Utilizing the EORTC Item Library to develop a tailored patient-reported outcome measure (PROM; CSCC-NAAP-32) to evaluate quality of life in resectable advanced (RA) cutaneous squamous cell carcinoma (CSCC).

Abstract

e18014 Background: RA CSCC most frequently involves the head and neck region, with close proximity to important functional structures. Standard-of-care treatment, typically surgery and radiation, can lead to significant functional impairment and disfiguration. Patients with RA CSCC often experience symptoms that negatively impact their physical, social, and psychological functioning, and overall health-related quality of life (HRQoL). New treatment strategies using neoadjuvant and/or adjuvant immunotherapies are being actively explored, with the potential to improve both oncologic and functional outcomes, that may be reflected in improved HRQoL. Currently, no CSCC-specific PROMs exist to capture the core symptoms and impacts that most affect HRQoL in RA CSCC. This study used the European Organization for Research Treatment of Cancer (EORTC) Item Library to develop a CSCC-specific PROM for the evaluation of neoadjuvant and/or adjuvant treatments. Methods: A targeted literature review of qualitative patient studies (n=12) in non-melanoma skin cancer (NMSC) and interviews with expert clinicians (n=4) were conducted to identify the core concepts (signs, symptoms, and impacts) that most affect HRQoL among patients with RA CSCC. A PROM was developed by selecting items from the EORTC Item Library which mapped to these core concepts. When no items were available to measure the concepts, de novo items were drafted using the same structure (eg, recall period, response options) as the items in EORTC Item Library. Results: From the literature review, 126 concepts were identified as potentially relevant to NMSC. This list was refined to 8 core concepts most relevant to RA CSCC following expert clinician interviews (Table). To measure these, 26 existing items were selected from the EORTC Item Library and 6 de novo items were drafted. These items were combined to form the CSCC Neoadjuvant, Adjuvant & Perioperative 32-item questionnaire (CSCC-NAAP-32). Conclusions: The CSCC-NAAP-32 is a tailored PROM to capture 8 core concepts that most affect HRQoL among RA CSCC. The CSCC-NAAP-32 will be tested and validated in a National Cancer Institute–sponsored randomized phase 3 trial (NRG-HN014, NCT06568172) of neoadjuvant immunotherapy in patients with stage III/IV RA CSCC. After further validation is completed, the CSCC-NAP-32 could be used for future studies exploring HRQoL in patients with RA CSCC. Eight core concepts most relevant to RA CSCC. Category Core concept Disease-related signs/symptoms Pain at tumor location Open wound at tumor location Disease- and treatment-related signs/symptoms Fatigue Treatment-related signs/symptoms Disfigurement Functional impairment Disease- and treatment-related impacts Psychological distress Role functioning Physical functioning