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Chronic GVHD after steroid-sensitive, -dependent, and -refractory acute GVHD: incidence and clinical outcomes.

Chronic graft-versus-host disease (cGVHD) is a major limitation to the long-term success of allogeneic hematopoietic cell transplantation (HCT). Our prior study of acute GVHD (aGVHD) defined distinct treatment-response groups based on the response to first-line corticosteroids: steroid-sensitive (SS), steroid-resistant (SR), and steroid-dependent (SD) aGVHDs. We conducted a retrospective, single-institution, cohort study to assess the incidence, risk factors, and clinical outcomes of patients with cGVHD after a previous diagnosis of SS, SD, or SR aGVHD, compared with those with no history of a

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… Research reported in this publication was supported by National Institutes of Health grant P30CA077598 using the Biostatistics and Bioinformatics Core shared resource of the Masonic Cancer Center, University of Minnesota and by the National Center for Advancing Translational Sciences of the National …

People Living with HIV Eligibility in Canadian Cancer Clinical Trials.

Background: People living with HIV (PLWH) have historically been excluded from cancer clinical trials, prompting the 2017 ASCO-Friends of Cancer Research recommendations to limit unjustified exclusions and promote equitable access. This study evaluated how Canadian Cancer Trials Group (CCTG) protocols align with these recommendations. Methods: We conducted a cross-sectional review of CCTG active trial protocols, abstracting HIV eligibility language and trial characteristics, and assessing associations using Chi-square tests. Results: Of 136 trials activated between 1999 and 2025, 81.6% involve

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… The multidisciplinary team—with expertise in hematology, infectious diseases, HIV-related malignancies, clinical trial design, biostatistics, pharmacy, equity, diversity, inclusion and community engagement—provided clinical and methodological oversight. …

Novel Immune-Related Gene Signature for Risk Stratification and Prognosis of Survival in ER (+) and/or PR (+) and HER2 (-) Breast Cancer.

Background: Although intrinsic molecular subtype has been widely used, there remains great clinical heterogeneity of prognosis in the estrogen receptor (ER)- and/or progesterone receptor (PR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC). Methods: The transcriptome expression data of messenger RNA (mRNA) were downloaded from The Cancer Genome Atlas (TCGA), Molecular Taxonomy of Breast Cancer International Consortium (METABRIC), and the Gene Expression Omnibus (GEO) databases. Immune-related genes were acquired from the ImmPort database and additional

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… Acquisition and analysis of data (provided statistical analysis and biostatistics, etc.): FD, JZ, FZ, and HY. Writing, review, and/or revision of the manuscript: FD, JZ, FZ, HY, and PY. Study supervision: PY and JZ. …

Adjuvant doxycycline to enhance anti-amyloid effects: Results from the dual phase 2 trial.

BackgroundAlthough, doxycycline use is associated with improved outcomes in amyloidosis in retrospective studies, evidence from clinical trials is limited.MethodsThis phase 2 trial of doxycycline (clinicaltrials.gov: NCT02207556) in newly diagnosed light chain (AL) amyloidosis enrolled 25 patients with systemic AL amyloidosis on treatment with doxycycline for 1 year along with chemotherapy. Outcomes of interest included mortality, organ response, and hematologic response rates at 1 year.FindingsThe median age was 62 years, 64% were male, and 68% had the AL lambda subtype. Patients had Mayo 201

Histone modifications across cancers: mechanisms, therapy and clinical translation.

Cancer continues to be a major cause of death across the globe, and epigenetic dysregulation, including histone modifications, has been recognized as a major hallmark of cancer development, heterogeneity, and drug resistance. This review seeks to offer an overview of histone modifications in cancer, including the more studied histone modifications such as acetylation and methylation, as well as the less explored histone modifications such as phosphorylation, ubiquitination, and glycosylation. It also examines the role of histone modifications in the dysregulation of the three categories of enz

Renal Transplantation in HIV-positive and HIV-negative People With Advanced Stages of Kidney Disease: Equity in Transplantation.

