Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab

Murtuza Bharmal, Sandra Nolte, Céleste Lebbé, Laurent Mortier, Andrew S Brohl, Nicola Fazio, Jean-Jacquez Grob, Sara Pusceddu, Glenn J Hanna, Jessica C Hassel, Felix Kiecker, Barbara Ellers-Lenz, Marcis Bajars, Gülseren Güzel, Paul Nghiem, Matthias Hunger, Michael Schlichting, Mickaël Henry-Szatkowski, Sandra P D'Angelo, Murtuza Bharmal, Sandra Nolte, Céleste Lebbé, Laurent Mortier, Andrew S Brohl, Nicola Fazio, Jean-Jacquez Grob, Sara Pusceddu, Glenn J Hanna, Jessica C Hassel, Felix Kiecker, Barbara Ellers-Lenz, Marcis Bajars, Gülseren Güzel, Paul Nghiem, Matthias Hunger, Michael Schlichting, Mickaël Henry-Szatkowski, Sandra P D'Angelo

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).

Keywords: FACT-M questionnaire; Merkel cell carcinoma; health-related quality of life; patient reported outcome; self report.

Figures

Figure 1.. Average difference in scores related…
Figure 1.. Average difference in scores related to nonprogression (magnitude of respective bars show by how much patients with nonprogression reported higher health-related quality of life compared with patients with progression).
FACT-M: Functional Assessment of Cancer Therapy – Melanoma; FACT-G: Functional Assessment of Cancer Therapy – General; MCC: Merkel cell carcinoma; VAS: Visual analog scale.
Figure 2.. Health-related quality of life-based deterioration-free…
Figure 2.. Health-related quality of life-based deterioration-free survival in terms of time to definitive deterioration based on Functional Assessment of Cancer Therapy – Melanoma and EQ visual analog scale versus progression-free survival (in median months).
FACT-M: Functional Assessment of Cancer Therapy – Melanoma; FACT-G: Functional Assessment of Cancer Therapy – General; MCC: Merkel cell carcinoma; NE: Not estimable; PFS: Progression-free survival; QFS: Deterioration-free survival; VAS: Visual analog scale.
Figure 3.. Health-related quality of life-based deterioration-free…
Figure 3.. Health-related quality of life-based deterioration-free survival rates based on Functional Assessment of Cancer Therapy – Melanoma and EQ visual analog scale versus progression-free survival rates; 6 and 12 months.
FACT-M: Functional Assessment of Cancer Therapy – Melanoma; FACT-G: Functional Assessment of Cancer Therapy – General; MCC: Merkel cell carcinoma; PFS: Progression-free survival; QFS: Deterioration-free survival; VAS: Visual analog scale.

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