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Real-World Effectiveness, Safety, and Tolerability of Facilitated Subcutaneous Immunoglobulin 10% in Secondary Immunodeficiency Disease: A Systematic Literature Review.

Background: Secondary immunodeficiency disease (SID) is a complex, heterogeneous condition that occurs when extrinsic factors weaken the immune system. Expert consensus guidelines recommend immunoglobulin replacement therapy to manage immunoglobulin G (IgG) levels and mitigate severe, recurrent, and persistent infections. Hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% is a dual-vial unit of IgG and recombinant human hyaluronidase; the latter enables absorption of higher volumes of IgG than conventional subcutaneous therapies. Methods: For this systematic literature review, E

Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials - insights from an expert virtual roundtable.

Early phase clinical trials provide an initial evaluation of therapies' risks and benefits to patients, including safety and tolerability, which typically relies on reporting outcomes by investigator and laboratory assessments. Use of patient-reported outcomes (PROs) to inform risks (tolerability) and benefits (improvement in disease symptoms) is more common in later than early phase trials. We convened a two-day expert roundtable covering: (1) the necessity and feasibility of a universal PRO core conceptual model for early phase trials; (2) the practical integration of PROs in early phase tri

The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.

BACKGROUND: In situations of unmet medical need or in the interests of public health, expedited approval pathways, including conditional marketing authorisation (CMA) and accelerated assessment (AA), speed up European Medicines Agency (EMA) marketing authorisation recommendations for medicinal products. CMAs are based on incomplete benefit-risk assessment data and authorisation remains conditional until regulator-imposed confirmatory postmarketing measures are fulfilled. For products undergoing AA, complete safety and efficacy data should be available, and postauthorisation measures may includ

Impact of e-cigarettes as cancer risk: A protocol for systematic review and meta-analysis.

BackgroundThe use of electronic cigarettes is one of the current public health problems on increasing alert, has been growing at an accelerating rate, and has become a public health emergency. Its importance is explained by the continuous growth and acceleration of oncological rates among all ages versus the absence of high-quality evidence, correlated to the use of nicotine derived products, being at their regular versions or the new ones. Available preclinical data indicate that activation of the sympathetic nervous system by nicotine inhaled from e-cigarettes may stimulate cancer developmen

Efficacy of ixazomib for the treatment of relapsed/refractory multiple myeloma: A protocol of systematic review and meta-analysis.

BackgroundOver the past years, ixazomib has been increasingly explored for the treatment of relapsed/refractory multiple myeloma (RRMM). However, its results are still contradictory. This study will explore the efficacy and safety of ixazomib for patients with RRMM.MethodsA systematic records search of Cochrane Library, PUBMED, EMBASE, CINAHL, ACMD, PsycINFO, WANGFANG, and China National Knowledge Infrastructure will be carried out from their origin to March 31, 2020 with no limitations of language and publication status. Trials will be selected by titles/abstracts, and full manuscripts by 2 i

Oral toxicity produced by chemotherapy: A systematic review.

IntroductionAntineoplastic chemotherapy remains one of the most widely used management strategies in cancer, either alone or in combination with other types of treatment. The main inconvenience of chemotherapy is its lack of selectivity, since it acts upon both tumor cells and rapidly multiplying normal cells such as bone marrow cells, hair follicle cells and oral and gastrointestinal mucosal cells.Material and methodAn exhaustive search was made of the main oral toxic effects of chemotherapy in the PubMed-Medline, Cochrane Library and Scopus databases. A total of 1293 articles were identified

A toolbox of different approaches to analyze and present PRO-CTCAE data in oncology studies.

BackgroundThe patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is used to assess symptomatic adverse events in oncology trials. Currently, no standard for PRO-CTCAE analysis exists.MethodsKey methods of descriptive analysis and longitudinal modeling using PRO-CTCAE data from an oncology clinical trial, DRiving Excellence in Approaches to Multiple Myeloma-2 (DREAMM-2), a phase II trial of belantamab mafodotin in multiple myeloma (NCT03525678), were explored. Descriptive methods included maximum postbaseline ratings, mean change over time, ratin

Combined lifestyle factors, incident cancer, and cancer mortality: a systematic review and meta-analysis of prospective cohort studies.

