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LifePearl™ microspheres (Terumo) are polyethylene glycol (PEG) embolization microspheres that can be loaded with chemotherapeutic drugs including doxorubicin, irinotecan, idarubicin and epirubicin¹. Philippe Pereira (SLK-Kliniken GmbH, Heilbronn, Germany) speaks to Interventional News about his experience using LifePearl microspheres in his interventional oncology practice. He shares his knowledge on how to achieve the optimal transarterial chemoembolization (TACE) procedure, and how the latest pooled analysis data from hepatocellular carcinoma (HCC) patients reinforce the evidence on efficacy and safety of drug-eluting microspheres (DEM) TACE with LifePearl microspheres in patients with HCC.
Pereira begins by outlining some of the current challenges of TACE. “Having a personalised approach to chemoembolization is very important and one of the main advantages of local therapies,” he stipulates, “and every chemoembolization is different—regarding the dose, the vessel anatomy, etc. He also stipulates the need to preserve the patient’s liver function following TACE. Altogether, you need a very high level of experience, and for the large majority of tumours, a superselectivity of your catheterisation is absolutely required”.
How do you perform your TACE procedures for HCC?
Next, Pereira details the advantages of using LifePearl microspheres as a means of overcoming the challenges often associated with TACE, drawing on his own experience, having used it for eight years. “In Germany, the preparation [for TACE] with cytotoxic drugs is no longer done in the radiology department, but in the pharmacies. As our pharmacists have said to me, it is really easy to load them with only few preparation steps required”. Another advantage, according to Pereira, is that the LifePearl microspheres are available in a variety of sizes, including “a very small size (100µm) for the treatment of primary and secondary liver tumours”. This is coupled with a narrow size distribution for targeted treatment. The third benefit, he continues, is the “long time stability” of LifePearl microspheres mixed with contrast medium allowing a smooth delivery²⁻³.
Furthermore, Pereira explains that he uses “a 2.4Fr Progreat microcatheter for TACE procedures and in some more difficult situations where you have a complex intrahepatic arterial anatomy, you should be very selective and we sometimes go to a 2.0Fr microcatheter”. OcclusafeTM micro balloon microcatheter can also allow for blood flow redistribution during TACE, which is not possible with a standard microcatheter and can be beneficial for some types of tumours.
What are the highlights of the latest clinical evidence with LifePearl microspheres from your perspective?
Pereira then outlines some of the key findings from the pooled analysis of 580 patients with unresectable HCC treated with LifePearl microspheres, first highlighting the “median overall survival of 50.8 months, which appears to be much more than 25–37 months usually obtained with [conventional] TACE”, although this figure can vary depending on the patient’s Barcelona Clinic Liver Cancer (BCLC) stage.
Also, of interest to Pereira is the “stratification following the ALBI [albumin-bilirubin] scores, allowing maybe a better selection of patients or a more personalised approach with DEM-TACE”. In addition, he notes “the importance of a low level of liver damage” observed in the patients treated with LifePearl microspheres, and that “a low level of hepatic damage is extremely important for continued targeted therapy with TACE or for allowing a stage migration with systemic treatment.”
In a similar vein, Pereira suggests some of the reasons why LifePearl microspheres achieved a greater median overall survival rate as compared to previous reports—“maybe because they have a higher elution rates as demonstrated in in vitro comparative testing, maybe in relation to the tighter size calibration of microspheres allowing a more targeted embolization, maybe both, since there is better standardisation for TACE with microspheres versus conventional TACE.” The improvement of the TACE technique over the years (with superselectivity, improved images etc) can also explain these latest outcomes.
What would be your recommendations for performing an optimal TACE procedure?
