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Progression-free survival as a surrogate endpoint in myeloma clinical trials: an evolving paradigm.

Measurement of overall survival (OS) remains the gold standard for interpreting the impact of new therapies for multiple myeloma in phase 3 trials. However, as outcomes have improved, it is increasingly challenging to use OS as the primary endpoint if timely approval of novel agents is to be ensured to enable maximum benefit for patients. Surrogate endpoints of OS, such as progression-free survival (PFS) and response to treatment, have contributed to approval decisions by the Food and Drug Administration (FDA) and European Medicines Agency as endpoints demonstrating clinical benefit, and the F

Hematologic Malignancies: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner.

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Multiple Myeloma in 2023 Ways: From Trials to Real Life.

Multiple myeloma is a chronic hematologic malignancy that obstinately tends to relapse. Basic research has made giant strides in better characterizing the molecular mechanisms of the disease. The results have led to the manufacturing of new, revolutionary drugs which have been widely tested in clinical trials. These drugs have been approved and are now part of the therapeutic armamentarium. As a consequence, it is essential to combine what we know from clinical trials with real-world data in order to improve therapeutic strategies. Starting with this premise, our review aims to describe the cu

Perspectives to mitigate payer uncertainty in health technology assessment of novel oncology drugs.

Reimbursement decisions on new oncology drugs are now often made while uncertainty remains about a drug's risk-benefit profile. One consequence of this is a delay in patient access to valuable new medicines. We share our perspectives on strategies to mitigate sources of uncertainty in the health technology assessment process. These include flexible approaches for evaluating the additional benefit, such as better use of surrogate endpoints and health-related quality of life data, and renewed research efforts to define the optimal target population and generate real-world evidence post-authorisa

Совпадение в полном тексте источника
… HRQoL, health-related quality of life; HTA, health technology assessment; MCID, minimal clinically important difference; OS, overall survival; PFS, progression-free survival. 10.1080/20016689.2018.1562861-F0001 Figure 1. … HRQoL, health-related quality of life; HTA, health technology assessment; MCID, minimal clinically important difference; OS, overall survival; PFS, progression-free survival. …

INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST): a randomized controlled trial of percutaneous vertebroplasty.

BACKGROUND: The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on

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… Pain Practice 2003 3 310 17166126 10.1111/j.1530-7085.2003.03034.x Bombardier C Hayden J Beaton DE Minimal clinically important difference. …

General population normative values for the EORTC QLQ-C30 by age, sex, and health condition for the French general population.

BackgroundGeneral population normative values for the widely used health-related quality of life (HRQoL) measure EORTC QLQ-C30 support the interpretation of trial results and HRQoL of patients in clinical practice. Here, we provide sex-, age- and health condition-specific normative values for the EORTC QLQ-C30 in the French general population.MethodsFrench general population data was collected in an international EORTC project. Online panels with quota samples were used to recruit sex and age groups. Number and type of comorbidities were assessed. Descriptive statistics were used to calculate

Воздействие дексаметазона на подстрекательские маркеры хирургического стресса: случайное испытание роботической истерэктомии.

Иммунодепрессивное действие дексаметазона может помочь уменьшить риск таких послеоперационных осложнений, как инфекция, образование сцепления и запоздалое исцеление ран. Дексаметасон может уменьшить повреждение тканей и ускорить восстановление, смягчив возбудительскую реакцию, модифицировав активность иммунных клеток и сократив высвобождение провоспалительных цитокинов. В этом первом произвольном эксперименте дексаметазона в роботизированной гистерэктомии мы стремились оценить его влияние на уменьшение C-реактивного белка (CRP) в качестве косвенного признака хирургического стресса. Methods Wom

Real-world treatment patterns for teclistamab and talquetamab in multiple myeloma (MM): experience from 609 patients.

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Ларингейл амилоидоз: один центр four- Серия пациентов, освещающих диагностические проблемы и клиническую неоднородность.

Ларингейл амилоидоз является редким заболеванием, которое может имитировать доброкачественные, злокачественные или функциональные расстройства гортани. Мы представляем единый центр four- Серия пациентов, демонстрирующих клиническую неоднородность при анатомическом распределении, амилоидном печатании, системном взаимодействии и управлении. Все four Эти случаи были подтверждены гистологически. Two Пациенты, по результатам специализированной оценки, имели локальный ларингеальный амилоидоз, one У пациента было ларинготражающее амилоидное осаждение в контексте известной множественной миэломы, и one

Limited duration of dexamethasone in newly diagnosed AL amyloidosis: impact on response, toxicity, and survival.

BACKGROUND: Systemic light chain amyloidosis (AL) is a life-threatening disease in which dexamethasone (Dex) is a core therapy but is limited by cumulative toxicity. The optimal duration of Dex, particularly in the era of daratumumab (Dara)-based regimens, is uncertain. METHODS: We retrospectively analyzed 216 newly diagnosed AL amyloidosis patients (2017-2023). Dex exposure was categorized as limited (≤3 months) or prolonged (>3 months) using restricted cubic spline-derived associations with hematologic response kinetics. Outcomes included hematologic and organ response, toxicity, and overal

Balloon kyphoplasty in the treatment of metastatic disease of the spine: a 2-year prospective evaluation.

There is currently little data on the longer term efficacy and safety of balloon kyphoplasty (BKP) in patients with metastatic vertebral compression fractures (VCFs). To prospectively assess the long-term efficacy and safety of BKP in treating thoracic and lumbar spinal metastatic fractures that result in pain or instability. Sixty-five patients (37 men, mean age: 66 years) underwent 99 BKP procedures. Patient-related outcomes of pain visual analogue scale (VAS) and Oswestry Disability Index were assessed pre- and post-operatively and after 3, 6, 12 and 24 months. Correction of vertebral heigh

Поврежденное когнитивное и поведенческое функционирование в детском возрасте и экономические результаты взрослой жизни.