BackgroundCancer poses a huge disease burden, which could be reduced by adopting healthy lifestyles mainly composed of healthy diet, body weight, physical activity, limited alcohol consumption, and avoidance of smoking. However, no systematic review has summarised the relations of combined lifestyle factors with cancer morbidity and mortality.MethodsEMBASE and PubMed were searched up to April 2019. Cohort studies investigating the association of combined lifestyle factors with risks of incident cancer and cancer mortality were selected. Summary hazard ratios (HRs) and 95% confidence intervals

Amyloidosis for the Gastroenterologist: A Comprehensive Systematic Review of Diagnosis and Management of Gastrointestinal Manifestations.

BackgroundAmyloidosis is a rare, multisystem disorder characterized by extracellular deposition of misfolded protein fibrils. Gastrointestinal (GI) amyloidosis is uncommon but under-recognized due to nonspecific symptoms, but early diagnosis is critical to improve quality of life and prognosis. This comprehensive systematic review aimed to summarize current literature on GI and hepatic manifestations of amyloidosis, highlighting diagnostic and management strategies across the major subtypes of amyloidosis, in particular AL (immunoglobulin light chain), ATTR (transthyretin), and AA (serum amylo

Financial Toxicity of Hematologic Malignancy Therapies, Including Cellular Therapy and Its Impact on Access to Care: Prospective Pilot Study.

BackgroundPatients with cancer often face significant financial challenges, known as financial toxicity (FT), which is associated with reduced quality of life. Patients with hematologic malignancies (HMs) are especially vulnerable due to intensive and prolonged treatments, frequent hospital visits, and a high risk of complications. While FT affects many in the general population, it is particularly severe among racial and ethnic minorities, especially those below the poverty line. To our knowledge, no studies have specifically examined FT in this vulnerable group in the United States.Objective

Advancing Multiple Myeloma Immunotherapy: A Review of Chimeric Antigen Receptor T-Cell and Bispecific T-Cell Engagers Cell Therapies in Revolutionizing Treatment.

Multiple Myeloma (MM) is a hematologic malignancy characterized by clonal plasma cell development, leading to serious complications. Despite traditional treatments, MM remains incurable, necessitating innovative therapeutic approaches. Chimeric Antigen Receptor (CAR) T-cell therapy and Bispecific T-cell engagers (BiTEs) are emerging immunotherapies showing promise in MM treatment. CAR T-cell therapy involves modifying patient T-cells to target specific antigens, primarily B Cell Maturation Antigen (BCMA). BiTEs, on the other hand, are non-IgG-like bispecific antibodies designed to engage both

Detection bias in open-label trials of anticancer drugs: a meta-epidemiological study.

OBJECTIVES: In anticancer clinical trials, particularly open-label trials, central reviewers are recommended to evaluate progression-free survival (PFS) and objective response rate (ORR) to avoid detection bias of local investigators. However, it is not clear whether the bias has been adequately identified, or to what extent it consistently distorts the results. Therefore, the objective of this study was to evaluate the detection bias in oncological open-label trials by confirming whether local investigators overestimate the PFS and ORR compared with the findings of central reviewers. DESIGN:

Development of a Mindfulness-Based Stress Reduction Program for Hematologic Malignancy Patients: A Delphi Study.

PurposeHematologic malignancies (HM) are a group of malignant clonal diseases that pose significant treatment challenges and adversely impact patient survival and quality of life. This study aimed to develop a Mindfulness-Based Stress Reduction (MBSR) program specifically for HM patients and to refine it for application in China.Patients and methodsA research team comprised of nursing directors, psychology experts, and other professionals was established, and then a literature review was conducted to assemble information needed to develop the MBSR intervention protocol. Following this, a Delph

Characteristics of post hoc subgroup analyses of oncology clinical trials: a systematic review.

