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Иксазомиб, помалидомид и дексаметасон в реанимированных или рефрактных миеломах, характеризующихся высокой степенью риска цитогенетики: 2014-01 Учёба.

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Stage-specific biomarkers in triple-negative breast cancer: Preliminary findings from bioinformatics approaches.

BackgroundIntegrated bioinformatics approaches were used to identify stage-specific candidate genes and potential drug targets in triple-negative breast cancer (TNBC).MethodsMicroarray (164 early-stage, 33 advanced-stage, and 53 normal samples) and RNA-seq (113 normal, 163 early-stage, and 30 advanced-stage TNBC samples) datasets were analyzed. Differentially expressed genes (DEGs) were identified, followed by co-expression analysis using Weighted Gene Co-expression Network Analysis (WGCNA) and protein-protein interaction analysis using the STRING database. miRNA co-regulation was evaluated us

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… Biostatistics 2003 ; 4 : 249 – 264 . 12925520 10.1093/biostatistics/4.2.249 26 Kenn M Cacsire Castillo-Tong D Singer CF , et al. Microarray normalization revisited for reproducible breast cancer biomarkers . …

Cancer evolution: mathematical models and computational inference.

Cancer is a somatic evolutionary process characterized by the accumulation of mutations, which contribute to tumor growth, clinical progression, immune escape, and drug resistance development. Evolutionary theory can be used to analyze the dynamics of tumor cell populations and to make inference about the evolutionary history of a tumor from molecular data. We review recent approaches to modeling the evolution of cancer, including population dynamics models of tumor initiation and progression, phylogenetic methods to model the evolutionary relationship between tumor subclones, and probabilisti

177Lu-PSMA Radioligand Therapy Is Favorable as Third-Line Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer. A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

In this systematic review and network meta-analysis (NMA), we aimed to assess the benefits and harms of third-line (L3) treatments in randomized controlled trials (RCTs) of patients with metastatic castration-resistant prostate cancer (mCRPC). Two reviewers searched for publications from 1 January 2006 to 30 June 2021. The review analyzed seven RCTs that included 3958 patients and eight treatments. Treatment with prostate-specific membrane antigen (PSMA)-based radioligand therapy (PRLT) resulted in a 1.3-times-higher rate of median PSA decline ≥50% than treatment with abiraterone, enzalutamide

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… Biostatistics. 2015;16:84–97. doi: 10.1093/biostatistics/kxu030. 32. Tierney J.F., Fisher D.J., Vale C.L., Burdett S., Rydzewska L.H., Rogozinska E., Godolphin P.J., White I.R., Parmar M.K.B. A framework for prospective, adaptive meta-analysis (FAME) of aggregate data from randomised trials. …

Repurposing Drugs for Acute Myeloid Leukemia: A Worthy Cause or a Futile Pursuit?

Acute myeloid leukemia (AML) is a clinically and genetically heterogenous malignancy of myeloid progenitor cells that affects patients of all ages. Despite decades of research and improvement in overall outcomes, standard therapy remains ineffective for certain subtypes of AML. Current treatment is intensive and leads to a number of secondary effects with varying results by patient population. Due to the high cost of discovery and an unmet need for new targeted therapies that are well tolerated, alternative drug development strategies have become increasingly attractive. Repurposing existing d

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… Estimation of clinical trial success rates and related parameters Biostatistics 2019 20 273 286 10.1093/biostatistics/kxx069 29394327 PMC6409418 5. Hwang T.J. Carpenter D. Lauffenburger J.C. Wang B. Franklin J.M. Kesselheim A.S. …

Surrogate endpoints in mature B-cell neoplasms - meaningful or misleading?

Indolent mature B-cell neoplasms are a group of diseases in which recent therapeutic advances have led to an improved overall survival (OS) extending beyond several years. While cause of celebration for patients and caregivers, the increasingly long observation periods necessary to capture treatment effects are complicating trial design and possibly hindering swift access to more effective therapies. Surrogate endpoints are a tool with the potential of earlier study readouts, however, their validity needs to be proven in each individual disease and therapeutic setting. The validation of surrog

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… Biostatistics. 2000;1:49–67. 17. Burzykowski T, Molenberghs G, Buyse M, Geys H, Renard D. Validation of surrogate end points in multiple randomized clinical trials with failure time end points. J R Stat Soc Ser C Appl Stat. 2002;50:405–22. 18. Burzykowski T, Buyse M. …

Изучение разрозненных представлений для согласования сетевых мер.

