Quality of life in cemiplimab-treated patients with locally advanced basal cell carcinoma in a Phase II clinical trial.

Aim: To evaluate health-related quality of life (HRQoL) in cemiplimab-treated patients with locally advanced basal cell carcinoma (laBCC). Materials & methods: Eighty-four patients with laBCC received cemiplimab 350 mg every 3 weeks (up to 9 cycles). HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires at baseline and each cycle. Mixed-effects repeated-measures models evaluated change from baseline across cycles. Results: Clinically meaningful improvement or maintenance was reported by 62–90% of patients on QLQ-C30 scales and by approximately 80% on Skindex-16 scales at Cycle 2, with consistent results at Cycle 9 except fatigue. Conclusion: Most cemiplimab-treated patients with laBCC reported improvement or maintenance of HRQoL with low symptom burden except fatigue. Clinical Trial Registration:ClinicalTrials.gov identifier NCT03132636, registered 28 April 2017. Plain Language Summary Locally advanced basal cell carcinoma (laBCC) is a type of skin cancer that has the potential to invade surrounding tissues including bone, cartilage, nerve and muscle. Cemiplimab-rwlc is approved in the US for patients with laBCC following a therapy called hedgehog inhibitor (HHI) treatment or for whom HHIs are not appropriate. In a Phase II clinical trial, intravenous (in the vein) cemiplimab 350 mg every 3 weeks for up to nine treatment cycles resulted in clinically meaningful antitumor activity in patients with laBCC who progressed on or were intolerant to HHIs. This analysis evaluated health-related quality of life, symptom burden, emotions and functional status in these patients using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (QLQ-C30) and Skindex-16 questionnaires. Baseline scores (scores at the start of the clinical trial) showed moderate to high levels of functioning and low symptom burden that, except for fatigue, were maintained or improved over the course of cemiplimab treatment. These results show that despite the presence of fatigue, health-related quality of life and functional status were maintained with cemiplimab across the study duration. Tweetable Abstract In patients with locally advanced basal cell carcinoma treated with cemiplimab every 3 weeks for nine treatment cycles, health-related quality of life and functional status were maintained despite the presence of fatigue. Article highlights In a Phase II trial, intravenous cemiplimab 350 mg every 3 weeks for up to nine treatment cycles resulted in clinically meaningful antitumor activity in patients with locally advanced basal cell carcinoma who progressed on or were intolerant to hedgehog inhibitors. Since an important component in cancer clinical trials is the measurement of patient-centric outcomes, this analysis evaluated patient-reported health-related quality of life (HRQoL) among participants in the clinical trial. HRQoL was evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30), which consists of a global health status/quality of life (GHS/QoL) scale, five functional scales and eight symptom scales; and the Skindex-16, which assesses the impact of skin disease on HRQoL based on symptom, emotional and functional subscales. Mixed-effects repeated-measures models were used to estimate overall least-squares (LS) mean (95% confidence interval [CI]) change from baseline across Cycles 2–9; absolute changes ≥10 points from baseline were considered clinically meaningful. Overall changes from baseline indicated maintenance for QLQ-C30 GHS/QoL, functioning and symptom scales, except for clinically meaningful worsening of fatigue (LS mean change: 12.0; 95% CI: 4.3–19.6). Clinically meaningful improvement or maintenance on QLQ-C30 GHS/QoL, functioning and symptom scales were reported at Cycle 2 by 88%, 69–81% and 62–90% of patients, respectively, with similar proportions at Cycle 6 (∼1 year of treatment) and consistent results at Cycle 9 except for fatigue. On the Skindex-16, overall change showed clinically meaningful improvement on the emotional subscale (LS mean change, -13.8; 95% CI: -21.4 to -6.2), with maintenance on symptom and functional subscales; clinically meaningful improvement or maintenance across all three subscales was reported by approximately 80% of patients at Cycle 2 that was generally maintained at Cycles 6 and 9. These results show that most patients with laBCC treated with cemiplimab reported clinically meaningful improvement or maintenance in GHS/QoL and functioning while maintaining low symptom burden, except for fatigue. [ABSTRACT FROM AUTHOR]