Background: The introduction of cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6is) has transformed the treatment landscape for patients with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC). To our knowledge, no studies have quantified health care resource utilization (HRU) or economic burden following CDK4/6i initiation in the Medicare population.
Objective: To describe HRU and quantify health care costs among Medicare-enrolled patients with HR+ HER2- MBC treated with CDK4/6is in the first-line setting.
Background: Although several types of psychotherapy effectively reduce psychological distress associated with personality disorders, randomised controlled trials (RCT) have systematically excluded older patients. We aimed to examine the effectiveness of group schema therapy combined with psychomotor therapy (GST + PMT) in later life compared with treatment as usual (TAU).
Methods: We did an open-label, multicentre, RCT in eight outpatient clinics for geriatric psychiatry in the Netherlands.
Polygenic risk scores (PRSs) have improved in predictive performance, but several challenges remain to be addressed before PRSs can be implemented in the clinic, including reduced predictive performance of PRSs in diverse populations, and the interpretation and communication of genetic results to both providers and patients. To address these challenges, the National Human Genome Research Institute-funded Electronic Medical Records and Genomics (eMERGE) Network has developed a framework and pipeline for return of a PRS-based genome-informed risk assessment to 25,000 diverse adults and children as part of a clinical study. From an initial list of 23 conditions, ten were selected for implementation based on PRS performance, medical actionability and potential clinical utility, including cardiometabolic diseases and cancer.
View Article and Find Full Text PDFWe investigated the effect of shortening time between innovations with the accelerated approval (AA) pathway on patient outcomes for three solid tumors. This real-world analysis evaluated patients receiving sequential AA pathway-approved innovations after initial treatment with existing therapies in three solid tumor case studies. Outcomes attributable to AA were estimated and assumed approval occurred at the time of conversion to approval and extrapolated to the US population.
View Article and Find Full Text PDFIntroduction: Although there is increasing interest in conducting cancer clinical trials in older adults, the benefit of such trials is unclear. We aimed to quantify the real-world clinical and economic effects of two phase 3 trials (CALGB 9343 and PRIME II) which showed that post-lumpectomy radiation therapy (RT) improves loco-regional recurrence but makes no improvement in overall survival among older women with early-stage breast cancer (ESBC).
Materials And Methods: We developed a health-transition model to quantify the incremental clinical and economic outcomes between scenarios with vs.
Background: Despite increasing focus on conducting cancer clinical trials in older adults, it is unclear whether such evidence influences practice patterns. We aimed to estimate the impact of cumulative evidence from older adult-specific trial results from the CALGB 9343 and PRIME II trials that found post-lumpectomy irradiation has little benefit among older adults with early-stage breast cancer (ESBC).
Methods: Patients diagnosed with ESBC between 2000 and 2018 were identified from the SEER registry data.
Introduction: Conducting older adult-specific clinical trials can help overcome the lack of clinical evidence for older adults due to their underrepresentation in clinical trials. Understanding factors contributing to the successful completion of such trials can help trial sponsors and researchers prioritize studies and optimize study design. We aimed to develop a model that predicts trial failure among older adult-specific cancer clinical trials using trial-level factors.
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