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Post-progression treatment in cancer randomized trials: a cross-sectional study of trials leading to FDA approval and published trials between 2018 and 2020.

BackgroundSuboptimal treatment upon progression may affect overall survival (OS) results in oncology randomized controlled trials (RCTs). We aim to assess the proportion of trials reporting post-progression treatment.MethodsThis cross-sectional analysis included two concurrent analyses. The first one examined all published RCTs of anti-cancer drugs in six high impact medical/oncology journals between January 2018 and December 2020. The second studied all US Food and Drug Administration (FDA) approved anti-cancer drugs during the same period. Included trials needed to study an anti-cancer drug

Patient Perspectives on Health Insurance Design: A Mixed-Methods Analysis.

There remains a persistent lack of patient-centered evidence on insurance reform and real-world experiences of patients with chronic disease. This study gathered insights around insurance design from chronic disease beneficiaries. This mixed-methods analysis comprised an online survey and virtual focus group sessions (August to December 2023) involving US residents with chronic disease and health insurance. Patients' perspectives on insurance design were explored. Survey data were analyzed descriptively. Key themes were identified from focus group transcripts and direct observations. In total,

Low- and no-calorie sweeteners and beverages and their associated health outcomes: an umbrella review of systematic reviews and meta-analyses.

BackgroundLong-term health effects of low- and no-calorie sweeteners (LNCSs) have not been established.ObjectiveThis review aimed to evaluate the associations between different types of LNCSs and a wide range of health outcomes from observational studies and randomized controlled trials (RCTs).MethodsWe systematically searched PubMed/MEDLINE, Embase, CINAHL, and Google Scholar from inception to December 2024 for meta-analyses. LNCSs were categorized into artificial sweeteners and other non-sugar sweeteners (NSSs), including non-nutritive sweeteners and sugar alcohols, along with their correspo

A Case Study of a Rare Disease (Fructosemia) Diagnosed in a Patient with Abdominal Pain.

Hereditary fructose intolerance is a rare genetic disorder that is inherited in an autosomal recessive manner, with mutations sometimes occurring spontaneously. Consuming fructose triggers biochemical abnormalities, disrupting liver processes like glycogenolysis and gluconeogenesis. Recent studies have revealed elevated intrahepatic fat levels in affected individuals. Symptoms include aversion to fructose-containing foods, hypoglycemia, liver and kidney dysfunction, and growth delays, with severe cases leading to liver enlargement, fatty liver disease, kidney failure, and life-threatening hypo

Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020.

ImportanceOf approximately 9 million patients with cancer in China in 2020, more than half were diagnosed with late-stage cancers. Recent regulatory reforms in China have focused on improving the availability of new cancer drugs. However, evidence on the clinical benefits of new cancer therapies authorized in China is not available.ObjectiveTo characterize the clinical benefits of cancer drugs approved in China, as defined by the availability and magnitude of statistically significant overall survival (OS) results.Design, setting, and participantsThis mixed-methods study comprising a systemati

Addressing clinical uncertainties in ATMP reimbursement: a review of methodological guidelines and European practice.

IntroductionAdvanced Therapy Medicinal Products (ATMPs) often present substantial clinical uncertainties at the time of reimbursement evaluation, particularly due to the lack of appropriate comparators and the absence of long-term clinical endpoints. This study primarily examined two methodological areas relevant to these challenges: indirect treatment comparisons (ITCs) and surrogate endpoints. In addition, the review was supplemented with an assessment of innovative trial designs to explore how emerging approaches may contribute to evidence generation for ATMPs.MethodsA structured literature

A Qualitative Study to Assess Collusion and Psychological Distress in Cancer Patients.

IntroductionCollusion is frequently encountered but least studied entity in palliative care services in India. Impact of collusion is manifold and identifying it requires good communication skills. Once identified, it gives an indication for existing healthy versus developing unhealthy collusion to be dealt within families.ObjectiveThe objective of this study was to identify the prevalence of collusion and its clinical and psychological correlates among patients and caregivers in a palliative cancer care.Materials and methodsWe describe systematic identification and unraveling of collusion acr

A Review on the Multidisciplinary Approach for Cancer Management in the Eastern Mediterranean Region: A Focus on Nutritional, Lifestyle and Supportive Care.

