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. 2020 Sep;16(27):2089-2099.
doi: 10.2217/fon-2020-0426. Epub 2020 Sep 17.

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

Murtuza Bharmal  1 , Sandra Nolte  2   3 , Céleste Lebbé  4 , Laurent Mortier  5 , Andrew S Brohl  6 , Nicola Fazio  7 , Jean-Jacquez Grob  8 , Sara Pusceddu  9 , Glenn J Hanna  10 , Jessica C Hassel  11 , Felix Kiecker  3 , Barbara Ellers-Lenz  12 , Marcis Bajars  13 , Gülseren Güzel  12 , Paul Nghiem  14 , Matthias Hunger  2 , Michael Schlichting  12 , Mickaël Henry-Szatkowski  2 , Sandra P D'Angelo  15
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Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab

Murtuza Bharmal et al. Future Oncol. 2020 Sep.

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.

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Figures

Figure 1.
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.
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.
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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