From the Department of Radiology, City of Hope Cancer Center, 1500 E Duarte Rd, Duarte, CA 91010 (F.E.B.); Interventional Radiology Service, Department of Radiology (F.E.B., C.T.S., E.Z., H.Y., A.B., S.B.S.), Department of Medicine (N.E.K.), Molecular Imaging and Therapy Service (R.Y.), and Department of Epidemiology and Biostatistics (M.H., C.S.M.), Memorial Sloan-Kettering Cancer Center, New York, NY; and Antitumor Assessment Core Facility, Sloan Kettering Institute, New York, NY (V.R.T.).
Radiology. 2021 Nov;301(2):474-484. doi: 10.1148/radiol.2021210213. Epub 2021 Aug 31.
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 (ρ = -0.83, = .003) and metabolic activity (ρ = -0.71, = .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. Clinical trial registration no. NCT04200417 © RSNA, 2021 See also the editorial by Georgiades et al in this issue.
背景 肺化疗栓塞术是一种新兴的治疗肺肿瘤的方法，但最佳的栓塞剂、药物和技术尚不清楚。目的 评估使用碘化油、丝裂霉素和微球进行支气管或肺动脉化疗栓塞治疗肺转移瘤的技术成功率和安全性。材料与方法 本前瞻性、单中心、单臂、I 期临床试验（2019 年 12 月至 2020 年 9 月）纳入了无法切除和无法消融的肺、支气管内或纵隔转移瘤且对全身化疗无效的患者。进行肺和支气管血管造影以确定肺转移瘤的血供。根据血管造影结果，使用碘化油和丝裂霉素乳剂进行支气管或肺动脉化疗栓塞，然后使用微球。主要终点是根据国立癌症研究所不良事件通用术语标准评估技术成功率和安全性。用等尾杰弗里斯先验区间估计比例的置信区间，用斯皮尔曼检验评估相关性。结果 10 名参与者（中位年龄 60 岁；四分位距 52-70 岁；6 名女性）接受了评估。10 名参与者中有 9 名（90%）的肺转移瘤由支气管动脉供应，10 名参与者中有 1 名（10%）的肺转移瘤由肺动脉供应。肿瘤内药物输送的技术成功率为 10 例（100%）（95%CI：78，100）。无严重不良事件（95%CI：0，22）。根据实体瘤反应评估标准，10 例治疗肿瘤中有 1 例（10%）有反应，根据实体瘤 PET 反应标准，10 例中有 4 例（40%）有反应。4-6 周时碘化油的保留与肿瘤体积缩小（ρ=-0.83，P=.003）和代谢活性降低（ρ=-0.71，P=.03）相关。药代动力学显示，2 分钟内 45%的丝裂霉素剂量呈爆发释放，55%的剂量以半衰期超过 5 小时的方式保留在肿瘤内。丝裂霉素浓度的初始肿瘤-血浆比为 380。结论 肺化疗栓塞术治疗肺、纵隔和支气管内转移瘤技术上是成功的，无严重不良事件。临床试验注册号 NCT04200417 参见本期 Georgiades 等人的社论。
