From the University of Colorado School of Medicine (Drs Ahnen and Byers) and the Denver Department of Veterans Affairs Medical Center (Dr Ahnen), Denver, Colo.
The use of surrogate end points in trials of colonic cancer chemoprevention
has great appeal. Potential agents could be tested more quickly using far
fewer patients than would be needed for trials using the development of colonic
cancer or adenomas as end points. In this issue of THE JOURNAL, Holt and colleagues1 report that increased dietary intake of low-fat dairy
foods can alter putative intermediate biomarkers of colonic cancer risk. This
study raises 2 important questions about the use of surrogate end points for
colonic cancer: (1) are there any surrogate end points, short of adenoma formation,
that reliably reflect colonic cancer risk and (2) is there currently a defined
role for surrogate end point studies in decision making about which agents
to test in colonic cancer chemoprevention trials? The answer to both of these
questions probably is no.
Ahnen DJ, Byers T. Proliferation Happens. JAMA. 1998;280(12):1095–1096. doi:10.1001/jama.280.12.1095