OBJECTIVES: Describe the process utilized to adapt the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for identifying adverse events (AEs) among non−small cell lung cancer (NSCLC) patients who have the epidermal growth factor receptor (EGFR) exon mutation.

METHODS: Cross-sectional, qualitative study was implemented among NSCLC patients with EGFR mutations in two stages between February and October 2018. During stage 1, a targeted literature review and qualitative clinician and patient interviews were conducted. Common AEs were then used to select relevant NSCLC items for stage 2 adaptation of the PRO-CTCAE.

RESULTS: A total of 18 NSCLC patients with EGFR mutations were interviewed across both stages.

During stage 1, 10 patient interviews were conducted (median age 55 years; 60% female; 100% on targeted therapy) identifying 13 AEs. The most frequently reported AEs were rash (90%), diarrhea (80%), sores on the mouth or tongue (80%), lack of appetite (70%), and weight loss (60%). Patients generally described these AEs as bothersome and impacting their quality of life.

The 10 most frequent stage 1 AEs were used to develop a draft PRO CTCAE for NSCLC patients. Two less frequently reported items relevant to targeted therapy (dry skin and acne) were later added. Thus, the updated PRO-CTCAE measure for use in stage 2 consisted of 12 items.

During stage 2, 8 patients were interviewed (median age 54.5 years; 50% female; 75% on chemotherapy) using the updated PRO-CTCAE. The most frequently reported AEs were nausea (100%), diarrhea (71%), itchiness (57%), dry skin (57%), and constipation (57%), which were captured on the newly developed PRO-CTCAE.

CONCLUSIONS: The PRO-CTCAE should be adapted for specific tumors, including NSCLC, by capturing patient perspectives to increase relevance and patient-centered AE reporting. Further work to engage and incorporate the patient voice into PRO-CTCAE development is ongoing.