| 付相君,楼丽姝,方 敏.PD-1抑制剂联合立体定向放疗治疗早期非小细胞肺癌——立体定向放疗联合免疫治疗模式研究解读[J].肿瘤学杂志,2024,30(2):166-175. |
| PD-1抑制剂联合立体定向放疗治疗早期非小细胞肺癌——立体定向放疗联合免疫治疗模式研究解读 |
| PD-1 Inhibitor with or without Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer： Interpretation of an Open-Label， Randomized Controlled Phase 2 Trial |
| 投稿时间：2024-01-30 |
| DOI：10.11735/j.issn.1671-170X.2024.02.B012 |
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| 中文关键词: 非小细胞肺癌 立体定向放疗 免疫治疗 无事件生存率 临床研究 |
| 英文关键词:non-small cell lung cancer stereotactic ablative radiotherapy immunotherapy event-free survival rate clinical trial |
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| 摘要点击次数: 246 |
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| 中文摘要: |
| 摘 要：立体定向放疗（stereotactic ablative radiotherapy，SABR）是无法手术的早期非小细胞肺癌（non-small cell lung cancer，NSCLC）的标准治疗方法，但治疗后局部复发或远处转移，或两者同时发生的情况很常见。该研究旨在探索免疫联合SABR（I-SABR）对比SABR治疗早期或孤立肺实质复发性淋巴结阴性NSCLC的疗效与安全性。2017年6月至2022年3月，研究共入组美国德克萨斯州3家中心的156例未经治疗NSCLC患者，其中141例接受分配的治疗。入组患者随机1∶1分为SABR治疗组(n=78)和I-SABR治疗组(n=78)。入组条件为年龄18岁及以上；病理证实为未经治疗的ⅠA~ⅠB期（肿瘤大小≤4 cm，N0M0）；ⅡA期（肿瘤大小≤5 cm，N0M0）或ⅡB期（肿瘤大小>5 cm且≤7 cm，N0M0）；以及孤立的实质性复发（肿瘤大小≤7 cm）的NSCLC患者。主要研究终点是无事件生存率，次要研究终点包括总生存率和治疗相关毒性等。中位随访时间33个月 (95%CI：28.7～38.1)，结果显示，I-SABR显著提高了4年无事件生存率［77% (95%CI：66%～91%) vs 53%(95%CI：42%～67%)］［符合方案集（per-protocol，PP），HR=0.38，95%CI：0.19~0.75，P=0.005 6；意向性（intention-to-treat，ITT）人群，HR=0.42，95%CI：0.22~0.80，P=0.008 0］。SABR组没有发生3级及以上的不良事件；I-SABR组中，10例患者(15%)出现了与纳武利尤单抗有关的3级免疫不良反应，没有3级及以上的毒性发生。因此，与单纯SABR相比，I-SABR显著提高了早期或孤立肺实质复发性淋巴结阴性NSCLC患者的4年无事件生存率，毒性可耐受。 |
| 英文摘要: |
| Abstract： Stereotactic ablative radiotherapy (SABR) is the standard treatment for medically inoperable early-stage non-small-cell lung cancer(NSCLC)， but regional or distant relapses， or both， are common. The study compared the efficacy and safety of SABR alone versus I-SABR for early-stage or isolated parenchymal recurrent node-negative NSCLC. From June 2017 to March 2022， 156 participants were enrolled， and 141 participants received treatment as per the protocol and were treated at three different hospitals in TX， USA. Participants randomly assigned to one of two groups (ITT population： n=78 in each group). People aged 18 years or older with histologically proven treatment-naive stage ⅠA～ⅠB (tumor size ≤4 cm， N0M0)， stage ⅡA (tumour size ≤5 cm， N0M0)， or stage ⅡB (tumor size >5 cm and ≤7 cm， N0M0) or isolated parenchymal recurrences (tumor size ≤7 cm) NSCLC were included in this trial. The primary endpoint was 4-year event-free survival (local， regional， or distant recurrence； second primary lung cancer； or death). Secondary endpoints included overall survival and treatment-related toxicity. The median follow-up time was 33 months(95%CI：28.7～38.1). I-SABR significantly improved 4-year event-free survival ［77% (66%～91%) vs 53% (95%CI： 42%～67%)； per-protocol population， HR=0.38， 95%CI： 0.19～0.75， P=0.005 6； ITT population， HR=0.42； 95%CI： 0.22～0.80， P=0.008 0)］. There was no grade 3 or higher adverse events associated with SABR. In the I-SABR group， ten participants(15%) had grade 3 immunologial adverse events related to nivolumab； none had grade 3 pneumonitis or grade 4 or higher toxicity. Compared with SABR alone， I-SABR significantly improved event-free survival at 4 years in people with early-stage treatment-naive or lung parenchymal recurrent node-negative NSCLC， with tolerable toxicity. |
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