Article
Rajat Thawani, Neha Agrawal, Nicholas F Taflin, Adel Kardosh, Emerson Y Chen
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
Summary
Cancer drugs should be clinically meaningful and thus not only prolong but also improve (or at least not worsen) patients' quality of life. Due to the increasing number of cancer drugs in the development pipeline and their rapidly increasing costs, it becomes more and more important to assess the overall comparative value of these therapies. Therefore, the most essential patient-relevant outcomes that determine the overall value of oncological therapies are overall survival (OS) and health-related quality of life (HRQoL). HRQoL instruments comprise of questions related to the main dimensions of a person's health status and can be understood as multidimensional subjective instruments which cover at least four domains: physical, mental, emotional and social well-being. In contrast, the general term ‘quality of life (QoL)’ may include broader aspects of well-being such as political and religious freedoms, etc. . Nevertheless, there is no single standard definition available either for HRQoL or for QoL.
To support treatment decision-making, cancer societies have developed frameworks to determine the clinical benefit of oncological therapies. These scales not only assess survival improvements, relative benefits (hazard ratio) and absolute benefits (median OS) but also consider toxicities and HRQoL measurements. HRQoL can be evaluated via various tools, wher
eby the most widely used instruments in cancer trials include the non-preference-based cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), the non-preference-based Functional Assessment of Cancer Therapy-General, and the preference-based generic EuroQol five-dimensional questionnaire (EQ-5D). In the case of individual disease-specific instruments, measures for particular malignancies maybe considered, for example the Lung Cancer Symptom Scale (LCSS). Besides the evaluation of physical and functional domains, disease symptomatology can be measured via the LCSS.
Antineoplastic agents, Health-related quality of life, Clinical efficacy, Drug approvals, Patient-relevant outcomes
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