Health-related Quality of Life Trajectory of Treatment-naive Patients with Merkel Cell Carcinoma Receiving Avelumab

Overview

Journal Future Oncol

Specialty Oncology

Date 2020 Sep 17

PMID 32938212

Citations 2

Authors

Murtuza Bharmal

Sandra Nolte

Celeste Lebbe

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

Gulseren Guzel

Paul Nghiem

Matthias Hunger

Michael Schlichting

Mickael Henry-Szatkowski

Sandra P DAngelo

Affiliations

Soon will be listed here.

Abstract

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). 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. 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). These findings show unique longitudinal HRQoL data for treatment-naive metastatic Merkel cell carcinoma patients treated with avelumab. : NCT02155647 (ClinicalTrials.gov).

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References

Bharmal M, Fofana F, Dias Barbosa C, Williams P, Mahnke L, Marrel A . Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma. Health Qual Life Outcomes. 2017; 15(1):247. PMC: 5741938. DOI: 10.1186/s12955-017-0815-5. View

Barnes S, Mallinckrodt C, Lindborg S, Carter M . The impact of missing data and how it is handled on the rate of false-positive results in drug development. Pharm Stat. 2007; 7(3):215-25. DOI: 10.1002/pst.310. View

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011; 20(10):1727-36. PMC: 3220807. DOI: 10.1007/s11136-011-9903-x. View

Bharmal M, Hunger M, Schlichting M . Psychometric Properties of EQ-5D-5L Scoring Algorithms for the United Kingdom in Metastatic Merkel Cell Carcinoma. Value Health. 2019; 22(10):1170-1177. DOI: 10.1016/j.jval.2019.05.010. View

Cormier J, Davidson L, Xing Y, Webster K, Cella D . Measuring quality of life in patients with melanoma: development of the FACT-melanoma subscale. J Support Oncol. 2005; 3(2):139-45. View

Soult M, Feliberti E, Silverberg M, Perry R . Merkel cell carcinoma: high recurrence rate despite aggressive treatment. J Surg Res. 2012; 177(1):75-80. DOI: 10.1016/j.jss.2012.03.067. View

Lemos B, Storer B, Iyer J, Phillips J, Bichakjian C, Fang L . Pathologic nodal evaluation improves prognostic accuracy in Merkel cell carcinoma: analysis of 5823 cases as the basis of the first consensus staging system. J Am Acad Dermatol. 2010; 63(5):751-61. PMC: 2956767. DOI: 10.1016/j.jaad.2010.02.056. View

Medina-Franco H, Urist M, Fiveash J, Heslin M, Bland K, Beenken S . Multimodality treatment of Merkel cell carcinoma: case series and literature review of 1024 cases. Ann Surg Oncol. 2001; 8(3):204-8. DOI: 10.1007/s10434-001-0204-4. View

. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990; 16(3):199-208. DOI: 10.1016/0168-8510(90)90421-9. View

10.

DAngelo S, Russell J, Lebbe C, Chmielowski B, Gambichler T, Grob J . Efficacy and Safety of First-line Avelumab Treatment in Patients With Stage IV Metastatic Merkel Cell Carcinoma: A Preplanned Interim Analysis of a Clinical Trial. JAMA Oncol. 2018; 4(9):e180077. PMC: 5885245. DOI: 10.1001/jamaoncol.2018.0077. View

11.

Schadendorf D, Lebbe C, Zur Hausen A, Avril M, Hariharan S, Bharmal M . Merkel cell carcinoma: Epidemiology, prognosis, therapy and unmet medical needs. Eur J Cancer. 2016; 71:53-69. DOI: 10.1016/j.ejca.2016.10.022. View

12.

Miller N, Bhatia S, Parvathaneni U, Iyer J, Nghiem P . Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma. Curr Treat Options Oncol. 2013; 14(2):249-63. PMC: 3651762. DOI: 10.1007/s11864-013-0225-9. View

13.

Lambert J, Marrel A, DAngelo S, Burgess M, Chmielowski B, Fazio N . Patient Experiences with Avelumab in Treatment-Naïve Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020; 13(4):457-467. PMC: 7340640. DOI: 10.1007/s40271-020-00428-5. View

14.

Kaufman H, Russell J, Hamid O, Bhatia S, Terheyden P, DAngelo S . Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016; 17(10):1374-1385. PMC: 5587154. DOI: 10.1016/S1470-2045(16)30364-3. View

15.

Kaufman H, Dias Barbosa C, Guillemin I, Lambert J, Mahnke L, Bharmal M . Living with Merkel Cell Carcinoma (MCC): Development of a Conceptual Model of MCC Based on Patient Experiences. Patient. 2018; 11(4):439-449. PMC: 6019419. DOI: 10.1007/s40271-018-0301-0. View

16.

Kaufman H, Hunger M, Hennessy M, Schlichting M, Bharmal M . Nonprogression with avelumab treatment associated with gains in quality of life in metastatic Merkel cell carcinoma. Future Oncol. 2017; 14(3):255-266. DOI: 10.2217/fon-2017-0470. View

17.

Bharmal M, Nolte S, Henry-Szatkowski M, Hennessy M, Schlichting M . Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naïve and previously treated patients with metastatic Merkel cell carcinoma. Health Qual Life Outcomes. 2020; 18(1):145. PMC: 7236271. DOI: 10.1186/s12955-020-01402-3. View