Racial and Ethnic Characteristics and Outcomes of Patients Diagnosed with CLL/SLL in the USA.

Introduction: This study was designed to compare outcomes among patients by race and ethnicity in the post-covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment era.

Methods: A nationwide electronic health record (EHR)-derived de-identified database was utilized that included patients diagnosed with CLL from 2013 to 2022 who received systemic therapy for their disease. Use of cBTKi therapy, time to next treatment or death (TTNT-D), and overall survival (OS) were compared by race in unadjusted (Kaplan-Meier method) and adjusted analyses (Cox proportional hazards regression).

Bayesian survival extrapolation for cost-effectiveness analysis: a case study of RELAY for ramucirumab in combination with erlotinib in the treatment of non-small-cell lung cancer.

Aim: Increasing trend for progression-free survival (PFS)-based primary endpoint in oncology has led to lack of mature overall survival (OS) data at the time of approval. To address this evidence gap in economic evaluations, we used a joint Bayesian approach to predict survival outcomes using immature OS data from the RELAY trial.

Methods: Patient data from RELAY and systematic literature review (SLR) of phase 3 randomized clinical trials with hazard ratio (HR) estimates of mature PFS and immature OS were considered.

Ready, Set, Move! Tracking Children's Modified Ride-On Car Use With a Custom Data Logger.

Purpose: To create and implement a next-generation, custom data logger to automatically track modified ride-on car (MROC) use in home and community settings, establish feasibility of long-term remote collection of community MROC use data, describe trends of MROC use, and explore parent perception of the MROC.

Methods: In this descriptive study, a custom data logger was constructed and integrated into MROCs using an Arduino Pro-Mini microprocessor to capture real-time use data remotely.

Results: It is feasible to automatically track MROC use in home and community settings.

Off to the park: a geospatial investigation of adapted ride-on car usage.

Purpose: Adapted ride-on cars (ROC) are an affordable, power mobility training tool for young children with disabilities. Previous qualitative research has identified environmental factors, such as weather and adequate drive space, as barriers to families' adoption of their ROC. However, we do not currently know the relationship between the built environment and ROC usage.

A network meta-analysis of immunotherapy-based treatments for advanced nonsquamous non-small cell lung cancer.

In the absence of head-to-head trials comparing immunotherapies for advanced nonsquamous non-small-cell lung cancer (NsqNSCLC), a network meta-analysis (NMA) was conducted to compare the relative efficacy of these treatments. A systematic literature review of randomized controlled trials evaluating first-line-to-progression and second-line treatments for advanced NsqNSCLC informed Bayesian NMAs for overall survival (OS) and progression-free survival (PFS) end points. Among first-line-to-progression treatments, pembrolizumab + pemetrexed + platinum showed the greatest OS benefit versus other regimens and a PFS benefit versus all but three regimens.

Efficacy and safety of first-line therapies in -mutated advanced non-small-cell lung cancer: a network meta-analysis.

To evaluate the comparative efficacy and safety of identified first-line therapies for patients with  mutation-positive (m+) advanced non-small-cell lung cancer (NSCLC), with a focus on ramucirumab + erlotinib. In the absence of head-to-head studies, a Bayesian network meta-analysis was conducted using randomized clinical trial data to evaluate first-line systemic therapies with erlotinib/gefitinib as the reference treatment. For progression-free survival, ramucirumab + erlotinib was comparable to osimertinib and dacomitinib in the primary analysis.

Study of patient characteristics, treatment patterns, testing patterns and outcomes in real-world patients with m non-small cell lung cancer.

Objective: This retrospective, observational study examined patient characteristics, treatment patterns, testing patterns, and outcomes of US patients receiving first-/second- or third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs).

Methods: This study used an electronic health record-derived de-identified database. Eligible patients had advanced m non-small cell lung cancer.

Patient-reported outcomes in RELAY, a phase 3 trial of ramucirumab plus erlotinib versus placebo plus erlotinib in untreated -mutated metastatic non-small-cell lung cancer.

Objective: In the phase 3 RELAY trial, ramucirumab/erlotinib demonstrated superior progression-free survival (PFS) over placebo/erlotinib in patients with -mutated metastatic NSCLC (median PFS 19.4 versus 12.4 months; HR = 0.

Reweighting Randomized Controlled Trial Evidence to Better Reflect Real Life - A Case Study of the Innovative Medicines Initiative.

Evidence from randomized controlled trials available for timely health technology assessments of new pharmacological treatments and regulatory decision making may not be generalizable to local patient populations, often resulting in decisions being made under uncertainty. In recent years, several reweighting approaches have been explored to address this important question of generalizability to a target population. We present a case study of the Innovative Medicines Initiative to illustrate the inverse propensity score reweighting methodology, which may allow us to estimate the expected treatment benefit if a clinical trial had been run in a broader real-world target population.

Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer.

