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术后非小细胞肺癌患者在接受辅助化疗期间使用或不使用分阶段中医药治疗的患者报告结局（NALLC 2）：一项随机、双盲、安慰剂对照试验
Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial
- 中国结合医学杂志（英文版） 2024年30卷第11期 页码：963-973
- Affiliations：
1.Oncology Department, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai (200437), China
2.Institute of Traditional Chinese Medicine Oncology, Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China
3.Oncology Department, Shanghai Pulmonary Hospital, Shanghai Tongji University, Shanghai (200433), China
4.Thoracic Surgery Department, Huadong Hospital, Shanghai Fudan University, Shanghai (200040), China
5.Thoracic Surgery Department, Shanghai Cancer Hospital, Shanghai Fudan University, Shanghai (200032), China
6.Oncology Department, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (200030), China
- Author bio：
Prof. CHEN Zhi-wei, E-mail: drchenzhiwei@163.com
Prof. XU Ling, E-mail: xulq67@aliyun.com;
- Funds：Project of Shanghai Municipal Commission of Science and Technology(16401970700;22Y31920400)
DOI：10.1007/s11655-024-4114-9
中图分类号：纸质出版日期：2024-11，
网络出版日期：2024-09-12，
录用日期：2024-03-29
- Accepted：
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术后非小细胞肺癌患者在接受辅助化疗期间使用或不使用分阶段中医药治疗的患者报告结局（NALLC 2）：一项随机、双盲、安慰剂对照试验[J]. 中国结合医学杂志（英文版）, 2024,30(11):963-973.
ZHANG Yi-lu, JIAO Li-jing, GONG Ya-bin, et al. Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(11):963-973.
术后非小细胞肺癌患者在接受辅助化疗期间使用或不使用分阶段中医药治疗的患者报告结局（NALLC 2）：一项随机、双盲、安慰剂对照试验[J]. 中国结合医学杂志（英文版）, 2024,30(11):963-973. DOI： 10.1007/s11655-024-4114-9.
ZHANG Yi-lu, JIAO Li-jing, GONG Ya-bin, et al. Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2024,30(11):963-973. DOI： 10.1007/s11655-024-4114-9.
摘要
目的:
2
评价分阶段中医药方案治疗对非小细胞肺癌 (Non-Small Cell Lung Cancer
NSCLC) 患者术后辅助化疗期间健康相关生活质量的影响
延长化疗期间肺癌中位无恶化时间的临床疗效.
方法:
2
研究采用多中心、前瞻性、随机对照、双盲试验设计
以2017年12月14日至2020年8月28日在上海5家医院收治的Ⅰb~Ⅲa期肺癌术后辅助化疗患者为研究对象
通过分层区组随机将180例患者按照2∶1比例随机分为治疗组 (分阶段中药+化疗) 120例与对照组 (分阶段中药安慰剂+化疗) 60例. 采用欧洲癌症研究与治疗组织 (European Organization for Research and Treatment of Cancer
EORTC) 研制的癌症生活质量量表QLQ-C30 (Quality-of-Life-Core 30
QLQ-C30) 评估NSCLC患者术后辅助化疗期间的患者报告结局 (Patient-Reported Outcomes
PROs)
并观察不良事件 (Adverse events
AEs) 评估安全性.
结果:
2
共173名患者纳入PRO分析
包括治疗组116例
对照组57例. 两组治疗前QLQ-C30量表总体健康状况 (Global Health Status
GHS) /生活质量 (Quality of Life
QoL) 分别为57.16±1.64和57.67±2.25 (
P
>
0.05) . 与治疗前比较
第18周时治疗组 QLQ-C30 GHS/QoL得分最小二乘均值 (Least Squares Mean
LSM) 上升17.83
95%CI: 14.29-21.38
对照组的得分下降 (LSM变化-13.67
95% CI -22.70 - -4.63)
两组之间在LSM GHS/QoL得分上存在差异31.63分
具有统计学意义 (95% CI 25.61-37.64
P
<
0.001) . 在躯体功能领域以及疲劳和食欲减退症状方面也观察到了相似的趋势. 在第18周
治疗组在总体健康状况和各症状得分改善 (包括稳定) 的比例高于对照组 (
P
<
0.001) . 治疗组在QLQ-C30 相关功能及症状的中位无恶化时间更长
GHS/QoL得分 (
HR
=0.33
95% CI 0.23-0.48
P
<
0.0010) 、身体功能 (
HR
=0.43
95% CI 0.25-0.75
P
=0.0005) 、疲劳 (
HR
=0.47
95% CI 0.30-0.72
P
<
0.0001) 和食欲减退 (
HR
=0.65
95% CI 0.42-1.00
P
=0.0215) . 治疗组的AEs发生率低于对照组 (9.83%
vs
. 15.79%
P
=0.52) .
结论:
2
分阶段中医药方案治疗有助于改善NSCLC患者术后辅助化疗期间的PROs
值得进一步的临床研究. (ClinicalTrials.gov注册号NCT03372694)
Abstract
Objective:
2
To investigate whether the combination of chemotherapy with staged Chinese herbal medicine (CHM) therapy could enhance health-related quality of life (QoL) in non-small-cell lung cancer (NSCLC) patients and prolong the time before deterioration of lung cancer symptoms
in comparison to chemotherapy alone.
Methods:
2
A prospective
double-blind
randomized
controlled trial was conducted from December 14
2017 to August 28
2020. A total of 180 patients with stage ⅠB–ⅢA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM (chemo+CHM) group (120 cases) or chemotherapy combined with placebo (chemo+placebo) group (60 cases) using stratified blocking randomization. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life-Core 30 Scale (QLQ-C30) was used to evaluate the patient-reported outcomes (PROs) during postoperative adjuvant chemotherapy in patients with early-stage NSCLC. Adverse events (AEs) were assessed in the safety analysis.
Results:
2
Out of the total 180 patients
173 patients (116 in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO analyses. The initial mean QLQ-C30 Global Health Status (GHS)/QoL scores at baseline were 57.16±1.64 and 57.67±2.25 for the two respective groups (
P
>
0.05). Compared with baseline
the chemo+CHM group had an improvement in QLQ-C30 GHS/QoL score at week 18 [least squares mean (LSM) change 17.83
95% confidence interval (CI) 14.29 to 21.38
]
. Conversely
the chemo+placebo group had a decrease in the score (LSM change –13.67
95% CI –22.70 to –4.63). A significant between-group difference in the LSM GHS/QoL score was observed
amounting to 31.63 points (95% CI 25.61 to 37.64
P
<
0.001). The similar trends were observed in physical functioning
fatigue and appetite loss. At week 18
patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group (
P
<
0.001). The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score [hazard ratio (HR)=0.33
95% CI 0.23 to 0.48
P
<
0.0010
]
physical functioning (
HR
=0.43
95% CI 0.25 to 0.75
P
=0.0005)
fatigue (
HR
=0.47
95% CI 0.30 to 0.72
P
<
0.0001) and appetite loss (
HR
=0.65
95% CI 0.42 to 1.00
P
=0.0215). The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group (9.83%
vs
. 15.79%
P
=0.52).
Conclusion:
2
The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy
which is worthy of further clinical research. (Registry No. NCT03372694)
关键词
非小细胞肺癌辅助化疗患者报告结局健康相关生活质量中医
Keywords
non-small-cell lung canceradjuvant chemotherapypatient-reported outcomehealth-related quality of lifeChinese herbal medicine
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