Abstract
BACKGROUND: Measurement of health-related quality of life (HRQoL) in patients with melanoma under immune checkpoint inhibitor therapy (ICI) under routine conditions and in survivorship is insufficient due to the absence of data and therapy-specific instruments in clinical trials. This pilot study aimed to collect and compare data on symptom burden and HRQoL in patients during and after ICI therapy. The benefit of a treatment-/disease-specific item list compared to a general-oncologic HRQoL instrument was examined. The results are intended to be used for planning a longitudinal study. METHODS: This cross-sectional, monocentric, questionnaire-based study included patients with melanoma stages II-IV treated at the University Hospital Dresden, Germany. HRQoL was measured in a treatment group (ongoing ICI therapy) and a survivor group (minimum one year therapy- and relapse-free after ICI). The treatment group was interviewed with the cancer-generic EORTC QLQ-C30 and the survivor group with the EORTC SURV100, both consisting of different scales (range 0-100). Hereby, an elevated HRQoL score indicates a better HRQoL. Additionally, a treatment-/disease-specific PRO-CTCAE item list was conducted in both groups. We performed descriptive and exploratory analysis aiming to identify and compare symptom burden in both groups. RESULTS: General health measured with EORTC C30/SURV100 in the treatment group (73 patients) was marginally lower than in the survivor group (26 patients) with a mean score of 61.0 (SD ± 21) vs. 67.0 (SD ± 21), which implies descriptively lower HRQoL scores in the treatment group than in clinical trials and population norm data. With almost similar demographic-clinical characteristics, the treatment group frequently reported pruritus and xerostomia, while survivors frequently reported aching joints, memory loss and a considerable emotional burden. The high prevalence of xerosis cutis, fatigue and sexual dysfunction was observed across both groups. In both groups, the specific PRO-CTCAE identified further relevant symptoms than the general instruments. CONCLUSIONS: Needs of patients during and after ICI therapy appear to differ with an assumed remaining symptom burden in survivors of melanoma. For measuring HRQoL a therapy-/disease-specific instrument should be considered. Rising numbers of patients undergoing ICI therapy and survivors underscore the need for comprehensive data on HRQoL and specific aspects of treatment.