Cancer is one of the leading causes of global morbidity and mortality and one of the most challenging global health conditions, impacting the lives of millions every year. The Eastern Mediterranean Region (EMR) is not on track to achieve the sustainable development goal (SDG) target 3.4 which aims to reduce premature mortality (i.e., before the age of 70 years) for non-communicable diseases (NCDs), including cancer, by a third by year 2030; instead, it is projected that the EMR will experience the least progress towards achieving this target. This review therefore highlights the importance of

Treatment of elderly patients with refractory/relapsed multiple myeloma: oral drugs adherence and the COVID-19 outbreak.

Once the treatment of refractory/relapsed multiple myeloma in the elderly is greatly influenced by the adherence of patients and family members, clinicians should be aware of patients' behavior and lifestyle, as it may influence the individual treatment plan for each patient. Furthermore, treatment with oral chemotherapy is of special value during the COVID-19 outbreak. Multidisciplinary healthcare involvement is crucial in the management of polypharmacy, adverse events and dose adjustment due to comorbidities and natural loss of renal function with age. Oral drugs simplify intake, reduce hosp

Beyond Numbers: Uses and Value of In-Trial Interview Data for Regulatory and Health Technology Assessment (HTA) Decision Making.

This research explores the growing importance of qualitative in-trial research (ITR) in regulatory and health technology assessment (HTA) decision making. Since 2020, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have emphasized incorporating patient experience data into drug development and approval. We reviewed regulatory guidance documents, drug approval records, and HTA reports from January 2017 to March 2025. This included labels and reviews for new drug applications from the FDA and EMA, the Patient-Focused Drug Development guidance series, guidance on rare d

A Standardized Method for Vertical Sleeve Gastrectomy Bariatric Surgery Investigations in Cancer.

Obesity is a global epidemic that has affected the lives of over 14% of adults worldwide and over a third of Americans. Obesity is associated with the increased risk of thirteen obesity-associated cancers and poor cancer outcomes. Bariatric surgery is the most effective method of sustained weight loss and has been steadily increasing in clinical use over the past 4 decades. Importantly, bariatric surgery is established to decrease cancer risk. Vertical sleeve gastrectomy (VSG) is currently the most common bariatric surgery procedure. To evaluate underlying mechanisms of bariatric associated ca

2024 Clinical Practice Guidelines for the Diagnosis and Pharmacologic Treatment of Overweight and Obesity by the Korean Society for the Study of Obesity.

The Korean Society for the Study of Obesity has published the 9th edition of its Clinical Practice Guidelines to provide updated, evidence-based recommendations for the management of overweight and obesity. Developed through a structured process of systematic literature review and expert consensus, these guidelines incorporate recent clinical evidence for obesity management. Key clinical questions were formulated using the Population, Intervention, Comparison, and Outcome framework and addressed through comprehensive evaluations of randomized controlled trials, cohort studies, systematic revie

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… preferences and reducing overall energy intake. 56 , 57 Semaglutide 2.4 mg has demonstrated greater weight loss efficacy than liraglutide (3.0 mg), likely due to its higher receptor affinity, longer half-life, and more pronounced effects on food cravings and eating behavior. 54 , 58 , 59 Tirzepatide … Changes in food preferences and ingestive behaviors after glucagon-like peptide-1 analog treatment: techniques and opportunities. Int J Obes (Lond) 2025;49:418–26. doi: 10.1038/s41366-024-01500-y. 58. Chao AM, Wadden TA, Walsh OA, Gruber KA, Alamuddin N, Berkowitz RI, et al. …

Neuropsychiatric Adverse Events with Monoclonal Antibodies Approved for Multiple Myeloma: An Analysis from the FDA Adverse Event Reporting System.

Background/Objectives: Monoclonal antibodies (mAbs) have revolutionized multiple myeloma (MM) treatment. However, post-marketing data on their neuropsychiatric safety are limited. This study aimed to evaluate neuropsychiatric adverse events (AEs) related to mAbs used for MM through a retrospective pharmacovigilance analysis using the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database. Methods: Individual case safety reports (ICSRs) from 2015 to 2023 with at least one neuropsychiatric AE and one of the MM-approved mAbs as the suspected drug (i.e., daratumumab, e

Characterizing the Patient Journey in Multiple Myeloma: Qualitative Review.

