Effects of para-toluenesulfonamide intratumoral injection on non-small cell lung carcinoma with severe central airway obstruction: A multi-center, non-randomized, single-arm, open-label trial
机构：[a]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Disease, FirstAffiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China[b]Affiliated Changhai Hospital of Second Military University, Shanghai, China[c]Sichuan People’s Hospital, Chengdu, Sichuan, China[d]First Affiliated Hospital of Third Military Medical University, Chongqing, China[e]Second Affiliated Hospital of Third Military Medical University, Chongqing, China[f]Second Affiliated Hospital (Tangdu Hospital) of Fourth Military Medical University, Xian, Shanxi, China[g]Affiliated Xiangya Hospital of Central South Hospital, Changsha, Hunan, China[h]General Hospital of People’s Liberation Army, Beijing, China[i]Affiliated Cancer Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China[j]Affiliated West China Hospital of Sichuan University, Chengdu, Sichuan, China[k]First Affiliated Hospital (Xijing Hospital) of Fourth Military Medical University, Xian, Shanxi, China[l]Affiliated Chest Hospital of Shanghai Jiaotong University, Shanghai, China[m]Chongqing Cancer Hospital, Chongqing, China[n]Affiliated Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China华中科技大学同济医学院附属同济医院[o]Beijing Cancer Hospital, Beijing, China[p]Shanghai First People’s Hospital, Shanghai, China[q]Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
Background: Severe malignant airway obstruction (SMAO) is a life-threatening form of non-small cell lung carcinoma (NSCLC). Objectives: To determine the efficacy and safety of para-toluenesulfonamide (PTS) intratumoral injection in NSCLC-SMAO. Methods: Ninety 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. Results: In 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 CI: 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). Conclusion: PTS intratumoral injection is effective and well tolerated for palliative therapy of NSCLC-SMAO. (C) 2016 Elsevier Ireland Ltd. All rights reserved.
基金：
This study was supported by Changjiang Scholars and Innovative Research Team in University ITR0961, The National Key Technology R&D Program of the 12th NationalFive-year Development Plan 2012BAI05B01 and National Key Scientific & Technology Support Program: Collaborative innovation of Clinical Research for chronic obstructivepulmonary disease and lung cancer No. 2013BAI09B09 (to Prof. Zhong).
第一作者机构：[a]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Disease, FirstAffiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
共同第一作者：
通讯作者：
通讯机构：[a]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Disease, FirstAffiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China[*1]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of RespiratoryDisease, First Affiliated Hospital of Guangzhou Medical University, Address: 151 Yanjiang Road, Guangzhou, Guangdong, China.
推荐引用方式(GB/T 7714)：
Shi-yue Li,Qiang Li,Wei-jie Guan,et al.Effects of para-toluenesulfonamide intratumoral injection on non-small cell lung carcinoma with severe central airway obstruction: A multi-center, non-randomized, single-arm, open-label trial[J].LUNG CANCER.2016,98:43-50.doi:10.1016/j.lungcan.2016.05.012.
APA：
Shi-yue Li,Qiang Li,Wei-jie Guan,Jiang Huang,He-ping Yang...&Nan-shan Zhong.(2016).Effects of para-toluenesulfonamide intratumoral injection on non-small cell lung carcinoma with severe central airway obstruction: A multi-center, non-randomized, single-arm, open-label trial.LUNG CANCER,98,
MLA：
Shi-yue Li,et al."Effects of para-toluenesulfonamide intratumoral injection on non-small cell lung carcinoma with severe central airway obstruction: A multi-center, non-randomized, single-arm, open-label trial".LUNG CANCER 98.(2016):43-50
