Antineoplastic agents
Health-related quality of life
Clinical efficacy
Drug approvals
Patient-relevant outcomes
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
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by Nicole Grossmann, Martin Robausch, Eleen Rothschedl, Claudia Wild, Judit Simon
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Feb 23rd 2020
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12 mins
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European Journal of Cancer, 129 (2020) 23-31
- The study investigates cancer drugs approved by the European Medicines Agency (EMA) that initially lack Health-related Quality of Life (HRQoL) information.
- Data was collected for cancer indications approved between January 2009 and October 2015, using sources like the EMA website, clinicaltrials.gov, and PubMed.
- Of 110 indications, 58 had no HRQoL data at approval; three years later, only 24 had updates, leaving 34 still without HRQoL information.
- 49 out of 76 therapies with HRQoL data used cancer-specific instruments.
- 30% of drugs initially lacked both HRQoL and median overall survival data, improving to 14% after three years.
- The conclusion emphasizes the need for regular re-evaluation and better standardization of HRQoL assessments for improved comparability
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, whereby 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.
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Antineoplastic agents, Health-related quality of life, Clinical efficacy, Drug approvals, Patient-relevant outcomes
