Abstract
The evaluation of anticancer drugs safety is currently based on considering the worst Adverse Event (AE) in a particular patient. The aim of the study was to define a new method which would better describe the impact of treatment on Quality of Life (QoL), combining Patient Reported Outcomes (PROs) and the monitoring of all AEs. A comparative approach to the classic National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) classification was performed to assess the interest of monitoring Area Under the Curve (AUC) of toxicities on quality of life. A negative impact on global health status, assessed by the VAS of EQ-5D-3L, was significantly identified for three AEs based on CTCAE grade alone versus seven when considering AUCtox assessment.
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