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

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 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).

CONCLUSION:

PTS intratumoral injection is effective and well tolerated for palliative therapy of NSCLC-SMAO.

• Authors: 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, Nan-Shan Zhong
• Journal: Lung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 98 Pg. 43-50 (08 2016) ISSN: 1872-8332 [Electronic] Ireland
• PMID: 27393505 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Chemical References

• Antineoplastic Agents
• Sulfonamides
• Toluene
• 4-toluenesulfonamide

Topics

• Adult
• Aged
• Aged, 80 and over
• Airway Obstruction (complications, diagnosis)
• Antineoplastic Agents (administration & dosage, adverse effects)
• Carcinoma, Non-Small-Cell Lung (complications, diagnosis, drug therapy, mortality)
• Female
• Humans
• Injections, Intralesional
• Lung Neoplasms (complications, diagnosis, drug therapy, mortality)
• Male
• Middle Aged
• Severity of Illness Index
• Sulfonamides (administration & dosage, adverse effects)
• Survival Analysis
• Toluene (administration & dosage, adverse effects, analogs & derivatives)
• Treatment Outcome
• Young Adult