The Comprehensive Analysis of Efficacy and Safety of CalliSpheres^® Drug-Eluting Beads Transarterial Chemoembolization in 367 Liver Cancer Patients: A Multiple-Center, Cohort Study

Abstract

This study aimed to investigate the efficacy, safety, and prognostic factors of drug-eluting beads transarterial chemoembolization (DEB-TACE) in treating Chinese patients with liver cancer. A total of 367 liver cancer patients from 24 medical centers were consecutively enrolled in this multiple-center, prospective cohort study, including 275 hepatocellular carcinoma (HCC) cases, 37 intrahepatic cholangiocarcinoma (ICC) cases, and 55 secondary liver cancer cases. All the patients received CalliSpheres® DEB-TACE treatment. Treatment response, overall survival (OS), change of liver function, and adverse events (AEs) were assessed. DEB-TACE treatment achieved 19.9% complete response (CR) and 79.6% objective response rate (ORR), with mean OS of 384 days [95% confidence interval (CI): 375‐393 days]. CR and ORR were both higher in HCC patients compared with primary ICC patients and secondary liver cancer patients, while no difference was discovered in OS. Portal vein invasion was an independent risk factor for CR, while portal vein invasion, previous conventional TACE (cTACE) treatment, and abnormal blood creatinine (BCr) were independent risk factors for ORR. In addition, largest nodule size ≥5.0 cm, abnormal albumin (ALB), and abnormal total bilirubin (TBIL) independently correlated with unfavorable OS. Most liver function indexes were recovered to baseline levels at 1‐3 months after DEB-TACE. Common AEs were pain, fever, vomiting, and nausea; most of them were at mild grade. CalliSpheres® DEB-TACE is efficient and well tolerated in Chinese liver cancer patients. Portal vein invasion, previous cTACE treatment, largest nodule size, abnormal BCr, ALB, and TBIL correlate with worse prognosis independently.

Drug-eluting beads transarterial chemoembolization with CalliSpheres microspheres for treatment of unresectable intrahepatic cholangiocarcinoma

“…Surgical resection is the potentially curative treatment option for patients with resectable ICC, and arterially directed therapies are generally accepted treatments for unresectable ICC according to the NCCN guidelines.TACE is a promising, minimally invasive intra-arterial therapy for unresectable liver tumors [11]. It allows the delivery of high doses of chemotherapeutic drugs directly to the tumor with very little systemic drug exposure and has become a valid alternative to systemic chemotherapy for unresectable ICC [12].…”

“…It allows the delivery of high doses of chemotherapeutic drugs directly to the tumor with very little systemic drug exposure and has become a valid alternative to systemic chemotherapy for unresectable ICC [12]. Compared with conventional lipiodol-TACE, DEB-TACE is superior to lipiodol in drug loading and releasing as well as embolization effects, is increasingly used in the treatment of ICC [11,13].…”

“…In vitro experiments have shown that approximately 90% of doxorubicin can be sequestered into a vial of 100-300 μm CSM within 30 min under given conditions [16]. Recently, several clinical studies have reported the safety and effectiveness of DEB-TACE with CSM for the treatment of liver cancer, with the results proved that CSM was efficient and well-tolerated not only in treating patients with HCC but also in secondary liver cancer [11,17].…”

Hepatitis B Virus Reactivation Potential Risk Factors in Hepatocellular Carcinoma via Transcatheter Arterial Chemoembolization: A Retrospective Research

“…TACE is recently recognized as the optimal treatment approach in curing unresectable intermediate- and advanced-stage HCC [ 13 ]. Most HCC patients have a comorbidity of HBV infection [ 14 ].…”

Apatinib-loaded CalliSpheres Beads for embolization in a rabbit VX2 liver tumor: characterization in vitro , pharmacokinetics and tumor response in vivo

“…It is composed of a polyvinyl alcohol hybrid hydrogel linked to sulfonate groups, negatively charged of which provides for binding sites that allow drugs with positively charged for interaction (Lewis, 2009 ). In recent years, TACE with CB (a kind of DEB made in China) has been used for the treatment of hypervascular tumor (Peng et al., 2020 ). Besides, some studies indicated combination of TACE and oral antiangiogenic drugs can yield significant clinical benefit in the treatment of advanced HCC (Zhu et al., 2014 ; Liu et al., 2020 ).…”