在标准治疗方案失败的结直肠癌肝转移患者中，regorafenib 联合载药微球经动脉化疗栓塞与regorafenib 单药治疗的疗效和安全性。
Treatment efficacy and safety of regorafenib plus drug-eluting beads-transarterial chemoembolization versus regorafenib monotherapy in colorectal cancer liver metastasis patients who fail standard treatment regimens.
机构信息
Department of Interventional Radiology, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, 1 Banshan Dong Lu, Gongshu District, Hangzhou, 310022, Zhejiang, China.
出版信息
J Cancer Res Clin Oncol. 2021 Oct;147(10):2993-3002. doi: 10.1007/s00432-021-03708-1. Epub 2021 Jul 24.
OBJECTIVE
This study aimed to evaluate the efficacy and safety of regorafenib plus drug-eluting beads-transarterial chemoembolization (DEB-TACE) versus regorafenib monotherapy in colorectal cancer liver metastases (CRLM) patients who failed standard treatment regimens.
METHODS
Totally, 76 eligible CRLM patients were analyzed, among which 42 patients received regorafenib monotherapy (as regorafenib group) and 34 patients received regorafenib plus DEB-TACE (as regorafenib plus DEB-TACE group).
RESULTS
Objective response rate (35.3% versus 7.1%, P = 0.002) and disease control rate (76.5% versus 47.6%, P = 0.011) were both increased in regorafenib plus DEB-TACE group compared with regorafenib group; meanwhile, negative conversion rate of carcinoembryonic antigen (66.7% versus 28.6%, P = 0.008) after treatment was elevated in regorafenib plus DEB-TACE group compared with regorafenib group. Notably, progression-free survival (PFS) (median value: 7.6 versus 4.1 months, P < 0.001) and overall survival (OS) (median value: 15.7 versus 9.2 months, P < 0.001) were both higher in regorafenib plus DEB-TACE group compared with regorafenib group. Furthermore, liver function indexes (alanine transaminase, aspartate aminotransferase, and cholinesterase levels) after treatment were all similar between the two groups (all P > 0.05). In addition, the occurrences of upper abdominal distending pain (P < 0.001), nausea and vomiting (P = 0.002) and fever (P = 0.002) were higher in regorafenib plus DEB-TACE group compared with regorafenib group, while the majority of these adverse events were mild and tolerable.
CONCLUSIONS
Regorafenib plus DEB-TACE is superior to regorafenib monotherapy regarding treatment response, PFS and OS, while induces tolerable post-embolization syndrome in CRLM patients who fail standard treatment regimens.
目的
本研究旨在评估regorafenib 联合载药微球经导管动脉化疗栓塞术（DEB-TACE）与regorafenib 单药治疗在标准治疗方案失败的结直肠癌肝转移（CRLM）患者中的疗效和安全性。
方法
共分析了 76 例符合条件的 CRLM 患者，其中 42 例接受了regorafenib 单药治疗（regorafenib 组），34 例接受了regorafenib 联合 DEB-TACE 治疗（regorafenib 联合 DEB-TACE 组）。
结果
与 regorafenib 组相比，regorafenib 联合 DEB-TACE 组的客观缓解率（35.3%比 7.1%，P=0.002）和疾病控制率（76.5%比 47.6%，P=0.011）均升高；同时，治疗后癌胚抗原（CEA）的转阴率（66.7%比 28.6%，P=0.008）也升高。值得注意的是，与 regorafenib 组相比，regorafenib 联合 DEB-TACE 组的无进展生存期（PFS）（中位值：7.6 比 4.1 个月，P<0.001）和总生存期（OS）（中位值：15.7 比 9.2 个月，P<0.001）均延长。此外，两组治疗后肝功能指标（丙氨酸转氨酶、天冬氨酸转氨酶和胆碱酯酶水平）无差异（均 P>0.05）。此外，与 regorafenib 组相比，regorafenib 联合 DEB-TACE 组的上腹部膨胀痛（P<0.001）、恶心呕吐（P=0.002）和发热（P=0.002）的发生率更高，但大多数不良反应为轻度且可耐受。
结论
对于标准治疗方案失败的 CRLM 患者，regorafenib 联合 DEB-TACE 在治疗反应、PFS 和 OS 方面优于 regorafenib 单药治疗，同时诱导可耐受的栓塞后综合征。
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