Результаты поиска

A phase 2 multicenter trial of ofatumumab and prednisone as initial therapy for chronic graft-versus-host disease.

Standard initial therapy of chronic graft vs. host disease (cGVHD) with glucocorticoids results in suboptimal response. Safety and feasibility of therapy with ofatumumab (1000 mg IV on days 0 and 14) and prednisone (1 mg/kg/day) was previously established in our phase I trial (n = 12). We now report the mature results of the phase II expansion of the trial (n = 38). The overall NIH severity of cGVHD was moderate (63%) or severe (37%) with 74% of all patients affected by the overlap subtype of cGVHD and 82% by prior acute cGVHD. The observed 6 month clinician-reported and 2014 NIH-defined overa

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… Acknowledgment This work was supported in part by Biostatistics Core shared resources at the H. Lee Moffitt Cancer Center & Research Institute, designated a comprehensive cancer center by the National Cancer Institute, National Institutes of Health (P30CA076292). …

Measurement properties of brief neuropathy screening items in cancer patients receiving taxanes, platinums, or proteasome inhibitors.

BackgroundTimely detection of chemotherapy-induced peripheral neuropathy (CIPN) is critical to effectively tailor chemotherapy dose levels and offer supportive care. The purpose of this secondary analysis was to determine the reliability and validity of the two Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) numbness and tingling severity and interference items to screen for CIPN in patients receiving taxanes, platinums, or proteasome inhibitors.MethodsParticipants (N = 142) completed the two PRO-CTCAE items, a 0-10 numerical rating scale of

Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma.

BACKGROUND: Despite major advances in therapy, multiple myeloma is still an incurable malignancy in the majority of patients. To increase survival, deeper remissions (i.e. CR) translating into longer PFS need to be achieved. Incorporation of new drugs (i.e. bortezomib and lenalidomide) as induction and maintenance treatment in an intensified treatment concept, including high dose melphalan (200 mg/m2), has resulted in increased CR rates, and is considered the standard of care for younger patients. Elotuzumab in combination with lenalidomide and dexamethasone has given better results as lenalid

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… The study design was developed with the Department of Biostatistics at the German Cancer Research Center, Heidelberg, see section "Statistical analysis". The study design was discussed with the sponsors, who had accepted the IIT design. …

Phase I studies of AZD1208, a proviral integration Moloney virus kinase inhibitor in solid and haematological cancers.

BackgroundProviral integration Moloney virus (PIM) kinases (PIM1, 2 and 3) are overexpressed in several tumour types and contribute to oncogenesis. AZD1208 is a potent ATP-competitive PIM kinase inhibitor investigated in patients with recurrent or refractory acute myeloid leukaemia (AML) or advanced solid tumours.MethodsTwo dose-escalation studies were performed to evaluate the safety and tolerability, and to define the maximum tolerated dose (MTD), of AZD1208 in AML and solid tumours. Secondary objectives were to evaluate the pharmacokinetics, pharmacodynamics (PD) and preliminary efficacy of

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… .; Analysis and interpretation of data (e.g., statistical analysis, biostatistics, computational analysis): J.C., K.T., D.J.D., Jde.B., D.L., M.M., G.L.U., H.K., L.S.C., V.G., R.G., K.K., K.M., K.V., J.E.P., E.D.; Writing, review and/or revision of the manuscript: J.C., K.T., D.J.D., Jde.B., D.L., M.M …

DNA-demethylating and anti-tumor activity of synthetic miR-29b mimics in multiple myeloma.

Aberrant DNA methylation plays a relevant role in multiple myeloma (MM) pathogenesis. MicroRNAs (miRNAs) are a class of small non-coding RNAs that recently emerged as master regulator of gene expression by targeting protein-coding mRNAs. However, miRNAs involvement in the regulation of the epigenetic machinery and their potential use as therapeutics in MM remain to be investigated. Here, we provide evidence that the expression of de novo DNA methyltransferases (DNMTs) is deregulated in MM cells. Moreover, we show that miR-29b targets DNMT3A and DNMT3B mRNAs and reduces global DNA methylation i

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… The raw intensity expression values were processed by Robust Multi-array Average (RMA) complete procedure (Irizarry Biostatistics 2003) with the re-mapped Chip Definition Files (CDF) from BrainArray libraries version 15.0.0 available at http://brainarray.mbni.med.umich.edu/Brainarray/Database/Custom …

Площадь метилирования ДНК клеток цереброспинальной жидкости в множестве склероза: исследование эпигеномной ассоциации.

