Microesferas Embozene TANDEM (CE)
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Calibration (Calibração)
Otimamente calibradas para oferecer mais escolhas de embolização
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Carregamento de medicamentos
Os tamanhos das microsferas permanecem estáveis durante o carregamento e armazenamento de medicamentos; a alteração de dimensão normal é inferior a 5%
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Tempos rápidos de carregamento de medicamentos:
30 a 120 minutos, conforme a prescrição
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Capacidade de carregamento de até 50 mg de medicamento / ml de microesferas:
- doxorrubicina-HCl em pó ou solução
- irinotecano-HCl
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Três tamanhos oferecidos em 2 e 3 ml de produto por seringa
De 40 μm a 100 μm
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Validade de três anos
A partir da data de fabrico
Países com Marcação CE
Esta informação destina-se a profissionais de saúde na EUROPA, exceto profissionais em França, dado as páginas seguintes serem destinadas a todos os profissionais de saúde internacionais mas não cumprirem a lei de publicidade francesa n.º 2011-2012, de 29 de dezembro de 2011, artigo 34. Os outros profissionais de saúde deverão contactar a Varian através de vis.support@varian.com.
A informação seguinte é exclusivamente reservada a profissionais de saúde em países com registos oficiais de produtos de saúde aplicáveis. Dado que este website conter informações, guias de referência e bases de dados destinadas a utilização por profissionais médicos, estes materiais não se destinam a prestar orientações médicas profissionais. Antes da respetiva utilização, consulte a rotulagem dos dispositivos para obter informações de prescrição e instruções de funcionamento.
Bibliografia
Ensaios clínicos de avaliação do TANDEM e Doxoreubicina ou 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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CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France.