PMARPOSE: метрики сети Connectome обычно рассматриваются как основные свойства мозга, и их изменения были связаны с развитием болезни Альцгеймера, множественным склерозом и травматическим повреждением мозга. Однако эти метрики являются фактически оцененными свойствами посредством многоэтапного распространения на основе местных оценок диффузии вокселя, региональной трактографии и картирования района, представляющего интерес. Эти процессы оценки в значительной степени зависят от выбора конкретных протоколов съемки и программного обеспечения, что приводит к эффекту в зависимости от участка.ПОДХОД

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… Tilak Ratnanather, Peter vanZijl, and Laurent Younes), (4) the biospecimen core (Abhay Moghekar, Jacqueline Darrow, Alexandria Lewis, and Richard O’Brien), (5) the informatics core (Roberta Scherer, Ann Ervin, David Shade, Jennifer Jones, Hamadou Coulibaly, Kathy Moser, and Courtney Potter), the (6) biostatistics …

Risk Factors and Impact on Survival of Pathological Fractures in Patients With Humeral Metastasis.

Background Bone metastases often cause pathological fractures and impair patients' quality of life and survival. Although several studies have been conducted on pathological fractures in the femur and spine, limited research has been done on the upper limbs. This study aimed to reveal the risk factors and determine how pathological fractures impact survival in patients with humeral metastasis. Methods This retrospective study was based on patients with humerus metastasis treated in the Nagoya-City University Hospital from 2010 to 2020. Patient characteristics, including sex, age at diagnosis o

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… More precisely, it is a modified version of R commander designed to add statistical functions frequently used in biostatistics [ 9 ]. Results In total, 31 patients were included in this study (Table 1 ). …

Nutritional Status Is Associated With Survival Following Spinal Surgery in Patients With Metastatic Spinal Tumors.

Background Preoperative and postoperative nutritional statuses are reported to influence the outcomes and complications of multidisciplinary treatment, including patient survival. However, a causal relationship between nutritional status and survival following spinal surgery has not been demonstrated in patients with metastatic spinal tumors. The present study was, therefore, designed to evaluate the correlation between the nutritional status and survival following spinal surgery in patients with metastatic spinal tumors. Methods Nutritional status was evaluated using the Japanese version of t

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… R is a modified version of R Commander designed to add statistical functions frequently used in biostatistics. The correlation between nutritional status and survival period was evaluated using Spearman’s rank correlation coefficient test. …

Behaviors, perceptions, and impact of the COVID-19 pandemic and vaccination on oncology patients in New Mexico with substantial representation of racial minorities and rural residents.

IntroductionThe COVID-19 pandemic has affected all sectors of life. This study helps us better understand the perceptions and practices related to the COVID-19 pandemic in the oncology patient population of New Mexico. It also explores patient knowledge regarding safe practices and perceptions regarding vaccination.MethodsThe data for this cross-sectional survey study was collected from July 20, 2021 to September 6, 2021.ResultsThere were no significant differences noted in the incidence of COVID-19 infection based on race, comorbidities, or modality of treatment regardless of vaccination stat

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… Supplementary Material Acknowledgements This research was partially supported by UNM Comprehensive Cancer Center Support Grant NCI P30CA118100 and the Biostatistics shared resource. CRediT authorship contribution statement S. …

Больше, чем сумка его частей: разорванная периферия мультиплексных сетей мозга в множестве склероза.

У людей с множественным склерозом (PwMS) были выявлены нарушения в работе сетей мозга, измеряемые с помощью структурных (MRI), диффузионных (dMRI) или функциональных (fMRI) MRI, что свидетельствует об актуальности регионов в ядре коннектома, но дает неоднозначные результаты в зависимости от изученной области подключения. Используя многослойный сетевой подход, мы интегрировали эти three Условия для отображения обогащенного представления организации мозга с ядром и исследования его изменений в PwMS. В этом ретроспективном поперечном исследовании мы выбрали PwMS и здоровый контроль с полными муль

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… Biostatistics 8 : 118 – 127 . 16632515 10.1093/biostatistics/kxj037 Jy , Y. , B. Psw , V. C , et al. 2020 . “ Brain Structural Covariance Networks in Obsessive‐Compulsive Disorder: A Graph Analysis From the ENIGMA Consortium .” …

Innovative trial approaches in immune-mediated inflammatory diseases: current use and future potential.

