{ "pageType": "product", "title": "Embozene TANDEM 微球(CE)", "videoId": "", "imageId": "https://varian.widen.net/content/pw2n9yoxa7/webp" }
  • 1

    校准

    严格校准,以适用于更多栓塞选择

  • 2

    药物装载

    药物装载不影响微球粒径,微球粒径变化 < 5%

  • 3

    高效药物装载

    30-120 分钟,取决于具体药物

  • 4

    每毫升微球最多可装载 50 mg 药物:

    - 盐酸多柔比星粉末或溶液 - 盐酸伊立替康

  • 5

    3 种粒径微球 x 2 ml/3 ml 注射器

    40 μm 至 100 μm

  • 6

    自制造之日起保质期为 3 年

    自制造之日起

CE 认证国家

此信息适用于除法国以外的所有欧洲医疗专业人员(以下页面信息不符合自 2011 年 12 月 29 日生效的法国广告法 N°2011-2012 第34条)。其他医疗保健专业人员应通过 vis.support@varian.com 联系瓦里安。

请注意,此信息仅供当地已获得医疗产品注册的国家/地区的医疗专业人员使用。本网站所含供执业医疗专业人员使用的信息、参考指南和数据库不作为专业医疗建议。使用前,请查阅产品标签的处方信息和操作说明。

参考文献

评估 TANDEM 和多柔比星或伊立替康的临床试验

Publication / Study Treatment Disease State & Staging Number of Patients Results Endpoints (*=Primary)
Richter et al, 2018¹
MIRACLE I
DEB-TACE with Doxorubicin HCC
ECOG: 0-2
Child-Pugh: A or B*
25 Freedom From:
30D SAEs: 92%
6M SAEs: 71%
6M tumor progression: 76%
Tumor control: 95%
12M Survival: 56% (w/o ascites 73%)
Safety (30D, 6M), Tumor progression (6M) Time to progression, Local tumor control, Survival (12M)
Mauri et al, 2018²
MIRACLE III
DEB-TACE with Irinotecan mCRC
ECOG: 0-1**
18 30 Day SAE-Free: 100% (18/18)
3M Tumor Control: 88.9% (17/18)
6M Tumor Control: 41.2% (7/17)
12M Tumor Control: 17.6% (3/17)
12M Survival: 44%
Safety (30D), Tumor control (3M), Secondary: Tumor control (6M, 12M), Survival (12M)
  • *One study patient 1/25 (4%) treated was Child-Pugh C.
  • **All study patients 18/18 (100%) treated were ECOG 0.
  • 1 Richter, G., et al., Safety and Feasibility of Chemoembolization with Doxorubicin-Loaded Small Calibrated Microspheres in Patients with Hepatocellular Carcinoma: Results of the MIRACLE I Prospective Multicenter Study. Cardiovasc Intervent Radiol (2018) 41:587–593
  • 2 Mauri, G., et al., Transarterial Embolization with Small-Size Particles Loaded with Irinotecan for the Treatment of Colorectal Liver Metastases: Results of the MIRACLE III Study. Cardiovasc Intervent Radiol (2018) 41:1708–1715.

评估使用多柔比星-TACE 治疗肝细胞癌的随机对照试验

  • Kawai, S., et al., Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma--a comparison of lipiodol-transcatheter arterial embolization with and without adriamycin (first cooperative study). The Cooperative Study Group for Liver Cancer Treatment of Japan. Cancer Chemother Pharmacol, 1992. 31 Suppl: p. S1-6.
  • Llovet, J.M., et al., Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet, 2002. 359(9319): p. 1734-9.
  • Brown, K.T., et al., Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone. J Clin Oncol, 2016. 34(17): p. 2046-53.
  • Malagari, K., et al., Prospective randomized comparison of chemoembolization with doxorubicin-eluting beads and bland embolization with BeadBlock for hepatocellular carcinoma. Cardiovasc Intervent Radiol, 2010. 33(3): p. 541-51.
  • Mabed, M., et al., A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. Eur J Cancer Care (Engl), 2009. 18(5): p. 492-9.
  • Lammer, J., et al., Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol, 2010. 33(1): p. 41-52.
  • van Malenstein, H., et al., A randomized phase II study of drug-eluting beads versus transarterial chemoembolization for unresectable hepatocellular carcinoma. Onkologie, 2011. 34(7): p. 368-76.
  • Sacco, R., et al., Conventional versus doxorubicin-eluting bead transarterial chemoembolization for hepatocellular carcinoma. J Vasc Interv Radiol, 2011. 22(11): p. 1545-52.
  • Golfieri, R., et al., Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma. British Journal of Cancer, 2014. 111(2): p. 255-264.

评估使用伊立替康-TACE 治疗结直肠肿瘤转移的随机对照试验

  • Fiorentini, G., et al., Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for hepatic metastases from colorectal cancer: final results of a phase III study. Anticancer Res, 2012. 32(4): p. 1387-95.
  • Martin, R.C., 2nd, et al., Irinotecan drug-eluting beads in the treatment of chemo-naive unresectable colorectal liver metastasis with concomitant systemic fluorouracil and oxaliplatin: results of pharmacokinetics and phase I trial. J Gastrointest Surg, 2012. 16(8): p. 1531-8.
  • Martin, R.C., 2nd, et al., Randomized controlled trial of irinotecan drug-eluting beads with simultaneous FOLFOX and bevacizumab for patients with unresectable colorectal liver-limited metastasis. Cancer, 2015. 121(20): p. 3649-58.

参考文献

注意:法律限制这些设备由医生或根据医生的命令销售。适应症、禁忌症、警告和使用说明附在每个设备的产品标签。使用信息仅限具有适用卫生机构注册的国家/地区。该材料不适合在法国使用。

如何订购

了解如何与瓦里安介入肿瘤解决方案开展商务合作。

联系我们

联系瓦里安介入解决方案中国区客户服务和支持团队:0571-63831538。

联系我们