Gontran Verset et al. Hepatic Oncology(2020)

Featured product: Occlusafe™ Temporary Occlusion Balloon Microcatheter

October 13, 2020

neutrals-100

Currently, only two recent retrospective studies have evaluated B-TACE using DEMs (B-DEM-TACE) in HCC and showed positive results in terms of safety and efficacy. We report here the first prospective study assessing the feasibility and safety of B-TACE using PEG embolizing microspheres loaded with 75 mg doxorubicin (B-DEM-TACE) in a selected population of HCC patients.

Evaluation of safety and efficacy of selective balloon-occluded transarterial chemoembolization using polyethylene glycol embolizing microspheres in patients with hepatocellular carcinoma.

• 24 patients with 40 HCC lesions underwent B-DEM-TACE
• Adverse events were evaluated at 24 h and 1 month
• Imaging response according to modified response evaluation criteria in solid tumours was assessed at 1, 3 and 6 months

Gontran Verset et al registry demonstrated:

neutrals-100

• Nine patients (37.5%) received a second treatment and two of them (22.2%) went on to a third treatment without worsening of the liver function.
• All 24 patients were candidates for multimodal treatment after B-DEM-TACE due to the lack of hepatic injury.

neutrals-100

Table2.Early and late laboratory toxicities(grade 1 according to Common Terminology Criteria of Adverse Events version 5)

neutrals-100

• The 1-month follow-up imaging post-treatment by contrast-enhanced MRI was available for 39 nodules and showed an overall response per nodule of 74.3% (48.7% CR and 25.6% PR) and a best overall response of 70.9% (41.7% CR and 29.2% PR)

neutrals-100

Gontran Verset et al concluded that B-DEM-TACE has proven to be an effective treatment for HCC patients with a very good safety profile. In our series we have observed fewer AEs than previously described with other catheters, suggesting an added value of this technique in terms of liver function preservation. If future trials will confirm these observations, B-DEM-TACE may become a valuable tool for intra-arterial LRTs mostly for frail patients.

neutrals-100

The main findings of Gontran Verset et al are that:

• This technique enables to improve the selectivity of TACE, which is an added value for the treatment of HCC particularly in cirrhotic patients, who are most likely to present an impaired liver function.
• Currently, a key point of locoregional therapy is the preservation of liver function, ever since the development of various systemic therapies that improve OS of these patients.

neutrals-100

European Economic Area Indications for use of Occlusafe™ Temporary Occlusion Balloon Catheter

• Occlusafe™ is intended to be used for gaining temporary occlusion in the peripheral vasculature. The Occlusafe™ provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow
• Occlusafe™ is not available for sale in all countries. This information is provided only in respect to markets where this product is approved or cleared
• Occlusafe™ is manufactured by Terumo Clinical Supply Co., Ltd. and exclusively distributed by Terumo Europe NV in the EMEA region. All brand names are trademarks or registered trademarks of TERUMO CORPORATION and their respective owners. Scientific and clinical data related to this document are on file at Terumo Clinical Supply Co., Ltd. Refer to Instructions for Use for additional information.

This literature summary is not a systemic review. It is only an example of Occlusafe™Temporary Occlusion Balloon Catheter related literatures.

Please contact your Terumo local sales representative for more information. All brand names are trademarks or registered trademarks of TERUMO CORPORATION and their respective owners. Refer to Instructions for Use for Contraindications, Warnings and Precautions.

©2021 TERUMO CLINICAL SUPPLY CO, LTD. CE0344

Manufacturer

TERUMO CLINICAL SUPPLY Co., Ltd.

3 Kawashima-Takehayamachi

Kakamigahara Gifu, Japan 501-6024

Tel: +81(0)3-6742-8770

Distributor

Terumo Europe N.V.

Interleuvenlaan 40

3001 Leuven Belgium

Tel: +32 16 38 12 11

neutrals-100