Purpose: The functional assessment of cancer therapy epidermal growth factor receptor inhibitor 18 (FACT-EGFRI-18) is a patient-reported outcomes questionnaire developed to assess the effect of EGFRI on health-related quality of life (HRQoL).
Methods: Ten native-speaking residents of The Netherlands who reported EGFRI-associated mucocutaneous adverse events (mcAEs) were administered the questionnaire. Patients were subsequently asked a standardized series of questions about the items' personal relevance.
Results: Responses reflected a major negative impact of mcAEs due to EGFRI on physical, social/emotional, and functional domains. In some cases, especially in the social/emotional domain, the responses to the qualitative interview indicated a greater impact on HRQoL than the numerical ratings previously selected for the Dutch FACT-EGFRI-18 questions.
Conclusions: Based on these interviews, we identified that the physical items associated with mcAEs interfere most with HRQoL. The results suggest that the FACT-EGFRI-18 can be applied to measure mcAE-related HRQoL in cancer patients undergoing EGFRI therapy. In addition, patients feel the need to rate their symptom burden, too, and we recommend additional adverse event items to be incorporated into the questionnaire.
Trial registration: ClinicalTrials.gov NCT01136005.