Pereira proceeds to speak about recommendations for carrying out an optimal TACE procedure in HCC patients, where superselectivity is key. In the German guidelines, Pereira states, it says that for HCC, “if you cannot be superselective, it is not recommended to perform TACE in HCC”. Moreover, in his opinion, Pereira says that this is true “independent of the size of the tumour”—even if there are “satellite” tumours surrounding it, “you should address each tumour-feeding artery in a selective way”. Another reason why selectivity matters so much for HCC, he elaborates, is to reduce the toxicity of the TACE, especially for patients with the beginnings of liver insufficiency. “It is very important because the TACE will be repeated and you keep, also, the possibility to move to another treatment.” In summary, Pereira states that, with selectivity, “you increase efficacy, and you reduce the adverse effects”.
Pereira returns next to his personal experience, and what is, for him, crucial for an optimal TACE procedure. “Imaging is important—good quality will reduce radiation,” he says. Going into more detail on imaging, Pereira specifies that real-time monitoring can help to analyse the perfusion of HCC tumours in some more tricky cases. “As HCC is mostly a highly perfused tumour, this online monitoring may work very well. It is not necessary for all patients, but in some cases, we use it if we are not sure whether there might be another tumour-feeding artery that we would need to perform TACE on.”
What do you think can be done to further improve clinical outcomes for TACE?
First of all, Pereira suggests that “to improve clinical outcomes, we need to improve training of interventional oncologists on performing TACE procedures—it is a prerequisite”.
Looking ahead to the potential for further innovation, Pereira suggests that “perhaps we need, in the future, resorption of the microspheres to be able to repeat the treatment”. BioPearlTM microspheres (Terumo) is an example of this technology to which Pereira refers to reinforce this point—access to the tumour over time can become problematic due to “changes in morphology in the already-treated tumour-feeding artery, such as if you need to treat the same tumour multiple times”. Resorbable microspheres can guard against this, Pereira underlines, but that how quickly different embolic agents are resorbed remains a question to be answered through future research.
Staying on the subject of future developments, Pereira suggests that we should also improve the possibility of loading DEM-TACE microspheres with different cytotoxic drugs or even immunotherapies, such as immune checkpoint inhibitors.” Pereira points out that there is some preliminary experience of loading embolic microspheres with immunotherapies and treating locally, but that this should be also studied further.
Summarising, Pereira believes that the first way to improve TACE procedures is for the interventional oncologist to develop and standardise the technical aspects, including use of imaging and microcatheters, but that another possible means of achieving better procedural outcomes is to better select the patients and “work together with hepato-oncologists to improve the treatment strategy by combining local and systemic therapies”.
1. LifePearl microspheres IFU PD111943-02 rev A 2018-01
2. De Baere T et al. J Vasc Interv Radiol 2016;27:1425–31
3. Pereira P et al. Anticancer Drugs 2016;27:873–878
Intended purpose: LifePearl™ microspheres are indicated for embolization of blood vessels supplying primary hypervascular tumours or metastases in the liver. Note: LifePearl microspheres can be loaded with chemotherapeutic drugs. When used for drug loading, drug loading should be done under a physician’s direction, choice and responsibility, based on type and dose of drug most beneficial to the patient. LifePearl microspheres are compatible with doxorubicin, epirubicin, idarubicin and irinotecan. LifePearl microspheres can be drug loaded prior to embolization and then, as a secondary action, elute a local, controlled, and sustained dose to the targeted tumour sites after embolization.
Occlusafe™ temporary occlusion balloon microcatheter is intended for use in the peripheral vasculature where temporary occlusion is desired. It provides temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow. For use in the peripheral vasculature for the infusion of contrast media, drugs and embolic materials.
Progreat™ is intended for the infusion of contrast media into all blood vessels. The catheter is also intended for drug infusion in intra-arterial therapy and for the infusion of embolic materials for haemostasis. Do not use this product in coronary and cerebral blood vessels.
Lifepearl microsphere and Occlusafe temporary occlusion balloon microcatheter are not available for sale in all countries. This information is provided only in respect to markets where these products are approved or cleared. The use of the LifePearl microspheres device is not cleared or approved in the USA by the Food and Drug Administration. Lifepearl microspheres are not approved in Canada. Please contact your Terumo local sales representative for more information. LifePearl microspheres are manufactured by MicroVention Europe SARL and exclusively distributed by Terumo Europe NV in EMEA region.
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