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.

• Authors: 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, Murtuza Bharmal
• Journal: The patient (Patient) Vol. 13 Issue 4 Pg. 457-467 (08 2020) ISSN: 1178-1661 [Electronic] New Zealand
• PMID: 32472503 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents, Immunological
• avelumab

Topics

• Activities of Daily Living
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Agents, Immunological (administration & dosage, adverse effects, therapeutic use)
• Carcinoma, Merkel Cell (drug therapy, pathology, psychology)
• Female
• Health Status
• Humans
• Interviews as Topic
• Longitudinal Studies
• Male
• Middle Aged
• Neoplasm Grading
• Quality of Life
• Skin Neoplasms (drug therapy, pathology, psychology)