不能手术的非小细胞肺癌患者接受常规分割与超分割加速放疗的长期生活质量比较——随机 CHARTWEL 试验结果。

Long-term quality of life in inoperable non-small cell lung cancer patients treated with conventionally fractionated compared to hyperfractionated accelerated radiotherapy - Results of the randomized CHARTWEL trial.

机构信息

Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center, Johannes Gutenberg University Mainz, Germany; German Cancer Consortium (DKTK), Frankfurt/Mainz, Germany; German Cancer Research Center (DKFZ), Heidelberg, Germany.

German Cancer Research Center (DKFZ), Heidelberg, Germany; German Cancer Consortium (DKTK), Dresden, Germany; Department of Radiation Oncology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany; OncoRay - National Center for Radiation Research in Oncology (NCRO), Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, and Helmholtz-Zentrum Dresden-Rossendorf, Germany; Helmholtz-Zentrum Dresden-Rossendorf, Institute of Radiooncology, Germany; National Center for Tumor Diseases (NCT), Dresden, Germany.

出版信息

Radiother Oncol. 2018 Feb;126(2):283-290. doi: 10.1016/j.radonc.2017.12.005. Epub 2017 Dec 19.

DOI:10.1016/j.radonc.2017.12.005

PMID:29273262

Abstract

BACKGROUND AND PURPOSE

To evaluate the quality of life (QoL) of patients with inoperable non-small cell lung cancer treated with conventionally fractionated radiotherapy (CF) vs. continuous hyperfractionated accelerated radiotherapy weekend-less (CHARTWEL).

MATERIAL AND METHODS

The largest monocentric subgroup of the phase III CHARTWEL trial was analyzed up to three years after randomization. QoL was assessed with the European Organization for Research and Treatment of Cancer QoL Core Questionnaire (QLQ-C30) and lung cancer module (QLQ-LC13) and compared using linear mixed models. QoL interrelations with recurrence, metastasis, and death were explored by multi-state modeling.

RESULTS

160 patients (98%) provided at least one QoL assessment. Average treatment differences of CF vs. CHARTWEL over three years were -5.4 points (95%CI [-13.6,2.8], p = 0.19) in global QoL, 11.9 ([2.8,21.0], p = 0.01) in fatigue, 13.4 ([3.5,23.3], p = 0.009) in pain, 10.5 ([1.3,19.6], p = 0.03) in dyspnea, and 5.2 ([-2.7,13.0], p = 0.19) in dysphagia. At 12 months, the probabilities of being disease-free with good, good or moderate, any global QoL, or alive were 5.1%, 20.3%, 34.2%, 54.4% under CF and 10.4%, 21.0%, 37.5%, 65.3% under CHARTWEL.

CONCLUSIONS

Over three years, QoL was similar or more favorable under CHARTWEL compared to CF. Modeling QoL together with disease states provided additional insight into treatment comparisons.

摘要

背景与目的

评估不能手术的非小细胞肺癌患者接受常规分割放疗（CF）与连续超分割加速放疗周末（CHARTWEL）治疗的生活质量（QoL）。

材料与方法

分析了 III 期 CHARTWEL 试验的最大单中心亚组，随访时间最长为随机分组后 3 年。使用欧洲癌症研究与治疗组织生活质量核心问卷（QLQ-C30）和肺癌模块（QLQ-LC13）评估 QoL，并通过线性混合模型进行比较。通过多状态模型探讨 QoL 与复发、转移和死亡的关系。

结果

160 例患者（98%）至少提供了一次 QoL 评估。CF 与 CHARTWEL 治疗 3 年的平均差异为全球 QoL 评分 -5.4 分（95%CI[-13.6,2.8]，p=0.19），疲劳评分 11.9 分（2.8,21.0]，p=0.01），疼痛评分 13.4 分（3.5,23.3]，p=0.009），呼吸困难评分 10.5 分（1.3,19.6]，p=0.03），吞咽困难评分 5.2 分（-2.7,13.0]，p=0.19）。在 12 个月时，CF 组无疾病、良好、良好或中度、任何全球 QoL 或存活的概率分别为 5.1%、20.3%、34.2%和 54.4%，CHARTWEL 组分别为 10.4%、21.0%、37.5%和 65.3%。