BackgroundDespite progress that has been made in the treatment of many immune-mediated inflammatory diseases (IMIDs), there remains a need for improved treatments. Randomised controlled trials (RCTs) provide the highest form of evidence on the effectiveness of a potential new treatment regimen, but they are extremely expensive and time consuming to conduct. Consequently, much focus has been given in recent years to innovative design and analysis methods that could improve the efficiency of RCTs. In this article, we review the current use and future potential of these methods within the context

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… Biostatistics. 2020. 27. Chu Y, Yuan Y. A Bayesian basket trial design using a calibrated Bayesian hierarchical model. Clin Trials. 2018;15(2):149–158. doi: 10.1177/1740774518755122. 28. Hobbs BP, Landin R. Bayesian basket trial design with exchangeability monitoring. … Biostatistics. 2019:1–16. 30. Park JJH, Siden E, Zoratti MJ, Dron L, Harari O, Singer J, Lester RT, Thorlund K, Mills EJ. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols. Trials. 2019;20(1):572. doi: 10.1186/s13063-019-3664-1. 31. …

Spontaneous genomic alterations in a chimeric model of colorectal cancer enable metastasis and guide effective combinatorial therapy.

Colon cancer is the second most common cause of cancer mortality in the Western world with metastasis commonly present at the time of diagnosis. Screening for propagation and metastatic behavior in a novel chimeric-mouse colon cancer model, driven by mutant p53 and β-Catenin, led to the identification of a unique, invasive adenocarcinoma. Comparison of the genome of this tumor, CB42, with genomes from non-propagating tumors by array CGH and sequencing revealed an amplicon on chromosome five containing CDK6 and CDK14, and a KRAS mutation, respectively. Single agent small molecule inhibition of

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… Biostatistics 5 : 557 – 572 . 15475419 10.1093/biostatistics/kxh008 44 Aguirre AJ , Brennan C , Bailey G , Sinha R , Feng B , et al ( 2004 ) High-resolution characterization of the pancreatic adenocarcinoma genome . …

Study protocol: Close Assessment and Testing for Chronic Graft-vs.-Host disease (CATCH).

Chronic graft-versus-host disease (GVHD) is an immune-mediated disorder that causes significant late morbidity and mortality following allogeneic hematopoietic cell transplantation. The "Close Assessment and Testing for Chronic GVHD (CATCH)" study is a multi-center Chronic GVHD Consortium prospective, longitudinal cohort study designed to enroll patients before hematopoietic cell transplantation and follow them closely to capture the development of chronic GVHD and to identify clinical and biologic biomarkers of chronic GVHD onset. Data are collected pre-transplant and every two months through

Сопоставимость, безопасность и стойкость на этапе III клинических испытаний при множественном склерозе.

СВЯЗЬ МЕЖДУ коморбидностью и снижением стойкости к лечению различных видов склероза (MS) с целью изменения заболеваний (DMT). Имеется ограниченная информация о связи совместимости с результатами в области безопасности. Цель исследования состояла в том, чтобы оценить связь между совместимостью и результатами в области безопасности и стойкостью. Мы провели two- метаанализ данных об отдельных участниках, полученных в ходе клинических испытаний на этапе III МНТ. Индивидуальные совпадающие и совпадающие нагрузки, определяемые как сумма всех совпадающих факторов (n=15), были осмотрены. Были проанали

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… Supplementary material Acknowledgements Amber Salter is supported (in part) by a Biostatistics/Informatics Junior Faculty Award (BI-2105-37656) from the National Multiple Sclerosis Society. This publication is based on research using data from Biogen provided by Biogen, Cambridge, USA. …

Development and 10-year history of a biosimilar: the example of Binocrit®.

