Patient experiences with avelumab in treatment-naïve metastatic Merkel cell carcinoma: Longitudinal qualitative interview findings from JAVELIN Merkel 200, a registrational clinical trial Journal Article


Authors: Lambert, J.; Marrel, A.; D’Angelo, S. P.; Burgess, M. A.; Chmielowski, B.; Fazio, N.; Gambichler, T.; Grob, J. J.; Lebbé, C.; Robert, C.; Russell, J.; Güzel, G.; Bharmal, M.
Article Title: Patient experiences with avelumab in treatment-naïve metastatic Merkel cell carcinoma: Longitudinal qualitative interview findings from JAVELIN Merkel 200, a registrational clinical trial
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. © 2020, The Author(s).
Keywords: clinical article; controlled study; aged; drug safety; systemic therapy; drug approval; cancer radiotherapy; follow up; cancer diagnosis; metastasis; tumor volume; cancer therapy; self report; multicenter study; cancer fatigue; merkel cell carcinoma; daily life activity; sleep disorder; qualitative research; longitudinal study; semi structured interview; muscle cramp; hair loss; single blind procedure; disease burden; human; male; female; priority journal; article; avelumab; physical well-being
Journal Title: The Patient: Patient-Centered Outcomes Research
Volume: 13
Issue: 4
ISSN: 1178-1653
Publisher: Springer Germany  
Date Published: 2020-08-01
Start Page: 457
End Page: 467
Language: English
DOI: 10.1007/s40271-020-00428-5
PUBMED: 32472503
PROVIDER: scopus
PMCID: PMC7340640
DOI/URL:
Notes: Sandra D'Angelo's affiliation is mislabeled on the original publication, MSK affiliation confirmed via communication with author -- Article -- Export Date: 3 August 2020 -- Source: Scopus
Altmetric
Citation Impact
BMJ Impact Analytics
MSK Authors
  1. Sandra Pierina D'Angelo
    252 D'Angelo