Psychometric Validation of the EORTC QLQ-HCC18 in Patients with Previously Treated Unresectable Hepatocellular Carcinoma

Abstract

Purpose: Demonstrate the measurement properties of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module (EORTC QLQ-HCC18) within a previously treated, unresectable HCC clinical trial population that was distinct from the published QLQ-HCC18 validation population. Methods: Analyses were conducted using data from BGB-A317-208, an open label, international, clinical trial of the monoclonal antibody tislelizumab in adult HCC patients. The EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-HCC18 were assessed at baseline as well as weeks 3 and 9. Psychometric validation of the QLQ-HCC18 included reliability, construct validity, ability to detect change, and meaningful within-patient change (MWPC). Known-groups validity and MWPC analyses were also stratified on several pre-defined subpopulations. Results: A total of 248 patients were included. The QLQ-HCC18 fatigue, nutrition, and index domains demonstrated acceptable internal consistency; acceptable test-retest reliability was found for fatigue, body image, nutrition, pain, sexual interest, and index domains. The QLQ-HCC18 fatigue domain achieved acceptable concurrent validity for 13 of 16 correlations; the index domain achieved acceptable concurrent validity for 15 of 16 correlations. Clear differentiation of the QLQ-HCC18 change scores between improvement and maintenance anchor groups were observed for body image, fatigue, pain, and index domains. Differentiation between deterioration and maintenance anchor groups were observed for fever and fatigue domains. MWPC point estimates defining improvement for the QLQ-HCC18 fatigue and index domains were -7.18 and -4.07, respectively; MWPC point estimates defining deterioration were 5.34 and 3.16, respectively. Conclusions: The EORTC QLQ-HCC18 fatigue and index domains consistently demonstrated robust psychometric properties, supporting the use of these domains as suitable patient-reported endpoints within a previously treated, unresectable HCC patient population.