Current medical research and opinion
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ASXL1 gene mutations include nonsense, missense, and frameshift mutations. Although their clinical significance is still debated, they may play an important role in the pathogenesis of several hematologic malignancies. ⋯ Further research on the role of ASXL1 mutations and therapeutic implications in neoplastic myeloid disorders is stringently needed. Given the relatively high prevalence of ASXL1 mutations, larger studies involving patients affected by these mutations will be feasible in the near future.
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The development and use of abuse-deterrent (AD) opioids is part of a multifaceted strategy to reduce misuse, abuse, and diversion, while maintaining access for patients with severe pain who may benefit from their analgesic efficacy. Morphine AD, extended-release (ER), injection-molded tablets (morphine-ADER-IMT; ARYMO ER; Egalet US Inc., Wayne, PA) is approved by the FDA as an AD opioid. As part of the characterization of AD opioids, assessments of their human abuse potential (HAP) are required. Evidence from HAP studies can guide clinicians on the use of AD opioids in clinical practice. Herein, we describe HAP study design, and how specific AD features can impact the conduct of a study and interpretation of its results. ⋯ Results from HAP studies with morphine-ADER-IMT and other AD opioids suggest that key study design features include the release profile (immediate-release vs extended-release) of the positive control, study drug doses, and the way the products are manipulated. These elements can directly impact the outcomes of the pharmacokinetic and pharmacodynamic (e.g. Maximum Drug Liking, Overall Drug Liking, and Take Drug Again) results. When evaluating HAP studies, it is important to understand study design features to assist in the interpretation of the results and understand the clinical relevance of the data to help guide clinical decision-making about the use of AD opioids.
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The current study evaluates the prognostic value of the 8th edition of the American Joint Committee on Cancer (AJCC) staging system for patients with anal carcinoma. ⋯ There is no evidence of significant improvement in the AJCC 8th edition compared to AJCC 6th (or 7th) edition in terms of overall or cancer-specific survival prediction.