Nature Reviews Gastroenterology & Hepatology ( IF 45.9 ) Pub Date : 2024-10-15 , DOI: 10.1038/s41575-024-01011-1 Eleni Kotsiliti
A multicentre, open-label, prospective, randomized controlled trial (TransMet) assessed liver transplantation plus chemotherapy in 94 patients (intention-to-treat population) with permanently unresectable colorectal liver metastases from resected BRAF-non-mutated colorectal cancer and with no extrahepatic disease. The trial took place in 20 tertiary centres in Europe between 2016 and 2021.
Patients were randomly assigned (1:1) to the liver transplantation group plus chemotherapy (group A) or chemotherapy alone (group B). Overall, 74 patients were included in the per-protocol analysis. In the intention-to-treat population, 5-year overall survival was 56.6% for group A and 12.6% for group B (HR 0.37; 95% CI 0.21–0.65; P = 0.0003), whereas in the per-protocol analysis population, it was 73.3% and 9.3%, respectively (HR 0.36; 95% CI 0.07–0.33; P = 0.0001).
中文翻译:
肝移植联合化疗提高结直肠肝转移患者的生存率
一项多中心、开放标签、前瞻性、随机对照试验 (TransMet) 评估了 94 例永久不可切除的结直肠肝转移患者(意向治疗人群)的肝移植加化疗,这些患者来自已切除的 BRAF 非突变结直肠癌且无肝外疾病。该试验于 2016 年至 2021 年在欧洲的 20 个三级中心进行。
患者被随机分配 (1:1) 至肝移植组加化疗组 (A 组) 或单独化疗组 (B 组)。总体而言,74 名患者被纳入按方案分析。在意向治疗人群中,A 组的 5 年总生存率为 56.6%,B 组为 12.6%(HR 0.37;95% CI 0.21-0.65;P = 0.0003),而在符合方案分析的人群中,分别为 73.3% 和 9.3%(HR 0.36;95% CI 0.07-0.33;P = 0.0001)。