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肺癌患者自我报告结局与神经认知功能的真实世界数据:PRO-Long研究

Real Life Data on Patient-Reported Outcomes and Neuro-Cognitive Functioning of Lung Cancer Patients: The PRO-Long Study.

作者信息

Van Der Weijst Lotte, Surmont Veerle, Schrauwen Wim, Lievens Yolande

机构信息

Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.

Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.

出版信息

Front Oncol. 2021 Jun 17;11:685605. doi: 10.3389/fonc.2021.685605. eCollection 2021.

DOI:10.3389/fonc.2021.685605
PMID:34222010
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8247464/
Abstract

INTRODUCTION

This report investigates the impact of systemic treatments (chemotherapy or immunotherapy) with(out) loco-regional radiotherapy, on HRQoL, toxicity and neurocognitive functioning (NCF) in locally advanced and metastatic non-small cell lung cancer patients enrolled in the PRO-Long study.

MATERIALS AND METHODS

Data on patient-reported HRQoL and fourteen toxicities was collected, while NCF was tested, up to one-year post-treatment. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30. Lung cancer, treatment and neuro-psychological related toxicities were scored with the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. NCF was evaluated with six neurocognitive tests. Mixed model analyses were conducted to determine statistical significance (p = .01). Meaningful clinical important differences (MCIDs) were applied for changes in HRQoL and NCF data, while toxicities were compared to baseline values.

RESULTS

In total, 50 patients were enrolled. Overall HRQoL (p = .357) nor its domains (physical, p = .643; role, p = .069; emotional, p = .254; cognitive, p = 494; social, p = .735) changed significantly over time. Meaningful improvements in overall HRQoL were seen in 22, 38 and 39% and deteriorations in 22, 5 and 28% of patients at 2-3, 6 and 12 months respectively post-treatment. Overall toxicity (p = .007), lack of appetite (p = .001), nausea (p = .004) and dysphagia (p = .000) significantly decreased over time. Treatment caused acute toxicity, such as dyspnoea (45%) and memory problems (42%), but also alleviated pre-existing symptoms, including lack of appetite (32%), anxiety (29%) and depression (28%) at 2/3 months. The NCF domains of visual memory (p = .000) and cognitive processing speed (p = .000) showed significant improvements over time. In terms of MCIDs, at 2-3 months (18%) and 6 months (15%), verbal memory was particularly impacted; at 12 months, visual memory (18%) and executive function (18%) deteriorated primarily.

CONCLUSION

The results suggest that therapy has no significant negative impact on overall HRQoL, its domains, and NCF. About one-third of patients reported a meaningful improved HRQoL at 1 year post-treatment. Treatment caused toxicity, but also alleviated pre-existing symptoms.

摘要

引言

本报告调查了在PRO-Long研究中纳入的局部晚期和转移性非小细胞肺癌患者接受(或未接受)局部区域放疗的全身治疗(化疗或免疫治疗)对健康相关生活质量(HRQoL)、毒性和神经认知功能(NCF)的影响。

材料与方法

收集患者报告的HRQoL和14种毒性的数据,同时在治疗后长达一年的时间里对NCF进行测试。使用欧洲癌症研究与治疗组织的QLQ-C30评估HRQoL。用不良事件通用术语标准的患者报告结局版本对肺癌、治疗及神经心理相关毒性进行评分。用六项神经认知测试评估NCF。进行混合模型分析以确定统计学显著性(p = 0.01)。对HRQoL和NCF数据的变化应用有临床意义的重要差异(MCID),同时将毒性与基线值进行比较。

结果

总共纳入了50名患者。总体HRQoL(p = 0.357)及其各领域(身体领域,p = 0.643;角色领域,p = 0.069;情感领域,p = 0.254;认知领域,p = 0.494;社会领域,p = 0.735)随时间均未发生显著变化。治疗后2至3个月、6个月和12个月时,分别有22%、38%和39%的患者总体HRQoL有有意义的改善,22%、5%和28%的患者总体HRQoL恶化。总体毒性(p = 0.007)、食欲不振(p = 0.001)、恶心(p = 0.004)和吞咽困难(p = 0.000)随时间显著降低。治疗导致急性毒性,如呼吸困难(45%)和记忆问题(42%),但在2/3个月时也缓解了一些既往存在的症状,包括食欲不振(32%)、焦虑(29%)和抑郁(28%)。视觉记忆(p = 0.000)和认知处理速度(p = 0.000)的NCF领域随时间显示出显著改善。就MCID而言,在2至3个月(18%)和6个月(15%)时,言语记忆受到的影响尤为明显;在12个月时,主要是视觉记忆(18%)和执行功能(18%)恶化。

结论

结果表明,治疗对总体HRQoL、其各领域和NCF没有显著负面影响。约三分之一的患者在治疗后1年报告HRQoL有有意义的改善。治疗导致了毒性,但也缓解了既往存在的症状。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47a/8247464/7355a1b26b0e/fonc-11-685605-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47a/8247464/48efd91a8bef/fonc-11-685605-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47a/8247464/0a906aaf9dc0/fonc-11-685605-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47a/8247464/7355a1b26b0e/fonc-11-685605-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47a/8247464/48efd91a8bef/fonc-11-685605-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47a/8247464/0a906aaf9dc0/fonc-11-685605-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47a/8247464/7355a1b26b0e/fonc-11-685605-g003.jpg

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