Patent expirations for several biological products have prompted the development of alternative versions, termed 'biosimilars', which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the 'reference' medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit® (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit® as a biosimilar included extensive a

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… Nadja Höbel, Biostatistics, Sandoz Biopharmaceuticals, Oberhaching, Germany. Andreas Seidl, Technical Development Biosimilars, HEXAL AG, Oberhaching, Germany. Pere Gascón, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain. References 1. …

A review of evidence supporting amyloid beta reduction as a surrogate endpoint in Alzheimer's disease.

Alzheimer's disease (AD) is a heterogeneous neurodegenerative disease driven by pathological depositions of proteins that accumulate over decades. Compelling genetic and neurobiological evidence suggests that amyloid accumulation in the brain initiates and drives early-stage AD. Measurement of fibrillar amyloid has been pivotal to the development and approval of disease-slowing treatments. Various biomarkers of AD pathophysiology provide evidence of target engagement and downstream effects on disease progression, and their use as surrogate endpoints may help identify and expeditiously bring ne

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… Biostatistics. 2000;1:49–67. doi: 10.1093/biostatistics/1.1.49. 76. Chen T., Hutchinson R.M., Rubel C., Murphy J., Xie J., Montenigro P., et al. A statistical framework for assessing the relationship between biomarkers and clinical endpoints in Alzheimer's Disease. …

A SITC vision: adapting clinical trials to accelerate drug development in cancer immunotherapy.

Clinical trials of cancer immunotherapy (IO) were historically based on a drug development paradigm built for chemotherapies. The remarkable clinical activity of programmed cell death protein 1/programmed death ligand 1 blockade, chimeric antigen receptor-T cells, and T cell engagers yielded new insights into how the mechanistic underpinnings of IO are reflected in the clinic. These insights and the sheer number of novel immunotherapies currently in the pipeline have made it clear that our strategies and tools for IO drug development must adapt. Recent innovations like engineered T cells and t

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… 2 10.1001/jamaoncol.2018.1002 29799989 55 Levit LA Peppercorn JM Tam AL et al Ethical framework for including research biopsies in oncology clinical trials ASCO 2019 37 2368 77 10.1200/JCO.19.01479 31343905 56 Wong CH Siah KW Lo AW Estimation of clinical trial success rates and related parameters Biostatistics … 2019 20 273 86 10.1093/biostatistics/kxx069 29394327 PMC6409418 57 Lee C Werner TL Deal AM et al Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers JCO Oncol Pract 2021 17 e77 93 10.1200/OP.20.00501 33186085 PMC8202063 58 Kurbegov D Hurley P Waterhouse …

Frequently asked questions on surrogate endpoints in oncology-opportunities, pitfalls, and the way forward.

Patients with cancer expect prolonged life (overall survival, OS) or better life (quality of life, QOL) from cancer treatments. However, majority of new cancer drugs are now being approved not based on improved OS or QOL, but based on surrogate endpoints such as tumor shrinkage or delayed tumor progression. These surrogate endpoints, including their validity as a proxy for overall survival, differ based on disease settings and lines of treatment but in general, most surrogate measures have weak correlation with outcomes that matter to patients. Nevertheless, they are being increasingly used as

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… Biostatistics. 2000;1(1):49–67. doi: 10.1093/biostatistics/1.1.49. 16. Institute for quality and efficiency in Health care: executive summaries Institute for Quality and Efficiency in Health Care (IQWiG) 2011. …

All-cause and immune checkpoint inhibitor-associated acute kidney injury in immune checkpoint inhibitor users: a meta-analysis of occurrence rate, risk factors and mortality.

BackgroundImmune checkpoint inhibitors (ICIs) have been associated with acute kidney injury (AKI). However, the occurrence rate of ICI-related AKI has not been systematically examined. Additionally, exposure to proton pump inhibitors (PPIs) and non-steroidal anti-inflammatory drugs (NSAIDs) were considered as risk factors for AKI, but with inconclusive results in ICI-related AKI. Our aim was to analyse the occurrence rate of all-cause AKI and ICI-related AKI and the occurrence rates of severe AKI and dialysis-requiring AKI, and to determine whether exposure to PPIs and NSAIDs poses a risk for

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… Biostatistics 2011;12:122–42. 10.1093/biostatistics/kxq046 13. Viechtbauer W. Conducting meta-analyses in R with the metafor package. J Stat Softw 2010;36:1–48. 10.18637/jss.v036.i03 14. Sterne JA, Sutton AJ, Ioannidis JPet al. …