Множественный склероз (MS) является хроническим воспалительным заболеванием центральной нервной системы, в которой метилация ДНК может увязывать генетические и экологические факторы риска. Methods: Мы профилировали содержание метилации ДНК по всему геному в клетках цереброспиновой жидкости (CSF) у людей с MS (pwMS) и совпадающими контрольными устройствами. Дифференцированные метилированные позиции (DMP) и регионы (DMR) были интегрированы с транскриптомными данными, аннотациями клеточного хроматина Т и анализом путей. Выражение гамма-протокадерина (ПХДГ) было оценено в первичных подмножествах C

Взаимосвязь между БМИ и когнитивом, инвалидностью и качеством жизненных показателей при множественном склерозе: вторичный анализ DISCOMS.

СВЯЗЬ МЕЖДУ индексом массы тела (ИОВ) и когнитивированием, инвалидностью и качеством жизни (QOL) является спорной при множественном склерозе (MS). Мы изучили связь между BMI и когнитивной функцией, инвалидностью и QoL в MS. МЕТОДЫ: Был проведен перекрестный вторичный анализ процесса ДИСКОМС для изучения связи между БМИ и когнитивом, инвалидностью и QoL. Когнитивная функция измерялась по методу проверки символических цифр (ССРМ), а инвалидность измерялась на основе расширенной шкалы показателей инвалидности (СЭДСС) и установленных пациентом ступеней инвалидности (ПДДС). Кольные маркеры измеряли

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… Charity Morgan, Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, USA. Eric Engebretson, Department of Neurology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. …

Глобальная распространенность и факторы риска суицидальных идеи при множественном склерозе: систематический обзор и мета-анализ.

СЮ, попытки и смерть часто описываются и расследуются в связи с такими хроническими неврологическими расстройствами, как множественный склероз (MS). В ходе этого систематического обзора и метаанализа была проведена оценка глобальной распространенности СИ у пациентов с НР и продемонстрированы связанные с этим факторы риска. Это может помочь врачу сократить число попыток самоубийства и улучшить состояние здоровья населения. МЕТОДЫ: Был проведен всеобъемлющий систематический поиск на PubMed, Scopus, Embase и Web of Science с целью поиска исследований, в которых сообщалось о распространенности SI

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… The study team included clinicians and researchers with expertise in neurology, epidemiology, and biostatistics. All members of the team have prior experience conducting systematic reviews and meta‐analyses. …

Proactive Identification and Digital Mental Health Intervention for the Treatment of Depression Among Individuals With Likely Incurable Cancer: A Pilot Randomized Clinical Trial.

BackgroundAlthough depression is prevalent and has significant consequences among individuals living with likely incurable cancer (ILLIC), optimal methods of identifying and treating depression in this population remain unknown.AimsTo evaluate a paradigm of (1) proactive identification (ID) (i.e., remotely and asynchronously from clinical encounters) of depression among ILLIC and (2) digital mental health intervention (DMHI) for depression treatment.MethodsIn this decentralized randomized clinical trial, ILLIC with elevated depressive symptoms were proactively identified using electronic healt

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… Supporting information Supporting Information S1 Acknowledgments This was supported by the National Cancer Institute at the National Institutes of Health (R01 CA281740 to E.M.G and J.D.), R42 MH108219 to J.D., the Biostatistics Shared Resource, Hollings Cancer Center, Medical University of South Carolina …

A comprehensive evaluation of potentially significant drug-drug, drug-herb, and drug-food interactions among cancer patients receiving anticancer drugs.

