IDDI in collaboration with Roche have identified why using disease-free survival as a primary endpoint in early breast cancer is the way forward
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.
The validation of surrogate endpoints follows a methodological framework that was developed by IDDI in collaboration with Hasselt University. 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, a subtype for which considerable improvements have been achieved over the last 15 years.
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. For more info on this: https://www.ncbi.nlm.nih.gov/pubmed/30709633
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 on IDDI Experience in the Validation of Biomarkers:
About IDDI:
International Drug Development Institute (IDDI) is an expert clinical trials service provider specialized in biostatistical and integrated eClinical services for pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology. IDDI optimizes the clinical development of drugs, biologics and devices thanks to proven statistical expertise and operational excellence. IDDI has offices in Louvain-la-Neuve (Belgium), Boston (MA) and Raleigh (NC) USA.