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Comparative effectiveness of laparoscopic versus open colectomy in colon cancer patients: a study protocol for emulating a target trial using cancer registry data.
J Cancer Res Clin Oncol
January 2025
Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, 17489, Greifswald, Germany.
Introduction: The objective of this study is to compare the 5 year overall survival of patients with stage I-III colon cancer treated by laparoscopic colectomy versus open colectomy.
Methods: Using Mecklenburg-Western Pomerania Cancer Registry data from 2008 to 2018, we will emulate a phase III, multicenter, open-label, two-parallel-arm hypothetical target trial in adult patients with stage I-III colon cancer who received laparoscopic or open colectomy as an elective treatment. An inverse-probability weighted Royston‒Parmar parametric survival model (RPpsm) will be used to estimate the hazard ratio of laparoscopic versus open surgery after confounding factors are balanced between the two treatment arms.
Bruton's tyrosine kinase inhibitor for multiple sclerosis: new hope or false dawn.
J Neurol
January 2025
Institute of Psychological Medicine and Clinical Neuroscience, Cardiff University, University Hospital of Wales, Heath Park, Cardiff, CF14 4XN, UK.
The first of several phase 3 trials examining efficacy in relapsing MS has not been able to demonstrate a significant benefit and has also raised important safety concerns. More results are on their way and it will be important to understand whether the safety signals identified are drug- or class-specific and whether other BTKi also fail to reach their endpoints for relapsing MS. However, as reported in preliminary data for another BTKi, it may be that they will have more of a role in progressive disease as hinted by the unraveling of relevant molecular mechanisms and pathways.
View Article and Find Full Text PDFConsiderations for manufacturing of cell and gene medicines for clinical development.
Cytotherapy
December 2024
Cancer Institute, University College London, London, UK. Electronic address:
The global changes from 2001 that elevated substantially modified cell therapies to the definition of "medicinal product" have been the catalyst for the dramatic expansion of the field to its current and future commercial success. Europe was the first to incorporate human somatic cells into drug legislation with the medicines directive of 2001 (2001/83/EC), which led to the development of the term "advanced therapy medicinal products" (ATMPs) to cover all substantially modified products, tissue-engineered products and somatic cells that are not substantially modified but that are used non-homologously. For convenience, I use the term "ATMPs" throughout this review.
View Article and Find Full Text PDFCASE (CemiplimAb-rwlc Survivorship and Epidemiology): a study in advanced basal cell carcinoma.
Future Oncol
January 2025
Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Patients diagnosed with metastatic basal cell carcinoma (BCC) have a poor prognosis. The current standard of care for adults with locally advanced or metastatic BCC who are not candidates for surgery or radiation therapy is treatment with hedgehog pathway inhibitors (HHIs). For patients who progress while on this therapy, further treatment options are limited.
View Article and Find Full Text PDFSafety, Tolerability, and Pharmacokinetics of NIM-1324 an Oral LANCL2 Agonist in a Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial.
Clin Transl Sci
January 2025
NIMML Institute, Blacksburg, Virginia, USA.
NIM-1324 is an oral investigational new drug for autoimmune disease that targets the Lanthionine Synthetase C-like 2 (LANCL2) pathway. Through activation of LANCL2, NIM-1324 modulates CD4+ T cells to bias signaling and cellular metabolism toward increased immunoregulatory function while providing similar support to phagocytes. In primary human immune cells, NIM-1324 reduces type I interferon and inflammatory cytokine (IL-6, IL-8) production.
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