免疫治疗时代局部晚期肺癌调强放疗：一项前瞻性研究

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports Pub Date : 2025-03-20 DOI:10.1016/j.jtocrr.2025.100828

Hideyuki Harada MD, PhD , Akito Hata MD , Masahiro Konno PhD , Nobuaki Mamesaya MD, PhD , Kiyoshi Nakamatsu MD, PhD , Koji Haratani MD, PhD , Takaya Yamamoto MD, PhD , Ryota Saito MD, PhD , Hiroshi Mayahara MD, PhD , Masaki Kokubo MD, PhD , Yuki Sato MD , Nobuki Imano MD, PhD , Takeshi Masuda PD, PhD , Haruyuki Fukuda MD, PhD , Toshikatsu Sado MD, PhD , Kenichi Yoshimura PhD , Yasumasa Nishimura MD, PhD , Kazuhiko Nakagawa MD, PhD , Isamu Okamoto MD, PhD , Nobuyuki Yamamoto MD, PhD

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引用次数: 0

摘要

化疗（CRT）加杜伐单抗是不可切除的局部晚期NSCLC的标准治疗方案。在免疫治疗时代，关于调强放疗（IMRT）适应CRT的前瞻性数据报道有限。在这项多中心前瞻性观察研究中，患者接受了适应IMRT的CRT（铂双重化疗加上60 Gy IMRT，在预先指定的放射方案下分为30个部分），然后是巩固杜伐单抗。主要终点是crt后42天内杜伐单抗的引入率。结果在2019年11月至2021年2月期间入组了32例不可切除的局部晚期NSCLC患者。在28例可评估病例中，28例患者中有24例（85.7%，90%置信区间：70.2%-95.0%）在CRT后引入durvalumab，达到主要终点。所有29例接受IMRT的患者均完成了计划的60 Gy放疗剂量。24例患者中有12例（50%）完成了一年的durvalumab治疗。在引入durvalumab的24例患者中，中位无进展生存期和总生存期分别为20.9个月（95%置信区间：6.9 -不可评估）和未达到。两年无进展生存率和总生存率分别为44%和73%。在安全性分析组的29例患者中，没有与治疗相关的死亡或4级非血液学不良事件。1级肺炎13例（45%），2级肺炎7例（24%），3级肺炎1例（3%）。结论在预先设定的放疗方案下完成imrt - CRT后，杜伐单抗引入率较高。它的有效性已被证明具有良好的安全性，包括严重肺炎的低发病率。试验注册大学医院医学信息网数据库ID: UMIN000038366

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Intensity-Modulated Radiotherapy for Locally Advanced Lung Cancer in the Immunotherapy Era: A Prospective Study WJOG12019L

Introduction

Chemoradiotherapy (CRT) followed by durvalumab is the standard of care for unresectable locally advanced NSCLC. Limited prospective data have been reported on intensity-modulated radiotherapy (IMRT)–adapted CRT in the immunotherapy era.

Methods

In this multicenter prospective observational study, patients underwent IMRT-adapted CRT (platinum-doublet chemotherapy plus 60 Gy IMRT in 30 fractions under a prespecified radiation protocol), followed by consolidative durvalumab. The primary outcome was the durvalumab introduction rate within 42 days post-CRT.

Results

Thirty-two patients with unresectable locally advanced NSCLC were enrolled between November 2019 and February 2021. Among the 28 evaluable cases, durvalumab was introduced in 24 (85.7%, 90% confidence interval: 70.2%–95.0%) of 28 patients after CRT, achieving the primary end point. All 29 patients who received IMRT completed the scheduled 60 Gy radiotherapy dose. One year of durvalumab treatment was completed in 12 of 24 patients (50%). In the 24 patients who were durvalumab-introduced, the median progression-free survival and overall survival were 20.9 (95% confidence interval: 6.9–not evaluable) months and not reached, respectively. Two-year progression-free survival and overall survival rates were 44% and 73%, respectively. Among the 29 patients in the safety analysis set, there were no treatment-related deaths or grade 4 nonhematological adverse events. Pneumonitis grade 1 was observed in 13 patients (45%), grade 2 in seven (24%), and grade 3 in one (3%).

Conclusions

High durvalumab introduction rate was reported after the completion of IMRT-adapted CRT under a prespecified radiation protocol. Its efficacy has been suggested, with favorable safety profiles, including a low incidence of severe pneumonitis.