PMID- 37660471 OWN - NLM STAT- MEDLINE DCOM- 20231129 LR - 20231129 IS - 1748-880X (Electronic) IS - 0007-1285 (Print) IS - 0007-1285 (Linking) VI - 96 IP - 1150 DP - 2023 Oct TI - Transarterial chemoembolization plus lenvatinib with or without a PD-1 inhibitor for advanced and metastatic intrahepatic cholangiocarcinoma: a retrospective real-world study. PG - 20230079 LID - 10.1259/bjr.20230079 [doi] LID - 20230079 AB - OBJECTIVES: Most patients with intrahepatic cholangiocarcinoma (ICC) present with locally advanced or metastatic disease. We report the combined potency of transarterial chemoembolization (TACE), lenvatinib and programmed cell death-1 (PD-1) inhibitors in patients with advanced and metastatic ICC. METHODS: This retrospective study enrolled 32 patients with advanced or metastatic ICC between January 2017 and August 2021. Eligible patients had received gemcitabine-based TACE combined with lenvatinib with or without PD-1 inhibitor in any line of treatment. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. Risk factors associated with OS were assessed using univariate and multivariate Cox regression analyses. RESULTS: Eighteen patients received a combination of TACE and lenvatinib (TL group) and 14 patients received TACE and lenvatinib plus aPD-1 inhibitor (TLP group). The median follow-up time was 19.8 months (range 1.8-37.8). The median OS was 25.3 months (95% CI 18.5-32.1) and the median PFS was 7.3 months (95% CI 4.9-9.7). Partial response was achieved in 10 patients (31.3%), and stable disease in 13 (40.6 %) with disease control rate of 71.9%. The median OS was comparable in the TL and TLP groups (22.4 vs 27.3 months, respectively; hazard ratio: 1.245, 95% CI 0.4245-3.653; p = 0.687). The regression analysis revealed that, regardless of treatment group, a favorable independent prognostic factor for OS was HBV/HCV infection (HR: 0.063, 95% CI 0.009-0.463; p = 0.007). There were no treatment-related deaths and 81.3% of study participants experienced adverse events (AEs), the majority of which were of moderate severity (71.8% Grade 1-2). CONCLUSIONS: Gemcitabine-based TACE plus lenvatinib with or without aPD-1 inhibitor was well tolerated and provided promising therapeutic outcomes for patients with advanced and metastatic ICC. ADVANCES IN KNOWLEDGE: Monotherapy with TACE, or Lenvatinib, or PD-1 inhibitors has shown limited efficacy over standard first-line chemotherapy in advanced and metastatic ICC. This work suggested the combined potency of these treatments and well-tolerance. FAU - Ning, Zhouyu AU - Ning Z AD - Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Xie, Lin AU - Xie L AD - Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Yan, Xia AU - Yan X AD - Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Hua, Yongqiang AU - Hua Y AD - Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Shi, Weidong AU - Shi W AD - Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Lin, Junhua AU - Lin J AD - Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Xu, Litao AU - Xu L AD - Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. FAU - Meng, Zhiqiang AU - Meng Z AD - Department of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. AD - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. LA - eng PT - Journal Article DEP - 20230903 PL - England TA - Br J Radiol JT - The British journal of radiology JID - 0373125 RN - 0 (Immune Checkpoint Inhibitors) RN - EE083865G2 (lenvatinib) RN - 0 (Gemcitabine) SB - IM MH - Humans MH - Immune Checkpoint Inhibitors MH - Retrospective Studies MH - *Carcinoma, Hepatocellular/therapy MH - *Chemoembolization, Therapeutic MH - *Liver Neoplasms/therapy MH - *Cholangiocarcinoma/therapy MH - Gemcitabine MH - *Bile Duct Neoplasms/therapy MH - Bile Ducts, Intrahepatic PMC - PMC10546439 EDAT- 2023/09/04 00:41 MHDA- 2023/11/29 06:42 PMCR- 2024/10/01 CRDT- 2023/09/03 18:03 PHST- 2024/10/01 00:00 [pmc-release] PHST- 2023/11/29 06:42 [medline] PHST- 2023/09/04 00:41 [pubmed] PHST- 2023/09/03 18:03 [entrez] AID - 10.1259/bjr.20230079 [doi] PST - ppublish SO - Br J Radiol. 2023 Oct;96(1150):20230079. doi: 10.1259/bjr.20230079. Epub 2023 Sep 3.