Assessment of efficacy and safety by CalliSpheres versus HepaSpheres for drug-eluting bead transarterial chemoembolization in unresectable large hepatocellular carcinoma patients

Abstract

This study aimed to compare efficacy and safety of HepaSpheres and CalliSpheres in unresectable large hepatocellular carcinoma (HCC) patients. One hundred and twenty-seven unresectable large HCC patients receiving drug-eluting bead transarterial chemoembolization (DEB-TACE) treatment with CalliSpheres or HepaSpheres microspheres were analyzed. Treatment response, Karnofsky performance status (KPS) score, adverse events, main liver function indexes, time to progression (TTP), and overall survival (OS) were analyzed. Objective response rate (82.7% vs. 63.8%, p¼.030) and disease control rate (100.0% vs. 91.5%, p¼.030) were increased in CalliSpheres group compared to HepaSpheres group at 1 month after treatment, while no difference was found between the two groups regarding treatment response at 3 or 6 months post treatment (all p>.05). The KPS score at 1, 3, and 6 months was similar between the two groups (all p>.05). As for the liver function, the ALT, AST, ALB, and TBIL levels at 7 and 30 days were of no difference between the two groups (all p>.05). In addition, the adverse events including nausea/vomiting, pain, fever, myelosuppression, biloma, and abscess were of no difference between the two groups, either (all p>.05). In terms of survival profile, there was no difference regarding TTP (6.3 months (95%CI: 5.9-6.6 months) vs. 6.0 months (95%CI: 5.6-6.4 months), p¼.082) or OS (23.0 months (95%CI: 20.1-25.9 months) vs. 22.0 months (95%CI: 20.2-23.8 months), p¼.571) between the two groups. In conclusion, CalliSpheres seems to be superior in short-term efficacy and equal in long-term efficacy as well as safety compared to HepaSpheres for DEB-TACE treatment in unresectable large HCC patients.

Early changes in peripheral blood cytokine levels after the treatment of metastatic hepatic carcinoma with CalliSpheres microspheres drug-eluting beads transcatheter arterial chemoembolization

“…For patients with unresectable metastatic hepatic carcinoma (MHC), especially the refractory liver metastatic carcinoma that has progressed after chemotherapy, often die of irreversible liver failure within 3-5 months (1). CalliSpheres microspheres transcatheter arterial chemoembolization (CSM-TACE) with domestic drugloaded microspheres has achieved good clinical effects in the treatment of various refractory liver cancers, and achieved the same therapeutic effect as imported drug-loaded microspheres (2,3), and CSM-TACE seems to have more advantages in the treatment of refractory liver metastatic carcinoma (4). TACE for the treatment of primary hepatocellular carcinoma (PHC) can cause a series of changes in the body's cytokines, thus further changing the tumor microenvironment (5)(6)(7)(8)(9).…”

CalliSpheres® microsphere transarterial chemoembolization combined with 125I brachytherapy for patients with non–small‐cell lung cancer liver metastases

“…In the current study, we found that among patients with liver metastases from NSCLC after radical surgery, CR, ORR, and DCR were 43.5%, 87.0%, and 100%, respectively, at 3 months; meanwhile, they were 78.3%, 100%, and 100% at 6 months after integrated interventional therapy. The possible explanations might be that 1) the efficacy of CSM-TACE was affected by tumor vascular condition, while 125 I brachytherapy distributed inside or around the edges of the tumor as intentionally planned, thus 125 I brachytherapy could complement the limitation of CSM-TACE, consequently the combination of the two treatments could present favorable efficacy (11,22); 2) CSM-TACE was able to embolize tumor blood vessels and release a certain concentration of chemotherapeutic agents into them stably and continuously, which could realize arterial chemoembolization (12), while 125 I brachytherapy served as radiotherapy, which could continuously irradiate tumor tissue and kill tumor and surrounding cells at different stages of fission (15). Thus, CSM-TACE was used to treat major lesions, while 125 I brachytherapy could consolidate the effect of CSM-TACE by controlling surrounding lesions.…”

“…Previous studies have reported that the adverse events related to CSM-TACE mainly include fever, pain, nausea, and vomiting, which are tolerable and manageable (11,12,25). Furthermore, the main adverse events related to 125 I brachytherapy are tolerable and controllable intraoperative pneumothorax and skin ulcerations; moreover, the complications of 125 I brachytherapy (including intrahepatic bile, vascular injury, and pneumothorax) are all manageable (14,15,22).…”

“…The specific methods were the same as those described in our previous studies (12,13). Different from previous studies, this study used CSM with an inner diameter ranging from 100 to 300 mm to load 20-mg lobaplatin injection.…”

“…In the past years, conventional transarterial chemoembolization (cTACE) has been viewed as a crucial treatment for liver metastases, while its therapeutic effect remains unsatisfactory (8)(9)(10). Recently, drug-eluting bead (DEB)-TACE has drawn a lot of attention in liver metastases, among which DEB-TACE using CalliSpheres ® microspheres (the first self-developed DEB in China) exhibits satisfying efficacy and tolerable safety not only in primary liver cancer but also in liver metastases (10)(11)(12)(13). For instance, CalliSpheres ® microsphere (CSM)-TACE shows acceptable survival benefits and tolerable safety in colorectal cancer liver metastases (13).…”