Department of Respiratory and Sleep Medicine, Royal Melbourne Hospital, Melbourne, VIC, Australia; Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.
The Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Lancet Respir Med. 2024 Jun;12(6):467-475. doi: 10.1016/S2213-2600(24)00010-9. Epub 2024 Mar 12.
Systematic mediastinal lymph node staging by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) improves accuracy of staging in patients with early-stage non-small-cell lung cancer (NSCLC). However, patients with locally advanced NSCLC commonly undergo only selective lymph node sampling. This study aimed to determine the proportion of patients with locally advanced NSCLC in whom systematic endoscopic mediastinal staging identified PET-occult lymph node metastases, and to describe the consequences of PET-occult disease on radiotherapy planning.
This prospective, international, multicentre, single-arm, international study was conducted at seven tertiary lung cancer centres in four countries (Australia, Canada, the Netherlands, and the USA). Patients aged 18 years or older with suspected or known locally advanced NSCLC underwent systematic endoscopic mediastinal lymph node staging before combination chemoradiotherapy or high-dose palliative radiotherapy. The primary endpoint was the proportion of participants with PET-occult mediastinal lymph node metastases shown following systematic endoscopic staging. The study was prospectively registered with Australian New Zealand Clinical Trials Registry, ACTRN12617000333314.
From Jan 30, 2018, to March 23, 2022, 155 patients underwent systematic endoscopic mediastinal lymph node staging and were eligible for analysis. 58 (37%) of patients were female and 97 (63%) were male. Discrepancy in extent of mediastinal disease identified by PET and EBUS-TBNA was observed in 57 (37% [95% CI 29-44]) patients. PET-occult lymph node metastases were identified in 18 (12% [7-17]) participants, including 16 (13% [7-19]) of 123 participants with clinical stage IIIA or cN2 NSCLC. Contralateral PET-occult N3 disease was identified in nine (7% [2-12]) of 128 participants staged cN0, cN1, or cN2. Identification of PET-occult disease resulted in clinically significant changes to treatment in all 18 patients. In silico dosimetry studies showed the median volume of PET-occult lymph nodes receiving the prescription dose of 60 Gy was only 10·1% (IQR 0·1-52·3). No serious adverse events following endoscopic staging were reported.
Our findings suggests that systematic endoscopic mediastinal staging in patients with locally advanced or unresectable NSCLC is more accurate than PET alone in defining extent of mediastinal involvement. Standard guideline-recommended PET-based radiotherapy planning results in suboptimal tumour coverage. Our findings indicate that systematic endoscopic staging should be routinely performed in patients with locally advanced NSCLC being considered for radiotherapy to accurately inform radiation planning and treatment decision making in patients with locally advanced NSCLC.
None.
经支气管内超声引导针吸活检术（EBUS-TBNA）系统性纵隔淋巴结分期可提高早期非小细胞肺癌（NSCLC）患者的分期准确性。然而，局部晚期 NSCLC 患者通常仅接受选择性淋巴结采样。本研究旨在确定在接受局部晚期 NSCLC 治疗的患者中，有多少患者通过系统的内镜纵隔分期发现了 PET 隐匿性淋巴结转移，并描述 PET 隐匿性疾病对放疗计划的影响。
这是一项在四个国家（澳大利亚、加拿大、荷兰和美国）的七家三级肺癌中心进行的前瞻性、国际、多中心、单臂、国际研究。年龄在 18 岁或以上，疑似或已知局部晚期 NSCLC 的患者在接受联合放化疗或高剂量姑息性放疗前接受系统的内镜纵隔淋巴结分期。主要终点是在系统内镜分期后，PET 显示隐匿性纵隔淋巴结转移的患者比例。该研究在澳大利亚和新西兰临床试验注册中心进行了前瞻性注册，注册号为 ACTRN12617000333314。
从 2018 年 1 月 30 日至 2022 年 3 月 23 日，共有 155 名患者接受了系统的内镜纵隔淋巴结分期，并符合分析条件。58 名（37%）患者为女性，97 名（63%）为男性。PET 和 EBUS-TBNA 确定的纵隔疾病范围存在差异，57 名（37%[95%CI 29-44]）患者存在这种情况。18 名（12%[7-17]）患者存在 PET 隐匿性淋巴结转移，其中 16 名（13%[7-19]）患者为临床 IIIA 期或 cN2 NSCLC。128 名分期为 cN0、cN1 或 cN2 的患者中，9 名（7%[2-12]）存在对侧 PET 隐匿性 N3 疾病。18 名患者的治疗均因发现 PET 隐匿性疾病而发生了显著的变化。在计算机体层摄影术（CT）剂量学研究中，接受 60 Gy 处方剂量的 PET 隐匿性淋巴结的中位体积仅为 10.1%（IQR 0.1-52.3）。未报告内镜分期后出现严重不良事件。
我们的研究结果表明，与单独使用 PET 相比，对局部晚期或不可切除 NSCLC 患者进行系统的内镜纵隔分期在确定纵隔受累范围方面更准确。基于 PET 的标准指南推荐的放疗计划导致肿瘤覆盖不理想。我们的研究结果表明，在考虑对局部晚期 NSCLC 患者进行放疗时，应常规进行系统的内镜纵隔分期，以准确地告知放疗计划和治疗决策，从而改善局部晚期 NSCLC 患者的治疗效果。
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