Quality of life in cemiplimab-treated patients with locally advanced basal cell carcinoma in a Phase II clinical trial.
Alexander J StratigosChieh-I ChenCristina IvanescuKarl D LewisKetty PerisOliver BechterJames HarnettVera MasteyMatthew ReaneyChristina DaskalopoulouPatrick R LaFontaineGerasimos KonidarisDenise BurySuk-Young YooKosalai MohanEbony CoatesTimothy BowlerMatthew G FuryAleksandar SekulicPublished in: Future oncology (London, England) (2024)
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.
Keyphrases
- clinical trial
- basal cell carcinoma
- phase ii
- locally advanced
- open label
- newly diagnosed
- rectal cancer
- squamous cell carcinoma
- neoadjuvant chemotherapy
- end stage renal disease
- phase iii
- double blind
- ejection fraction
- radiation therapy
- phase ii study
- randomized controlled trial
- study protocol
- prognostic factors
- peritoneal dialysis
- risk factors
- preterm birth
- psychometric properties