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https://www.readbyqxmd.com/read/28817826/the-safety-and-efficacy-of-the-s1-temozolomide-regimen-in-patients-with-metastatic-neuroendocrine-tumors
#1
Jiuda Zhao, Hong Zhao, Yihebali Chi
<br><br>Purpose Both capecitabine alone and capecitabine in combination with temozolomide have activities against neuroendocrine tumors (NETs). However, the role of S-1 in NETs is still unknown. We performed a study to evaluate the safety and efficacy of the S-1 plus temozolomide (STEM) regimen in patients with locally advanced or metastatic NETs. Methods A retrospective review was conducted in 20 patients with locally advanced or metastatic NETs treated with the STEM regimen. Of the patients, 15 (75...
August 17, 2017: Neuroendocrinology
https://www.readbyqxmd.com/read/28817755/measuring-toxic-effects-and-time-to-treatment-failure-for-nivolumab-plus-ipilimumab-in-melanoma
#2
Alexander N Shoushtari, Claire F Friedman, Pedram Navid-Azarbaijani, Michael A Postow, Margaret K Callahan, Parisa Momtaz, Katherine S Panageas, Jedd D Wolchok, Paul B Chapman
Importance: Nivolumab plus ipilimumab (nivo + ipi) is a standard treatment of advanced melanoma. Two randomized trials describe high objective response rates by Response Evaluation Criteria in Solid Tumors. The trials assessed toxic effects using the Common Terminology Criteria for Adverse Events (CTCAE), which may underestimate incidence of clinically significant immune-related adverse events (AEs). Objective: To describe detailed toxic effects and time to treatment failure of patients with melanoma treated with nivo + ipi in a prospective cohort...
August 17, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28817753/efficacy-and-safety-of-durvalumab-in-locally-advanced-or-metastatic-urothelial-carcinoma-updated-results-from-a-phase-1-2-open-label-study
#3
Thomas Powles, Peter H O'Donnell, Christophe Massard, Hendrik-Tobias Arkenau, Terence W Friedlander, Christopher J Hoimes, Jae Lyun Lee, Michael Ong, Srikala S Sridhar, Nicholas J Vogelzang, Mayer N Fishman, Jingsong Zhang, Sandy Srinivas, Jigar Parikh, Joyce Antal, Xiaoping Jin, Ashok K Gupta, Yong Ben, Noah M Hahn
Importance: The data reported herein were accepted for assessment by the US Food and Drug Administration for Biologics License Application under priority review to establish the clinical benefit of durvalumab as second-line therapy for locally advanced or metastatic urothelial carcinoma (UC), resulting in its recent US approval. Objective: To report a planned update of the safety and efficacy of durvalumab in patients with locally advanced/metastatic UC. Design, Setting, and Participants: This is an ongoing phase 1/2 open-label study of 191 adult patients with histologically or cytologically confirmed locally advanced/metastatic UC whose disease had progressed on, were ineligible for, or refused prior chemotherapy from 60 sites in 9 countries as reported herein...
August 17, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28817604/therapeutic-flexible-airway-endoscopy-of-small-children-in-a-tertiary-referral-center-11-years-experience
#4
Wen-Jue Soong, Pei-Chen Tsao, Yu-Sheng Lee, Chia-Feng Yang
OBJECTIVES: Use of therapeutic flexible airway endoscopy (TFAE) is very limited in pediatrics. We report our clinical experiences and long term outcomes of TFAE in small children from a single tertiary referral center. METHODS: This is a retrospective cohort study. Small children with their body weight no more than 5.0 kg who had received TFAE between 2005 and 2015 were enrolled. Demographic information and outcomes were reviewed and analyzed from medical charts and TFAE videos...
2017: PloS One
https://www.readbyqxmd.com/read/28817548/conclusions-from-the-analysis-of-adverse-events-in-the-polish-health-care-system-in-judicial-decisions-of-civil-courts-between-2011-and-2013
#5
Marcin Mikos, Jolanta Budzowska, Grzegorz Juszczyk, Aleksandra Czerw, Tomasz Banaś, Monika Urbaniak
No abstract text is available yet for this article.
August 9, 2017: Polish Archives of Internal Medicine
https://www.readbyqxmd.com/read/28817490/an-open-trial-of-iloperidone-for-mixed-episodes-in-bipolar-disorder
#6
Vivek Singh, Jodi Gonzalez Arnold, Thomas J Prihoda, Melissa Martinez, Charles L Bowden
BACKGROUND: Mixed mood states in bipolar disorder are difficult to treat and when present indicate worse illness trajectories. Several medications are US Food and Drug Administration approved to treat mixed episodes; however, the clinical trials have been short term and rarely reported depression response. METHODS: We conducted a 5-month open-label trial examining the tolerability and efficacy of iloperidone for bipolar disorder mixed episodes. RESULTS: Mania and depression scores significantly improved over the course of the study for study completers (ie, 60%-68% improvement for manic symptoms and 41%-49% for depression symptoms)...
