ICI have shown significant clinical benefit for patients diagnosed with varied types of cancer. With an increasing use of these therapies, it is of urgent interest to achieve a comprehensive understanding of the overall patient experience – thus PROs should be systematically included in clinical ICI trials. We conducted a systematic review of published literature to identify and categorize PRO instruments and examine related utility and measurement issues in studies reporting on ICI.
Literature was searched using PubMed, Embase, PsycINFO, Medline and CINAHL databases (June 2017). Search terms included controlled vocabulary and specific keywords related to: (1) Food and Drug Administration (FDA) approved ICI, (2) PRO, and (3) Oncology. Eight reviewers independently screened titles/abstracts followed by a full text selection based on predefined criteria. We included clinical trials, intervention studies, systematic reviews, study protocols, observational studies, and case reports. Information regarding the clinical trial protocol and PRO tools was collected. (PROSPERO CRD42018090912).
Of the 24 articles included in the review, 13 reported PRO data from primary clinical studies, nine were quality-adjusted life year analyses, and two were study protocols. These articles referred to a total of 14 clinical trials reporting PRO results. Of these, 12 used cancer-specific (11 EORTC-QLQ-C30 and 1 FACT-G) and 11 a generic quality of life (QoL) questionnaire (10 EQ-5D and 1 SF-36). Whereas in seven cases, only cancer-specific and generic questionnaires were used, five studies combined them with disease-specific modules, and two included a symptom-specific questionnaire. Furthermore, six studies used PROs to conduct analyses of health economics and work productivity.
Cancer-specific or generic QoL questionnaires are the most widely used PRO measures in clinical ICI trials. As ICI therapies exhibit unique characteristics different from conventional cancer therapies, such broad instruments may not capture the specific ICI-related symptoms, toxicities, and impact on the patient’s QoL. Hence, the adaptation or development of ICI specific PRO tools should be further investigated.
Clinical trial identification
Legal entity responsible for the study
Centre Hospitalier Universitaire Vaudois (CHUV) - University of Lausanne (UNIL) and McMaster University.
Has not received any funding.
All authors have declared no conflicts of interest.