Survival-Inferred Fragility of Statistical Significance in Phase III Oncology Trials.

Background: Statistical significance currently defines superiority in phase III oncology trials. However, this practice is increasingly questioned. Here, we estimated the fragility of phase III oncology trials.

Evolving Paradigms in the Treatment of Oligometastatic Pancreatic Ductal Adenocarcinoma.

Multiple randomized trials have suggested that the addition of comprehensive metastasis-directed therapy to best systemic therapy improves disease control and survival among patients with oligometastatic disease, even for histologies with a high propensity for rapid spread. Here, we review the growing literature supporting the oligometastatic paradigm in pancreatic ductal adenocarcinoma. We summarize key details from nascent institutional series and reflect on the recently reported phase II randomized EXTEND trial.

Incomplete Toxicity Reporting and Use of Toxicity-Minimizing Language in Phase III Oncology Trials.

Purpose: This study aimed to determine complete toxicity reporting (CTR), and the use of subjective toxicity-minimizing language (TML) among phase III oncology trials.

Methods: Two-arm superiority-design phase III oncology trials published from 2002 to 2020 were reviewed for toxicity data. CTR was defined as reporting total adverse events (TAEs), total serious adverse events (SAEs), total deaths, and study therapy discontinuations because of toxicity.

Body composition as a novel biomarker of recurrence risk in patients with triple-negative breast cancer.

Background And Hypothesis: Triple-negative breast cancer (TNBC) patients are at increased risk for recurrence compared to other subtypes of breast cancer. Previous evidence showed that adiposity may contribute to worsened cancer control. Current measures of obesity, such as body-mass index (BMI), are poor surrogates of adiposity, while visceral-to-subcutaneous adiposity ratio (VSR), which can be measured from routine computed tomography (CT) imaging, is a direct adiposity measure.

Justification, margin values, and analysis populations for oncologic noninferiority and equivalence trials: a meta-epidemiological study.

Background: Noninferiority (NI) and equivalence trials evaluate whether an experimental therapy's effect on the primary endpoint (PEP) is contained within an acceptable margin compared to standard-of-care. The reliability and impact of this conclusion, however, is largely dependent on the justification for this design, the choice of margin, and the analysis population used.

Methods: A meta-epidemiological study was performed of phase 3 randomized NI and equivalence oncologic trials registered at ClinicalTrials.