August 16, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28817489/the-use-of-granulocyte-colony-stimulating-factor-in-clozapine-rechallenge-a-systematic-review
#7
John Lally, Steffi Malik, Amir Krivoy, Eromona Whiskey, David M Taylor, Fiona P Gaughran, Robert J Flanagan, Aleksandar Mijovic, James H MacCabe
PURPOSE/BACKGROUND: Clozapine is associated with hematological abnormalities, with neutropenia and agranulocytosis of most concern. Granulocyte colony-stimulating factor (G-CSF) has been used to support clozapine rechallenge after neutropenia with the aim of maintaining the neutrophil count. This study aims to explore the practice, use, safety, and efficacy of G-CSF in this context. METHODS/PROCEDURES: We conducted a systematic review to identify all studies investigating or describing G-CSF as a prophylaxis to enable continued clozapine treatment during a rechallenge...
August 16, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28817421/association-of-stop-bang-questionnaire-as-a-screening-tool-for-sleep-apnea-and-postoperative-complications-a-systematic-review-and-bayesian-meta-analysis-of-prospective-and-retrospective-cohort-studies
#8
Mahesh Nagappa, Jayadeep Patra, Jean Wong, Yamini Subramani, Mandeep Singh, George Ho, David T Wong, Frances Chung
BACKGROUND: The risk of postoperative complications increases with undiagnosed obstructive sleep apnea (OSA). The high-risk OSA (HR-OSA) patients can be easily identified using the STOP-Bang screening tool. The aim of this systematic review and meta-analysis is to determine the association of postoperative complications in patients screened as HR-OSA versus low-risk OSA (LR-OSA). METHODS: The following data bases were searched from January 1, 2008, to October 31, 2016, to identify the eligible articles: Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, Cochrane Databases of Systematic Reviews, Medline-in-Process & other nonindexed citations, Google Scholar, Embase, Web of Sciences and Scopus...
August 11, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28817405/cutaneous-eruptions-in-patients-receiving-immune-checkpoint-blockade-clinicopathologic-analysis-of-the-nonlichenoid-histologic-pattern
#9
Genevieve J Kaunitz, Manisha Loss, Hira Rizvi, Sowmya Ravi, Jonathan D Cuda, Karen B Bleich, Jessica Esandrio, Inbal Sander, Dung T Le, Luis A Diaz, Julie R Brahmer, Charles G Drake, Travis J Hollmann, Mario E Lacouture, Matthew D Hellmann, Evan J Lipson, Janis M Taube
Cutaneous eruptions are among the most common immune-related adverse events (irAEs) associated with anti-programmed cell death protein 1/programmed cell death ligand 1 therapy, and are often clinically and histologically characterized as lichenoid. Nonlichenoid patterns may also occur and are likely to be encountered by surgical pathologists, given the increasing clinical use of these agents. The purpose of this study is to describe the histopathologic features of nonlichenoid cutaneous irAEs from patients receiving anti-programmed cell death protein 1/programmed cell death ligand 1 therapies for a variety of underlying advanced malignancies...
August 15, 2017: American Journal of Surgical Pathology
https://www.readbyqxmd.com/read/28817397/real-world-data-on-paliperidone-palmitate-for-the-treatment-of-schizophrenia-and-other-psychotic-disorders-a-systematic-review-of-randomized-and-nonrandomized-studies
#10
Robin Emsley, Eduard Parellada, Miquel Bioque, Berta Herrera, Teresa Hernando, Marta García-Dorado
The aim of this study was to perform a systematic review of the effects of 1-month paliperidone palmitate (PP1M) for the treatment of schizophrenia and related psychotic disorders in terms of outcomes reported in real-world evidence studies. A systematic review of real-world randomized and nonrandomized studies with PP1M was performed and is reported according to PRISMA guidelines. Comparative effectiveness data with oral antipsychotics indicate that PP1M has a lower likelihood of relapse-related events, including rehospitalization, and these differences are clinically relevant...
August 16, 2017: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28817373/cabozantinib-as-salvage-therapy-for-patients-with-tyrosine-kinase-inhibitor-refractory-differentiated-thyroid-cancer-results-of-a-multicenter-phase-ii-international-thyroid-oncology-group-trial
#11
Maria E Cabanillas, Jonas A de Souza, Susan Geyer, Lori J Wirth, Michael E Menefee, Stephen V Liu, Komal Shah, John Wright, Manisha H Shah
Purpose Sorafenib and lenvatinib are oral multikinase inhibitors targeting vascular endothelial growth factor receptor (VEGFR) and approved for radioiodine (RAI)-refractory differentiated thyroid cancer (DTC). However, there are no approved second- or third-line therapies. MET is implicated in resistance to VEGFR inhibitors. Cabozantinib is an oral multikinase inhibitor targeting MET in addition to VEGFR and is approved for medullary thyroid cancer. In a phase I study of cabozantinib, five of eight patients with DTC previously treated with a VEGFR-targeted therapy had an objective response to cabozantinib...
