Background: Standard parametric survival models are commonly used to estimate long-term survival in oncology health technology assessments; however, they can inadequately represent the complex pattern of hazard functions or underlying mechanism of action (MoA) of immuno-oncology (IO) treatments.
Objective: The aim of this study was to explore methods for extrapolating overall survival (OS) and provide insights on model selection in the context of the underlying MoA of IO treatments.
Methods: Standard parametric, flexible parametric, cure, parametric mixture and landmark models were applied to data from ATLANTIC (NCT02087423; data cut-off [DCO] 3 June 2016). The goodness of fit of each model was compared using the observed survival and hazard functions, together with the plausibility of corresponding model extrapolation beyond the trial period. Extrapolations were compared with updated data from ATLANTIC (DCO 7 November 2017) for validation.
Results: A close fit to the observed OS was seen with all models; however, projections beyond the trial period differed. Estimated mean OS differed substantially across models. The cure models provided the best fit for the new DCO.
Conclusions: Standard parametric models fitted to the initial ATLANTIC DCO generally underestimated longer-term OS, compared with the later DCO. Cure, parametric mixture and response-based landmark models predicted that larger proportions of patients with metastatic non-small cell lung cancer receiving IO treatments may experience long-term survival, which was more in keeping with the observed data. Further research using more mature OS data for IO treatments is needed.
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http://dx.doi.org/10.1007/s40273-019-00806-4 | DOI Listing |
Diagnostics (Basel)
December 2024
Star Medica Chihuahua Hospital, Perif. de la Juventud 6103, Fracc. El Saucito, Chihuahua 31110, Mexico.
: This international multicenter study aimed to assess the effectiveness of the Pivot-Shift Meter (PSM) mobile application in diagnosing and classifying anterior cruciate ligament (ACL) injuries, emphasizing the need for standardization to improve diagnostic precision and treatment outcomes. : ACL evaluations were conducted by eight experienced orthopedic surgeons across five Latin American countries (Bolivia, Chile, Colombia, Ecuador, and Mexico). The PSM app utilized smartphone gyroscopes and accelerometers to standardize the pivot-shift test.
View Article and Find Full Text PDFNoise Health
January 2025
Department of Internal Medicine, Faculty of Medicine, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.
Background: The effect of background noise on auscultation accuracy for different lung sound classes under standardised conditions, especially at lower to medium levels, remains largely unexplored. This article aims to evaluate the impact of three levels of Gaussian white noise (GWN) on the ability to identify three classes of lung sounds.
Methods And Materials: A pre-post pilot study assessing the impact of GWN on a group of students' ability to identify lung sounds was conducted.
J Magn Reson Imaging
January 2025
Advanced Diagnostic and Interventional Radiology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Breast cancer continues to be a major health concern, and early detection is vital for enhancing survival rates. Magnetic resonance imaging (MRI) is a key tool due to its substantial sensitivity for invasive breast cancers. Computer-aided detection (CADe) systems enhance the effectiveness of MRI by identifying potential lesions, aiding radiologists in focusing on areas of interest, extracting quantitative features, and integrating with computer-aided diagnosis (CADx) pipelines.
View Article and Find Full Text PDFEur Radiol
January 2025
Department of Diagnostic and Interventional Radiology, University Hospital of Heidelberg, Heidelberg, Germany.
Objectives: We hypothesized that semiquantitative visual scoring of lung MRI is suitable for GOLD-grade specific characterization of parenchymal and airway disease in COPD and that MRI scores correlate with quantitative CT (QCT) and pulmonary function test (PFT) parameters.
Methods: Five hundred ninety-eight subjects from the COSYCONET study (median age = 67 (60-72)) at risk for COPD or with GOLD1-4 underwent PFT, same-day paired inspiratory/expiratory CT, and structural and contrast-enhanced MRI. QCT assessed total lung volume (TLV), emphysema, and air trapping by parametric response mapping (PRM, PRM) and airway disease by wall percentage (WP).
J Neurol
January 2025
John Walton Muscular Dystrophy Research Centre, Newcastle University, Newcastle-upon-Tyne, UK.
PROPEL (ATB200-03; NCT03729362) compared the efficacy and safety of cipaglucosidase alfa plus miglustat (cipa + mig), a two-component therapy for late-onset Pompe disease (LOPD), versus alglucosidase alfa plus placebo (alg + pbo). The primary endpoint was change in 6-min walk distance (6MWD) from baseline to week 52. During PROPEL, COVID-19 interrupted some planned study visits and assessment windows, leading to delayed visits, make-up assessments for patients who missed ≥ 3 successive infusions before planned assessments at weeks 38 and 52, and some advanced visits (end-of-study/early-termination visits).
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