TY - JOUR
T1 - Patient Experiences with Avelumab in Treatment-Naïve Metastatic Merkel Cell Carcinoma
T2 - Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial
AU - Lambert, Jérémy
AU - Marrel, Alexia
AU - D’Angelo, Sandra P.
AU - Burgess, Melissa A.
AU - Chmielowski, Bartosz
AU - Fazio, Nicola
AU - Gambichler, Thilo
AU - Grob, Jean Jacques
AU - Lebbé, Céleste
AU - Robert, Caroline
AU - Russell, Jeffrey
AU - Güzel, Gülseren
AU - Bharmal, Murtuza
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2020/8/1
Y1 - 2020/8/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85085618063&partnerID=8YFLogxK
U2 - 10.1007/s40271-020-00428-5
DO - 10.1007/s40271-020-00428-5
M3 - Article
C2 - 32472503
AN - SCOPUS:85085618063
SN - 1178-1653
VL - 13
SP - 457
EP - 467
JO - Patient
JF - Patient
IS - 4
ER -