Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy.
Aged
Airway Obstruction
/ etiology
Antineoplastic Agents, Phytogenic
/ administration & dosage
Bronchoscopy
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Feasibility Studies
Female
Humans
Injections, Intralesional
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Paclitaxel
/ administration & dosage
Prospective Studies
Quality of Life
Stents
Treatment Outcome
airway obstruction
chemotherapy
interventional bronchoscopy
lung cancer
Journal
Chest
ISSN: 1931-3543
Titre abrégé: Chest
Pays: United States
ID NLM: 0231335
Informations de publication
Date de publication:
09 2019
09 2019
Historique:
received:
25
10
2018
revised:
19
12
2018
accepted:
01
02
2019
pubmed:
19
2
2019
medline:
8
5
2020
entrez:
19
2
2019
Statut:
ppublish
Résumé
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. 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. 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. 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. ClinicalTrials.gov; No.: NCT02066103; URL: www.clinicaltrials.gov.
Sections du résumé
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
ClinicalTrials.gov; No.: NCT02066103; URL: www.clinicaltrials.gov.
Identifiants
pubmed: 30776363
pii: S0012-3692(19)30155-2
doi: 10.1016/j.chest.2019.02.006
pmc: PMC6717117
pii:
doi:
Substances chimiques
Antineoplastic Agents, Phytogenic
0
Paclitaxel
P88XT4IS4D
Banques de données
ClinicalTrials.gov
['NCT02066103']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
562-570Subventions
Organisme : NCI NIH HHS
ID : R42 CA141907
Pays : United States
Informations de copyright
Copyright © 2019 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
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