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http://dx.doi.org/10.1016/j.jgg.2017.04.003 | DOI Listing |
Purpose: Novel therapies targeting specific genomic alterations are a promising treatment approach for relapsed/refractory cancer. Patients with specific alterations may be more likely to respond. Trial designs should maximize opportunities for such patients to enroll on these trials.
View Article and Find Full Text PDFDiabetes Ther
December 2024
Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
Introduction: ONWARDS 5 evaluated the effectiveness and safety of insulin icodec (icodec) titrated with a dosing guide app (icodec with app) versus once-daily insulin analogs in insulin-naive adults with type 2 diabetes. The insulin glargine U300 (glargine U300) stratum was too small to enable a robust post hoc efficacy comparison. Augmentation methodology was applied to increase the glargine U300 group size using real-world data (RWD), to facilitate efficacy comparisons of icodec with app versus glargine U300, and to demonstrate the potential of the augmentation methodology to strengthen underpowered treatment comparisons (AUGMENT study).
View Article and Find Full Text PDFOncology
December 2024
Liver Transplant Institute, Inonu University Faculty of Medicine, Malatya, Turkey.
Introduction: Presence of macroscopic portal vein thrombosis (PVT) in patients with hepatocellular carcinoma (HCC) has been found to be a major poor prognosis characteristic.
Aims: The aim of the study was to examine patients with PVT for their clinical characteristics and factors related to both PVT and survival.
Methods: A large HCC database containing 1,094 patients with PVT and 2,513 patients without PVT was examined.
Purpose: We introduce a novel algorithmic approach to design phase I trials for oncology drug combinations.
Methods: Our proposed Toxicity Adaptive Lists Design (TALE) is straightforward to implement, requiring the prespecification of a small number of parameters that define rules governing dose escalation, de-escalation, or reassessment of previously explored dose levels. These rules effectively regulate dose exploration and control the number of toxicities.
AJNR Am J Neuroradiol
January 2025
From the Departments of Brain and Behavioral Sciences (L.P., D.P., V.D.G., S.O., R.B., A.P.), and Molecular Medicine (F.D., E.M.V.), University of Pavia, Pavia, Italy.
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