Fidelman Nicholas, Kerlan Robert K, Hawkins Randall A, Pampaloni Miguel, Taylor Andrew G, Kohi Maureen P, Kolli K Pallav, Atreya Chloe E, Bergsland Emily K, Kelley R Kate, Ko Andrew H, Korn W Michael, Van Loon Katherine, McWhirter Ryan M, Luan Jennifer, Johanson Curt, Venook Alan P
Department of Radiology, University of California San Francisco, San Francisco, CA, USA.
Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
J Gastrointest Oncol. 2016 Dec;7(6):860-874. doi: 10.21037/jgo.2016.08.04.
This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of radioembolization of liver-dominant metastatic gastrointestinal cancer using Y glass microspheres.
Between June 2010 and October 2013, 42 adult patients (26 men, 16 women; median age 60 years) with metastatic chemotherapy-refractory unresectable colorectal (n=21), neuroendocrine (n=11), intrahepatic bile duct (n=7), pancreas (n=2), and esophageal (n=1) carcinomas underwent 60 lobar or segmental administrations of Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for up to 5.5 years after radioembolization. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Time to maximum response, response duration, progression-free survival (PFS) (hepatic and extrahepatic), and overall survival (OS) were measured.
Median target dose and activity were 109.4 Gy and 2.6 GBq per treatment session, respectively. Majority of clinical AE were grade 1 or 2 in severity. Patients with colorectal cancer had hepatic objective response rate (ORR) of 25% and a hepatic disease control rate (DCR) of 80%. Median PFS and OS were 1.0 and 4.4 months, respectively. Patients with neuroendocrine tumors (NET) had hepatic ORR and DCR of 73% and 100%, respectively. Median PFS was 8.9 months for this cohort. DCR and median PFS and OS for patients with cholangiocarcinoma were 86%, 1.1 months, and 6.7 months, respectively.
Y glass microspheres device has a favorable safety profile, and achieved prolonged disease control of hepatic tumor burden in a subset of patients, including all patients enrolled in the neuroendocrine cohort.
本前瞻性单机构试点研究旨在记录使用钇玻璃微球对以肝脏为主的转移性胃肠道癌进行放射性栓塞的可行性、安全性和有效性。
2010年6月至2013年10月期间，42例成年患者（26例男性，16例女性；中位年龄60岁），患有转移性化疗难治性不可切除的结直肠癌（n = 21）、神经内分泌癌（n = 11）、肝内胆管癌（n = 7）、胰腺癌（n = 2）和食管癌（n = 1），接受了60次钇玻璃微球的叶或节段给药。前瞻性收集放射性栓塞后长达5.5年的临床和实验室不良事件（AE）数据。使用实体瘤疗效评价标准（RECIST）1.1版评估影像学反应。测量达到最大反应的时间、反应持续时间、无进展生存期（PFS）（肝脏和肝外）和总生存期（OS）。
每次治疗的中位靶剂量和活度分别为109.4 Gy和2.6 GBq。大多数临床AE的严重程度为1级或2级。结直肠癌患者的肝脏客观缓解率（ORR）为25%，肝脏疾病控制率（DCR）为80%。中位PFS和OS分别为1.0个月和4.4个月。神经内分泌肿瘤（NET）患者的肝脏ORR和DCR分别为73%和100%。该队列的中位PFS为8.9个月。胆管癌患者的DCR以及中位PFS和OS分别为86%、1.1个月和6.7个月。
钇玻璃微球装置具有良好的安全性，并在一部分患者中实现了肝脏肿瘤负荷的长期疾病控制，包括神经内分泌队列中的所有患者。
