D'Agnano Vito, Perrotta Fabio, Stella Giulia Maria, Pagliaro Raffaella, De Rosa Filippo, Cerqua Francesco Saverio, Schiattarella Angela, Grella Edoardo, Masi Umberto, Panico Luigi, Bianco Andrea, Iadevaia Carlo
Department of Translational Medical Sciences, University of Campania L. Vanvitelli, 80131 Naples, Italy.
U.O.C. Clinica Pneumologica L. Vanvitelli, Monaldi Hospital, A.O. dei Colli, 80131 Naples, Italy.
Cancers (Basel). 2024 Aug 16;16(16):2860. doi: 10.3390/cancers16162860.
The recent advances in precision oncology for lung cancer treatment has focused attention on the importance of obtaining appropriate specimens for tissue diagnosis as well as comprehensive molecular profiling. CT scan-guided biopsies and bronchoscopy are currently the main procedures employed for tissue sampling. However, growing evidence suggests that ultrasound-guided biopsies may represent an effective as well as safe approach in this diagnostic area. This study explores the safety and the diagnostic yield for cancer molecular profiling in ultrasound-guided percutaneous lung lesion biopsies (US-PLLB).
One hundred consecutive patients with suspected lung cancer, between January 2021 and May 2024, who had ultrasound-guided lung biopsies have been retrospectively analyzed. Molecular profiling was conducted with next-generation sequencing Genexus using Oncomine precision assay or polymerase chain reaction according to specimen quality. Qualitative immunohistochemical assay of programmed death ligand 1 (PD-L1) expression was evaluated by the Dako PD-L1 immunohistochemistry 22C3 pharmDx assay. The co-primary endpoints were the molecular diagnostic yield and the safety profile of US-guided lung biopsies.
From January 2021 to May 2024, 100 US-guided lung biopsies were carried out and 95 were considered for inclusion in the study. US-PLLB provided informative tissue for a histological evaluation in 93 of 95 patients with an overall diagnostic accuracy of 96.84% [Sensitivity: 92.63%; Specificity: 96.84%; PPV: 100%; NPV: 100%]. Sixty-Six patients were diagnosed with NSCLC (69.47%) and were considered for molecular diagnostic yield evaluation and PD-L1 testing. Four patients had malignant lymphoid lesions. US-PLLB was not adequate to achieve a final diagnosis in three patients (3.16%). Complete molecular profiling and PD-L1 evaluation were achieved in all patients with adenocarcinoma (molecular diagnostic yield: 100%). PD-L1 evaluation was achieved in 28 of 29 patients (96.55%) with either SCC or NOS lung cancer. The overall complication rate was 9.47% (n = 9). Six patients (6.31%) developed pneumothorax, while three patients (3.16%) suffered mild haemoptysis without desaturation.
According to our findings, US-guided lung biopsy is a safe, minimally invasive procedure in patients with suspected lung malignancies, providing an excellent diagnostic yield for both comprehensive molecular profiling and PD-L1 testing. In addition, our results suggest that US-guided biopsy may also be an effective diagnostic approach in patients with suspected lung lymphoma.
肺癌精准肿瘤治疗的最新进展使人们将注意力集中在获取合适的组织标本用于组织诊断以及全面分子谱分析的重要性上。CT扫描引导下活检和支气管镜检查是目前用于组织采样的主要方法。然而，越来越多的证据表明，超声引导下活检可能是该诊断领域一种有效且安全的方法。本研究探讨了超声引导下经皮肺穿刺活检（US-PLLB）在癌症分子谱分析中的安全性和诊断率。
回顾性分析了2021年1月至2024年5月期间连续100例接受超声引导下肺活检的疑似肺癌患者。根据标本质量，使用Oncomine精准检测或聚合酶链反应通过新一代测序Genexus进行分子谱分析。采用Dako PD-L1免疫组织化学22C3试剂进行程序性死亡配体1（PD-L1）表达的定性免疫组织化学检测。共同主要终点是超声引导下肺活检的分子诊断率和安全性。
2021年1月至2024年5月，共进行了100例超声引导下肺活检，其中95例被纳入研究。US-PLLB为95例患者中的93例提供了用于组织学评估的信息性组织，总体诊断准确率为96.84%[敏感性：92.63%；特异性：96.84%；阳性预测值：100%；阴性预测值：100%]。66例患者被诊断为非小细胞肺癌（69.47%），并被纳入分子诊断率评估和PD-L1检测。4例患者有恶性淋巴病变。3例患者（3.16%）US-PLLB不足以获得最终诊断。所有腺癌患者均完成了完整的分子谱分析和PD-L1评估（分子诊断率：100%）。29例鳞状细胞癌或非特指型肺癌患者中的28例（96.55%）完成了PD-L1评估。总体并发症发生率为9.47%（n = 9）。6例患者（6.31%）发生气胸，3例患者（3.16%）出现轻度咯血但未出现氧饱和度下降。
根据我们的研究结果，超声引导下肺活检对于疑似肺恶性肿瘤患者是一种安全、微创的方法，在全面分子谱分析和PD-L1检测方面均具有出色的诊断率。此外，我们的结果表明，超声引导下活检对于疑似肺淋巴瘤患者也可能是一种有效的诊断方法。
