared to preoperative values (3.0(3.0∼4.0)) and post-operative values (1.0(0∼1.0)). When the pain severity after the operation (1.0(1.0∼2.75)) was compared with the severity of pain before the operation (5.0 (3.0∼5.0)), it was determined that there was a significant decrease in pain severity in patients diagnosed with chronic migraine, the difference between the mean pain severity values was statistically significant, and the prevalence of pain decreased at a significant level after the operation. Conclusion: The results of the present study indicate that the elimination of synonasal structural changes, which were hypothesized to trigger pain in migraine patients, could have a pain-reducing effect on the frequency and severity of the pain. Address correspondence and reprint requests to Ayfer Ertekin, MD, Ozel Siirt Hayat Hastanesi, Noroloji Klinigi, Hukumet Cad., Ataturk Bulv., No. 32 Merkez, Siirt, Turkey; E-mail: ayfertekin1976@gmail.com Received 26 June, 2020 Accepted 9 November, 2020 The authors have no conflict of interest and also declare that no funding was received for the conduct of this study. Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcraniofacialsurgery.com). © 2021 by Mutaz B. Habal, MD.
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One-Half Wedge Osteotomy Genioplasty for Correction of Chin Deviation Based on Three-Dimensional Computed Tomography Measurements and Simulation

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Conventional operations correcting chin deviations mainly rely on the observation and experience of the surgeons during the operation. We have created a new surgical method, one-half wedge osteotomy genioplasty (1/2WOG), that combines three-dimensional computed tomography measurements and simulation. This study eval uated the clinical effect of chin deviation correction with the 1/2WOG method. A total of 38 patients (15 men and 23 women) who underwent 1/2WOG between October 2019 and October 2014 were evaluated. The chin deviation angle and distance, and partial chin deformity were measured preoperatively using three-dimensional computed tomography data. Precise calculations and osteotomy lines were achieved by preoperative simulation. All patients underwent the same surgery by the same surgical team. The clinical effect of 1/2WOG was evaluated according to the preoperative and postoperative data and patient satisfaction. All 38 patients achieved satisfactory aesthetic results without major complications such as chin nerve injury or bone nonunion. Eight patients occured numbness of the lower lip after surgery; at 6-month follow-up, the numbness was reduced in 2 patients and disappeared in 6 patients. Compared with preoperative data, the chin deviation angle, chin deviation distance, and gonion-m enton difference were significantly reduced postoperatively. During the 12-month follow-up, the patient satisfaction rate reached 90%. We conclude that chin deviation can be improved by 1/2WOG. The combination of digital technology measurements and simulation can increase the accuracy of the osteotomy line design, thus reducing surgical trauma and increasing patient satisfaction, which is worthy of clinical promotion. Address correspondence and reprint requests to Bin Yang, MD, PhD, Plastic Surgery Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No. 33, Badachu Road, Shijingshan District, Beijing 100144, China; E-Mail: ybdoctor_psh@163.com Received 30 November, 2020 Accepted 7 December, 2020 The study was funded by the 2018 Project of Beijing Municipal Science and Technology Commission (No. Z181100001718187) and the Chinese Academy of Medical Sciences Initiative for Innovative Medicine from Chinese Academy of Medical Science (No. 2016-I2M-1-018). The authors report no conflicts of interest. Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcraniofacialsurgery.com). © 2021 by Mutaz B. Habal, MD.
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Fibula Free Flap Salvage From 10-hour Prolonged Arterial Insufficiency and Venous Thrombosis

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Fibula free flaps are standard in facial reconstructions after head and neck cancer resection and typically have short flap ischemia times, often under 2 hours. Methods for short-term flap ischemia are characterized, but methods for extremely prolonged flap ischemia have not been well-described. We describe a 72-year-old patient who underwent composite floor of mouth and mandible resection with fibula free flap reconstruction. Patient intraoperative instability forced flap ischemia of over 10 hours with arterial insufficiency and venous thrombosis. Despite complicated and extremely prolonged ischemia, aggressive local and systemic anticoagulants with intraoperative leach therapy were still effective in flap salvage. The flap ultimately survived without necrosis. This case describes a method to guide surgeons faced with situations of forced, prolonged flap ischemia. Traditionally indicated in short-term ischemia, anticoagulation and leach methods can be effective for intraoperative treatment of extremely prolonged flap ischemia, arterial insufficiency, and venous thrombosis. Address correspondence and reprint requests to Kalpesh T. Vakharia, MD, MS, University of Maryland School of Medicine, 419 W. Redwood Street, Suite #370, Baltimore, MD 21201; E-mail: kvakharia@som.umaryland.edu Received 13 November, 2020 Accepted 30 November, 2020 Disclosures: No outside sources of support to report. The authors report no conflicts of interest. © 2021 by Mutaz B. Habal, MD.
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Potential Complications With Cryopreserved Cadaveric Veins in Arteriovenous Loop Formation for Head and Neck Microvascular Reconstruction

