• Shi-Yue Li, Qiang Li, Wei-Jie Guan, Jiang Huang, He-Ping Yang, Guo-Ming Wu, Fa-Guang Jin, Cheng-Ping Hu, Liang-An Chen, Guo-Liang Xu, Shou-Zhi Liu, Chang-Gui Wu, Bao-Hui Han, Ying Xiang, Jian-Ping Zhao, Jie Wang, Xin Zhou, Hui-Ping Li, and Nan-Shan Zhong.
• State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
• Lung Cancer. 2016 Aug 1; 98: 43-50.

BackgroundSevere malignant airway obstruction (SMAO) is a life-threatening form of non-small cell lung carcinoma (NSCLC).ObjectivesTo determine the efficacy and safety of para-toluenesulfonamide (PTS) intratumoral injection in NSCLC-SMAO.MethodsNinety patients with NSCLC-SAO received repeated courses of PTS intratumoral injection until tumor sizes had reduced by 50% or greater. Primary endpoint was objective alleviation rate, assessed by chest computed tomography (CT) and bronchoscopy, at day 7 and 30 following final dosing. Secondary endpoints included airway obstruction, spirometry, quality-of-life and survival time.ResultsIn full-analysis set (N=88), using RECIST criteria, PTS treatment resulted in a significant objective alleviation rate [chest CT: 59.1% (95%CI: 48.1%-69.5%), bronchoscopy: 48.9% (95%CI: 38.1%-59.8%) at day 7; chest CT: 43.2% (95%CI: 32.7%-54.2%), bronchoscopy: 29.6% (95%CI: 20.3%-40.2%) at day 30]. There was a remarkable increase in FVC (mean difference: 0.35 liters, 95%CI: 0.16-0.53 liters), FEV1 (mean difference: 0.27 liters, 95%CI: 0.07-0.48 liters), Baseline Dyspnea Index (mean difference: 64.8%, 95%CI: 53.9-74.7%) and Functional Assessment of Cancer Therapy-Lung Cancer Subscale (mean difference: 6·9, 95%CI: 3.8-9.9) at day 7 post-treatment. We noted significantly reduced prevalence of atelectasis (by 42.9%) and Eastern Cooperative Oncology Group physical performance scale (mean difference: 7.2, 95%CI: 3.9-10.5). Median survival time was 394 days in full-analysis set and 460 days in per-protocol set. Adverse events were reported in 64.0% of subjects. Seven severe adverse events (7.9%) were reported, of which three led to death (drug-related in one case).ConclusionPTS intratumoral injection is effective and well tolerated for palliative therapy of NSCLC-SMAO.Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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