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Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy.

ABSTRACT: 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.

SUBMITTER: Yarmus L

PROVIDER: S-EPMC6717117 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy.

Yarmus Lonny L Mallow Christopher C Akulian Jason J Lin Cheng Ting CT Ettinger David D Hales Russell R Voong Kinh Ranh KR Lee Hans H Feller-Kopman David D Semaan Roy R Seward Kirk K Wahidi Momen M MM

Chest 20190215 3

<h4>Background</h4>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.<h4>Methods</h4>In this multicentered prospective trial, 23 patients with non- ...[more]

PMID: 30776363

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Project description:ObjectivesTo evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components.Design and settingA feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.ParticipantsConsecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.InterventionsParticipants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Main outcome measuresBlinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.ResultsAt discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported.ConclusionsBoth interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a different trial design, is needed to ascertain the effectiveness of combining the interventions into a stepped care intervention and comparing to a no intervention arm. Findings will guide design changes for an adequately powered randomised controlled trial, using RMDQ as the primary outcome.Trial registrationISRCTN registry 33808269.

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Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy.

Publications

Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy.

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