Effects of para-toluenesulfonamide intratumoral injection onpulmonary adenoid cystic carcinoma compl

State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of RespiratoryHealth, The First Affliated Hospital of Guangzhou Medical University, Guangzhou 510120, ChinaCorresondcnce to: Nan-Shan Zhong, MD. State Key Laboratory of Respiratory Disease, National Cliical Research Center for Respiratory Disease.Guangzhou Institute of Respiratory Health, The First Affliated Hospital of Guanpzhou Medical University, 151 Yaniang Road, Guangzhou 510120.China. Email; nanshan@vip.163.com

Abstract: Pulmonary adenoid cystic carcinoma (ACC) is a rare type of non-small cell lung carcinoma thatmay develop life-threatening severe malignant airway obstruction (SMAO). Currently, limited therapeuticapproaches exist for ACC-SMA0. We investigated the efficacy and safety of para-toluenesulfonamide (PTS)intratumoral injection for ACC-SMAO. In this phase Ill, multicenter, non-randomized, single-arm, openabel trial, we recruited eight hospitalized patients with ACC-SMAO between October 2009 and Januar2011. Within the first vear, patients received PTS injection for 2-3 sessions weekly, with 2 weeks as a singlecourse. Pre- and post-treatment assessments, including vital sign assessment, dyspnea index, chest computedtomography (CT), were performed shortly before PTS injection and at day 30 post-treatment, We extendedthe observation to 5 vears to determine overall survival, The primary endpoint was the CT-assessed airwayobiective response rate (ORR) at day 30. The kev secondary endpoint was the overall survival (OS) at5 vears post-treatment, At baseline, mean airway tumor cross-sectional area was 1533 mm2 (n-8), and themean airway obstruction rate was 86.1%. The airway ORR reached 100% (333% complete remission and66.7% partial remission). PTS treatment reduced the airway tumor size from 158.2 to 22.7 mm2 and theaverage airway obstruction rate decreased from 83.1% to 14.4% (n-6). The 5-vear overall surviva rate was...