CalliSpheres® drug-eluting beads (DEB) transarterial chemoembolization (TACE) is equally efficient and safe in liver cancer patients with different times of previous conventional TACE treatments: a result from CTILC study

An investigation of efficacy, safety, and prognostic factors of drug‐eluting beads‐transarterial chemoembolization operation with CalliSpheres® Microspheres in treating Chinese hepatocellular carcinoma patients

“…In this present study, we found that DEB‐TACE with CSM achieved CR rate of 37.9% and ORR rate of 81.8% in HCC patients, and CR in our study was numerically higher compared with the previous studies, which might due to: (a) the beads used in the DEB‐TACE procedures varied among studies, which might result in different treatment responses, such as, in a previous study they used DcBeads ® in the DEB‐TACE procedure; (b) the criteria that used to assess treatment responses were different among studies, which led to differentiate CR rates; for example, a previous study used mRECIST criteria and European Association for the Study of the Liver (EASL) criteria, while only mRECIST criteria was used in our study; (c) histological types of liver cancers were inconsistent among studies, and thereby, different CR rates were observed; for instance, a previous study enrolled HCC patients, primary intrahepatic cholangiocarcinoma patients, and secondary liver cancer patients, while only HCC patients were included in our study; (d) skills of surgeons might be different among these studies, thereby leading to different CR rates. As to survival profiles, there are some previous studies investigate OS in liver cancer patients treated by DEB‐TACE; for example, median OS treated by DEB‐TACE with DcBeads ® in a study is 369 days (95% CI: 310‐589 days), and another study shows that mean OS in liver cancer patients treated by DEB‐TACE with CSM is 384 days (95% CI 373‐395 days) . In our study, we observed that mean PFS and OS in 66 HCC patients treated by DEB‐TACE with CSM were 13.7 (95% CI: 11.7‐15.8) months and 18.8 (95% CI: 16.3‐21.2) months, respectively.…”

“…In our study, we observed that mean PFS and OS in 66 HCC patients treated by DEB‐TACE with CSM were 13.7 (95% CI: 11.7‐15.8) months and 18.8 (95% CI: 16.3‐21.2) months, respectively. OS in our study was numerically better compared with the previous studies, and the reasons might be the following: (a) The follow‐up durations that might affect OS data were different among studies; for example, the median follow‐up duration in a previous studies was shorter than that in our study, and thus, decreased OS was observed in the previous study; (b) the beads were different among these studies, and thus, OS might be different; (c) baseline characteristics of patients vary among studies; for instance, age in a previous study (85.5% patients >60 years) was older than that in our study (mean age of 59.4 ± 9.9 years), thereby leading to reduced OS in the previous study compared to ours; (d) surgical skills were critical to OS in patients treated by DEB‐TACE; thus, inconsistent surgical skills among studies might result in different OS . These results revealed that DEB‐TACE with CSM achieved satisfactory CR, ORR, and survival profiles in Chinese HCC patients.…”

“…For DEB‐TACE using CSM, a cohort study enrolling 38 Chinese liver cancer patients shows that DEB‐TACE with CSM obtains CR rate of 26.3% and ORR rate of 86.8% . Another study discloses CR of 16.2% and ORR of 75.8% in liver cancer patients treated by DEB‐TACE with CSM . Considering that CSM is the first drug‐eluting beads product in China, more comprehensive studies investigating the efficacy of DEB‐TACE with CSM in Chinese patients are needed.…”

“…Regarding the beads used in DEB‐TACE, several previous studies applying HepaSphere ® , DcBeads ® , and some other beads have been reported . CalliSpheres ® Microspheres (CSM), which is a type of microbeads made of polyvinyl alcohol hydrogel, is the first DEB product developed in China, and it is able to load some positively charged drugs such as adriamycin, pirarubicin, and epirubicin due to its negatively charged functional groups . A previous study investigating the pharmacokinetics of DEB‐TACE with CSM in rabbit liver has demonstrated that DEB‐TACE with CSM presents well performance in drug loading, drug releasing, and tolerance, whereas DEB‐TACE with CSM has just been used for treating HCC patients in clinical practice within the past 2 years, and limited information about the treatment efficacy of DEB‐TACE with CSM in HCC patients is reported .…”

<p>Drug-eluting Bead-Transcatheter Arterial Chemoembolization for Advanced Hepatocellular Carcinoma Refractory to Conventional Lipiodol-based Transcatheter Arterial Chemoembolization</p>

“…Furthermore, we evaluated HCC status of the liver with "up-to-seven (UT7) criteria" 24 because intrahepatic tumor factors such as size and number of tumor are known to be associated with effectiveness of TACE and patients' survival after TACE. 25,26 Written informed consent was obtained from all participants before treatment, and this study was approved by our institutional ethics committee (Ethics Committee, University of Toyama, Approved Number: [25][26][27][28][29][30][31]. This study was conducted in accordance with the Declaration of Helsinki.…”