BackgroundPeople with HIV are at a greater risk of end-stage kidney disease than the general population. Considering the risk of death after end-stage kidney disease, access to renal transplantation in people with HIV is critically important.MethodsWe included all adult patients on chronic dialysis in Ontario, Canada, between 1 April 2007 and 31 December 2020. We determined the probability of kidney transplantation with competing risk of death over time since the initiation of dialysis by calculating the adjusted subdistribution hazard ratios (sdHR; 95% confidence interval [CI]). We also compa

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… Matthew A Weir, ICES, Kidney, Dialysis & Transplantation Research Program, London, Ontario, Canada; Division of Nephrology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada. …

Inflammatory stromal and T cells mediate human bone marrow niche remodeling in clonal hematopoiesis and myelodysplasia.

Somatic mutations in hematopoietic stem/progenitor cells (HSPCs) can lead to clonal hematopoiesis of indeterminate potential (CHIP) and progression to myelodysplastic syndromes (MDS). Using single-cell and anatomical profiling of a large cohort of human bone marrow (BM), we show that the HSPC BM niche in CHIP and MDS is undergoing inflammatory remodeling. This includes loss of CXCL12⁺ adipogenic stromal cells and the emergence of a distinct population of inflammatory mesenchymal stromal cells (iMSCs), which arise in CHIP and become more prevalent in MDS. Functional studies in primary BM HSPC-M

An Observational Analysis of a Large Cohort of Pneumocystis jirovecii Pneumonia.

BACKGROUND: Pneumocystis jirovecii pneumonia (PCP) is increasingly seen in patients who are non-HIV immunocompromised hosts, yet modern risk factors and outcomes are poorly recognized and defined. METHODS: A retrospective review was conducted of adult patients who met criteria for proven or probable PCP from 2017 to 2024 across a large academic multicenter health system. The primary outcome was mortality among cohorts, defined by etiology of immunosuppression through univariate and age-adjusted logistic regression. Secondary analyses included trends in annual diagnoses and testing patterns.

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… Emily R Thompson, Division of Clinical Trials and Biostatistics, Mayo Clinic, Phoenix, Arizona, USA. Andrew H Limper, Division of Pulmonary and Critical Care, Mayo Clinic, Rochester, Minnesota, USA. Ayan Sen, Department of Critical Care, Mayo Clinic, Phoenix, Arizona, USA. …

Модель "Прогнозное выживание" включает результаты, о которых сообщают пациенты, для пациентов, не имеющих права на трансплантацию, с несколькими миеломами.

Разработка перспективных инструментов, специально предназначенных для самих пациентов, представляет собой важный шаг в деле расширения возможностей пациентов участвовать в совместном принятии решений. Включение результатов, сообщаемых пациентами, может повысить точность этих перспективных инструментов. Мы провели ретроспективное демографическое исследование пациентов, имеющих право на трансплантацию (TIE), с множественным диагнозом миеломы (MM) в период с января 2007 и декабрь 2018. Была разработана многовариантная модель регрессии Кокса для прогнозирования риска смерти внутри 1-year период с

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… Rinku Sutradhar, Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada; Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. …

Open-label pilot study of romiplostim for thrombocytopenia after autologous hematopoietic cell transplantation.

There are no standard treatments to prevent or hasten the recovery from severe conditioning-regimen-induced thrombocytopenia occurring after autologous hematopoietic cell transplantation (auto-HCT). We conducted an open-label, single-arm pilot study of romiplostim, a thrombopoietin receptor agonist, to enhance platelet recovery in patients with multiple myeloma or lymphoma undergoing auto-HCT. All patients were treated weekly with romiplostim starting day +1 after auto-HCT until the platelet count was >50 × 109/L without transfusion. Compared with contemporary retrospective data from romiplost

Safety and efficacy of extended dosing intervals of denosumab in patients with solid cancers and bone metastases: a retrospective study.

