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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

Bilateral Pathological Femoral Fractures Secondary to Long-Term Tenofovir Disoproxil Fumarate-Induced Osteomalacia in a Woman Living with HIV: A Case Report.

BACKGROUND: People living with HIV on long-term antiretroviral therapy (ART) face increased risks of bone loss and fragility fractures, partly due to tenofovir disoproxil fumarate (TDF), a commonly used nucleoside reverse transcriptase inhibitor. TDF is associated with proximal tubular dysfunction, renal phosphate wasting, osteomalacia, and pathological fractures. This case highlights severe, bilateral femoral fractures as a rare but debilitating manifestation of chronic TDF-induced osteomalacia in a postmenopausal woman. CASE PRESENTATION: A 43-year-old African woman with HIV (diagnosed >15

The impact of smoking on outcomes among patients undergoing hematopoietic SCT for the treatment of acute leukemia.

A paucity of research exists examining the potential impact of tobacco use on cancer treatment outcomes, especially among patients treated with hematopoietic SCT (HSCT). A retrospective cohort study design was used to examine the impact of smoking on duration of hospitalization and overall survival among 148 consecutive patients undergoing HSCT for treatment of acute leukemia from 1999 to 2005. Of the 148 patients, 15% reported current smoking, 30% former smoking, and 55% never used tobacco. Patients were followed for a median 3.5 years (interquartile range=2.1-5.5). Compared to no history of

New developments in the treatment of peripheral T-cell lymphoma - role of Belinostat.

Peripheral T-cell lymphomas (PTCL) represent a heterogeneous group of rare malignancies that with the exception of anaplastic lymphoma kinase expressing anaplastic large cell lymphoma, share a poor outcome after standard (eg, anthracycline-based) chemotherapy. Most patients are either refractory to initial therapy or eventually relapse. Randomized studies for relapsed/refractory PTCL are not available, however, recently published data show that conventional chemotherapy has very limited efficacy in the salvage setting. Thus, novel drugs are urgently needed to improve the outcome in this settin

Impact of maintenance therapy on survival after autologous stem cell transplant for multiple myeloma regardless of response: a global analysis.

The effect of different maintenance therapies on outcome after autologous hematopoietic cell transplantation (AHCT) was analyzed in newly diagnosed multiple myeloma (NDMM) patients using global real-world data. NDMM patients transplanted between 2013 and 2017 were selected from the Worldwide Network for Blood and Marrow Transplantation (WBMT) registry. Overall survival (OS) was evaluated as primary and progression-free survival (PFS), non-relapse mortality and relapse/progression incidence as secondary endpoints. Multivariable 6- month landmark analyses were performed using Cox proportional ha

Is De-escalated Bisphosphonates Therapy a Suitable Alternative to Standard Dosing in Malignant Tumor Patients With Bone Metastases: A Systematic Review and Meta-Analysis.

Background: Previous studies have preliminarily identified the non-inferior efficacy for reducing skeletal-related event (SRE) rates between de-escalated (Q12w) and standard (Q3-4w) bone-targeting agents therapy in malignant tumor patients with bone metastases. In this study, we aim to make further efforts to analyze whether the de-escalated bisphosphonates (BPs) strategy is a suitable option by comprehensively retrieving and synthesizing state-of-the-art evidence. Methods: An extensive electronic search for randomized controlled trials (RCTs) comparing a BPs standard strategy with the de-esca

An Integrated Health-System Specialty Pharmacy Model for Coordinating Transitions of Care: Specialty Medication Challenges and Specialty Pharmacist Opportunities.

Adherence and persistence to specialty medications are necessary to achieve successful outcomes of costly therapies. The increasing use of specialty medications has exposed several unique barriers to certain specialty treatments' continuation. Integrated specialty pharmacy teams facilitate transitions in sites of care, between different provider types, among prescribed specialty medications, and during financial coverage changes. We review obstacles encountered within these types of transitions and the role of the specialty pharmacist in overcoming these obstacles. Case examples for each type

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… Documentation can include, but is not limited to, prior authorization approval information, patient’s last medication fill date, plan for accessing the medication post-discharge, and counseling provided for new medication starts. … American Medical Association . 2018 Prior Authorization State Law Chart. American Medical Association; Chicago, IL, USA: 2018. 43. Fein A., Gill L., Long D. Specialty Pharmacy Industry Outlook: What’s Next? …

Prevalence and treatment of postobstructive pneumonia among older adults with advanced cancer.

