From the Departments of Interventional Radiology (E.C.E., D.B.B.), Biostatistics (L.D.), and Transplant Surgery (L.M.), Vanderbilt University Medical Center, 1161 21st Ave S, CCC-1118 Medical Center North, Nashville, TN 37232; Vanderbilt University School of Medicine, Nashville, Tenn (S.B.); Department of Interventional Radiology, Cancer Treatment Centers of America, Atlanta, Ga (H.K.); Department of Interventional Radiology, Miami Cardiac and Vascular Institute, Miami, Fla (R.T.G.); Department of Interventional Radiology, University of Kansas, Kansas City, Kan (Z.S.C.); Department of Interventional Radiology, University of Utah, Salt Lake City, Utah (R.O.); Department of Interventional Radiology, University of Maryland, Baltimore, Md (N.M.A.); Department of Interventional Radiology, Carolinas Medical Center, Charlotte, NC (E.A.W.); Department of Interventional Radiology, Christiana Medical Center, Newark, Del (C.G.); Department of Interventional Radiology, Providence Sacred Heart, Spokane, Wash (J.S.B.); Department of Interventional Radiology, Sanford Health, Sioux Falls, SD (S.R.P.); Department of Interventional Radiology, Roswell Park Memorial Institute, Buffalo, NY (M.P.); Department of Interventional Radiology, University of Texas, Houston, Tex (A.K.A.A.); Department of Interventional Radiology, University of Minnesota, Minneapolis, Minn (J.G.); Department of Radiation Oncology, Sarah Cannon Research Institute, Nashville, Tenn (A.S.K.); and Department of Interventional Radiology, Stanford University, Palo Alto, Calif (D.Y.S.).
Radiology. 2022 Oct;305(1):228-236. doi: 10.1148/radiol.220387. Epub 2022 Jun 28.
Background Patients with unresectable, chemorefractory hepatic metastases from colorectal cancer have considerable mortality. The role of transarterial radioembolization (TARE) with yttrium 90 (Y) microspheres is not defined because most reports are from a single center with limited patient numbers. Purpose To report outcomes in participants with colorectal cancer metastases treated with resin Y microspheres from a prospective multicenter observational registry. Materials and Methods This study treated enrolled adult participants with TARE using resin microspheres for liver-dominant metastatic colorectal cancer at 42 centers, with enrollment from July 2015 through August 2020. TARE was used as the first-, second-, or third-line therapy or beyond. Overall survival (OS), progression-free survival (PFS), and toxicity outcomes were assessed by line of therapy by using Kaplan-Meier analysis for OS and PFS and Common Terminology Criteria for Adverse Events, version 5, for toxicities. Results A total of 498 participants (median age, 60 years [IQR, 52-69 years]; 298 men [60%]) were treated. TARE was used in first-line therapy in 74 of 442 participants (17%), second-line therapy in 180 participants (41%), and third-line therapy or beyond in 188 participants (43%). The median OS of the entire cohort was 15.0 months (95% CI: 13.3, 16.9). The median OS by line of therapy was 13.9 months for first-line therapy, 17.4 months for second-line therapy, and 12.5 months for third-line therapy (χ = 9.7; = .002). Whole-group PFS was 7.4 months (95% CI: 6.4, 9.5). The median PFS by line of therapy was 7.9 months for first-line therapy, 10.0 months for second-line therapy, and 5.9 months for third-line therapy (χ = 8.3; = .004). TARE-attributable grade 3 or 4 hepatic toxicities were 8.4% for bilirubin (29 of 347 participants) and 3.7% for albumin (13 of 347). Grade 3 and higher toxicities were greater with third-line therapy for bilirubin ( = .01) and albumin ( = .008). Conclusion Median overall survival (OS) after transarterial radioembolization (TARE) with yttrium 90 microspheres for liver-dominant metastatic colorectal cancer was 15.0 months. The longest OS was achieved when TARE was part of second-line therapy. Grade 3 or greater hepatic function toxicity rates were less than 10%. Clinical trial registration no. NCT02685631 Published under a CC BY 4.0 license. See also the editorial by Liddell in this issue.
背景 无法切除、化疗耐药的结直肠癌肝转移患者死亡率相当高。钇 90（Y）微球的经动脉放射栓塞（TARE）的作用尚未确定，因为大多数报告来自单个中心，患者数量有限。
目的 报告使用树脂 Y 微球治疗结直肠癌肝转移患者的结果，这些患者来自一个前瞻性多中心观察性登记处。
材料与方法 本研究在 42 个中心对 498 名患有结直肠癌肝转移的成年参与者进行了 TARE 治疗，入组时间为 2015 年 7 月至 2020 年 8 月。TARE 作为一线、二线或三线治疗或以上治疗。通过 Kaplan-Meier 分析评估按治疗线的总生存期（OS）、无进展生存期（PFS）和毒性结局，通过通用不良事件术语标准，第 5 版（Common Terminology Criteria for Adverse Events, version 5, CTCAE v5）评估毒性。
结果 共有 498 名参与者（中位年龄，60 岁[IQR，52-69 岁]；298 名男性[60%]）接受了治疗。442 名参与者中的 74 名（17%）接受了一线治疗，180 名（41%）接受了二线治疗，188 名（43%）接受了三线治疗或以上治疗。整个队列的中位 OS 为 15.0 个月（95%CI：13.3，16.9）。按治疗线的中位 OS 分别为一线治疗 13.9 个月，二线治疗 17.4 个月，三线治疗 12.5 个月（χ=9.7；=0.002）。全组 PFS 为 7.4 个月（95%CI：6.4，9.5）。按治疗线的中位 PFS 分别为一线治疗 7.9 个月，二线治疗 10.0 个月，三线治疗 5.9 个月（χ=8.3；=0.004）。TARE 相关的 3 级或 4 级肝毒性为胆红素（29/347 名参与者）的 8.4%和白蛋白（347 名参与者中的 13 名）的 3.7%。对于胆红素（=0.01）和白蛋白（=0.008），三线治疗的 3 级及以上毒性更高。
结论 使用钇 90 微球进行经动脉放射栓塞（TARE）治疗结直肠癌肝转移患者的中位总生存期（OS）为 15.0 个月。当 TARE 作为二线治疗的一部分时，OS 最长。3 级或以上肝功能毒性发生率低于 10%。
临床试验注册号 NCT02685631 发表于 CC BY 4.0 许可下。请同时参见本期杂志中 Liddell 的社论。