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Vessel depletion in the head and neck from radiation or previous surgical intervention adds to the operative complexity by limiting reconstructive options. Arteriovenous (AV) loop vascular grafts provide a conduit to bypass these nonviable local vessels to provide adequate blood flow. In certain situations, autolo gous donor vascular options are deficient or not readily available for creation of the AV loop. Cadaveric vein grafts provide an alternative option in these circumstances, but the efficacy and safety has not yet been delineated. In this study we discuss our experience utilizing cryopreserved cadaveric vein grafts for AV loop creation in head and neck reconstruction. In our initial cohort we aim to elucidate potential challenges and complications associated with the use of cadaveric vein grafts. Address correspondence and reprint requests to Sameep P. Kadakia, MD, Division of Plastic Surgery, Wright State University Boonshoft School of Medicine, Mailing, 30 East Apple Street, Suite 2200, Dayton, OH 45409; E-mail: Sameep8779@gmail.com Received 14 November, 2020 Accepted 21 November, 2020 The authors report no conflicts of interest. © 2021 by Mutaz B. Habal, MD.
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Protective Effects of Helmet Type on Facial Injuries

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The compulsory use of helmet by motorcyclists has lowered the incidence of facial trauma, but there are few studies evaluating the effects of different helmet types on such injuries. The authors collected retrospective data from the medical records of 287 motorcyclists presenting facial injuries treated at the max illofacial surgery department of the "University Magna Graecia" of Catanzaro city in South Italy between 1 January 2007 and 1 August 2018. Patients were wearing 2 types of crash helmets at the time of the trauma, full face ones or open-face ones, and were compared using the Facial Injury Severity Scale (FISS). Those wearing open-face helmet were 3 times more than those wearing full-face helmet, with a higher FISS score. The purpose of this study was to investigate the impact of Italy's compulsory helmet law on the change in helmet use and in particular if protection offered by helmets w4as different according to helmet type. The authors correlated the FISS scores among motorcyclists wearing these 2 tipologies of crash helmet. Address correspondence and reprint requests to Carmelo Lo Faro, MD, Maxillofacial Surgery Unit University of Campania "Luigi Vanvitelli", Piazza Miraglia 80138 Naples, Italy; E-mail: carmelolofaro28@gmail.com Received 29 October, 2020 Accepted 21 November, 2020 The authors report no conflicts of interest. Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcraniofacialsurgery.com). © 2021 by Mutaz B. Habal, MD.
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Pneumosinus Dilatans: A Novel Algorithm for its Classification and Management

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Background: Pneumosinus dilatans (PD) is a rare condition in which one or more paranasal sinuses are pathologically hyperaerated. Patients commonly present with an aesthetic complaint, however it has been associated with several serious conditions. The etiology is largely theoretical and the management remains unstandardized, potentially leading to missed diagnoses. This article aims to establish a presumptive classification scheme and management algorithm based on a comprehensive review of the literature. Materials and Methods: A systematic review of all available publications on the search term "Pneumosinus dilatans" was conducted in PubMed. Associated conditions were identified and clustered based on the number and anatomic location of the sinuses involved. The resultant data was used to formulate an evidence-based algorithm for the evaluation and management of PD patients. Results: A total of 145 patients from 103 articles were included. The majority of patients were male (57.2%) with an average age of 32.6 years-old at onset. The frontal sinus was most commonly involved (62.8%) and one pathologic sinus was most common (84.6%). 51% of patients presented with an associated condition; with it least common in frontal sinus PD (29.7% cases) and most common in ethmoid sinus PD (81.5%). To date, no articles to date have proposed a management algorithm for PD based on the number or location of sinus involved. Conclusions: A standardized evidence-based management algorithm and classification scheme for patients with PD will not only lead to the highest-quality treatment, but will also be instrumental in elucidating an etiology for this rare, and potentially serious, condition. Address correspondence and reprint requests to Joseph A. Ricci, MD, Assistant Professor, Division of Plastic and Reconstructive Surgery, Department of Surgery, Montefiore Medical Center, 1776 Eastchester Road, Suite 200, Bronx, NY 10461; E-mail: Dr.Joseph.Ricci@gmail.com Received 17 October, 2020 Accepted 10 December, 2020 The author report no relevant financial disclosures related to this work. Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcraniofacialsurgery.com). © 2021 by Mutaz B. Habal, MD.
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Management of Maxillofacial Trauma in Attempt Suicide Patients During COVID-19 Pandemic

