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IDDI’s findings suggest that it is appropriate to use disease-free survival (DFS) as a surrogate for overall survival (OS) in trials in HER-2-positive, early breast cancer.
Although frequently used as a primary endpoint, DFS has not been formally validated as a surrogate for OS in early breast cancer. Roche Germany commissioned IDDI to investigate this issue in the specific group of HER2-positive breast cancer.
IDDI conducted a literature review and secured data from the relevant clinical trials, which were then used in a meta-analysis that confirmed that DFS can indeed be used as primary endpoint, because it has sufficiently high correlation with OS in this situation.
The results were published in Lancet Oncology (Lancet Oncol 2019; 20: 361–70), a prestigious journal in the field of oncology, and were also the subject of an accompanying editorial in the same issue of the journal.
IDDI has long-standing experience in the challenging statistical issues that characterize the identification and validation of biomarkers of diagnostic utility, prognostic and/or predictive ability, and those that can potentially be used as surrogate endpoints in clinical trials.
Learn more at www.IDDI.com