Patient-Centred Outcomes, ICON Plc, Lyon, France.
University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA.
Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5.
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.
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.
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.
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.
avelumab 获批用于治疗转移性 Merkel 细胞癌，这是一种罕见的侵袭性皮肤癌，预后较差。本研究为临床试验中的一项定性研究，旨在探讨转移性 Merkel 细胞癌患者接受avelumab 治疗时的体验。
所有入组 II 期、开放标签、国际 JAVELIN Merkel 200 试验（NCT02155647）的转移性 Merkel 细胞癌初治患者均受邀在接受 avelumab 治疗前（基线）和第 13 周、第 25 周参加可选的半结构化电话访谈。访谈由经过培训的专业人员进行，录音、转录并进行分析。基线时识别的关键概念在随访访谈中进行评估。
29 例患者完成了基线访谈；19 例患者至少完成了 1 次随访访谈。基线访谈描述了患者在被正确诊断为 Merkel 细胞癌之前的艰难历程、无症状疾病导致的负面心理负担，以及对 avelumab 成功治疗的期望。在试验期间，大多数患者报告说希望增加或持续增加，并愿意对抗转移性 Merkel 细胞癌。自我报告疾病改善的患者（n=12）还报告身体状况稳定或改善，日常活动能力提高，精力更充沛，担忧减少，乐观积极。6 例报告病情稳定（n=4）或恶化（n=3）的患者报告身体状况恶化。9 例患者报告在接受 avelumab 治疗当天及之后出现疲劳/疲倦。基线和纵向体验在各国相似。
本研究表明，转移性 Merkel 细胞癌患者在一线 avelumab 治疗成功后，在身体和心理健康方面均有明显获益。