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The maxillofacial surgeon trained well to face the surgical challenges. In case of dealing with self-inflicted trauma, the surgeon must face the surgical as well as the psychological status of the patients. Five patients received in the emergency room suffering from maxillofacial trauma resulted from suicidal at tempts. Unfortunately, 1 patient died, the other patients managed by providing surgical and psychological support. The cornerstone of managing such type of trauma needs appropriate communication between the family, surgical team, and the psychiatric. Address correspondence and reprint requests to Saif Saadedeen Abdulrazaq, Assistant Professor, BDS, FIBMS, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Baghdad, Baghdad, Iraq; E-mail: saifdento@gmail.com, drsaif.sa@codental.uobaghdad.edu.iq Received 31 October, 2020 Accepted 4 December, 2020 The authors report no conflicts of interest. © 2021 by Mutaz B. Habal, MD.
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Impact of Transmission Control Measures on the Epidemiology of Maxillofacial Injuries in Wuhan City During the COVID-19 Epidemic

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In December 2019, a novel coronavirus (severe acute respiratory syndrome coronavirus 2) emerged in Wuhan City. The present study aimed to assess the demographic variables, causes, and patterns of maxillofacial injuries managed at a teaching hospital in Wuhan City during the transmission control measures in the coronavirus disease 2019 (COVID-19) epidemic. In this retrospective study, all patients treated for maxillofacial injuries in the hospital between January 23 and April 7 (2019 and 2020) were involved. Epidemiologic information, including the number of patients, gender, age, etiology, time since injury to the clinic visit, and type of maxillofacial injuries, was recorded. Data of the 2 periods (2019 and 2020) were compared and analyzed. A total of 337 patients had maxillofacial injuries at the 2-time intervals: 74 in 2020 and 263 in 2019. The characteristics of maxillofacial injuries had changes during the transmission control measures in the COVID-19 epidemic, which included the number of patients, gender, age, etiology, time since injury to the clinic visit, and type of maxillofacial injuries. The transmission control measures during the COVID-19 epidemic had a significant impact on the epidemiology of maxillofacial injuries in Wuhan City. Address correspondence and reprint requests to Zhi Li, DDS, MD, Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, 237 Luoyu Road, Wuhan 430079, China; E-mail: zhili@whu.edu.cn Received 26 October, 2020 Accepted 4 December, 2020 Y-TY and XX contributed equally to this work. The authors report no conflicts of interest. Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcraniofacialsurgery.com). © 2021 by Mutaz B. Habal, MD.
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Is Decreased Local Bone Quality an Independent Risk Factor for Complications Following Fracture Fixation of Facial Bones

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Purpose: Although osteoporosis is associated with increased risks of complications of fracture fixation in the orthopedic literature, the association between local bone quality (LBQ) and complications of facial fracture fixation is unknown. The authors aim to identify that if decreased LBQ is an independent risk factor for complications following facial fracture fixation? Methods: The authors conducted a prospective cohort study on patients over age of 50 years who underwent open reduction and rigid internal fixation for facial fractures. The primary predictor was LBQ (low or normal), decided by a combination of 3 panoramic indices. Other predictors included age, gender, body mass index (BMI), comorbidities, trauma-related characteristics, etc. The outcome variable was the presence of hardware-related, fracture-healing, wound, or neurosensory complications during 2-year follow-up. Univariate and multivariate regressions were performed to identify any significant association between predictor and outcome variables. Results: The sample was composed of 69 patients (27 females) with an average age of 58.6 ± 8.6 years and BMI of 25 ± 3.8. Low-LBQ patients were significantly older, more females, had lower BMI, mainly injured from falls, had more complications compared to their normal-LBQ counterparts. However, multivariable logistic regressions demonstrated that only age (adjusted OR: 1.12, P = 0.031, 95% CI: 1.01, 1.23) and diabetes (adjusted OR: 12.63, P = 0.029, 95% CI: 1.3, 122.53) were significantly associated with overall complications after confounding adjustment. Conclusions: The results of the present study indicate that reduced LBQ is not an independent risk factor for complications following facial fracture fixation. The increased risk of complications in low-LBQ patients is more likely to be attributed to other age-related comorbidities such as diabetes. Therefore, the authors recommend detailed workup and good control of comorbidities in elderly trauma patient. Address correspondence and reprint requests to Yan Han, MD, PhD, Chair and Professor, Department of Plastic and Reconstructive Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China; E-mail: 13720086335@163.com; Haizhong Zhang, MD, PhD, Professor, Department of Oral and Maxillofacial Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China; E-mail: zhanghaizhong301@gmail.com Received 20 September, 2020 Accepted 10 December, 2020 YC, YH, and ZN contributed equally to this work. The authors report no conflicts of interest. Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcraniofacialsurgery.com). © 2021 by Mutaz B. Habal, MD.
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