Patient-reported symptom monitoring in patients with lung cancer (SYMPRO-Lung trial): long-term, post-hoc survival results of a multicentre, stepped-wedged, cluster-randomised clinical trial.

We aimed to assess the effect of PRO symptom monitoring on overall and progression-free survivalin patients with stage I-IV lung cancer in a real-world clinical setting, with follow-up extending to 5 years.

我们的目标是评估PRO症状监测对I-IV期肺癌患者总体和无进展生存率的影响，在现实世界的临床环境中，随访时间延长至5年。

Methods

The SYMPRO-Lung trial was a multicentre, stepped-wedged, cluster-randomised clinical trial across 14 medical centres in the Netherlands.

SYMPRO-Lung试验是一项在荷兰14个医疗中心进行的多中心、分步楔形、群组随机临床试验。

Patients were eligible for inclusion if they were aged 18 years or older with stage I-IV lung cancer (new-onset or recurrent; cytologically or histologically confirmed or radiological suspected) and were starting new treatment.

如果患者年龄在18岁或以上，患有I-IV期肺癌（新发或复发；细胞学或组织学证实或放射学怀疑），并且正在开始新的治疗，那么他们就有资格被纳入研究。

All hospitals started with a control period (standard of care) and, according to randomisation by a computer-generated allocation sequence, crossed over at predefined timepoints to the intervention period (completing weekly online symptom assessments for 1 year).

所有医院开始时都有一个对照期（标准护理），然后根据计算机生成的分配序列进行随机化，按照预定的时间点交叉到干预期（完成为期一年的每周在线症状评估）。

The primary outcome for SYMPRO-Lung trial was health-related quality of life, which has been previously reported.

SYMPRO-Lung试验的主要结果是与健康相关的生活质量，这之前已经有过报道。

In this post-hoc analysis, we assessed long-term survival outcomes of overall survivaland progression-free survival, with overall survivalas the primary outcome.

在这项事后分析中，我们评估了总体生存率和无进展生存率的长期生存结果，以总体生存率为主要结果。

Survival analyses in the intention-to-treatpopulation was performed using Cox mixed-effects modelling, adjusted for age, sex, stage, histology, Eastern Cooperative Oncology Group performance status, systemic treatment line, and a random effect for site clustering.

在意向治疗人群中进行了生存分析，使用Cox混合效应模型，根据年龄、性别、分期、组织学、东部肿瘤协作组表现状态、系统治疗线和站点聚类的随机效应进行了调整。

The study is registered with Netherlands Trial Register, NL7897, and is complete.

该研究已在荷兰试验注册处注册，编号为NL7897，并已完成。

Results

Of the 515 patients initially enrolled to the SYMPRO-Lung trial between Oct 24, 2019, and Sept 16, 2021, 446 (87%) patients were included in this post-hoc analysis (230 [52%] male; 216 [48%] female). 235 (53%) were assigned to the pooled intervention group and 211 (47%) patients to the control group. 69 (13%) of 515 patients were excluded due to the absence of informed consent for the use of their data in follow-up research or because linkage to the Netherlands Cancer Registry could not be established.

在2019年10月24日至2021年9月16日期间，共有515名患者最初被纳入SYMPRO-Lung试验，其中446名（87%）患者被纳入这项事后分析（230名[52%]为男性；216名[48%]为女性）。235名（53%）被分配到综合干预组，211名（47%）患者被分配到对照组。由于缺乏同意使用其数据进行后续研究的知情同意，或无法与荷兰癌症登记处建立联系，共有69名（13%）的515名患者被排除在外。

At a median follow-up 50 months (IQR 46-55), median overall survivalwas 26 months in the intervention group (IQR 9-not reached, 95% CI 21-33) compared with 21 months (IQR 10-54, 95% CI 17-26) in the control group.

在中位随访50个月（四分位数间距46-55）时，综合干预组的中位总生存期为26个月（四分位数间距9-未达到，95%置信区间21-33），而对照组为21个月（四分位数间距10-54，95%置信区间17-26）。

Analyses adjusting for confounders showed that PRO symptom monitoring might be associated with improved overall survival(hazard ratio[HR] 0·80, 95% CI 0·63-1·00, p=0·049).

调整混杂因素后的分析显示，PRO症状监测可能与改善总生存期相关（风险比[HR] 0·80，95%置信区间0·63-1·00，p=0·049）。

Analyses adjusting for confounders showed that PRO symptom monitoring showed no significant difference in progression-free survivalbetween groups (0·86, 0·70-1·07; p=0·18).

调整混杂因素后的分析显示，PRO症状监测在两组间无显著差异的无进展生存期（0·86，0·70-1·07；p=0·18）。

interpretation

Weekly PRO symptom monitoring was associated with meaningful improvement in long-term overall survivalamong patients with stage I-IV lung cancer.

每周进行PRO症状监测与肺癌患者长期总生存期的显著改善相关。

Median overall survivalwas 5 months longer in the intervention group than in the control group.

综合干预组的中位总生存期比对照组长5个月。

These findings underscore the value of implementing PRO symptom monitoring within routine care for patients with lung cancer.

这些发现强调了在肺癌患者常规护理中实施PRO症状监测的价值。

funding

Roche Netherlands, Stichting Kwaliteitsgelden Medisch Specialisten, and Zorginnovatiefonds.

罗氏荷兰公司、荷兰医学专家质量基金和医疗创新基金。

translation

For the Dutch translation of the abstract see Supplementary Materials section.

摘要的荷兰语翻译请参见补充材料部分。