Safety and Efficacy of Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in the Downstaging of Intermediate-Stage Hepatocellular Carcinoma (HCC) in Patients With a Child-Pugh Score of 8-9

Abstract

According to the EASL Guidelines for the management of hepatocellular carcinoma, transcatheter arterial chemoembolization is the first-line treatment recommended for intermediate-stage HCC. Furthermore, it is widely accepted that patients beyond the Milan criteria can be considered for a liver transplant after successful downstaging to within the Milan criteria. Response to downstaging treatments significantly influences not just drop-outs, but also the rate of post-transplantation tumor recurrences. TACE with degradable starch microspheres represents an alternative to conventional TACE with lipiodol and TACE with drug-eluting beads, and it leads to transient arterial occlusion allowing lower activation of hypoxia-inducible factors and less release of vascular endothelial growth factor, a promoter of neoangiogenesis, tumor proliferation, and metastatic growth. In patients with intermediate-stage HCC and a Child-Pugh score of 8 or 9, life expectancy may be dominated by cirrhotic liver dysfunction, rather than by the tumor progression itself; hence, locoregional treatments might also be detrimental, precipitating liver dysfunction to an extent that survival is shortened rather than prolonged. Data on tolerability, toxicity, and effectiveness of DSM-TACE are limited but encouraging. Between January 2015 and October 2020, 50 consecutive patients with intermediate-stage hepatocellular carcinoma and a Child-Pugh score of 8/9, who had undergone DSM-TACE as the first-line treatment, were eligible for the study. A total of 142 DSM-TACEs were performed, with a mean number of 2.84 procedures per patient. The mean time-to-downstaging was 19.2 months, with six patients successfully downstaged. OS was about 100% at six months, 81.8% at 12 months, and 50% at 24 months. Twenty-two patients experienced adverse events after chemoembolization. The median OS and safety of DSM-TACE in this study are comparable with other published investigations in this field. Furthermore, 12% of patients were successfully downstaged. Hence, the results of the current investigation demonstrate that DSM-TACE is effective and safe in intermediate-stage HCC, achieving an interesting downstaging rate. Such data were observed in the population subset with a Child-Pugh score of 8 or 9, in which life expectancy may be determined by cirrhotic liver dysfunction, so the achievement of a balance between the safety and efficacy profile of the TACE treatment is crucial.

Efficacy and Safety of Distal Radial Access for Transcatheter Arterial Chemoembolization (TACE) of the Liver

“…According to both the CTCAE and the CIRSE classification systems, patients experienced a global rate of adverse events after chemoembolization that is comparable to previous data on cTACE, DSM-TACE, or DEB-TACE, performed with conventional femoral or radial accesses [19,20,39,[54][55][56], and on other procedures in the endovascular fields [57][58][59]. Finally, in our investigation, we did not observe significant differences in terms of safety endpoints between the group undergoing DEB-TACE with femoral access and the group undergoing DEB-TACE with distal radial access.…”

“…A 5-Fr 125 cm hydrophilic-angiographic catheter (Cobra, Simmons, Multipurpose; Radifocus Glidecath; Terumo Corp, Tokyo, Japan) with a hydrophilic guide wire (Radifo-cus™ Guide Wire M Standard Type 0.035" 260 Cm Angled; Terumo Corp, Tokyo, Japan) was used for the selective celiac trunk catheterization and the cannulation of the common hepatic artery. Subsequently, the remaining endovascular procedural steps were performed as previously described [19].Whenever possible, a superselective approach (via tumorfeeding vessels) was obtained using the above microcatheter; alternatively, a pattern of segmental, lobar, or whole-liver (proper hepatic artery) chemoembolization was followed. LifePearl microspheres 200 ± 50 µm (Terumo Corp, Tokyo, Japan) were loaded with Doxorubicin, at a dose of 75 mg/m 2 body surface area, and non-ionic iodinated contrast media, according to the manufacturer's instructions for use.…”

“…Assessment of vascular access-site complications (VASCs), including radial artery occlusion, was performed at the patient's discharge and at 4 weeks after each treatment by clinical assessment and doppler ultrasound. Patient follow-up and possible repetition of the treatment followed the same schedule and indications as previously described [19].…”

Role of Pretransplant Treatments for Patients with Hepatocellular Carcinoma Waiting for Liver Transplantation

“…DSM-TACE using DSM, which is decomposed by blood amylase and has a short arterial embolization period in the body of up to 50 min, has been reported in cases of portal vein thrombosis [ 109 , 110 , 111 ]. Minici et al [ 112 , 113 ] reported that DSM-TACE could be used safely and effectively as bridging or downstaging for patients with poor hepatic reserve (Child-Pugh score 8–9 points). Radioembolization using Yttrium-90 is reported to treat target lesions more completely for early intermediate stage HCC than conventional TACE [ 114 ].…”

Chemoembolization for Hepatocellular Carcinoma: A Critical Review of The 2021 CIRSE Recommendations with Presentation of A Technique for A Degradable Starch Microsphere - Chemoembolization

“…Minici et al [26] studied 50 of their own patients who received a total of 142 treatment procedures from 2015 to 2020. Treatment consisted of a mixture of DSM, non-ionic contrast medium and doxorubicin (50 mg) -but without lipiodol.…”