Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

BACKGROUND: Malignant airway obstruction (MAO) occurs in 30% of patients with advanced-stage lung cancer, leading to debilitating dyspnea, cough, and hemoptysis. Other than recanalization of the airways, these patients lack long-lasting palliative therapy. The goal of this study was to determine the safety and feasibility of local injection of paclitaxel into the airway wall with a novel microinjection catheter. METHODS: In this multicentered prospective trial, 23 patients with non-small cell lung cancer and MAO were enrolled from July 2014 through June 2016 to undergo rigid bronchoscopy with recanalization, followed by injection of 1.5 mg of paclitaxel with a novel injection catheter. Primary end points consisted of safety (adverse events, severe adverse events, and unanticipated adverse device effects) as well as feasibility (number of injections, injection success). Secondary end points consisted of airway patency improvement, quality of life metrics, and need for further interventions and/or stenting. RESULTS: Nineteen patients underwent rigid bronchoscopy with successful recanalization and paclitaxel injection. There were no adverse events, severe adverse events, or unanticipated adverse device effects. There was an average of 3.4 injections given for a total dose of 1.5 mg of paclitaxel in all patients. There was significantly less stenosis postprocedure vs preprocedure (25%-50% vs 75%-90%; P < .001), which was unchanged at 6 weeks (25%-50%). None of the participants required further interventions or airway stenting. CONCLUSIONS: The injection of paclitaxel after recanalization of MAO in patients with non-small cell lung cancer is safe and feasible, using a novel airway injection device. TRIAL REGISTRY:; No.: NCT02066103; URL:

Full Text

Duke Authors

Cited Authors

  • Yarmus, L; Mallow, C; Akulian, J; Lin, CT; Ettinger, D; Hales, R; Voong, KR; Lee, H; Feller-Kopman, D; Semaan, R; Seward, K; Wahidi, MM

Published Date

  • September 2019

Published In

Volume / Issue

  • 156 / 3

Start / End Page

  • 562 - 570

PubMed ID

  • 30776363

Pubmed Central ID

  • PMC6717117

Electronic International Standard Serial Number (EISSN)

  • 1931-3543

Digital Object Identifier (DOI)

  • 10.1016/j.chest.2019.02.006


  • eng

Conference Location

  • United States