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Common pitfalls in oncology drug applications aiming for conditional marketing authorization.
Br J Clin Pharmacol
January 2025
Parexel International, Durham, North Carolina, USA.
Early approval mechanisms, such as conditional approval in the EU, have been used extensively to provide timely access to therapeutic innovations to cancer patients with unmet medical needs. While based on promising early evidence, such approvals are challenging from many perspectives due to the lack of comprehensive data. The limitation typically relates to data that demonstrates clinical benefit via early endpoints and is only acceptable when the early evidence is particularly convincing to assume that the benefits of early access are greater than the potential harms.
View Article and Find Full Text PDFMidterm Results of Fenestrated Frozen Elephant Trunk Technique for Acute Type A Aortic Dissection.
Ann Thorac Surg Short Rep
June 2024
Department of Cardiovascular Surgery, Fukushima Medical University, Fukushima, Japan.
Background: There is limited experience and knowledge of the use of the fenestrated frozen elephant trunk (FET) technique in acute type A aortic dissection (ATAAD). This study's aims were to assess the clinical outcomes of the fenestrated FET technique for ATAAD and to identify its best practices and pitfalls.
Methods: This study included 101 patients who underwent emergency surgical aortic repair for ATAAD at our hospital between October 2018 and April 2023.
Demystifying Volume Status: An Ultrasound-Guided Physiologic Framework.
Chest
January 2025
Department of Medicine, University of British Columbia. Electronic address:
Topic Importance: Accurate assessment of a patient's volume status is crucial in many conditions, informing decisions on fluid prescribing, vasoactive agents, and decongestive therapies. Determining a patient's volume status is challenging, due to limitations in examination and investigations and the complexities of fluid homeostasis in disease states. Point-of-care ultrasound (POCUS) is useful in assessing hemodynamic parameters related to volume status, fluid responsiveness, and fluid tolerance.
View Article and Find Full Text PDFPitfalls and perils from FDA-approved germ-line cancer predisposition tests.
Oncotarget
December 2024
The FDA approval on September 29, 2023, for "class III " blood tests to assess hereditary cancer risk make widely available tests that may be obtained through a Direct to Consumer (DTC) path. There is concern that germ-line predisposition tests may not be reimbursed by insurance adding financial burdens to individuals and families. It is generally agreed in the fields of oncology and genetics that germ-line testing for disease susceptibility including cancer is best performed under care of a healthcare provider with genetic counseling.
View Article and Find Full Text PDFPrimary Cardiac Myxofibrosarcoma of the Left Atrium with Heterologous Elements Mimicking a Cardiac Myxoma.
Am J Case Rep
January 2025
Department of Anatomic Pathology and Cytopathology, University Hospital "Dr. José Eleuterio González", Monterrey, Mexico.
BACKGROUND Primary cardiac malignancies are extremely rare, with an incidence of 0.07% on autopsy series. Primary sarcomas represent up to 95% of malignant neoplasms, with myxofibrosarcomas accounting for only 10%.
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