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基线健康相关生活质量和健康相关生活质量早期变化对晚期肺癌患者治疗反应和生存的预后影响:中国的一项前瞻性观察研究。

Prognostic effects of health-related quality of life at baseline and early change in health-related quality of life on response to treatment and survival in patients with advanced lung cancer: a prospective observational study in China.

机构信息

Department of Nursing, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.

Department of Clinical Research, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.

出版信息

BMJ Open. 2022 Feb 14;12(2):e047611. doi: 10.1136/bmjopen-2020-047611.

DOI:10.1136/bmjopen-2020-047611
PMID:35165103
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8845204/
Abstract

OBJECTIVES

To investigate the relationship among baseline health-related quality of life (HRQoL), early changes in HRQoL from baseline to completion of the first cycle of chemotherapy, and prognosis in patients with advanced lung cancer.

DESIGN

This was a prospective, observational study.

SETTING

The study was conducted in a national cancer centre in South China.

PARTICIPANTS

A total of 243 patients with chemo-naïve with advanced lung cancer were enrolled.

INTERVENTION

None.

PRIMARY AND SECONDARY OUTCOME MEASURES

The Functional Assessment of Cancer Therapy-Lung was used to assess HRQoL at baseline and at the end of the first cycle of chemotherapy. The Trial Outcome Index (TOI) and Lung Cancer Scale (LCS) were calculated as predictive indicators. Response to treatment was evaluated as per the Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1. Survival data were gathered from follow-up to September 2019.

RESULTS

Patients with 5-point or greater decreases in TOI (65% vs 48%, adjusted risk ratio (aRR)=2.19, 95% CI 1.09 to 4.41) or 2-point or greater decreases in LCS (72% vs 48%, aRR=3.29, 95% CI 1.50 to 7.22) from baseline to completion of the first cycle of chemotherapy were more likely to show stable or progressive disease than those whose HRQoL had improved. Baseline TOI ≤54 (80.0% vs 69.9%, adjusted hazard risk (aHR)=1.36, 95% CI 1.01 to 1.84) and LCS ≤21 (77.6% vs 72.5%, aHR=1.36, 95% CI 1.01 to 1.83) were associated with higher risk for death compared with TOI>54 and LCS>21. Area under the curve analysis indicated that early changes in LCS and baseline LCS scores could better predict response to treatment and overall survival than the corresponding TOI values.

CONCLUSIONS

Higher pretreatment HRQoL scores could predict longer survival, while declining HRQoL values could predict unfavourable treatment outcome among patients with advanced lung cancer. The use of the LCS is recommended for the routine collection of patient-reported HRQoL.

TRIAL REGISTRATION NUMBER

NCT01914120.

摘要

目的

探讨初治晚期肺癌患者基线健康相关生活质量(HRQoL)、化疗第一周期结束时基线至基线的 HRQoL 早期变化与预后的关系。

设计

这是一项前瞻性、观察性研究。

地点

研究在华南地区的一家国家癌症中心进行。

参与者

共纳入 243 例初治晚期肺癌、无化疗的患者。

干预措施

无。

主要和次要结局测量

采用癌症治疗功能评估-肺量表(Functional Assessment of Cancer Therapy-Lung,FACT-L)在基线和化疗第一周期结束时评估 HRQoL。计算治疗结果指数(Trial Outcome Index,TOI)和肺癌量表(Lung Cancer Scale,LCS)作为预测指标。根据实体瘤反应评估标准(Response Evaluation Criteria in Solid Tumors,RECIST)V.1.1 评估治疗反应。随访至 2019 年 9 月获取生存数据。

结果

与 HRQoL 改善的患者相比,化疗第一周期结束时 TOI 下降 5 分或以上(65%比 48%,调整风险比[aRR]=2.19,95%CI 1.09 至 4.41)或 LCS 下降 2 分或以上(72%比 48%,aRR=3.29,95%CI 1.50 至 7.22)的患者更有可能出现稳定或进展性疾病。与 TOI>54 和 LCS>21 的患者相比,基线时 TOI≤54(80.0%比 69.9%,调整危险比[aHR]=1.36,95%CI 1.01 至 1.84)和 LCS≤21(77.6%比 72.5%,aHR=1.36,95%CI 1.01 至 1.83)与死亡风险增加相关。曲线下面积分析表明,LCS 和基线 LCS 评分的早期变化可以比相应的 TOI 值更好地预测治疗反应和总生存。

结论

较高的预处理 HRQoL 评分可预测更长的生存时间,而 HRQoL 值的下降可预测晚期肺癌患者的不良治疗结果。建议常规收集患者报告的 HRQoL 时使用 LCS。

临床试验注册号

NCT01914120。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/bbeb6b46a602/bmjopen-2020-047611f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/5f75cb06d62d/bmjopen-2020-047611f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/a602915827ae/bmjopen-2020-047611f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/2a341f8d84e5/bmjopen-2020-047611f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/bbeb6b46a602/bmjopen-2020-047611f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/5f75cb06d62d/bmjopen-2020-047611f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/a602915827ae/bmjopen-2020-047611f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/2a341f8d84e5/bmjopen-2020-047611f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bcb/8845204/bbeb6b46a602/bmjopen-2020-047611f04.jpg

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