AimMore than half of patients with breast, lung, or prostate cancer who have bone metastases have evidence of skeletal-related events (SREs). Denosumab is a fully human monoclonal antibody that binds to and neutralizes receptor activator of nuclear factor kappa-B ligand (RANKL) on osteoblasts and their precursors. The United States Food and Drug Administration (FDA)-approved dose of denosumab is 120 mg every 4 weeks; however, other schedules have been used in practice for patient convenience. Evidence for the safety and efficacy of alternative dosing intervals is lacking.Patient & methodsAdult

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… Caulfield, Department of Pharmaceutical Services, Emory Healthcare, Atlanta, GA, USA Zeyuan Wang, Department of Biostatistics and Bioinformatics, Rollins School of Public Health. Alexa Boykin, Medical Science Liason, Novocure Inc., Atlanta, GA, USA. Bradley C. …

Colorectal cancer cells promote osteoclastogenesis and bone destruction through regulating EGF/ERK/CCL3 pathway.

Bone metastasis of colorectal cancer (CRC) cells leads to osteolysis. Aberrant activation of osteoclasts is responsible for bone resorption in tumor. In general, bone marrow-derived monocytes (BMMs) differentiate into osteoclasts, however, how CRC cells interact with BMMs and how to regulate the differentiation is elusive. We here report that CRC cells promote bone resorption in bone metastasis. Transcriptomic profiling revealed CCL3 up-regulated in MC-38 conditional medium treated BMMs. Further investigation demonstrated that CCL3 produced by BMMs facilitated cell infusion and thus promoted t

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… Analysis and interpretation of data (e.g., statistical analysis, biostatistics): G.Z., Q.J., Z.Y., W. W. Writing, review, and/or revision of the manuscript: G.Z., Q.J., Z.Y., K.X., X.W. …

Identification of Long Non-Coding RNAs Deregulated in Multiple Myeloma Cells Resistant to Proteasome Inhibitors.

While the clinical benefit of proteasome inhibitors (PIs) for multiple myeloma (MM) treatment remains unchallenged, dose-limiting toxicities and the inevitable emergence of drug resistance limit their long-term utility. Disease eradication is compromised by drug resistance that is either present de novo or therapy-induced, which accounts for the majority of tumor relapses and MM-related deaths. Non-coding RNAs (ncRNAs) are a broad class of RNA molecules, including long non-coding RNAs (lncRNAs), that do not encode proteins but play a major role in regulating the fundamental cellular processes

Molecular targets for anticancer therapies in companion animals and humans: what can we learn from each other?

Despite clinical successes in the treatment of some early stage cancers, it is undeniable that novel and innovative approaches are needed to aid in the fight against cancer. Targeted therapies offer the desirable feature of tumor specificity while sparing healthy tissues, thereby minimizing side effects. However, the success rate of translation of these therapies from the preclinical setting to the clinic is dramatically low, highlighting an important point of necessary improvement in the drug development process in the oncology field. The practice of a comparative oncology approach can addres

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… Biostatistics. 2019;20:273–286. doi: 10.1093/biostatistics/kxx069. 6. Mak IWY, Evaniew N, Ghert M. Lost in translation: animal models and clinical trials in cancer treatment. Am J Transl Res. 2014;6:114–118. 7. Garden OA, Volk SW, Mason NJ, Perry JA. …

PET Molecular Imaging: A Holistic Review of Current Practice and Emerging Perspectives for Diagnosis, Therapeutic Evaluation and Prognosis in Clinical Oncology.

PET/CT molecular imaging has been imposed in clinical oncological practice over the past 20 years, driven by its two well-grounded foundations: quantification and radiolabeled molecular probe vectorization. From basic visual interpretation to more sophisticated full kinetic modeling, PET technology provides a unique opportunity to characterize various biological processes with different levels of analysis. In clinical practice, many efforts have been made during the last two decades to standardize image analyses at the international level, but advanced metrics are still under use in practice.