BACKGROUND: The patient experience of multiple myeloma (MM) is multifaceted and varies substantially between individuals. Current published information on the patient perspective and treatment of MM is limited, making it difficult to gain insights into patient needs regarding the condition. OBJECTIVE: In this review, a combined research method approach (ie, the review of published literature and social media posts) was undertaken to provide insight into patients' perspectives on the burden and treatment of MM, the impact of the COVID-19 pandemic, and the impact of MM on caregivers of patients

Dietary patterns among individuals with plasma cell disorders- opportunities for targeted interventions.

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… Assessing gender differences in food preferences and physical activity: a population-based survey. Front Nutr. 2024;11:1348456. 14. Kuckuck S, van der Valk ES, Scheurink AJW, van der Voorn B, Iyer AM, Visser JA, et al. …

Effect of the specific proteasome inhibitor bortezomib on cancer-related muscle wasting.

BACKGROUND: Muscle wasting, a prominent feature of cancer cachexia, is mainly caused by sustained protein hypercatabolism. The enhanced muscle protein degradation rates rely on the activity of different proteolytic systems, although the Adenosine triphosphate (ATP)-ubiquitin-proteasome-dependent pathway and autophagy have been shown to play a pivotal role. Bortezomib is a potent reversible and selective proteasome and NF-κB inhibitor approved for the clinical use, which has been shown to be effective in preventing muscle wasting in different catabolic conditions. The aim of the present study h

The habenula as a novel link between the homeostatic and hedonic pathways in cancer-associated weight loss: a pilot study.

BACKGROUND: Little is known about the brain mechanisms underlying cancer-associated weight loss (C-WL) in humans despite this condition negatively affecting their quality of life and survival. We tested the hypothesis that patients with C-WL have abnormal connectivity in homeostatic and hedonic brain pathways together with altered brain activity during food reward. METHODS: In 12 patients with cancer and 12 healthy controls, resting-state functional connectivity (RSFC, resting brain activity observed through changes in blood flow in the brain which creates a blood oxygen level-dependent signa

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… In this particular study, fMRI based on https://en.wikipedia.org/wiki/Blood-oxygen-level_dependent signals were analysed while the patients perceived pleasant and unpleasant food pictures based on a food preference questionnaire provided to patients. 41 , 42 Generalized anhedonia has been reported in … Brain activity correlated with food preferences: a functional study comparing advanced non‐small cell lung cancer patients with and without anorexia. Nutrition 2013;29:1013–1019. 43. Brintzenhofe‐Szoc KM, Levin TT, Li Y, Kissane DW, Zabora JR. …

Music Therapy and Nursing Cotreatment in Integrative Hospice and Palliative Care.

Integrative hospice and palliative care is a philosophy of treatment framing patients as whole persons composed of interrelated systems. The interdisciplinary treatment team is subsequently challenged to consider ethical and effective provision of holistic services that concomitantly address these systems at the end of life through cotreatment. Nurses and music therapists, as direct care professionals with consistent face-to-face contact with patients and caregivers, are well positioned to collaborate in providing holistic care. This article introduces processes of referral, assessment, and tr

Overview of nutritional approach in hematopoietic stem cell transplantation: COVID-19 update.

The coronavirus disease 2019 (COVID-19) is caused by the newly discovered SARS-CoV-2. Hematopoietic stem cell transplantation (HSCT) is a high-risk procedure. The novelty of COVID-19 has created more uncertainty during all phases of HSCT. It is thought that HSCT patients taking immunosuppressive agents are more likely to contract COVID-19 than healthy individuals are. Appropriate care precautions should be taken with patients undergoing HSCT to minimize the risk of COVID-19, and appropriate treatment methods must be followed in patients infected with COVID-19. Malnutrition has become a signifi

Prevention and management of adverse events of novel agents in multiple myeloma: a consensus of the European Myeloma Network.

During the last few years, several new drugs have been introduced for treatment of patients with multiple myeloma, which have significantly improved the treatment outcome. All of these novel substances differ at least in part in their mode of action from similar drugs of the same drug class, or are representatives of new drug classes, and as such present with very specific side effect profiles. In this review, we summarize these adverse events, provide information on their prevention, and give practical guidance for monitoring of patients and for management of adverse events.