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Feasibility and potential clinical benefit of dose de-escalation in stereotactic ablative radiotherapy for lung cancer lesions with ground glass opacities.
Phys Imaging Radiat Oncol
October 2024
Department of Radiation Oncology, Hospital Clínic, Barcelona Spain.
Introduction: Treatment of neoplasic lung nodules with ground glass opacities (GGO) faces two primary challenges. First, the standard practice of treating GGOs as solid nodules, which effectively controls the tumor locally, but might increase associated toxicities. The second is the potential for dose calculation errors related to increased heterogeneity.
View Article and Find Full Text PDFA Likelihood Perspective on Dose-Finding Study Designs in Oncology.
Pharm Stat
December 2024
Biostatistics Innovation Group, Gilead Sciences, Foster City, California, USA.
Dose-finding studies in oncology often include an up-and-down dose transition rule that assigns a dose to each cohort of patients based on accumulating data on dose-limiting toxicity (DLT) events. In making a dose transition decision, a key scientific question is whether the true DLT rate of the current dose exceeds the target DLT rate, and the statistical question is how to evaluate the statistical evidence in the available DLT data with respect to that scientific question. This article introduces generalized likelihood ratios (GLRs) that can be used to measure statistical evidence and support dose transition decisions.
View Article and Find Full Text PDFClinical, histological and safety outcomes with long-term maintenance therapies for eosinophilic esophagitis: A systematic review and meta-analysis.
Clin Gastroenterol Hepatol
December 2024
Gastroenterology and Digestive Endoscopy, IRCCS Ospedale San Raffaele.
Background And Aim: Our aim was to evaluate outcomes of maintenance treatments for EoE among observational studies (OSs) and randomized controlled trials (RCTs).
Materials And Methods: Studies reporting histological success of maintenance therapy ≥ 48 weeks were included. Primary outcome was histological success rate (defined as <15/<6 eos/HPF).
Prolonged antithrombotic treatment after de-escalation of dual antiplatelet therapy in patients after acute coronary syndrome - which strategy should be applied? The ELECTRA-SIRIO 2 investigators standpoint.
Int J Cardiol
December 2024
Department of Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy.
De-escalation of dual antiplatelet (DAPT) intensity may be considered in patients with high risk of bleeding after acute coronary syndrome. Some high risk patients after de-escalation may require antithrombotic therapy prolonged over 12 months. With the current guideline recommended strategies, there are some doubts and uncertainties with respect to the transition period.
View Article and Find Full Text PDFDe-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive early breast cancer (HELEN-006): a multicentre, randomised, phase 3 trial.
Lancet Oncol
November 2024
Department of Breast Disease, Henan Breast Cancer Centre, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China. Electronic address:
Background: A previous phase 2 trial showed promising outcomes for patients with HER2-positive early-stage breast cancer using neoadjuvant de-escalation chemotherapy with paclitaxel, trastuzumab, and pertuzumab. We aimed to evaluate the efficacy of weekly nab-paclitaxel compared with the standard regimen of docetaxel plus carboplatin, both with trastuzumab and pertuzumab, as neoadjuvant therapies for patients with HER2-positive breast cancer.
Methods: HELEN-006 was a multicentre, randomised, phase 3 trial done at six hospitals in China.
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