Abstract：
OBJECTIVE: Systemic chemotherapy (SYS) is the first-line treatment of unresectable intrahepatic cholangiocarcinoma (ICC). However, the survival benefit of SYS is still limited. This study compared the efficacy and safety of patients with unresectable ICC treated with transarterial chemoembolization (TACE) plus SYS to SYS alone.
METHODS: The multicenter retrospective cohort study included patients aged ≥ 18 years old with pathologically diagnosed ICC. Patients with unmeasurable lesions, not receiving SYS treatment, Child-Pugh grade C, Eastern Cooperative Oncology Group performance status score of 3 or higher, prior liver resection, incomplete medical information, or discontinuation of the first SYS treatment were excluded. Data collection was mainly from the hospital system, and the survival outcome of patients was obtained through follow-up. Overall survival (OS) was estimated using the Kaplan-Meier method and compared using the log-rank test. Propensity score matching at a 1:1 ratio using the nearest neighbor matching algorithm was performed to reduce selection bias between the TACE plus SYS and SYS alone groups. The Cox proportional hazards model was used to identify prognostic factors associated with OS and to estimate their hazard ratios. Modified Response Evaluation Criteria in Solid Tumors criteria were utilized to evaluate the response of tumors to therapy.
RESULTS: Between June 2016 and February 2023, 118 unresectable ICC patients from three hospitals were included in this study. Of them, 37 were in the TACE plus SYS group and 81 were in the SYS alone group. The median OS in the combination group was 11.3 months, longer than the 6.4 months in the SYS alone group (P = 0.011). A greater objective response rate (ORR) and disease control rate (DCR) were observed in the combination group than in the SYS alone group (ORR, 48.65 vs. 6.17%, P < 0.001; DCR, 89.19 vs. 62.96%, P = 0.004). There were 16 patients in each group after matching, and the matched results remained consistent regarding OS and tumor response. Adverse events (AEs) were similar in the two groups after matching.
CONCLUSIONS: Compared to SYS alone, the combination treatment of TACE plus SYS was more effective than SYS alone in improving OS, ORR, and DCR without any significant increase in AEs. TACE plus SYS may be a viable treatment option for patients with unresectable ICC.
METHODS: The multicenter retrospective cohort study included patients aged ≥ 18 years old with pathologically diagnosed ICC. Patients with unmeasurable lesions, not receiving SYS treatment, Child-Pugh grade C, Eastern Cooperative Oncology Group performance status score of 3 or higher, prior liver resection, incomplete medical information, or discontinuation of the first SYS treatment were excluded. Data collection was mainly from the hospital system, and the survival outcome of patients was obtained through follow-up. Overall survival (OS) was estimated using the Kaplan-Meier method and compared using the log-rank test. Propensity score matching at a 1:1 ratio using the nearest neighbor matching algorithm was performed to reduce selection bias between the TACE plus SYS and SYS alone groups. The Cox proportional hazards model was used to identify prognostic factors associated with OS and to estimate their hazard ratios. Modified Response Evaluation Criteria in Solid Tumors criteria were utilized to evaluate the response of tumors to therapy.
RESULTS: Between June 2016 and February 2023, 118 unresectable ICC patients from three hospitals were included in this study. Of them, 37 were in the TACE plus SYS group and 81 were in the SYS alone group. The median OS in the combination group was 11.3 months, longer than the 6.4 months in the SYS alone group (P = 0.011). A greater objective response rate (ORR) and disease control rate (DCR) were observed in the combination group than in the SYS alone group (ORR, 48.65 vs. 6.17%, P < 0.001; DCR, 89.19 vs. 62.96%, P = 0.004). There were 16 patients in each group after matching, and the matched results remained consistent regarding OS and tumor response. Adverse events (AEs) were similar in the two groups after matching.
CONCLUSIONS: Compared to SYS alone, the combination treatment of TACE plus SYS was more effective than SYS alone in improving OS, ORR, and DCR without any significant increase in AEs. TACE plus SYS may be a viable treatment option for patients with unresectable ICC.
摘要：
目的：全身化疗（SYS）是不可切除的肝内胆管癌（ICC）的一线治疗方法。然而,SYS的生存优势仍然有限。这项研究比较了经肝动脉化疗栓塞（TACE）加SYS与单独SYS治疗的不可切除ICC患者的疗效和安全性。
方法：多中心回顾性队列研究纳入年龄≥18岁且病理诊断为ICC的患者。患有无法测量的病变的患者，未接受SYS处理,Child-PughC级,东部肿瘤协作组表现状态得3分或更高，先前的肝切除术，不完整的医疗信息，或首次SYS治疗的终止被排除.数据收集主要来自医院系统，并通过随访获得患者的生存结局。使用Kaplan-Meier方法估计总生存期（OS），并使用对数秩检验进行比较。使用最近邻匹配算法以1:1的比率进行倾向评分匹配,以减少TACE加SYS和SYS单独组之间的选择偏差。Cox比例风险模型用于确定与OS相关的预后因素并估计其风险比。使用实体肿瘤标准中的修改的反应评估标准来评估肿瘤对治疗的反应。
结果：在2016年6月至2023年2月之间，本研究纳入了来自三家医院的118名不可切除的ICC患者。其中,TACE加SYS组37例，SYS单独组81例。联合组的中位OS为11.3个月，比单独SYS组的6.4个月长(P=0.011)。联合组的客观反应率（ORR）和疾病控制率（DCR）比单独SYS组（ORR，48.65vs.6.17%，P<0.001；DCR，89.19vs.62.96%,P=0.004)。配对后每组16例,并且匹配的结果在OS和肿瘤反应方面保持一致。匹配后两组不良事件（AE）相似。
结论：与单独的SYS相比，在改进操作系统方面，TACE加SYS的组合处理比单一SYS更有效，ORR,和DCR，AE没有任何显著增加。TACE加SYS可能是不可切除ICC患者的可行治疗选择。
方法：多中心回顾性队列研究纳入年龄≥18岁且病理诊断为ICC的患者。患有无法测量的病变的患者，未接受SYS处理,Child-PughC级,东部肿瘤协作组表现状态得3分或更高，先前的肝切除术，不完整的医疗信息，或首次SYS治疗的终止被排除.数据收集主要来自医院系统，并通过随访获得患者的生存结局。使用Kaplan-Meier方法估计总生存期（OS），并使用对数秩检验进行比较。使用最近邻匹配算法以1:1的比率进行倾向评分匹配,以减少TACE加SYS和SYS单独组之间的选择偏差。Cox比例风险模型用于确定与OS相关的预后因素并估计其风险比。使用实体肿瘤标准中的修改的反应评估标准来评估肿瘤对治疗的反应。
结果：在2016年6月至2023年2月之间，本研究纳入了来自三家医院的118名不可切除的ICC患者。其中,TACE加SYS组37例，SYS单独组81例。联合组的中位OS为11.3个月，比单独SYS组的6.4个月长(P=0.011)。联合组的客观反应率（ORR）和疾病控制率（DCR）比单独SYS组（ORR，48.65vs.6.17%，P<0.001；DCR，89.19vs.62.96%,P=0.004)。配对后每组16例,并且匹配的结果在OS和肿瘤反应方面保持一致。匹配后两组不良事件（AE）相似。
结论：与单独的SYS相比，在改进操作系统方面，TACE加SYS的组合处理比单一SYS更有效，ORR,和DCR，AE没有任何显著增加。TACE加SYS可能是不可切除ICC患者的可行治疗选择。