IntroductionDuring the cancer treatment path, cancer patients use numerous drugs, including anticancer, supportive, and other prescribed medications, along with herbs and certain products. This puts them at risk of significant drug interactions (DIs). This study describes DIs in cancer patients and their prevalence and predictors.MethodsA cross-sectional study design was used to achieve the study objectives. The study was carried out in two centers in the northern West Bank, Palestine. The Lexicomp® Drug Interactions tool (Lexi-Comp, Hudson OH, USA) was applied to check the potential DIs. In a

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… Daniel WW Biostatistics: A Foundation for analysis in the health sciences 1999 7 New York John Wiley & Sons 22. …

Molecular Evaluation of Low-grade Low-stage Endometrial Cancer With and Without Recurrence.

Low-grade, low-stage endometrioid carcinomas (LGLS EC) demonstrate 5-yr survival rates up to 95%. However, a small subset of these tumors recur, and little is known about prognostic markers or established mutation profiles associated with recurrence. The goal of the current study was to identify the molecular profiles of the primary carcinomas and the genomic differences between primary tumors and subsequent recurrences. Four cases of LGLS EC with recurrence and 8 cases without recurrence were evaluated via whole-exome sequencing. Three of the 4 recurrent tumors were evaluated via Oncomine Com

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… Biostatistics 2004;5:557–72. 33. Hammerman PS, Sos ML, Ramos AH, et al. Mutations in the DDR2 kinase gene identify a novel therapeutic target in squamous cell lung cancer. Cancer Discov 2011;1:78–89. 34. Prandi D, Baca SC, Romanel A, et al. …

High-dose chemotherapy and autologous stem cell transplantation of patients with multiple myeloma in an outpatient setting.

BACKGROUND: High-dose (HD) chemotherapy with melphalan and autologous blood stem cell transplantation (ABSCT) for treatment of symptomatic multiple myeloma (MM) on an outpatient basis has been well established in the USA and Canada, whereas in Germany and Western Europe an inpatient setting is the current standard. We report on a German single-centre program to offer the procedure on an outpatient basis to selected patients. METHODS: Major requirements included: patients had to have family and/or other caregivers, had to be able to reach the hospital within 45 min and have an ECOG performance

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… KL and TB performed biostatistics. SSa, GE, HG, JH, JS, SS, MWH and ADH were involved in patient enrolment, clinical decision making, helped design the study and contributed data for patient characteristics and/or transplantation parameters. …

Clinical impact of airflow obstruction after allogeneic hematopoietic stem cell transplantation.

Criteria for airflow obstruction (AFO) at one year after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in pulmonary function tests (PFTs) are more stringent than the bronchiolitis obliterans syndrome (BOS) criteria of the National Institutes of Health. This single-center, retrospective cohort study evaluated the clinical impact of the AFO criteria at any time after transplantation. In 132 patients who underwent allo-HSCT from 2006 to 2016, the 2-year cumulative incidence of AFO was 35.0%, and the median time to diagnosis of AFO was 101 days after transplantation (range 35-716

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… More precisely, it is a modified version of R commander designed to add statistical functions frequently used in biostatistics. Results Patient characteristics Patient characteristics and the status of the development of AFO are summarized in Table 1 . …

Machine learning in onco-pharmacogenomics: a path to precision medicine with many challenges.

Over the past two decades, Next-Generation Sequencing (NGS) has revolutionized the approach to cancer research. Applications of NGS include the identification of tumor specific alterations that can influence tumor pathobiology and also impact diagnosis, prognosis and therapeutic options. Pharmacogenomics (PGx) studies the role of inheritance of individual genetic patterns in drug response and has taken advantage of NGS technology as it provides access to high-throughput data that can, however, be difficult to manage. Machine learning (ML) has recently been used in the life sciences to discover

Characteristics and Outcomes of Patients With Hematologic Malignancies Hospitalized With Respiratory Viral Infections.

BackgroundRespiratory viral infections in patients with hematologic malignancies or hematopoietic stem cell transplants (HCTs) are associated with increased morbidity and mortality. However, the hospital presentations and courses of these infections remain under-described.MethodsWe performed a multicenter retrospective cohort study of hospitalized patients with hematologic malignancy or HCT at 2 comprehensive cancer centers between January 2019 and June 2023. We included all patients with acute viral respiratory infection (identified based on a constellation of test results and objective physi

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… Andrew P Michelson, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, Saint Louis, Missouri, USA; Data Science, and Biostatistics, Institute for Informatics, Washington University School of Medicine, Saint Louis, Missouri, USA. …

Competing risks of treatment discontinuation of atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma.

