Landscape assessment of patient-reported outcome item coverage of tyrosine kinase inhibitor-associated AEs

Background Patient-reported outcomes (PROs) are critical for assessing symptomatic adverse events (AEs) in non-small-cell lung cancer (NSCLC) clinical trials. However, PROs may not fully capture tyrosine kinase inhibitor (TKI)-specific AEs in metastatic NSCLC patients. This study evaluated coverage of TKI-related symptomatic AEs by commonly used PRO item libraries. Methods We compiled a list of FDA-approved TKIs for NSCLC with alterations in EGFR, ALK, ROS1, RET, MET, and NTRK. Symptomatic AEs were extracted from clinical trials reported in US Prescribing Information (ie,, drug labels). The European Organisation for Research and Treatment of Cancer (EORTC), Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) item libraries were searched for items corresponding to extracted AEs. Items were classified according to the AE’s physical, functional, or social/emotional impact. Results Data from 17 drug labels covering 29 clinical trials of 17 TKIs were analyzed. By TKI, EORTC covered the highest average percentage of AEs (99%), followed by PRO-CTCAE (86%), and PROMIS (47%). Of the 15 most common AEs, 8 were covered by all 3 item libraries. EORTC and PRO-CTCAE covered 15 AEs, whereas PROMIS covered 8. Of the 8 AEs covered by all 3 libraries, PROMIS included the most items assessing functional and social/emotional impact. Conclusions EORTC and PRO-CTCAE covered more symptomatic AEs than PROMIS. For the AEs it covered, PROMIS had the most items assessing functional and social/emotional impact. Our assessment is a starting point for improving PRO coverage of AEs associated with new treatments like TKIs.