Landscape assessment of patient-reported outcome item coverage of tyrosine kinase inhibitor-associated adverse events.

BACKGROUND

Patient-reported outcomes are critical for assessing symptomatic adverse events in non-small-cell lung cancer (NSCLC) clinical trials, but these reports may not fully capture tyrosine kinase inhibitor-specific adverse events in patients with metastatic NSCLC. This study evaluated coverage of tyrosine kinase inhibitor-related symptomatic adverse events by commonly used patient-reported outcomes item libraries.

METHODS

We compiled a list of US Food and Drug Administration-approved tyrosine kinase inhibitors for NSCLC with alterations in EGFR, ALK, ROS1, RET, MET, and NTRK. Symptomatic adverse events 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 version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item libraries were searched for items corresponding to extracted adverse events. Items were classified according to the adverse event's physical, functional, and social or emotional impact.

RESULTS

Data from 17 drug labels covering 29 clinical trials of 17 tyrosine kinase inhibitors were analyzed. By tyrosine kinase inhibitor, EORTC covered the highest average percentage of adverse events (99%), followed by PRO-CTCAE (86%) and PROMIS (47%). Of the 15 most common adverse events, 8 were covered by all 3 item libraries. The EORTC and PRO-CTCAE covered 15 adverse events, whereas PROMIS covered 8. Of the 8 adverse events covered by all 3 libraries, PROMIS included the most items assessing functional and social or emotional impact.

CONCLUSIONS

The EORTC and PRO-CTCAE covered more symptomatic adverse events than PROMIS. For the adverse events it covered, PROMIS had the most items assessing functional and social or emotional impact. Our assessment is a starting point for improving patient-reported outcome coverage of adverse events associated with new treatments such as tyrosine kinase inhibitors.