Department of Oncology and Radiotherapy, Oulu University Hospital (OYS), MRC Oulu, P.B. 22, 90029, Oulu, Finland.
Docrates Cancer Center, Helsinki, Finland.
J Cancer Res Clin Oncol. 2019 Mar;145(3):765-774. doi: 10.1007/s00432-018-02835-6. Epub 2019 Jan 21.
Patient-reported outcome (PRO) follow-up has been shown to improve quality of life (QoL) and survival of cancer patients receiving chemotherapy. Kaiku Health application is a web-based electronic PRO (ePRO) tool which is designed for follow-up of cancer patients receiving immune checkpoint inhibitors (ICI). Purpose of the current study is to investigate whether symptoms collected by Kaiku Health ePRO tool on cancer patients receiving immune checkpoint inhibitors (ICI) follows to symptoms reported in clinical trials and whether coupling of specific symptoms does occur.
We retrospectively collected data on symptom timing and severity, and QoL of patients followed with Kaiku Health IO module in two Finnish cancer centers between 2017 and 2018. Kaiku Health IO module consists of 18 adaptive questions, which assess the presence and severity of symptoms. Patients were requested (via e-mail) to fill online symptom questionnaires with 3-7 day interval and QoL questionnaires (QLQ-C30) with 1-2 month interval.
The IO module was used to follow 37 patients who had filled in total 559 symptom questionnaires. There was good adherence to ePRO follow-up with a median of 11 questionnaires filled per patient. The reported symptoms and their severity follow closely what has been seen in clinical trials investigating ICIs. Correlation analysis of the symptoms showed the strongest positive correlations between itching and rash; nausea and vomiting, decreased appetite, or stomach pain; cough and shortness of breath.
The results of the current study suggest that real-world symptom data collected through the ePRO application on cancer patients receiving ICI therapy aligns with the data from clinical trials. Correlations between different symptoms occur, which might reflect therapeutic efficiency, side effects, or tumor progression. These correlations should be further investigated with data coupled to clinical outcomes.
患者报告的结局（PRO）随访已被证明可以改善接受化疗的癌症患者的生活质量（QoL）和生存率。Kaiku Health 应用程序是一种基于网络的电子 PRO（ePRO）工具，专为接受免疫检查点抑制剂（ICI）治疗的癌症患者的随访而设计。本研究的目的是调查接受免疫检查点抑制剂（ICI）治疗的癌症患者通过 Kaiku Health ePRO 工具收集的症状是否与临床试验中报告的症状相符，以及是否会出现特定症状的关联。
我们回顾性地收集了 2017 年至 2018 年期间在芬兰两家癌症中心接受 Kaiku Health IO 模块随访的患者的症状出现时间、严重程度和生活质量数据。Kaiku Health IO 模块由 18 个自适应问题组成，用于评估症状的存在和严重程度。患者通过电子邮件被要求每隔 3-7 天在线填写症状问卷，每隔 1-2 个月填写一次生活质量问卷（QLQ-C30）。
IO 模块共用于随访 37 名患者，共填写了 559 份症状问卷。患者对 ePRO 随访的依从性良好，中位数为每位患者填写了 11 份问卷。报告的症状及其严重程度与临床试验中研究 ICI 非常吻合。对症状的相关性分析显示，瘙痒和皮疹之间存在最强的正相关；恶心、呕吐、食欲减退或胃痛；咳嗽和呼吸急促之间也存在最强的正相关。
本研究结果表明，通过接受 ICI 治疗的癌症患者 ePRO 应用程序收集的真实世界症状数据与临床试验数据相符。不同症状之间存在相关性，这可能反映了治疗效果、副作用或肿瘤进展。应进一步结合临床结果的数据对这些相关性进行研究。
