Authors: | Bharmal, M.; Nolte, S.; Lebbé, C.; Mortier, L.; Brohl, A. S.; Fazio, N.; Grob, J. J.; Pusceddu, S.; Hanna, G. J.; Hassel, J. C.; Kiecker, F.; Ellers-Lenz, B.; Bajars, M.; Güzel, G.; Nghiem, P.; Hunger, M.; Schlichting, M.; Henry-Szatkowski, M.; D'Angelo, S. P. |
Article Title: | Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab |
Abstract: | Aim: To evaluate changes in health-related quality of life (HRQoL) in a Phase II trial (NCT02155647) of treatment-naive patients with metastatic Merkel cell carcinoma treated with avelumab (15-month follow-up). Materials & methods: Mixed-effect Models for Repeated Measures were applied to HRQoL data (FACT-M; EQ-5D-5L) to assess changes over time. Clinically derived progression-free survival was compared with HRQoL deterioration-free survival. Results: Overall, we saw relative stability in HRQoL among 116 included patients, with nonprogression associated with statistically and clinically meaningful better HRQoL compared with progressive disease. Deterioration-free survival rates (49-72% at 6 months, 40-58% at 12 months) were consistently higher/better compared with progression-free survival rates (41/31% at 6/12 months). Conclusion: These findings show unique longitudinal HRQoL data for treatment-naive metastatic Merkel cell carcinoma patients treated with avelumab. Clinical trial registration: NCT02155647 (ClinicalTrials.gov). © 2020 EMD Serono. |
Keywords: | adult; aged; middle aged; major clinical study; treatment duration; disease free survival; follow up; progression free survival; quality of life; tumor volume; self report; merkel cell carcinoma; asia; health-related quality of life; north america; patient-reported outcome; patient reported outcome; western europe; human; male; female; priority journal; article; avelumab; fact-m questionnaire; australia and new zealand; european quality of life 5 dimensions 5 level questionnaire |
Journal Title: | Future Oncology |
Volume: | 16 |
Issue: | 27 |
ISSN: | 1479-6694 |
Publisher: | Future Medicine |
Date Published: | 2020-09-01 |
Start Page: | 2089 |
End Page: | 2099 |
Language: | English |
DOI: | 10.2217/fon-2020-0426 |
PUBMED: | 32938212 |
PROVIDER: | scopus |
PMCID: | PMC9437770 |
DOI/URL: | |
Notes: | Article -- Export Date: 2 November 2020 -- Source: Scopus |