To analyze patient-reported swallowing difficulties, healthcare resource utilization and associated costs during the PROCLAIM study. Patients with stage III non-squamous non-small cell lung cancer received pemetrexed-cisplatin (PemCis) combined with concurrent thoracic radiotherapy followed by consolidation pemetrexed, or concurrent chemoradiotherapy with etoposide-cisplatin (EtoCis) followed by standard consolidation chemotherapy. Patient - reported swallowing function was measured using diaries.

Association of baseline symptom burden with efficacy outcomes: Exploratory analysis from the randomized phase III REVEL study in advanced non-small-cell lung cancer.

Objectives: The REVEL study demonstrated improved efficacy with ramucirumab plus docetaxel versus placebo plus docetaxel for previously treated advanced/metastatic non-small-cell lung cancer (NSCLC) without further detriment to patient quality of life, symptoms, or functioning. This post hoc analysis explored the association between baseline Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index (ASBI) and efficacy.

Materials And Methods: Baseline ASBI scores were the average of the 6 LCSS symptom components.

Relative efficacy of interventions in the treatment of second-line non-small cell lung cancer: a systematic review and network meta-analysis.

Background: Locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after first-line treatment has a poor prognosis. Recent randomized clinical trials (RCTs) have demonstrated survival benefits of alternative treatments to docetaxel. However, information is lacking on which patients benefit the most and what drug or regimen is optimal.

Treatment patterns, duration and outcomes of pemetrexed maintenance therapy in patients with advanced NSCLC in a real-world setting.

Objectives: In patients with non-squamous non-small-cell lung cancer (NSCLC), maintenance therapy regimens, including pemetrexed, have been shown to prolong overall survival (OS) and progression-free survival (PFS). The purpose of this study was to describe real-world maintenance use of pemetrexed and associated outcomes in patients with advanced NSCLC.

Methods: This was a retrospective, observational study that used longitudinal, demographically and geographically diverse electronic health record data in the United States.

Treatment Patterns by EGFR Mutation Status in Non-Small Cell Lung Cancer Patients in the USA: A Retrospective Database Analysis.

Introduction: Targeted therapies, including tyrosine kinase inhibitors (TKIs) that target the sensitizing epidermal growth factor receptor (EGFR) gene are recommended for patients with non-small cell lung cancer (NSCLC). Most patients with NSCLC who test positive for the EGFR mutation and receive TKIs develop resistance to these drugs. Questions remain regarding which treatment sequence is optimal for patients with EGFR-mutant NSCLC, and few studies have evaluated patterns of TKI treatment use in NSCLC, irrespective of EGFR mutation status, in a real-world setting.

Treatment Decisions for Advanced Non-Squamous Non-Small Cell Lung Cancer: Patient and Physician Perspectives on Maintenance Therapy.

Introduction: Advanced non-small cell lung cancer (NSCLC) is a severe disease with burdensome symptoms and traditionally poor outcomes. The treatment of advance disease is based on chemotherapy, with the recent addition of immunotherapy. Patients who respond to initial treatment can opt to receive maintenance therapy (MT).

Antiangiogenic therapy for patients with aggressive or refractory advanced non-small cell lung cancer in the second-line setting.

A majority of patients with advanced or metastatic non-small cell lung cancer (NSCLC) will experience disease progression after first-line therapy. Patients who have advanced NSCLC that is especially aggressive, which is defined as disease that rapidly progresses on first-line treatment or disease that is refractory to first-line treatment, have a critical unmet medical need. These patients have a poor prognosis in the second-line setting.

Modeling Clinically Validated Physical Activity Assessments Using Commodity Hardware.

Consumer-grade wearable activity devices such as Fitbits are increasingly being used in research settings to promote physical activity (PA) due to their low-cost and widespread popularity. However, Fitbit-derived measures of activity intensity are consistently reported to be less accurate than intensity estimates obtained from research-grade accelerometers (i.e.

Efficacy and Safety of Ramucirumab With Docetaxel Versus Placebo With Docetaxel as Second-Line Treatment of Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis According to Patient Age in the REVEL Trial.

Introduction: Ramucirumab, a recombinant human immunoglobulin G1 monoclonal antibody receptor antagonist designed to block the ligand-binding site of vascular endothelial growth factor receptor-2 (VEGFR-2), was evaluated as second-line treatment in combination with docetaxel in patients with non-small-cell lung cancer in the REVEL trial (NCT01168973). Ramucirumab significantly improved overall survival (OS) and progression-free survival (PFS). We report age subgroup analysis results primarily on the basis of a 65-year cutoff.

Real-World Treatment Sequences and Outcomes Among Patients With Non-Small Cell Lung Cancer (RESOUNDS) in the United States: Study Protocol.

Background: Survival outcomes are related to treatment choices in a line of therapy and to treatment sequences across all lines of therapy.

Objective: The Real-World Treatment Sequences and Outcomes among Patients with NSCLC (RESOUNDS) study is designed to (1) evaluate treatment sequences used for patients who receive at least two lines of therapy for non-small cell lung cancer (NSCLC) in the United States and (2) evaluate patient outcomes in terms of progression-free and overall survival related to treatment sequencing. Additional objectives include the evaluation of symptoms, comorbidities, and health care resource utilization and costs.