BACKGROUND & AIMS: Atezolizumab plus bevacizumab (Atezo/Bev) is considered standard first-line therapy for unresectable hepatocellular carcinoma (HCC), yet reasons for treatment discontinuation vary, and conventional survival endpoints do not capture the time-varying probability of each cause. This multicentre retrospective study aimed to quantify the cause-specific discontinuation and its predictors. METHODS: We analysed 685 consecutive patients treated with Atezo/Bev (10 excluded). Time-to-discontinuation was defined from treatment initiation to cessation and right-censored at last follow-u

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… Tutorial in biostatistics: competing risks and multi-state models Stat Med 26 2007 2389 2430 10.1002/sim.2712 17031868 17 Celsa C. Cabibbo G. Fulgenzi C.A.M. …

Remineralization Rate of Lytic Lesions of the Spine in Multiple Myeloma Patients Undergoing Radiation Therapy.

Study DesignRetrospective cohort study.ObjectiveIn general, Multiple Myeloma (MM) patients are treated with systemic therapy including chemotherapy. Radiation therapy can have an important supportive role in the palliative management of MM-related osteolytic lesions. Our study aims to investigate the degree of radiation-induced remineralization in MM patients to gain a better understanding of its potential impact on bone mineral density and, consequently, fracture prevention. Our primary outcome measure was percent change in bone mineral density measured in Hounsfield Units (Δ% HU) between pre

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… Lee, PhD, from the MGH Biostatistics Center for their support and advice on design and statistical analysis. …

Characteristics and prognosis of patients with COVID-19 and hematological diseases in Japan: a cross-sectional study.

The Japanese Society of Hematology performed an observational cross-sectional study to clarify the morbidity, prognosis, and prognostic factors in patients with COVID-19 with hematological diseases (HDs) in Japan. The study included patients with HDs who enrolled in our epidemiological survey and had a COVID-19 diagnosis and a verified outcome of up to 2 months. The primary endpoints were characteristics and short-term prognosis of COVID-19 in patients with HDs. A total of 367 patients from 68 institutes were enrolled over 1 year, and the collected data were analyzed. The median follow-up amon

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… All statistical analyses were performed in EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan), a customized version of R Commander designed to include statistical functions often used in biostatistics [ 16 ]. …

Low-dose peripheral blood stem cell graft after high-dose chemotherapy - an evaluation of hematopoietic reconstitution.

BackgroundHigh-dose (HD) chemotherapy followed by autologous blood stem-cell transplantation (ASCT) is the standard treatment for multiple myeloma (MM) patients. However, the collection of sufficient peripheral blood stem cell (PBSC) grafts can be challenging, and the question arises whether reinfusion of low-dose grafts will lead to a hematopoietic recovery.MethodsThe hematopoietic recovery of 148 MM patients who underwent HD melphalan chemotherapy and received PBSC transplants with varying CD34+ cells doses (3-4 × 106 [n = 86], 2-2.5 × 106 [n = 53], 6 [n = 9] per kg body weight [bw]) was ana

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… TB, KK and MK performed biostatistics. SSa, PP, AS, MC, KJ, PW, CMT and KK were involved in patient selection as well as clinical decision making and contributed data for patient characteristics and/or transplantation parameters. All authors revised and approved the submitted manuscript. …

The Survivor Unmet Needs Survey (SUNS) for haematological cancer survivors: a cross-sectional study assessing the relevance and psychometric properties.

BackgroundRelevant and psychometrically sound needs assessment tools are necessary for accurate assessment of haematological cancer survivors unmet needs. No previous study has developed nor psychometrically evaluated a comprehensive needs assessment tool for use with population-based samples of haematological cancer survivors. This study aimed to assess the validity and reliability of the Survivor Unmet Needs Survey (SUNS) with haematological cancer survivors.MethodsThe relevance, content and face validity of the SUNS to haematological cancer survivors was assessed using qualitative interview

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… CD is a professor in biostatistics. She has over 18 years of experience in health research and teaching. FT is a post-doctoral research fellow. …