ARTICLE | Politics & Policy

ASCO provides perspective on clinically meaningful outcomes

March 17, 2014 11:29 PM UTC

The American Society for Clinical Oncology published a perspective in the Journal of Clinical Oncology defining clinically meaningful outcomes for clinical trials for pancreatic, breast, lung and colon cancers. Working groups for the cancers each chose overall survival (OS) as the primary endpoint of interest and then provided a range of improvements over the median OS with current therapy that would be the minimum incremental improvement needed to "define a clinically meaningful outcome."

For example, the breast cancer working group said 4.5-6 months was the minimum improvement in median OS over current therapy that would be clinically meaningful in patients with previously untreated, metastatic, triple-negative breast cancer. The working groups all noted that gains in OS should be accompanied by little to no increase in toxicity compared with existing therapies. ...