Drug-eluting beads transarterial chemoembolization by CalliSpheres is effective and well tolerated in treating intrahepatic cholangiocarcinoma patients: A preliminary result from CTILC study

Abstract

This study aimed to investigate the efficacy and safety of drug-eluting beads (DEB) transarterial chemoembolization (TACE) treatment in Chinese intrahepatic cholangiocarcinoma (ICC) patients.37 ICC patients underwent DEB-TACE treatment in CTILC study (registered on clinicaltrials.gov with registry No. NCT03317483) were included in this present study. Treatment response was assessed according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Overall survival (OS) was calculated from the time of DEB-TACE operation until the date of death from any causes. Liver function change and adverse events (AEs) were recorded during and after DEB-TACE operation.3 (8.1%) patients achieved complete response (CR) and 22 (59.5%) patients achieved partial response (PR), with objective response rate (ORR) of 67.6%. After DEB-TACE treatment, mean OS was 376 days (95%CI: 341-412 days). Multivariate logistic regression analysis revealed that Bilobar disease (P = .040, OR: 0.105, 95% CI: 0.012-0.898) and portal vein invasion (P = .038, OR: 0.104, 95% CI: 0.012-0.881) could independently predict less possibility of ORR. Patients with ALB abnormal, TP abnormal, ALT abnormal and AST abnormal were increased at 1-week post DEB-TACE treatment (P = .034, P = .001, P < .001, P = .006, respectively), while returned to the levels at baseline after 1 to 3 months (all P > .050). Besides, most of the AEs were mild including pain, fever, vomiting, and nausea in this study.DEB-TACE was effective and well tolerated in treating ICC patients, and bilobar disease as well as portal vein invasion were independently correlated with less probability of ORR achievement.

Conflict of interest statement

The authors have no conflicts of interests to disclose.

Figures

Figure 1

Treatment response of DEB-TACE in ICC patients. (A) Treatment response of DEB-TACE in patients. (B) Treatment response of DEB-TACE in treated nodules. Comparison among groups was determined by Chi-Squared test. P < .05 was considered significant.

Figure 2

OS of DEB-TACE treatment in ICC patients. K–M curve was performed to evaluate the OS.

Figure 3

CT and DSA images of 2 patients at pre-operation and post-operation. (A–D) CT and DSA images of 1 patient at preoperation and postoperation. (E–H) CT and DSA images of another patient at preoperation and postoperation. Scan parameters were that: tube voltage was 120 kv; automatic pipe technology to adjust current; collimator width was 128 × 0. 625 mm; the reconstruction was 5 mm; a thick layer of reconstruction interval was 5 mm; screw pitch was 0.914. Enhanced scan USED MEDRAD double cylinder of high-pressure syringe injected iodine alcohol (containing iodine 300 mg/ml) from peripheral vein intravenous (dose of 1.5 ml/kg). When abdominal aorta CT value arrive to 100 HU, it delays after 5 seconds and begins to scan, and after arterial phase late 30 seconds and 150 seconds, respectively, it began to scan portal venous phase and delayed phase.