Bronchial or pulmonary artery chemoembolization for unresectable and unablatable lung metastases: A phase I clinical trial Journal Article
| Authors: | Boas, F. E.; Kemeny, N. E.; Sofocleous, C. T.; Yeh, R.; Thompson, V. R.; Hsu, M.; Moskowitz, C. S.; Ziv, E.; Yarmohammadi, H.; Bendet, A.; Solomon, S. B. |
| Article Title: | Bronchial or pulmonary artery chemoembolization for unresectable and unablatable lung metastases: A phase I clinical trial |
| Abstract: | Background: Lung chemoembolization is an emerging treatment option for lung tumors, but the optimal embolic, drug, and technique are unknown. Purpose: To determine the technical success rate and safety of bronchial or pulmonary artery chemoembolization of lung metastases using ethiodized oil, mitomycin, and microspheres. Materials and Methods: Patients with unresectable and unablatable lung, endobronchial, or mediastinal metastases, who failed systemic chemotherapy, were enrolled in this prospective, single-center, single-arm, phase I clinical trial (December 2019–September 2020). Pulmonary and bronchial angiography was performed to determine the blood supply to the lung metastases. Based on the angiographic findings, bronchial or pulmonary artery chemoembolization was performed using an ethiodized oil and mitomycin emulsion, followed by microspheres. The primary objectives were technical success rate and safety, according to the National Cancer Institute Common Terminology Criteria for Adverse Events. CIs of proportions were estimated with the equal-tailed Jeffreys prior interval, and correlations were evaluated with the Spearman test. Results: Ten participants (median age, 60 years; interquartile range, 52–70 years; six women) were evaluated. Nine of the 10 participants (90%) had lung metastases supplied by the bronchial artery, and one of the 10 participants (10%) had lung metastases supplied by the pulmonary artery. The technical success rate of intratumoral drug delivery was 10 of 10 (100%) (95% CI: 78, 100). There were no severe adverse events (95% CI: 0, 22). The response rate of treated tumors was one of 10 (10%) according to the Response Evaluation Criteria in Solid Tumors and four of 10 (40%) according to the PET Response Criteria in Solid Tumors. Ethiodized oil retention at 4–6 weeks was correlated with reduced tumor size (p = -0.83, P = .003) and metabolic activity (p = -0.71, P = .03). Pharmacokinetics showed that 45% of the mitomycin dose underwent burst release in 2 minutes, and 55% of the dose was retained intratumorally with a half-life of more than 5 hours. The initial tumor-to-plasma ratio of mitomycin concentration was 380. Conclusion: Lung chemoembolization was technically successful for the treatment of lung, mediastinal, and endobronchial metastases, with no severe adverse events. © 2021 Radiological Society of North America Inc.. All rights reserved. |
| Keywords: | adult; clinical article; treatment outcome; treatment response; aged; middle aged; iodinated poppyseed oil; chemoembolization; tumor volume; lung metastasis; correlation analysis; drug retention; patient safety; drug blood level; phase 1 clinical trial; drug half life; mitomycin; drug tumor level; pulmonary artery; drug release; lung angiography; microsphere; tumor metabolism; human; male; female; article; bronchial artery; lung blood flow |
| Journal Title: | Radiology |
| Volume: | 301 |
| Issue: | 2 |
| ISSN: | 0033-8419 |
| Publisher: | Radiological Society of North America, Inc. |
| Date Published: | 2021-11-01 |
| Start Page: | 474 |
| End Page: | 484 |
| Language: | English |
| DOI: | 10.1148/radiol.2021210213 |
| PROVIDER: | scopus |
| PMCID: | PMC8574062 |
| PUBMED: | 34463550 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 December 2021 -- Source: Scopus |
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