Irreversible electroporation (IRE) fails to demonstrate efficacy in a prospective multicenter phase II trial on lung malignancies

TY - JOUR

T1 - Irreversible electroporation (IRE) fails to demonstrate efficacy in a prospective multicenter phase II trial on lung malignancies

T2 - the ALICE trial

AU - Ricke, Jens

AU - Jürgens, Julian H W

AU - Deschamps, Frederic

AU - Tselikas, Lambros

AU - Uhde, Katja

AU - Kosiek, Ortrud

AU - De Baere, Thierry

PY - 2015/4

Y1 - 2015/4

N2 - PURPOSE: To assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.MATERIALS AND METHODS: Patients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife® (Angiodynamics). System settings for the ablation procedure followed the manufacturer's recommendations. The Mann-Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up was 12 months.RESULTS: The expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8-27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).CONCLUSIONS: IRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.

AB - PURPOSE: To assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.MATERIALS AND METHODS: Patients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife® (Angiodynamics). System settings for the ablation procedure followed the manufacturer's recommendations. The Mann-Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up was 12 months.RESULTS: The expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8-27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).CONCLUSIONS: IRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Electroporation

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Lung

KW - Lung Neoplasms

KW - Male

KW - Middle Aged

KW - Prospective Studies

KW - Radiography, Interventional

KW - Tomography, X-Ray Computed

KW - Treatment Outcome

KW - Clinical Trial, Phase II

KW - Journal Article

KW - Multicenter Study

U2 - 10.1007/s00270-014-1049-0

DO - 10.1007/s00270-014-1049-0

M3 - SCORING: Journal article

C2 - 25609208

VL - 38

SP - 401

EP - 408

JO - CARDIOVASC INTER RAD

JF - CARDIOVASC INTER RAD

SN - 0174-1551

IS - 2

ER -