Patient Experiences with Avelumab in Treatment-Naïve Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial

Jérémy Lambert, Alexia Marrel, Sandra P. D’Angelo, Melissa A. Burgess, Bartosz Chmielowski, Nicola Fazio, Thilo Gambichler, Jean-Jacques Grob, Céleste Lebbé, Caroline Robert, Jeffrey Russell, Gülseren Güzel and Murtuza Bharmal ()
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Jérémy Lambert: Patient-Centred Outcomes, ICON Plc
Alexia Marrel: Patient-Centred Outcomes, ICON Plc
Sandra P. D’Angelo: University of Pittsburgh Medical Center Hillman Cancer Center
Melissa A. Burgess: Memorial Sloan Kettering Cancer Center
Bartosz Chmielowski: UCLA Jonsson Comprehensive Cancer Center
Nicola Fazio: IRCCS
Thilo Gambichler: Ruhr University
Jean-Jacques Grob: Aix-Marseille University
Céleste Lebbé: Université de Paris, INSERM U976, and Dermatology and CIC, AP-HP, Saint Louis Hospital
Caroline Robert: Institut Gustave Roussy
Jeffrey Russell: Immunocore, LLC
Gülseren Güzel: Merck KGaA
Murtuza Bharmal: EMD Serono

The Patient: Patient-Centered Outcomes Research, 2020, vol. 13, issue 4, No 7, 457-467

Abstract: Abstract Background and Objective Avelumab is approved for the treatment of metastatic Merkel cell carcinoma, a rare aggressive skin cancer with a poor prognosis. The aim of this qualitative study embedded in a clinical trial was to explore patient experiences while receiving avelumab. Methods All treatment-naïve patients with metastatic Merkel cell carcinoma entering part B of the phase II, open-label, international, JAVELIN Merkel 200 trial (NCT02155647) were invited to participate in optional semi-structured phone interviews before avelumab administration (baseline) and at weeks 13 and 25. Interviews were conducted by trained professionals, audio-recorded, transcribed and analysed. Key concepts identified at baseline were assessed during follow-up interviews. Results Twenty-nine patients completed the baseline interview; 19 had at least one follow-up interview. Baseline interviews described the patients’ challenging journeys before being correctly diagnosed with Merkel cell carcinoma, the negative psychological burden of living with a symptomless disease and the hope for avelumab to be a successful therapy. During the trial, most patients reported an increased or continued sense of hope and willingness to fight metastatic Merkel cell carcinoma. Patients who self-reported disease improvement (n = 12) also reported stability or improvement in physical well-being and ability to do daily activities, having more energy, worrying less and being optimistic. Six patients who reported their condition as stable (n = 4) or worsened (n = 3) reported a worsening of physical well-being. Nine patients reported fatigue/tiredness on the day of and after receiving avelumab. Baseline and longitudinal experiences were similar across countries. Conclusions This study suggests that patients experience perceptible benefits in physical and psychological well-being following treatment success with first-line avelumab in metastatic Merkel cell carcinoma.

Date: 2020
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DOI: 10.1007/s40271-020-00428-5

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