Abstract：
UNASSIGNED: We assessed the preliminary efficacy and toxicity of intrapleural instillation of nivolumab in patients with large pleural effusion. Patients with metastatic cancers who have a large volume of pleural effusion and required evacuation were eligible. Thoracentesis followed by nivolumab (40 mg, single intrapleural instillation) was performed. The primary endpoint was 3-month recurrence-free survival. A total of 13 patients were enrolled. The study was terminated after stage 1 as no efficacy was observed; 7 patients (54%) had a recurrence of pleural effusion at 3 months. Thirteen (100%) patients had no recurrence, dyspnea, or cough within 1 month, and the median time to recurrence was 1.9 months (95% confidence interval [CI], 1.35-2.5). No adverse events were identified. We concluded that a single intrapleural instillation of the nivolumab at 40 mg was ineffective and well-tolerated in cancer patients with pleural effusion.
摘要：
■我们评估了大量胸腔积液患者胸腔内滴注纳武单抗的初步疗效和毒性。有大量胸腔积液并需要撤离的转移性癌症患者符合资格。胸腔穿刺术，然后用nivolumab（40毫克，进行单次胸膜内滴注）。主要终点为3个月无复发生存期。共纳入13例患者。由于未观察到疗效，该研究在1期后终止；7例患者（54％）在3个月时出现胸腔积液复发。13例（100%）患者无复发，呼吸困难,或在1个月内咳嗽，中位复发时间为1.9个月(95%置信区间[CI]，1.35-2.5)。没有发现不良事件。我们得出的结论是，在胸腔积液的癌症患者中，单次胸腔内滴注40mg的nivolumab无效且耐受性良好。