August 17, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28817342/hypoglycemia-risk-related-to-double-dose-is-markedly-reduced-with-basal-insulin-peglispro-versus-insulin-glargine-in-patients-with-type-2-diabetes-mellitus-in-a-randomized-trial-imagine-8
#12
Cynthia Harris, Thomas Forst, Tim Heise, Leona Plum-Mörschel, Elaine Watkins, Qianyi Zhang, Ludi Fan, Parag Garhyan, Niels Porksen
BACKGROUND: Basal insulin peglispro (BIL) has a peripheral-to-hepatic distribution of action that resembles endogenous insulin and a prolonged duration of action with a flat pharmacokinetic/pharmacodynamic profile at steady state, characteristics that tend to reduce hypoglycemia risk compared to insulin glargine (GL). The primary objective was to demonstrate that clinically significant hypoglycemia (blood glucose ≤54 mg/dL [3.0 mmol/L] or symptoms of severe hypoglycemia) occurred less frequently within 84 h after a double dose (DD) of BIL than a DD of GL...
August 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28817316/filling-quality-of-the-reports-of-adverse-drug-reactions-received-at-the-pharmacovigilance-centre-of-s%C3%A3-o-paulo-brazil-missing-information-hinders-the-analysis-of-suspected-associations
#13
Adalton Ribeiro, Silvana Lima, Maria-Elisa Zampieri, Mirtes Peinado, Albert Figueras
Background The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). Research Design and Methods A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm...
August 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28817277/discovery-and-characterization-of-r-6-neopentyl-2-pyridin-2-ylmethoxy-6-7-dihydropyrimido-2-1-c-1-4-oxazin-4-9h-one-pf-06462894-an-alkyne-lacking-metabotropic-glutamate-receptor-5-negative-allosteric-modulator-profiled-in-both-rat-and-non-human-primates
#14
Antonia F Stepan, Michelle M Claffey, Matthew R Reese, Gayatri Balan, Gabriela Barreiro, Jason Barricklow, Michael J Bohanon, Brian P Boscoe, Gregg D Cappon, Lois K Chenard, Julie Cianfrogna, Laigao Chen, Karen J Coffman, Susan E Drozda, Joshua R Dunetz, Somraj Ghosh, Xinjun Hou, Christopher Houle, Kapil Karki, John T Lazzaro, Jessica Y Mancuso, John M Marcek, Emily L Miller, Mark A Moen, Steven V O'Neil, Isao Sakurada, Marc Skaddan, Vinod Parikh, Deborah L Smith, Patrick E Trapa, Jamison B Tuttle, Patrick R Verhoest, Daniel P Walker, Annie C Won, Ann S Wright, Jessica Whritenour, Kenneth Zasadny, Margaret M Zaleska, Lei Zhang, Christopher L Shaffer
We previously observed a cutaneous type IV immune response in non-human primates (NHP) with the mGlu5 negative allosteric modulator (NAM) 7. To determine if this adverse event was chemotype- or mechanism-based, we evaluated a distinct series of mGlu5 NAMs. Increasing the sp(3) character of high-throughput screening hit 40 afforded a novel morpholinopyrimidone mGlu5 NAM series. Its prototype, (R)-6-neopentyl-2-(pyridin-2-ylmethoxy)-6,7-dihydropyrimido[2,1-c][1,4]oxazin-4(9H)-one (PF-06462894, 8), possessed favorable properties and a predicted low clinical dose (2 mg twice daily)...
August 17, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28817231/effect-of-once-weekly-dulaglutide-on-hba1c-and-fasting-blood-glucose-in-patient-subpopulations-by-gender-duration-of-diabetes-and-baseline-hba1c
#15
Baptist Gallwitz, Samuel Dagogo-Jack, Vivian Thieu, Luis-Emilio Garcia-Perez, Imre Pavo, Maria Yu, Kenneth E Robertson, Nan Zhang, Francesco Giorgino
To evaluate the efficacy and safety of dulaglutide 1.5 mg and 0.75 mg in type 2 diabetes patients by subgroups of gender, duration of diabetes, and baseline HbA1c in the dulaglutide clinical development program (AWARD-1 to -6 and -8 clinical trials). MATERIALS AND METHODS: Change in HbA1c was analysed by gender, duration of diabetes (<5 years, ≥5 years and <10 years, ≥10 years), and baseline HbA1c (<8.5%, ≥8.5%) in pooled and individual studies. Changes from baseline in weight, hypoglycaemia, and gastrointestinal adverse events were evaluated for individual trials...
