Health-related quality of life in brain tumor patients: as an endpoint in clinical trials and its value in clinical care

ABSTRACT Health-related quality of life (HRQoL) plays a role as a (secondary) endpoint in clinical trials for brain tumor patients as well as in daily clinical practice. HRQoL can be classified as a patient-centered endpoint, assessing a direct clinical benefit for the patient. Although HRQoL is a meaningful endpoint because it reflects the patient’s perspective, several methodological concerns raise doubt over the appropriateness of HRQoL as an endpoint in trials. HRQoL could possibly be considered as co-primary endpoint in future trial designs, together with a surrogate endpoint such as progression-free survival, to ensure that both a direct treatment effect and a direct clinical benefit for the patient will be assessed. Routine assessment of HRQoL has proven to be feasible in clinical practice and was found to facilitate the communication between patients and physicians. However, despite discussion of HRQoL issues, so far this did not have an impact on patient management and clinical decisions.