患者报告结局对检查点抑制剂治疗期间症状监测的影响：一项随机对照试验中黑色素瘤患者的健康相关生活质量
Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial.
作者信息
Tolstrup Lærke K, Pappot Helle, Bastholt Lars, Möller Sören, Dieperink Karin B
机构信息
Department of Oncology, Odense University Hospital, Odense, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
出版信息
J Patient Rep Outcomes. 2022 Jan 21;6(1):8. doi: 10.1186/s41687-022-00414-5.
INTRODUCTION
In a randomized controlled trial, we previously investigated if melanoma patients receiving checkpoint inhibitors had fewer severe immune-related adverse events (irAEs) when they reported symptoms using electronic patient-reported outcomes (ePRO) with triggered alerts as an add-on to standard care, compared to standard care alone. The aim of this study is to examine between-group differences in health-related quality of life (HRQoL) and associations between irAEs severity and HRQoL.
METHODS
The study population of 138 patients completed the EuroQol EQ-5D-5L Index and FACT-M questionnaires at baseline and weeks 24 and 48. We analyzed HRQoL from all patients who completed at least one questionnaire. Missing FACT-M items were imputed following existing guidelines.
RESULTS
There was no difference in HRQoL at baseline as measured EQ-5D-5L between the intervention and the control group. Between baseline and 48 weeks, mean EQ-5D-5L scores were unchanged among patients in the intervention group (p = 0.81) but decreased significantly among patients in the control group (p = 0.03). Consequently, patients in the intervention group had higher mean scores than those in the control group (p = 0.05) at 48 weeks. Mean FACT-M scores did not differ significantly between the two groups at any of the time points. There were observed no between-group differences in mean EQ-5D-5 and mean FACT-M scores between patients with severe irAEs and patients who had none.
CONCLUSION
Melanoma patients receiving CPIs who self-reported irAEs using ePRO with triggered alerts as a supplement to standard care maintained their HRQoL compared to patients who received standard care alone. Patients in the intervention group had a significantly better HRQoL measured by EQ-5D-5L than controls 48 weeks after baseline. The results suggest that including ePRO in standard care increases melanoma patients´ well-being. Further and larger studies are needed to confirm this finding and examine the impact of severe irAEs on cancer patients' HRQoL.
TRIAL REGISTRATION
Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered https://clinicaltrials.gov/ .
引言
在一项随机对照试验中，我们之前研究了与单纯标准治疗相比，接受检查点抑制剂的黑色素瘤患者在使用电子患者报告结局（ePRO）并触发警报作为标准治疗的补充来报告症状时，是否有更少的严重免疫相关不良事件（irAE）。本研究的目的是检查健康相关生活质量（HRQoL）的组间差异以及irAE严重程度与HRQoL之间的关联。
方法
138名患者的研究人群在基线、第24周和第48周完成了欧洲五维健康量表（EuroQol EQ-5D-5L）指数和FACT-M问卷。我们分析了所有完成至少一份问卷的患者的HRQoL。按照现有指南对缺失的FACT-M项目进行了估算。
结果
干预组和对照组在基线时通过EQ-5D-5L测量的HRQoL没有差异。在基线和48周之间，干预组患者的平均EQ-5D-5L评分没有变化（p = 0.81），但对照组患者的评分显著下降（p = 0.03）。因此，在48周时，干预组患者的平均评分高于对照组（p = 0.05）。在任何时间点，两组之间的平均FACT-M评分均无显著差异。在有严重irAE的患者和没有严重irAE的患者之间，观察到EQ-5D-5和FACT-M平均评分没有组间差异。
结论
与仅接受标准治疗的患者相比，使用ePRO并触发警报作为标准治疗补充自我报告irAE的接受检查点抑制剂的黑色素瘤患者维持了他们的HRQoL。在基线后48周，通过EQ-5D-5L测量，干预组患者的HRQoL明显优于对照组。结果表明，在标准治疗中纳入ePRO可提高黑色素瘤患者的幸福感。需要进一步的大规模研究来证实这一发现，并检查严重irAE对癌症患者HRQoL的影响。
试验注册
Clinicaltrials.gov NCT03073031，于2017年3月8日注册，追溯注册https://clinicaltrials.gov/ 。
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