August 17, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28817180/preventable-and-mitigable-adverse-events-in-cancer-care-measuring-risk-and-harm-across-the-continuum
#16
Allison Lipitz-Snyderman, David Pfister, David Classen, Coral L Atoria, Aileen Killen, Andrew S Epstein, Christopher Anderson, Elizabeth Fortier, Saul N Weingart
BACKGROUND: Patient safety is a critical concern in clinical oncology, but the ability to measure adverse events (AEs) across cancer care is limited by a narrow focus on treatment-related toxicities. The objective of this study was to assess the nature and extent of AEs among cancer patients across inpatient and outpatient settings. METHODS: This was a retrospective cohort study of 400 adult patients selected by stratified random sampling who had breast (n = 128), colorectal (n = 136), or lung cancer (n = 136) treated at a comprehensive cancer center in 2012...
August 17, 2017: Cancer
https://www.readbyqxmd.com/read/28817126/principles-for-vertical-ridge-augmentation-in-the-atrophic-posterior-mandible-a-technical-review
#17
Istvan A Urban, Alberto Monje, Jaime Lozada, Hom-Lay Wang
Guided bone regeneration has become more predictable due to advances in material sciences. Nevertheless, vertical ridge augmentation (VRA) remains a potential challenge due to the complexity of soft tissue management. This becomes more complicated in the posterior atrophic mandible due to limited access and poorer blood supply. As such, a number of critical elements must be taken into consideration in treatment planning. Anatomical structures potentially jeopardize intraoperative adverse events such as bleeding or neurosensory disturbances...
September 2017: International Journal of Periodontics & Restorative Dentistry
https://www.readbyqxmd.com/read/28816986/efficacy-and-safety-of-endocrine-monotherapy-as-first-line-treatment-for-hormone-sensitive-advanced-breast-cancer-a-network-meta-analysis
#18
Jingwen Zhang, Yanhong Huang, Changyi Wang, Yuanfang He, Shukai Zheng, Kusheng Wu
BACKGROUND: Endocrine therapy was recommended as the preferred first-line treatment for hormone receptor-positive (HR+, i.e., ER+ and/or PgR+), human epidermal growth factor receptor-2-negative (HER2-) postmenopausal advanced breast cancer (ABC), but which endocrine monotherapy is optimal lacks consensus. We aimed to identify the optimal endocrine monotherapy with a network meta-analysis. METHODS: We performed a network meta-analysis for a comprehensive analysis of 6 first-line endocrine monotherapies (letrozole, anastrozole, exemestane, tamoxifen, fulvestrant 250 mg and 500 mg) for HR+ HER2- metastatic or locally advanced breast cancer in postmenopausal patients...
August 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28816963/efficacy-and-safety-evaluation-of-fludarabine-based-chemotherapy-regimen-for-patients-with-non-hodgkin-lymphoma-a-meta-analysis
#19
Xiaoping Zhang, Zheng Ge, Baoan Chen, Ran Liu, Chong Gao
This meta-analysis was performed to evaluate the efficacy and safety of fludarabine (F)-based regimen for the treatment of non-Hodgkin lymphoma (NHL) compared with other regimens with no F contained.PubMed, Embase, Cochrane Library, Wanfang, VIP, and CNKI databases were searched to identify eligible literatures. R software version 3.12 was used for statistical analysis. Odds ratio (OR) with 95% confidence interval (CI) were utilized to express the complete response, overall response and adverse events outcomes...
August 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28816937/effect-of-perioperative-oral-care-on-prevention-of-postoperative-pneumonia-associated-with-esophageal-cancer-surgery-a-multicenter-case-control-study-with-propensity-score-matching-analysis
#20
Sakiko Soutome, Souichi Yanamoto, Madoka Funahara, Takumi Hasegawa, Takahide Komori, Shin-Ichi Yamada, Hiroshi Kurita, Chika Yamauchi, Yasuyuki Shibuya, Yuka Kojima, Hirokazu Nakahara, Takahiko Oho, Masahiro Umeda
The aim of this study was to investigate the effectiveness of oral care in prevention of postoperative pneumonia associated with esophageal cancer surgery.Postoperative pneumonia is a severe adverse event associated with esophageal cancer surgery. It is thought to be caused by aspiration of oropharyngeal fluid containing pathogens. However, the relationship between oral health status and postoperative pneumonia has not been well investigated.This study included 539 patients with esophageal cancer undergoing surgery at 1 of 7 university hospitals...
August 2017: Medicine (Baltimore)
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