A5077284234- Hemoglobinopathies and Related Disorders
- Acute Myeloid Leukemia Research
- Cancer Immunotherapy and Biomarkers
- Health Systems, Economic Evaluations, Quality of Life
- Myeloproliferative Neoplasms: Diagnosis and Treatment
- CAR-T cell therapy research
- Chronic Myeloid Leukemia Treatments
- Blood groups and transfusion
- Iron Metabolism and Disorders
- Erythropoietin and Anemia Treatment
- Statistical Methods in Clinical Trials
- Histone Deacetylase Inhibitors Research
- Protein Degradation and Inhibitors
- Childhood Cancer Survivors' Quality of Life
- Advanced Causal Inference Techniques
- Economic and Financial Impacts of Cancer
- Cutaneous Melanoma Detection and Management
- Cancer survivorship and care
- Melanoma and MAPK Pathways
- Renal cell carcinoma treatment
- Multiple Myeloma Research and Treatments
- Computational Drug Discovery Methods
- Kruppel-like factors research
- Viral-associated cancers and disorders
- Cancer Risks and Factors
Bristol-Myers Squibb (United States)
2019-2025
The Bristol-Myers Squibb Children's Hospital
2020
City University of New York
2018
Fordham University
2013-2015
Memorial Sloan Kettering Cancer Center
2013-2014
City College of New York
2014
PURPOSE Nivolumab 1 mg/kg plus ipilimumab 3 (NIVO1+IPI3) is approved for first-line treatment of patients with advanced melanoma in several countries. We conducted a phase IIIb/IV study (CheckMate 511) to determine if nivolumab (NIVO3+IPI1) improves the safety profile combination. PATIENTS AND METHODS Patients (N = 360) age 18 years or older previously untreated, unresectable stage III IV were randomly assigned 1:1 NIVO3+IPI1 NIVO1+IPI3 once every weeks four doses. After 6 weeks, all...
Abstract Objective Optimism and social support serve as protective factors against distress in medically ill patients. Very few studies have specifically explored the ways which these variables interact to impact quality of life (QOL), particularly among patients with advanced cancer. The present study examined role optimism a moderator relationship between anxiety, depression, hopelessness, QOL Methods Participants ( N = 168) completed self‐report assessments psychosocial, spiritual,...
Cancer patients who smoke are advised to quit smoking reduce treatment complications and future cancer risk. This study's main objective was evaluate the efficacy of a novel, presurgical cessation intervention in newly diagnosed scheduled for surgical hospitalization.We conducted parallel-arm, randomized controlled trial comparing our hospital-based, tobacco "best practices" model (BP; counseling nicotine replacement therapy) with BP enhanced by behavioral tapering regimen (scheduled reduced...
Myelodysplastic neoplasms (MDS) are characterized by ineffective hematopoiesis, peripheral blood cytopenias, and an increased risk of progression to acute myeloid leukemia. One the main treatment goals is improving quality life (QoL), particularly for patients with lower-risk MDS (LR-MDS) who may live longer compromised QoL. The QOL-E© a patient-reported outcome (PRO) measure specifically developed address lack health-related QoL questionnaire MDS. objective this study was evaluate...
In the phase 3 CheckMate 76 K trial, adjuvant nivolumab significantly improved recurrence-free survival and distant metastasis-free versus placebo in patients with resected stage IIB/C melanoma. We report patient-reported outcomes from K. Change baseline to week 53 health-related quality of life (HRQoL), as measured using EORTC QLQ-C30 EQ-5D-5L utility index visual analog scale (VAS), was compared between treatment groups linear mixed-effect models. Time confirmed deterioration (TTCD) HRQoL...
Myelofibrosis symptoms compromise health-related quality of life (HRQoL). Ruxolitinib can reduce myelofibrosis symptom severity, but many patients discontinue ruxolitinib due to loss response or unacceptable toxicity. Fedratinib is an oral, selective JAK2 inhibitor approved in the United States for treatment with intermediate-2 high-risk myelofibrosis. The single-arm, phase II JAKARTA2 trial assessed fedratinib 400 mg/d (starting dose) previously treated ruxolitinib. Patient-reported changes...
Patients with myelodysplastic syndromes (MDS) often experience chronic anemia and long-term red blood cell transfusion dependence associated significant burden on clinical health-related quality of life (HRQoL) outcomes. In the MEDALIST trial (NCT02631070), luspatercept significantly reduced in patients lower-risk MDS who had ring sideroblasts were refractory to, intolerant or ineligible for prior treatment erythropoiesis-stimulating agents. We evaluated effect HRQoL enrolled using EORTC...
Abstract Background Knowledge of treatment assignment may affect patient-reported outcomes (PROs), which is concern in oncology, where open-label trials are common. This study measured the magnitude bias by comparing PROs for similar patient groups oncology with different degrees concealment. Methods Individual data from ipilimumab arms 2 melanoma and docetaxel non-small cell lung cancer (NSCLC) were adjusted differences using propensity score weighting. Patients aware CA184-022 CheckMate...
