Microesferas Embozene TANDEM (CE)
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Calibración
Estrechamente calibradas para permitir más opciones de embolización
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Carga de medicamentos
Los tamaños de la microesfera se mantienen estables durante la carga del medicamento y durante el almacenamiento; el cambio de tamaño típico es inferior al 5 %
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Tiempos de carga rápida de medicamentos
De 30 a 120 minutos según la prescripción
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Miecroesferas capaces de cargar hasta 50 mg de fármaco/ml:
- doxorubicina-HCl polvo o solución
- irinotecán-HCl
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Tres tamaños ofrecidos en 2 y 3 ml de producto por jeringa
De 40 a 100 μm
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Vida útil de tres años
A partir de la fecha de fabricación
Países con marcado CE
Esta información es para los profesionales sanitarios de EUROPA, excepto los que ejercen en Francia, ya que las páginas siguientes están destinadas a todos los profesionales sanitarios internacionales y no cumplen con la Ley francesa de publicidad N.° 2011-2012 del 29 de diciembre de 2011, artículo 34. Otros profesionales de la salud deben pornerse en contacto con Varian mediante vis.support@varian.com.
Tenga en cuenta que esta información está reservada exclusivamente para profesionales de la salud en países con registros de productos de la autoridad sanitaria aplicable. En la medida en que este sitio contenga información, guías de referencia y bases de datos destinadas a ser utilizados por profesionales médicos con licencia, dichos materiales no están destinados a ofrecer asesoramiento médico profesional. Antes de su uso, consulte el etiquetado del dispositivo para obtener información prescriptiva e instrucciones de funcionamiento.
Bibliografía
Ensayos clínicos que evalúan TANDEM y Doxorubicina o Irinotecan
Publication / Study | Treatment | Disease State & Staging | Number of Patients | Results | Endpoints (*=Primary) |
|---|---|---|---|---|---|
Richter et al, 2018¹ | DEB-TACE with Doxorubicin | HCC | 25 | Freedom From: | Safety (30D, 6M), Tumor progression (6M) Time to progression, Local tumor control, Survival (12M) |
Mauri et al, 2018² | DEB-TACE with Irinotecan | mCRC | 18 | 30 Day SAE-Free: 100% (18/18) | 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.
Randomized Controlled Trials Evaluating Doxorubicin-TACE for Treatment of HCC
- 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.
Randomized Controlled Trials Evaluating Irinotecan-TACE for Treatment of mCRC
- 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.
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