Iivanainen Sanna, Alanko Tuomo, Vihinen Pia, Konkola Teemu, Ekstrom Jussi, Virtanen Henri, Koivunen Jussi
Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland.
Docrates Cancer Center, Helsinki, Finland.
JMIR Form Res. 2020 Oct 28;4(10):e17898. doi: 10.2196/17898.
Immune checkpoint inhibitors (ICIs) have become a standard of care for various tumor types. Their unique spectrum of side effects demands continuous and long-lasting assessment of symptoms. Electronic patient-reported outcome (ePRO) follow-up has been shown to improve survival and quality of life of cancer patients treated with chemotherapy.
This study aimed to investigate whether ePRO follow-up of cancer patients treated with ICIs is feasible. The study analyzed (1) the variety of patient reported symptoms, (2) etiology of alerts, (3) symptom correlations, and (4) patient compliance.
In this prospective, one-arm, multi-institutional study, we recruited adult cancer patients whose advanced cancer was treated with anti-programmed cell death protein 1 (PD)- ligand (L)1 agents in outpatient settings. The ePRO tool consisted of a weekly questionnaire evaluating the presence of typical side effects, with an algorithm assessing the severity of the symptom according to National Cancer Institute Common Terminology Criteria for Adverse Events and an urgency algorithm sending alerts to the care team. A patient experience survey was conducted monthly. The patients were followed up to 6 months or until disease progression.
A total of 889 symptom questionnaires was completed by 37 patients (lung cancer, n=15; melanoma, n=9; genitourinary cancer, n=9; head and neck cancer, n=4). Patients showed good adherence to ePRO follow-up. The most common grade 1 symptoms were fatigue (28%) and itching (13%), grade 2 symptoms were loss of appetite (12%) and nausea (12%), and grade 3-4 symptoms were cough (6%) and loss of appetite (4%). The most common reasons for alerts were loss of appetite and shortness of breath. In the treatment benefit analysis, positive correlations were seen between clinical benefit and itching as well as progressive disease and chest pain.
According to the results, ePRO follow-up of cancer patients receiving ICIs is feasible. ePROs capture a wide range of symptoms. Some symptoms correlate to treatment benefit, suggesting that individual prediction models could be generated.
Clinical Trials Register, NCT3928938; https://clinicaltrials.gov/ct2/show/NCT03928938.
免疫检查点抑制剂（ICIs）已成为多种肿瘤类型的标准治疗方法。其独特的副作用谱需要对症状进行持续且长期的评估。电子患者报告结局（ePRO）随访已被证明可改善接受化疗的癌症患者的生存率和生活质量。
本研究旨在调查对接受ICIs治疗的癌症患者进行ePRO随访是否可行。该研究分析了（1）患者报告的症状种类，（2）警报的病因，（3）症状相关性，以及（4）患者依从性。
在这项前瞻性、单臂、多机构研究中，我们招募了成年癌症患者，这些患者的晚期癌症在门诊环境中接受抗程序性细胞死亡蛋白1（PD）-配体（L）1药物治疗。ePRO工具包括一份每周问卷，评估典型副作用的存在情况，以及一种根据美国国立癌症研究所不良事件通用术语标准评估症状严重程度的算法和一种向护理团队发送警报的紧急算法。每月进行一次患者体验调查。对患者随访6个月或直至疾病进展。
37名患者（肺癌，n = 15；黑色素瘤，n = 9；泌尿生殖系统癌症，n = 9；头颈癌，n = 4）共完成了889份症状问卷。患者对ePRO随访表现出良好的依从性。最常见的1级症状是疲劳（28%）和瘙痒（13%），2级症状是食欲不振（12%）和恶心（12%），3 - 4级症状是咳嗽（6%）和食欲不振（4%）。警报的最常见原因是食欲不振和呼吸急促。在治疗获益分析中，临床获益与瘙痒以及疾病进展与胸痛之间存在正相关。
根据结果，对接受ICIs治疗的癌症患者进行ePRO随访是可行的。ePRO能够捕捉广泛的症状。一些症状与治疗获益相关，这表明可以生成个体预测模型。
临床试验注册，NCT3928938；https://clinicaltrials.gov/ct2/show/NCT03928938 。
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