JAMA oncology
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Comparative Study
Patterns in Health Care Access and Affordability Among Cancer Survivors During Implementation of the Affordable Care Act.
Cancer survivors face ongoing health issues and need access to affordable health care, yet studies examining health care access and affordability in this population are lacking. ⋯ Despite higher rates of insurance coverage, cancer survivors reported greater difficulties accessing and affording health care compared with adults without cancer. Importantly, the proportion of survivors reporting these issues continued a downward trend throughout our observation period in the years following the implementation of the Affordable Care Act. Our findings suggest incremental improvement in health care access and affordability after recent health care reform and provide an important benchmark as additional changes are likely to occur in the coming years.
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Comparative Study
Assessment of Tumor Sequencing as a Replacement for Lynch Syndrome Screening and Current Molecular Tests for Patients With Colorectal Cancer.
Universal tumor screening for Lynch syndrome (LS) in colorectal cancer (CRC) is recommended and involves up to 6 sequential tests. Somatic gene testing is performed on stage IV CRCs for treatment determination. The diagnostic workup for patients with CRC could be simplified and improved using a single up-front tumor next-generation sequencing test if it has higher sensitivity and specificity than the current screening protocol. ⋯ Up-front TS in CRC is simpler and has superior sensitivity to current multitest approaches to LS screening, while simultaneously providing critical information for treatment selection.
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Comparative Study
Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing.
The debate about the role of the Food and Drug Administration (FDA) in the regulation of laboratory-developed tests (LDTs) has focused attention on the analytical performance of all clinical laboratory testing. This study provides data comparing the performance of LDTs and FDA-approved companion diagnostics (FDA-CDs) in proficiency testing (PT) provided by the College of American Pathologists Molecular Oncology Committee. ⋯ This study demonstrates the high degree of accuracy and comparable performance of both LDTs and FDA-CDs for 3 oncology analytes. More significantly, the majority of laboratories using FDA-CDs have modified the scope of their assay to allow for more clinical practice variety, rendering them LDTs. These findings support both the excellent and equivalent performance of both LDTs and FDA-CDs in clinical diagnostic testing.
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Comment Multicenter Study
Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial.
Therapeutic options are needed for patients with advanced gastric cancer whose disease has progressed after 2 or more lines of therapy. ⋯ Pembrolizumab monotherapy demonstrated promising activity and manageable safety in patients with advanced gastric or gastroesophageal junction cancer who had previously received at least 2 lines of treatment. Durable responses were observed in patients with PD-L1-positive and PD-L1-negative tumors. Further study of pembrolizumab for this group of patients is warranted.