BackgroundSubgroup analyses in clinical trials assess intervention effects on specific patient subgroups, ensuring generalizability. However, they are usually only able to generate hypotheses rather than definitive conclusions. This study examined the prevalence and characteristics of post hoc subgroup analysis in oncology.MethodsWe systematically reviewed published subgroup analyses from 2000 to 2022. We included articles presenting secondary, post hoc, or subgroup analyses of interventional clinical trials in oncology, cancer survivorship, or cancer screening, published separately from the o

A Systematic Review of Sildenafil Mortality Through the Years.

Sildenafil is a medication used for the treatment of erectile dysfunction. It was approved by the U.S. Food and Drug Administration (FDA) in 1998. Several articles have raised concerns regarding the use of sildenafil and the occurrence of serious adverse events, such as myocardial ischemia, stroke, and even death. Our aim is to systematically review the existing literature on mortality associated with sildenafil use. The method used for this systematic review was completed by searching three databases: PubMed, Scopus, and Web of Science. Articles were screened and assessed for eligibility. Thi

Telemedicine in Hematopoietic Cell Transplantation and Chimeric Antigen Receptor-T Cell Therapy.

Telemedicine has played an important role in delivering healthcare for primary care, chronic disease patients, and those with solid organ malignancies. However, its application in subspecialties such as hematologic malignancies, hematopoietic cell transplantation (HCT), or chimeric antigen receptor-T cell (CAR-T) therapy is not widespread since physical examination is a vital component in delivering care. During the COVID-19 pandemic, we widely used telemedicine, since protecting our immunocompromised patients became our top priority. The employment of HCT and CAR-T therapies continues to grow

Chemopreventive Potential of Caryophyllane Sesquiterpenes: An Overview of Preliminary Evidence.

Chemoprevention is referred to as a strategy to inhibit, suppress, or reverse tumor development and progression in healthy people along with high-risk subjects and oncologic patients through using pharmacological or natural substances. Numerous phytochemicals have been widely described in the literature to possess chemopreventive properties, although their clinical usefulness remains to be defined. Among them, caryophyllane sesquiterpenes are natural compounds widely occurring in nature kingdoms, especially in plants, fungi, and marine environments. Several structures, characterized by a commo

Perceptions of Older Adults with Hematological Cancer on Diet and Exercise Behavior and Its Role in Navigating Daily Tasks.

Diet and exercise are associated with the maintenance of physical function, independence and better health-related quality of life in cancer survivors. Adherence to healthy diet and exercise guidelines, however, remains low. The aim of this study was to explore the perceptions of hematological cancer survivors (HCS, ≥50 years) on the role of diet and exercise in navigating daily tasks using a qualitative descriptive research method. Eligible HCS completed an online survey gathering demographic information including physical functioning, exercise frequency, malnutrition and frailty risk. Follow

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… The impact of cancer treatment on the diets and food preferences of patients receiving outpatient treatment. Nutr. Cancer. 2015;67:339–353. doi: 10.1080/01635581.2015.990577. 12. Boltong A., Keast R., Aranda S. …

Упражнения и питание в гематологических заболеваниях: свидетельства перевода и новые меры вмешательства.

Пациенты, страдающие гематологическими микроорганизмами, включая лейкемию, лимфому и миелому, живут дольше из - за прогресса в лечении. Тем не менее такое лечение часто приводит к токсичным последствиям, влияющим на качество жизни пациентов (QoL). Хотя мероприятия, связанные с образом жизни, такие, как упражнение и питание, приносят пользу, снижая риск заболевания раком и улучшая результаты лечения твердых опухолей, их применение в гематологических опухолей по-прежнему недостаточно изучено. В настоящем описательном обзоре рассматриваются текущие данные о роли физических упражнений и питания в

Trimodal prehabilitation for hematopoietic stem cell transplantation: A best evidence summary.

ObjectiveTo systematically evaluate and synthesize the best practice evidence of trimodal prehabilitation comprising exercise, nutritional optimization, and psychological support in patients undergoing hematopoietic stem cell transplantation, so as to enhance patients' physiological reserve and stress resistance, and provide a scientific basis and practical reference for formulating individualized prehabilitation programs in clinical practice.MethodsA comprehensive computerized literature search was conducted across multiple databases and evidence sources, including UpToDate, BMJ Best Practice