Fidelman Nicholas, Kerlan Robert K, Hawkins Randall A, Taylor Andrew G, Kohi Maureen P, Kolli K Pallav, Bergsland Emily K, Kelley R Kate, Ko Andrew H, Korn W Michael, McWhirter Ryan M, Luan Jennifer, Venook Alan P
Department of Radiology, University of California San Francisco, 505 Parnassus Avenue, Room M-361, San Francisco, CA, 94143, USA,
J Gastrointest Cancer. 2014 Jun;45(2):168-80. doi: 10.1007/s12029-013-9566-7.
This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of treatment of liver-dominant metastatic gastrointestinal cancer using (90)Y glass microspheres.
Between June 2010 and November 2012, 30 adult patients (22 men, eight women; median age 61 years) with metastatic chemotherapy-refractory unresectable colorectal (n = 15), neuroendocrine (n = 9), intrahepatic cholangiocarcinoma (n = 3), pancreas (n = 2), and esophageal (n = 1) carcinomas underwent 45 lobar or segmental administrations of (90)Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for 6 months after each treatment. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors, version 1.1. Time to maximum response, response duration, progression-free survival (hepatic and extrahepatic), and overall survival were measured.
Median target dose and activity were 111.6 Gy and 2.5 GBq per treatment session, respectively. All but three clinical AE were grade 1 or 2 in severity. Serious AE included an unplanned hospital admission for carcinoid crisis, grade 3 vomiting, and grade 4 gastric ulcer. Patients with colorectal cancer had hepatic objective response rate (ORR) of 27 % and a disease control rate (DCR) of 73 %. Median progression-free and overall survival were 1.0 and 4.9 months, respectively. Patients with neuroendocrine tumors had hepatic ORR and DCR of 78 % and 100 %, respectively. Median progression-free survival was 18.5 months for this cohort.
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-90玻璃微球治疗以肝脏为主的转移性胃肠道癌的可行性、安全性和疗效。
2010年6月至2012年11月期间，30例成年患者（22例男性，8例女性；中位年龄61岁），患有转移性化疗难治性不可切除的结直肠癌（n = 15）、神经内分泌癌（n = 9）、肝内胆管癌（n = 3）、胰腺癌（n = 2）和食管癌（n = 1），接受了45次钇-90玻璃微球的叶或段给药。每次治疗后前瞻性收集6个月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（肝内和肝外）和总生存期。
每次治疗的中位靶剂量和活度分别为111.6 Gy和2.5 GBq。除3例临床AE外，所有AE严重程度均为1级或2级。严重AE包括因类癌危象计划外住院、3级呕吐和4级胃溃疡。结直肠癌患者的肝脏客观缓解率（ORR）为27%，疾病控制率（DCR）为73%。中位无进展生存期和总生存期分别为1.0个月和4.9个月。神经内分泌肿瘤患者的肝脏ORR和DCR分别为78%和100%。该队列的中位无进展生存期为18.5个月。
钇玻璃微球装置具有良好的安全性，并且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。
