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

• Published in: The patient : patient-centered outcomes research Vol. 13; no. 4; pp. 457 - 467
• Main Authors: Lambert, Jérémy, Marrel, Alexia, D’Angelo, Sandra P., Burgess, Melissa A., Chmielowski, Bartosz, Fazio, Nicola, Gambichler, Thilo, Grob, Jean-Jacques, Lebbé, Céleste, Robert, Caroline, Russell, Jeffrey, Güzel, Gülseren, Bharmal, Murtuza
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01-08-2020; Springer Nature B.V
• Subjects: Activities of Daily Living; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antineoplastic Agents, Immunological - administration & dosage; Antineoplastic Agents, Immunological - adverse effects; Antineoplastic Agents, Immunological - therapeutic use; Cancer therapies; Carcinoma, Merkel Cell - drug therapy; Carcinoma, Merkel Cell - pathology; Carcinoma, Merkel Cell - psychology; Chemotherapy; Clinical trials; FDA approval; Female; Health Administration; Health Economics; Health Status; Humans; Immunotherapy; Interviews; Interviews as Topic; Longitudinal Studies; Male; Medical prognosis; Medicine; Medicine & Public Health; Metastasis; Middle Aged; Monoclonal antibodies; Neoplasm Grading; Original; Original Research Article; Patient satisfaction; Pharmacoeconomics and Health Outcomes; Public Health; Quality of Life; Quality of Life Research; Skin cancer; Skin Neoplasms - drug therapy; Skin Neoplasms - pathology; Skin Neoplasms - psychology; Targeted cancer therapy; United States > US
• ISSN: 1178-1653; 1178-1661
• DOI: 10.1007/s40271-020-00428-5

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.