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… A statistical measure of tissue heterogeneity with application to 3D PET sarcoma data Biostatistics 2003 4 433 448 10.1093/biostatistics/4.3.433 12925510 152. El Naqa I. Grigsby P.W. Apte A. Kidd E. Donnelly E. Khullar D. Chaudhari S. Yang D. Schmitt M. Laforest R. …

Abstracts of the 3rd International Conference on Cancer Cachexia, September 23–25, 2016 in Washington, DC, USA

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… Pistilli 1,3,5 1 Division of Exercise Physiology; 2 Animal Models and Imaging Facility; 3 West Virginia University Cancer Institute; 4 Department of Biostatistics; 5 West Virginia Clinical and Translational Sciences Institute, West Virginia University, Morgantown, WV, USA The aims of this project were … Christopher C Coss 2 , Samuel K Kulp 1 , Tanios Bekaii‐Saab 3 and Ching‐Shih Chen 1,5 1 Divisions of Medicinal Chemistry & Pharmacology; 2 Pharmaceutics & Pharmaceutical Chemistry, College of Pharmacy; 3 Division of Medical Oncology, Department of Internal Medicine, College of Medicine; 4 Center for Biostatistics …

Tumor-Specific Success Probabilities and Factors Associated With Phase III Trials in Oncology Drug Development.

Despite advances in novel therapeutic modalities, such as molecularly targeted agents and immunotherapies, the probability of success in Phase III oncology trials remains low. This study quantitatively characterized success probabilities of Phase III trials in oncology drug development and evaluated the factors associated with trial success. Phase III interventional oncology drug trials registered at ClinicalTrials.gov between 2007 and 2023 with publicly available primary endpoint results were included. Trial success was defined as the achievement of at least one primary endpoint, and tumor-sp

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… W., “Estimation of Clinical Trial Success Rates and Related Parameters,” Biostatistics 20 (2019): 273–286. 7. Hay M., Thomas D. W., Craighead J. L., Economides C., and Rosenthal J., “Clinical Development Success Rates for Investigational Drugs,” Nature Biotechnology 32 (2014): 40–51. 8. …

Кровеносный барьер проницаемость в зависимости от степени заболевания и времени многократного склерозового диагноза в оптическом неврите.

Динамическая магнитная резонансная визуализация, усиливающаяся контрастом, является перспективным биомаркером, позволяющим в vivo количественно определить проницаемость кровеносного барьера. ЦЕЛИ: Изучение взаимосвязи между проницаемостью мозга и кровеносным барьером, остротой оптического неврита и множественным преобразованием склероза в оптический неюрит. МЕТОДЫ: Модели Gjedde-Patlak, полученные с помощью динамических контрастно усиленных магнитных резонансных изображений, использовались для оценки проницаемости кровеносного барьера (Ki) в 78 Пациенты оптического неврита. :: 2017 Критерии Mc

Radiation Therapy for Plasma Cell Disease of the Brain and Skull: Poor Palliation and Survival After Treatment for Central Nervous System Involvement.

PurposeMyeloma lesions of the head can present with central nervous system (CNS) involvement (leptomeningeal disease or brain metastasis), cranial neuropathy (CN), or impending neurologic involvement (INI). We analyzed response and survival after palliative radiation therapy (RT) to the brain and/or skull for myeloma lesions to determine whether CNS involvement fared worse than other RT indications.Methods and materialsWe retrospectively analyzed 54 palliative RT courses administered at our institution from 2008 to 2019. Eleven courses were administered for CNS disease, 28 for CN, and 15 for I

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… Acknowledgments The authors would like to thank the Abramson Cancer Center clinical informatics team for their assistance in collecting data for this study, as well as the Perelman School of Medicine Center for Clinical Epidemiology and Biostatistics for their review of this manuscript. …

Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma.

PurposeDabrafenib plus trametinib improved relapse-free survival (RFS) versus placebo (hazard ratio [HR], 0.47; P BRAF V600-mutant stage III melanoma (BRF115532; COMBI-AD; ClinicalTrials.gov identifier: NCT01682083). We present an updated RFS analysis on the basis of extended study follow-up and a cure-rate model analysis to estimate the fraction of patients expected to remain relapse free long term.MethodsIn this phase III trial, patients with resected BRAF V600-mutant stage III melanoma were randomly assigned to 12 months of adjuvant dabrafenib plus trametinib versus placebo. We report updat

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… Biostatistics 8:576-594, 2007 14. Othus M, Barlogie B, Leblanc ML, et al. : Cure models as a useful statistical tool for analyzing survival. Clin Cancer Res 18:3731-3736, 2012 15. …