Efficacy and Safety of Drug-Eluting Beads Transarterial Chemoembolization Combining Immune Checkpoint Inhibitors in Unresectable Intrahepatic Cholangiocarcinoma: A Propensity Score Matching Analysis

Abstract

PurposeTo assess the effectiveness and safety of drug-eluting beads transarterial chemoembolization plus immune checkpoint inhibitors (DEB-TACE+ICIs) versus chemotherapy (gemcitabine+cisplatin) for patients with unresectable intrahepatic cholangiocarcinoma (iCCA).Materials and MethodsThis retrospective study included unresectable iCCA patients treated with DEB-TACE+ICIs or chemotherapy between May, 2019 and August, 2021. The differences in tumor responses, progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the 2 groups. Patient baseline characteristics, PFS, and OS were compared among 2 groups before and after propensity score-matching (PSM). Factors affecting PFS and OS were analyzed by Cox’s proportional hazards regression model.ResultsThe study included 49 patients with unresectable iCCA patients, 20 in the DEB-TACE+ICIs group and 29 in the chemotherapy group. PSM analysis created 20 pairs of patients in 2 groups. The patients in the DEB-TACE+ICIs group had a higher objective response rate (55.0% vs. 20.0%, P=0.022), higher PFS (median, 7.2 vs. 5.7 months, P=0.036), and higher OS (median, 13.2 vs. 7.6 months, P=0.015) than those in the chemotherapy group. Multivariate analyses suggested that chemotherapy, tumor size >5cm, and multiple tumors were the independent risk factors for PFS and OS. The incidence of TRAEs was similar between the 2 groups.ConclusionCompared to chemotherapy, DEB-TACE plus ICIs improved survival and was well-tolerated in patients with unresectable iCCA.

Clinical efficacy of TACE combined with targeted or immune drugs for the treatment of unresectable intrahepatic cholangiocarcinoma

“…In the present research, the results of univariate and multivariate analysis showed that for the treatment of ICC, the type of treatment, bilirubin level (≤ 20 / > 20 µmol/L), number of tumors (single/multiple) and number of TACE (≤ 3 / > 3) were independent prognostic factors for PFS. CA199 (≤ 37 / > 37 U/mL), ALT (≤ 35 / > 35 U/L) and number of TACE (≤ 3 / > 3) were independent prognostic factors for OS, ndings consistent with previously published literature (Sun et al 2022;Yang et al 2022). Among the factors, a high bilirubin concentration (> 20 µmol/L) and large number of tumors were risk factors for PFS.…”

DEB-TACE with irinotecan versus C-TACE for unresectable intrahepatic cholangiocarcinoma: a prospective clinical study

“…Then, some clinical studies have shown that using 100–300 μm beads may improve efficacy and safety of TACE. Most studies of efficacy and safety of DEB-TACE in ICC using 100–300 μm beads to treat ICC patients ( Martin et al, 2022 ; Yang, et al, 2022 ). In a retrospective, single institution study conducted from 2010 to 2012, 61 participants were treated with TACE performed with 100–300 μm or 300–500 μm DEBs.…”

Locoregional therapy combined with systemic therapy (LRT + ST) for unresectable and metastatic intrahepatic cholangiocarcinoma: a systematic review and meta-analysis

“…The score is rated out of 9 stars: >6 stars indicate a low risk of bias, 4-6 stars indicate a moderate risk of bias, and <4 stars indicate a high risk of bias. Out of the ten studies included [20][21][22][23][24][25][26][27][28][29] in the systematic review, three studies [24][25][26] were determined to be of good quality, and seven studies [20][21][22][23][27][28][29] were determined to be of acceptable quality. Details of the quality assessment are shown in Supplementary Table 2.…”

“…Ten cohort studies were deemed eligible and included in the descriptive analysis; of the 3,791 patients in these studies, 1,120 (29.5%) were treated with LRT + ST. ADT was performed in six articles 20,[22][23][24]27,28 , EBRT in three 25,26,29 , and ablation in one 21 (Table 1). Further details of the included literature are provided in Supplementary Table 3.…”