West China School of Medicine, Sichuan University, Chengdu, 610000, China.
Regenerative Medicine Research Center, West China Hospital, Sichuan University, Chengdu, 610000, China.
BMC Gastroenterol. 2023 Apr 12;23(1):122. doi: 10.1186/s12876-023-02754-y.
Currently, surgical resection is the most commonly performed and effective treatment for intrahepatic cholangiocarcinoma (ICC) worldwide. However, the prognosis of ICC is unsatisfactory. This study aimed to compare the efficacy and safety of neoadjuvant chemotherapy followed by surgery and upfront surgery in treating intrahepatic cholangiocarcinoma (ICC). The study also intends to explore whether chemotherapy should be introduced before surgery and which populations should be considered for neoadjuvant chemotherapy.
Four databases, including PubMed, EMBASE, Cochrane Library, and Web of Science, were searched from their inception dates to January 2022 for relevant articles. The statistical analysis was performed using the Review Manager Software (version5.3). The non-randomized interventions (ROBINS-I) was used to assess the methodological quality of included studies and the overall quality of evidence was assessed through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool. Moreover, the primary outcomes included 1-year, 3-year and 5-year overall survival (OS), while the secondary outcomes were R0 resection, 1-year, 3-year and 5-year recurrence-free survival (RFS), postoperative complications and ninety-day postoperative mortality.
Five studies involving 2412 patients were included in this meta-analysis. There was no significant difference in 1-year OS, 3-year OS, 1-year, 3-year and 5-year RFS, postoperative complications and ninety-day postoperative mortality between the two groups. However, the meta-analysis showed that the neoadjuvant chemotherapy group had a better 5-year OS benefit in ICC patients than the upfront surgery group (OR = 1.27, 95% CI: 1.02-1.58), while the R0 resection rate was lower in neoadjuvant chemotherapy group than that in the upfront surgery group (OR = 0.49, 95% CI: 0.26-0.91).
Compared with the upfront surgery, neoadjuvant chemotherapy followed by surgery could prolong the 5-year OS without increasing the risk of postoperative complications in ICC patients. Considering that the patients in the neoadjuvant chemotherapy followed by surgery group had more advanced ICC cases, the benefits of neoadjuvant chemotherapy may be more significant in patients with more advanced ICC.
目前，手术切除是全球范围内治疗肝内胆管癌（ICC）最常用且有效的方法。然而，ICC 的预后仍不理想。本研究旨在比较新辅助化疗后手术与直接手术治疗肝内胆管癌（ICC）的疗效和安全性。本研究还旨在探讨手术前是否应引入化疗以及哪些人群应考虑新辅助化疗。
从建库日期到 2022 年 1 月，我们在 PubMed、EMBASE、Cochrane 图书馆和 Web of Science 四个数据库中检索了相关文章。使用 Review Manager 软件（版本 5.3）进行统计分析。使用非随机干预措施（ROBINS-I）评估纳入研究的方法学质量，并通过推荐评估、制定和评估（GRADE）工具评估总体证据质量。此外，主要结局包括 1 年、3 年和 5 年总生存率（OS），次要结局包括 R0 切除率、1 年、3 年和 5 年无复发生存率（RFS）、术后并发症和 90 天术后死亡率。
纳入的 5 项研究共纳入 2412 例患者。两组患者 1 年 OS、3 年 OS、1 年、3 年和 5 年 RFS、术后并发症和 90 天术后死亡率无显著差异。然而，荟萃分析显示，新辅助化疗组 ICC 患者的 5 年 OS 获益优于直接手术组（OR=1.27，95%CI：1.02-1.58），而新辅助化疗组 R0 切除率低于直接手术组（OR=0.49，95%CI：0.26-0.91）。
与直接手术相比，新辅助化疗后手术可延长 ICC 患者的 5 年 OS，且不会增加术后并发症的风险。考虑到新辅助化疗后手术组的 ICC 患者病情更严重，新辅助化疗在病情更严重的 ICC 患者中可能具有更大的获益。
