Quality-adjusted survival as an end point in breast cancer trials

Author(s): AJ Martin, RJ Simes

Breast cancer treatment recommendations will often require an appraisal of likely benefits in relation to likely side effects on survival and quality of life end points, and possibly also an evaluation of the size of the anticipated net clinical benefit against financial costs. Quality-adjusted survival (QAS) analysis methods provide a formal approach for deriving an estimate of net clinical benefit to facilitate this appraisal process. QAS analysis methods have been applied in trials with breast cancer patients of adjuvant therapies as well as treatments for advanced/metastatic disease. QAS analyses based solely on trial data may fail to capture plausible longer-term benefits; thus, methods to explore the possible outcomes of treatment beyond the limits of trial data have been developed. These modeling approaches can help researchers gain insights and identify future research priorities, but do not replace the need for long-term evidence from randomized trials.