This article is a how-to guide on Bayesian computation using Gibbs sampling, demonstrated in the context of Latent Class Analysis (LCA). It written for students quantitative psychology or related fields who have working knowledge Bayes Theorem and conditional probability experience writing computer programs statistical language R . The overall goals are to provide an accessible self-contained tutorial, along with practical tool. We begin how typically described academic articles. Technical...
Abstract Background Patients with transfusion‐dependent (TD) β‐thalassemia require long‐term red blood cell transfusions (RBCTs) that lead to iron overload, impacting health‐related quality of life (HRQoL). Methods The impact luspatercept, a first‐in‐class erythroid maturation agent, versus placebo on HRQoL patients TD was evaluated in the phase 3 BELIEVE trial. assessed at baseline and every 12 weeks using 36‐item Short Form Health Survey (SF‐36) Transfusion‐dependent Quality Life...
Abstract Background Ipilimumab has shown long-term overall survival (OS) in patients with advanced melanoma clinical trials, but robust real-world evidence is lacking. We present outcomes from the IMAGE study (NCT01511913) receiving ipilimumab and/or non-ipilimumab (any approved treatment other than ipilimumab) systemic therapies. Methods was a multinational, prospective, observational assessing adult treated or therapies between June 2012 and March 2015 ≥3 years of follow-up. Adjusted OS...
Objectives The non-transfusion-dependent beta-thalassaemia-patient-reported outcome (NTDT-PRO) questionnaire was developed for assessing anaemia-related tiredness/weakness (T/W) and shortness of breath (SoB) among patients with NTDT. Psychometric properties were evaluated using blinded data from the BEYOND trial ( NCT03342404 ). Design Analysis a phase 2, double-blind, randomised, placebo-controlled trial. Setting USA, Greece, Italy, Lebanon, Thailand UK. Participants Adults (≥18 years)...
TPS9619 Background: The oncology burden on healthcare resources and patients increases as the number of individuals with cancer grows, necessitating treatment options offering improved convenience to patients. SC delivery monoclonal antibodies in various indications has previously been shown be effective, well tolerated, preferred by over IV infusion. In CheckMate 67T (NCT04810078), noninferiority exposure (time-averaged serum concentration at Day 28 trough steady state) efficacy (objective...
4535 Background: NIVO IV has improved outcomes in multiple tumor types. Evolving treatment paradigms have created a need for administration options that address burden and improve efficiencies of healthcare systems. In phase 1/2 study (CheckMate 8KX), pts were highly satisfied with SC preferred it over [Lonardi et al, ESMO 2022; Lonardi SITC 2023]. CheckMate 67T (NCT04810078) is multicenter, randomized, open-label, 3 demonstrated pharmacokinetic objective response rate noninferiority vs...
Triplet regimens containing immunomodulatory drugs and proteasome inhibitors (PIs) have improved outcomes extended survival for patients with relapsed/refractory multiple myeloma (RRMM). We evaluated updated health-related quality of life (HRQoL) findings from the phase 2 ELOQUENT-3 clinical trial (NCT02654132) after 4 years treatment elotuzumab plus pomalidomide dexamethasone (EPd) assessed impact addition on patients' HRQoL. HRQoL was as an exploratory endpoint using MD Anderson Symptom...
Patients with myelofibrosis (MF) experience an array of symptoms that impair health-related quality life (HRQoL). Fedratinib, oral, selective Janus-kinase 2 (JAK2) inhibitor, was investigated in the randomized, placebo-controlled, phase III JAKARTA study adult patients intermediate- or high-risk JAK-inhibitor-naïve MF. The effect fedratinib 400 mg/d on patient-reported MF and HRQoL assessed. Participants completed modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0), which evaluates 6...
Community-based organizations (CBOs) serving persons living with HIV or AIDS face the challenge of an aging population more chronic diseases. This study assessed cancer programming needs service (ASOs) in New York, Jersey, and Connecticut by conducting a community assessment. Sixty (58%) 103 completed survey. ASOs conduct activities most related to early steps along care continuum, but they also express great interest expanding cancer-focused into new areas. have resources capacities...
7032 Background: Enasidenib (ENA) is an oral inhibitor of mutant-IDH2 (mIDH2) proteins. In the phase 3 IDHENTIFY trial, ENA improved event-free survival (EFS), overall response, and complete remission rate vs conventional care regimens (CCR) ( P < 0.01 for all) in patients (pts) ≥ 60 years age with m IDH2 R/R AML 2 or prior treatments (Tx) (DiNardo 2021). Pt-reported HRQoL was a secondary trial endpoint. Methods: open-label, randomized (NCT02577406). Pts were preselected to CCR (SC...
Abstract Background: In clinical trials, the single-item-per-screen format is commonly used for electronic patient-reported outcomes (ePROs). However, participant preferences this over multiple items per screen have not been investigated. This study evaluated vs. multiple-items-per-screen ePRO formats, effect on completion times, and comparability of scores between formats. Methods: Participation in randomized, crossover, observational involved both formats an tablet device during two...