Publications by authors named "M Buyse"
Purpose: Oral mucositis (OM) is a debilitating side effect of cisplatin and intensity-modulated radiation therapy (IMRT) in patients with head and neck cancer. The phase 3 ROMAN trial showed avasopasem manganese (AVA) significantly decreased individual endpoints of incidence and duration of severe oral mucositis (SOM, World Health Organization [WHO] grade 3-4), with nominal decrease in severity (WHO grade 4) and significant increase in the delay in onset of SOM. We sought to determine the Net Treatment Benefit (NTB) of AVA versus placebo (PBO) using the generalized pairwise comparisons (GPC) method.
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- Current treatment options are limited by the expectation that alternative therapies must be proven "non-inferior" to existing ones, making trials expensive and complex.
- Non-inferiority trials often overlook important factors like variability in treatment outcomes and place excessive burdens of proof on alternatives, especially in terms of toxicity and cost.
- The authors suggest moving away from labeling trials as superiority or non-inferiority, advocating instead for a simpler description of trials as "comparative" to promote better patient-centered treatment options.
Background: Evidence suggests that ctDNA may be a reliable biomarker to monitor metastatic colorectal cancer (CRC) evolution. Nevertheless, evidence on the potential of liquid biopsy in this setting is still low quality, mostly consisting of retrospective studies.
Methods: COPERNIC is an international, multicenter clinical trial.
Unlocking the full potential of clinical trials through comprehensive CSR and IPD sharing can revolutionize cancer care, enhance safety evaluations, and reduce bias in systematic reviews. It is time for all stakeholders to embrace transparency and advance patient-centered outcomes.
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- The study found that big clinical trials for a type of cancer called diffuse large B-cell lymphoma have confusing and different definitions for what they are trying to measure.
- This makes it hard to understand and compare the results from these studies because they may be looking at different things.
- The authors suggest that people involved in these trials should talk more to clearly define what they want to find out and the best ways to measure it.