Among 124 older adults with advanced cancer who were hospitalized with pneumonia, 7.3% met criteria for postobstructive pneumonia. There were no differences in antibiotic duration, antibiotic spectrum, 30-day and 90-day readmissions, or mortality between those with and without postobstructive pneumonia. Bacteria were identified in 5 patients with postobstructive pneumonia.

Vertebroplasty in patients with multiple myeloma with vertebral compression fractures: protocol for a single-blind randomised controlled trial.

INTRODUCTION: Multiple myeloma (MM) is a plasma cell cancer where about 1/3 of the patients present with pathological fractures at the time of diagnosis. Despite treatment, the majority of the patients will develop additional fractures. Because survival and prognosis has improved significantly over the last two decades for patients with MM, there is an increased need to focus on optimal fracture treatment. Traditionally, fracture pain is treated conservatively with opioids, bisphosphonates, bracing and radiation therapy. Vertebral augmentation has been used for the last three decades as a mini

Optimizing individualized therapy decision-making in multiple myeloma (MM): integration and impact of the Revised Myeloma Comorbidity Index in the MM-tumor board.

Multiple Myeloma (MM) is a hematological disease predominantly affecting elderly patients. The complexity of current treatment necessitates individualized approaches. Therein, functional assessment (FA) tools, such as the Revised Comorbidity Index (R-MCI) at our University- and Comprehensive Cancer Center Freiburg, play a crucial role. This study aimed to determine (a) the implementation of the R-MCI in our MM-tumor board (MM-TB), (b) its impact on treatment guidance at baseline and (c) potential changes during follow-up. This exploratory study investigated R-MCI coverage and distribution in a

A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis.

BackgroundThis phase III, randomized, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of tanezumab in subjects with cancer pain predominantly due to bone metastasis receiving background opioid therapy.MethodsSubjects were randomized (stratified by (1) tumor aggressiveness and (2) presence/absence of concomitant anticancer treatment) to placebo or tanezumab 20 mg. Treatment was administered by subcutaneous injection every 8 weeks for 24 weeks (3 doses) followed by a 24-week safety follow-up period. The primary outcome was change in daily average pain in t

Assessment of kidney transplant suitability for patients with prior cancers: is it time for a rethink?

Kidney transplant recipients have up to a 100-fold greater risk of incident cancer compared with the age/sex-matched general population, attributed largely to chronic immunosuppression. In patients with a prior history of treated cancers, the type, stage and the potential for cancer recurrence post-transplant of prior cancers are important factors when determining transplant suitability. Consequently, one of the predicaments facing transplant clinicians is to determine whether patients with prior cancers are eligible for transplantation, balancing between the accelerated risk of death on dialy

:: воздействие программы < < Передовая практика > > на пациентов с повторной/отправленной миеломой, принимающих Селинксор.

Передовая практика (БП) в области лечения раковых заболеваний включает в себя многоплановый подход, включающий индивидуальные планы лечения, основанную на фактических данных медицину, оптимальное использование вспомогательных услуг и просвещение пациентов. Мы изучили последствия программы BP для пациентов с реанимацией/отменой множественных миелом (RRMM), получающих селинксор. Особенности программы BP, специфичные для селинксора, инициировали селинксор при дозах ≤80 gg раз в неделю и переднее использование стандартизованных антиметиков. К числу конечных точек исследования относятся время, необ

Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: Results of a single-center, multi-arm phase Ib study.

BACKGROUND: Carboplatin and paclitaxel (CT) is one of the standard chemotherapy regimens used in various tumor types. Preclinical models have suggested that selinexor, a first-in-class oral potent selective inhibitor of nuclear export Exportin-1, and CT exerts antitumor activity in multiple malignancies. METHODS: This was a single-center, multi-arm phase Ib study utilizing a "basket type" expansion. CT and selinexor was employed as one of the 13 parallel arms. Advanced relapsed/refractory solid tumors following standard therapy or where the addition of selinexor to standard regimens deemed ap

How to Manage Patients with Lenalidomide-Refractory Multiple Myeloma.

