PDF(Pubmed)
Abstract：
BACKGROUND: Although transbronchial diagnostic procedures are sometimes difficult to perform because of the patient\'s respiratory or general conditions, endoscopic ultrasound with bronchoscope-guided fine-needle aspiration (EUS-B-FNA), a known transesophageal diagnostic procedure, might be useful for such cases. We conducted this prospective three-center observational study to evaluate the safety and efficacy of EUS-B-FNA in suspected lung cancer patients with poor respiratory or general conditions.
METHODS: Patients with suspected lung cancer with respiratory failure, Eastern Cooperative Oncology Group performance status of 2 or higher, or severe respiratory symptoms, were enrolled. The primary endpoints were the diagnostic yield of lung cancer and its safety, and the secondary endpoints were the success rate of molecular and programmed death ligand 1 (PD-L1) analyses, and the 6-month survival rate in patients with lung cancer.
RESULTS: We enrolled 30 patients, of which 29 were included in the analysis. Among them, 26 were eventually diagnosed with lung cancer. The diagnostic yield for lung cancer was 100% (26/26). There were no adverse events associated with EUS-B-FNA requiring procedure discontinuation. The success rates of molecular analysis for EGFR, ALK, ROS-1, and BRAF were 100% (14/14), 100% (11/11), 100% (9/9), and 75% (6/8), respectively. The success rate of the PD-L1 analysis was 100% (15/15). The 6-month survival rate in patients with lung cancer was 53.8% (95% confidence interval [CI]: 33.4-76.4), and the median overall survival (OS) was 196 days (95% CI: 142-446).
CONCLUSIONS: EUS-B-FNA is a safe and effective diagnostic method, even in patients with suspected lung cancer with poor respiratory or general conditions.
BACKGROUND: This clinical trial was registered at https://www.umin.ac.jp/ctr/index.htm (UMIN000041235, approved on 28/07/2020).
METHODS: Patients with suspected lung cancer with respiratory failure, Eastern Cooperative Oncology Group performance status of 2 or higher, or severe respiratory symptoms, were enrolled. The primary endpoints were the diagnostic yield of lung cancer and its safety, and the secondary endpoints were the success rate of molecular and programmed death ligand 1 (PD-L1) analyses, and the 6-month survival rate in patients with lung cancer.
RESULTS: We enrolled 30 patients, of which 29 were included in the analysis. Among them, 26 were eventually diagnosed with lung cancer. The diagnostic yield for lung cancer was 100% (26/26). There were no adverse events associated with EUS-B-FNA requiring procedure discontinuation. The success rates of molecular analysis for EGFR, ALK, ROS-1, and BRAF were 100% (14/14), 100% (11/11), 100% (9/9), and 75% (6/8), respectively. The success rate of the PD-L1 analysis was 100% (15/15). The 6-month survival rate in patients with lung cancer was 53.8% (95% confidence interval [CI]: 33.4-76.4), and the median overall survival (OS) was 196 days (95% CI: 142-446).
CONCLUSIONS: EUS-B-FNA is a safe and effective diagnostic method, even in patients with suspected lung cancer with poor respiratory or general conditions.
BACKGROUND: This clinical trial was registered at https://www.umin.ac.jp/ctr/index.htm (UMIN000041235, approved on 28/07/2020).
摘要：
背景：尽管由于患者的呼吸或一般状况，有时难以进行经支气管的诊断程序，内镜超声与支气管镜引导细针穿刺（EUS-B-FNA），已知的经食道诊断程序,可能对这种情况有用。我们进行了这项前瞻性三中心观察性研究，以评估EUS-B-FNA在呼吸或一般状况较差的疑似肺癌患者中的安全性和有效性。
方法：疑似肺癌伴呼吸衰竭患者，东部肿瘤协作组表现为2或更高，或严重的呼吸道症状，已注册。主要终点是肺癌的诊断率及其安全性，次要终点是分子和程序性死亡配体1（PD-L1）分析的成功率，肺癌患者的6个月生存率。
结果：我们招募了30名患者，其中29人被纳入分析。其中,26人最终诊断为肺癌。肺癌的诊断率为100%(26/26)。没有与需要停止手术的EUS-B-FNA相关的不良事件。EGFR分子分析的成功率，ALK,ROS-1和BRAF为100%(14/14)，100%(11/11)100%(9/9)和75%（6/8），分别。PD-L1分析的成功率为100%(15/15)。肺癌患者的6个月生存率为53.8%(95%可信区间[CI]:33.4-76.4),中位总生存期（OS）为196天（95%CI：142-446）。
结论：EUS-B-FNA是一种安全有效的诊断方法，即使是在怀疑患有呼吸不良或一般状况的肺癌患者中。
背景：该临床试验在https://www注册。乌明。AC.jp/ctr/index。htm（UMIN000041235，2020年7月28日批准）。
方法：疑似肺癌伴呼吸衰竭患者，东部肿瘤协作组表现为2或更高，或严重的呼吸道症状，已注册。主要终点是肺癌的诊断率及其安全性，次要终点是分子和程序性死亡配体1（PD-L1）分析的成功率，肺癌患者的6个月生存率。
结果：我们招募了30名患者，其中29人被纳入分析。其中,26人最终诊断为肺癌。肺癌的诊断率为100%(26/26)。没有与需要停止手术的EUS-B-FNA相关的不良事件。EGFR分子分析的成功率，ALK,ROS-1和BRAF为100%(14/14)，100%(11/11)100%(9/9)和75%（6/8），分别。PD-L1分析的成功率为100%(15/15)。肺癌患者的6个月生存率为53.8%(95%可信区间[CI]:33.4-76.4),中位总生存期（OS）为196天（95%CI：142-446）。
结论：EUS-B-FNA是一种安全有效的诊断方法，即使是在怀疑患有呼吸不良或一般状况的肺癌患者中。
背景：该临床试验在https://www注册。乌明。AC.jp/ctr/index。htm（UMIN000041235，2020年7月28日批准）。
