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初治转移性默克尔细胞癌患者接受avelumab 治疗的体验:来自 JAVELIN Merkel 200 注册临床研究的纵向定性访谈结果。

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

机构信息

Patient-Centred Outcomes, ICON Plc, Lyon, France.

University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA.

出版信息

Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5.

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.

摘要

背景与目的

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。

方法

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。

结果

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。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2123/7340640/6a95a93f5c78/40271_2020_428_Fig1_HTML.jpg

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