Although lenalidomide-based combinations, such as lenalidomide plus a proteasome inhibitor or an anti-CD38 monoclonal antibody, improve the overall response rate, progression-free survival, and overall survival of patients with relapsed/refractory multiple myeloma (RRMM), there is a tendency to use these regimens as a frontline treatment. This strategy has led to the development of refractoriness early in the disease course, usually after the patient's first treatment. Since lenalidomide-free regimens have so far shown limited efficacy in lenalidomide-refractory patients, there is an unmet nee

Menstrual patterns and gonado-sexual health following hematopoietic transplant in reproductive age women and the role of hormone replacement therapy.

BackgroundMenstrual patterns, reproductive sequelae, sexual health, and the role of hormone replacement therapy (HRT) among women following hematopoietic stem cell transplantation (HSCT) remain underexplored. This study evaluated menstrual resumption, ovarian reserve, fertility outcomes, sexual function, and attitudes towards HRT among women who underwent HSCT.MethodsThis single-centre retrospective, cross-sectional analysis included women aged 18-45 years who had undergone HSCT for haematological malignancies and were on follow-up of at least 6 months post-HSCT. Data collected encompassed dem

CARBOMETASPINE: protocol for a multicenter, prospective, randomized controlled trial of carbonfiber spinal fixation in metastatic disease.

BACKGROUND: Spinal metastases frequently cause neurological compromise and mechanical instability. Titanium fixation limits postoperative imaging and hinders stereotactic body radiotherapy (SBRT) planning because of artefacts. METHODS: CARBOMETASPINE is a multicentre, prospective, randomised controlled trial. A total of 226 adults with unstable or epidurally infiltrating spinal metastases will be randomised 1 : 1 : 1 to: (I) carbonfibre/PEEK fixation + postoperative SBRT (5 × 5 Gy); (II) titanium fixation + postoperative SBRT; (III) preoperative SBRT + titanium fixation. The primary endpoint i

Hypertension, smoking, and preexistence of multiple cardiac risk factors correlate with carfilzomib-induced cardiovascular adverse events in a racially diverse population.

BackgroundUse of the proteasome inhibitor carfilzomib has become a standard of care in patients with relapsed/refractory multiple myeloma. An association between carfilzomib and cardiovascular adverse events has been well documented, but this had not been investigated in a racially diverse population. Black patients in particular are underrepresented in the reported outcomes of treatment with carfilzomib.ObjectiveThe purpose of this study was to identify risk factors for carfilzomib-associated cardiovascular events in a diverse, single-center population.MethodsWe conducted a retrospective revi

Прогнозирующая Симптомная модель включает симптомы, о которых сообщают пациенты, для пациентов, не имеющих права на трансплантацию, с несколькими миеломами.

ВВЕДЕНИЕ: Пациенты с несколькими миэломами (ММ), имеющими право на трансплантацию (TIE), имеют высокий уровень симптомного бремени. Цель этого исследования заключалась в разработке и подтверждении перспективной модели прогнозирования симптомов у пациентов с ТИЭ ММ. МЕТОДЫ: В рамках этого исследования, основанного на данных о населении, с использованием многочисленных баз данных административной медицинской помощи, увязанных с использованием уникального зашифрованного идентификатора пациента в Онтарио, Канада, симптомы были выявлены с использованием саморегистрируемой системы оценки симптомов Э

CAR T-Cell Therapy for Patients with Multiple Myeloma: Current Evidence and Challenges.

The therapeutic landscape of multiple myeloma (MM) has benefited from an emergence of novel therapies over the last decade. By inducing T-cell kill of target cancer cells, chimeric antigen receptor (CAR) T-cell therapies have improved outcomes of patients with hematologic malignancies. B-cell maturation antigen (BCMA) is the current target antigen of choice for most CAR T-cell products under investigation for MM. However, their shortcomings deal with logistical and clinical challenges, including limited availability, manufacturing times, and toxicities. This article provides an overview of rec