Метформин был назван следующим: one :: из наиболее важных медицинских агентов первой линии в управлении типом 2 Болит диабет. Поскольку метформин является главным образом антигипергликемическим агентом, он также оказывает огромное влияние на различные системы и процессы. Он действует главным образом путем активации AMPK (Adenosine Monophosphate-Activated Protein Kinase) в клетках и сокращения выхода глюкозы из печени. Кроме того, она сокращает производство современных продуктов гликации и реактивных видов кислорода в эндотелии, помимо регулирования глюкозы и липидного метаболизма в кардиомиоки

Treatment Approaches for Managing Patients with Hematological Malignancies in the Time of COVID-19 Pandemic.

Background/aimThe COVID-19 pandemic is a unique challenge to the care of patients with hematological malignancies. We aim to provide supportive guidance to clinicians making individual patients decisions during the COVID-19 pandemic, in particular during periods that access to healthcare resources may be limited.ConclusionThis review also provides recommendations, which are convenient in evaluating indications for therapy, reducing therapy-associated immunosuppression, and reducing healthcare utilization in patients with specific hematological malignancies in the COVID-19 era. Specific decisio

Current Trends and Challenges in the Clinical Translation of Nanoparticulate Nanomedicines: Pathways for Translational Development and Commercialization.

The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effecti

Кассетная нефропатия в СИС: Раннее признание и экстракорпоральные стратегии улучшения результатов.

Острая почечная травма (АКИ), вызванная кастами, является частой, но недостаточно признанной причиной дисфункции почек в отделении интенсивной терапии. Она возникает, когда фильтрованные белки или пигменты - свободные световые цепи (ФЛК) в множестве миеломы, миоглобин в хабдомиолизе, билирубин в тяжелом холестазе или гемоглобин в внутриваскулярном гемолизе - возникают внутри почечных трубок, образуя обструктивные касты и вызывая окислительные и подстрекательские травмы. Раннее распознавание имеет важное значение, поскольку традиционные маркеры (кротинин, мочи) задерживаются. Формирующиеся биом

Пациентская и физиологическая точка зрения на многократные миеломные данные, представленные в ASCO и EHA 2025Подкаст.

В этом простом подкасте выдержки из ежегодного совещания Американского общества клинической онкологии (АСКО) 2025 обсуждаются и дополняются дополнительными соображениями Европейской ассоциации гематологии (ЕАГ) 2025 Конгресс. Эти выводы были сделаны с точки зрения одного из экспертов-пациентов и врача, оба из которых обладают опытом и знаниями в области миеломы (ММ). Этот подкаст призван расширить охват сложных данных о ММ от этих научных совещаний до более широкой аудитории, включая неспециалистов, что позволит пациентам и медицинским работникам принимать более обоснованные решения о лечении.

Oral health status and quality of life in female patients receiving low dose bone-modifying agents for cancer treatment-induced bone loss: a single-center exploratory study.

INTRODUCTION: Breast cancer patients, undergoing low-dose bone-modifying agent (LD-BMA) therapy for cancer treatment-induced bone loss (CTIBL), represent an emerging category at risk of Medication-Related (MRONJ) low (<1%) but not absent. However, data on their oral health status and quality of life related are currently limited. This single-center exploratory study aimed to assess oral health conditions, periodontal status, and oral health-related quality of life in non-metastatic breast cancer patients under LD-BMA therapy for CTIBL. MATERIALS AND METHODS: Forty patients were consecutively

Modeling treatment-dependent glioma growth including a dormant tumor cell subpopulation.

BackgroundTumors comprise a variety of specialized cell phenotypes adapted to different ecological niches that massively influence the tumor growth and its response to treatment.MethodsIn the background of glioblastoma multiforme, a highly malignant brain tumor, we consider a rapid proliferating phenotype that appears susceptible to treatment, and a dormant phenotype which lacks this pronounced proliferative ability and is not affected by standard therapeutic strategies. To gain insight in the dynamically changing proportions of different tumor cell phenotypes under different treatment conditi

Paraneoplastic Syndrome After Kidney Transplantation: Frequency, Risk Factors, Differences to Paraneoplastic Occurrence of Glomerulonephritis in the Native Kidney, and Implications on Long-Term Kidney Graft Function.

Posttransplant malignancies are an important complication of solid organ transplantation. Kidney transplant recipients are at particularly high risk of cancer development. The most relevant risk factors of carcinogenesis are the use of immunosuppressive agents and oncogenic viral infections. Additionally, immune dysregulation caused by these factors may predispose to various types of organ damage. Paraneoplastic glomerular diseases are one of the most interesting and understudied cancer manifestations. The appropriate diagnosis of paraneoplastic glomerular damage can be challenging in kidney t

Nanomedicine Meets Immunotherapy: Advancing Adoptive Cell Therapy with Nanoparticles in the Treatment of Cancer with Sustainability Perspectives.

Immunotherapy has achieved remarkable clinical success in certain cancers, particularly through adoptive cell therapy (ACT), where T cell engineering with chimeric antigen receptor (CAR) has driven major clinical breakthroughs in the treatment of hematologic malignancies. However, efficacy against solid tumors remains limited due to multiple barriers, including the scarcity of tumor-specific antigens, antigen heterogeneity, immunosuppressive tumor microenvironment, and physical obstruction of T cell infiltration by dense extracellular matrix. Nanoparticle (NP)-based approaches can overcome the