title: 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.
abstract: Severe malignant airway obstruction (SMAO) is a life-threatening form of non-small cell lung carcinoma (NSCLC).
  
  
  
  To determine the efficacy and safety of para-toluenesulfonamide (PTS) intratumoral injection in NSCLC-SMAO.
  
  
  
  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.
  
  
  
  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 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).
  
  
  
  PTS intratumoral injection is effective and well tolerated for palliative therapy of NSCLC-SMAO.
authors.affiliation: 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.
authors.forename: Shi-Yue
authors.initials: SY
authors.lastname: Li
authors.affiliation: Affiliated Changhai Hospital of Second Military University, Shanghai, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Wei-Jie
authors.initials: WJ
authors.lastname: Guan
authors.affiliation: Sichuan People's Hospital, Chengdu, Sichuan, China.
authors.forename: Jiang
authors.initials: J
authors.lastname: Huang
authors.affiliation: First Affiliated Hospital of Third Military Medical University, Chongqing, China.
authors.forename: He-Ping
authors.initials: HP
authors.lastname: Yang
authors.affiliation: Second Affiliated Hospital of Third Military Medical University, Chongqing, China.
authors.forename: Guo-Ming
authors.initials: GM
authors.lastname: Wu
authors.affiliation: Second Affiliated Hospital (Tangdu Hospital) of Fourth Military Medical University, Xian, Shanxi, China.
authors.forename: Fa-Guang
authors.initials: FG
authors.lastname: Jin
authors.affiliation: Affiliated Xiangya Hospital of Central South Hospital, Changsha, Hunan, China.
authors.forename: Cheng-Ping
authors.initials: CP
authors.lastname: Hu
authors.affiliation: General Hospital of People's Liberation Army, Beijing, China.
authors.forename: Liang-An
authors.initials: LA
authors.lastname: Chen
authors.affiliation: Affiliated Cancer Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
authors.forename: Guo-Liang
authors.initials: GL
authors.lastname: Xu
authors.affiliation: Affiliated West China Hospital of Sichuan University, Chengdu, Sichuan, China.
authors.forename: Shou-Zhi
authors.initials: SZ
authors.lastname: Liu
authors.affiliation: First Affiliated Hospital (Xijing Hospital) of Fourth Military Medical University, Xian, Shanxi, China.
authors.forename: Chang-Gui
authors.initials: CG
authors.lastname: Wu
authors.affiliation: Affiliated Chest Hospital of Shanghai Jiaotong University, Shanghai, China.
authors.forename: Bao-Hui
authors.initials: BH
authors.lastname: Han
authors.affiliation: Chongqing Cancer Hospital, Chongqing, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Xiang
authors.affiliation: Affiliated Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Zhao
authors.affiliation: Beijing Cancer Hospital, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Wang
authors.affiliation: Shanghai First People's Hospital, Shanghai, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
authors.forename: Hui-Ping
authors.initials: HP
authors.lastname: Li
authors.affiliation: 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. Electronic address: nanshan@vip.163.com.
authors.forename: Nan-Shan
authors.initials: NS
authors.lastname: Zhong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000402:Airway Obstruction / Q000150:complications* / Q000175:diagnosis; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D015552:Injections, Intralesional; D008175:Lung Neoplasms / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis; D014050:Toluene / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D055815:Young Adult; D000096926:Benzenesulfonamides
chemical_list: D000970:Antineoplastic Agents; D013449:Sulfonamides; D014050:Toluene; C025417:4-toluenesulfonamide; D000096926:Benzenesulfonamides
keywords: Bronchoscopy; Computed tomography; Non-small cell lung carcinoma; Para-toluenesulfonamide; Severe airway obstruction; Survival