在PET-CT引导下省略不可切除的III期非小细胞肺癌临床靶体积的可行性：一项II期临床试验。

Feasibility of omitting the clinical target volume under PET-CT guidance in unresectable stage III non-small-cell lung cancer: A phase II clinical trial.

作者信息

Cui Tianxiang, Zhang Anmei, Cui Jianxiong, Chen Lu, Chen Guangpeng, Dai Hongya, Qin Xianli, Li Guanghui, Sun Jianguo

机构信息

Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, China.

出版信息

Radiother Oncol. 2023 Apr;181:109505. doi: 10.1016/j.radonc.2023.109505. Epub 2023 Feb 9.

DOI:10.1016/j.radonc.2023.109505

PMID:36764460

Abstract

BACKGROUND

This clinical trial aims at investigate the feasibility of CTV-omitted, positron-emission tomography computed tomography (PET-CT) combined with intensity-modulated radiation therapy (IMRT) for unresectable stage III NSCLC.

METHODS AND MATERIALS

This was a single-center, phase II clinical trial initiated in July 2016. Patients with unresectable stage III NSCLC undergoing routine IMRT were randomly enrolled into the study group (CTV-omitted under PET-CT guidance) and the control group (CTV-delineated). Patients received platinum-based dual-drug concurrent chemoradio therapy. In the study group, the PGTV dose was 60 Gy given in 30 daily 2 Gy fractions; in the control group, the PCTV dose was 54 Gy given in 30 daily 1.8 Gy fractions, and the PGTV dose was 60 Gy given in 30 daily 2 Gy fractions. The primary endpoint was the incidence of radiation respiratory events or esophagitis with grade 3 or higher. The secondary endpoints included objective response rate (ORR), locate control rate, progression-free survival (PFS), failure pattern and overall survival (OS).

RESULTS

A total of 90 patients were enrolled between July 2016 and March 2019. The incidence of radiation respiratory events or esophagitis with grade 3 or higher was 11.1 % in the study group, significantly lower than the rate of 28.9 % in the control group (P = 0.035), basically due to the reduced irradiated volumes of the lungs and esophagus in the study group. The median PFS was 9.0 months versus 10.0 months (P = 0.597), and the median OS 31.0 months versus 26.0 months (P = 0.489) in the study group and the control group, respectively. The failure pattern was not significantly different between the two groups (P = 0.826).

CONCLUSION

Omitting the CTV under PET-CT guidance has high feasibility to reduce severe radiation associated toxicity in IMRT for unresectable stage III NSCLC, without compromising the efficacy.

摘要

背景

本临床试验旨在研究在不可切除的III期非小细胞肺癌（NSCLC）中，省略临床靶区（CTV）的正电子发射断层扫描计算机断层扫描（PET-CT）联合调强放射治疗（IMRT）的可行性。

方法和材料

这是一项于2016年7月启动的单中心II期临床试验。将接受常规IMRT的不可切除III期NSCLC患者随机纳入研究组（PET-CT引导下省略CTV）和对照组（勾画CTV）。患者接受铂类双药同步放化疗。研究组中，计划靶体积（PGTV）剂量为60 Gy，分30次，每日2 Gy；对照组中，临床靶体积（PCTV）剂量为54 Gy，分30次，每日1.8 Gy，PGTV剂量为60 Gy，分30次，每日2 Gy。主要终点是3级或更高等级的放射性呼吸事件或食管炎的发生率。次要终点包括客观缓解率（ORR）、局部控制率、无进展生存期（PFS）、失败模式和总生存期（OS）。

结果

2016年7月至2019年3月期间共纳入90例患者。研究组中3级或更高等级的放射性呼吸事件或食管炎的发生率为11.1%，显著低于对照组的28.9%（P = 0.035），这主要是由于研究组中肺和食管的受照体积减小。研究组和对照组的中位PFS分别为9.0个月和10.0个月（P = 0.597），中位OS分别为31.0个月和26.0个月（P = 0.489）。两组间的失败模式无显著差异（P = 0.826）。