巴塞罗那临床肝癌分期和肝移植对肝细胞癌患者的生存获益：一项多中心队列研究。

Barcelona Clinic Liver Cancer staging and transplant survival benefit for patients with hepatocellular carcinoma: a multicentre, cohort study.

机构信息

Unità di Chirurgia Epatobiliare e Trapianto Epatico, Azienda Ospedaliera, Università di Padova, Padova, Italy.

出版信息

Lancet Oncol. 2011 Jul;12(7):654-62. doi: 10.1016/S1470-2045(11)70144-9. Epub 2011 Jun 16.

DOI:10.1016/S1470-2045(11)70144-9

PMID:21684210

Abstract

BACKGROUND

Allocation of deceased-donor livers to patients with chronic liver failure is improved by prioritising patients by 5-year liver transplantation survival benefit. The Barcelona Clinic Liver Cancer (BCLC) staging has been proposed as the standard means to assess for prognosis of patients with hepatocellular carcinoma. We aimed to create a prediction model linking the BCLC stage of patients with hepatocellular carcinoma to their 5-year liver transplant benefit.

METHODS

A large cohort of consecutive patients with hepatocellular carcinoma (n=1328) from the ITA.LI.CA database (n=2951) were judged as potentially eligible for liver transplantation according to the following criteria: absence of macroscopic vascular invasion or metastases, age 70 years or younger, and absence of relevant extra-hepatic comorbidities. To assess the correlation between BCLC staging and non-liver transplantation survival, we did Cox univariate and multivariate analyses including the following covariates: BCLC stage, year of diagnosis, age, sex, cause of cirrhosis, model for end-stage liver disease score, α-fetoprotein concentrations, and treatment. Liver-transplantation survival benefit for patients was calculated, using Monte Carlo simulation analysis, as the patient's 5-year life expectancy with liver transplantation (estimated by the Metroticket model) minus the 5-year life expectancy without liver transplantation according to BCLC stage.

FINDINGS

83 (6%) of 1328 patients had BCLC 0 stage disease, 614 (46%) had BCLC A, 500 (38%) had BCLC B-C, and 131 (10%) had BCLC D. In the Cox non-liver transplantation survival multivariate model, hazard ratios associated with increasing BCLC stages were 1.530 (95% CI 1.107-2.116) for BCLC A versus BCLC 0, 1.572 (1.350-1.830) for BCLC B-C versus BCLC A, and 1.470 (1.164-1.856) for BCLC D versus BCLC B-C. Results of the Monte Carlo simulation analysis confirmed the significant effect of BCLC classification on transplant benefit; in the adjusted model, a median 5-year transplant benefit of 11.19 months (IQR 10.73-11.67) for BCLC 0, 13.49 months (11.51-15.57) for BCLC A, 17.36 months (15.06-19.28) for BCLC B-C, and 28.46 months (26.38-30.34) for BCLC D.

INTERPRETATION

Liver transplantation could result in survival benefit for patients with hepatocellular carcinoma and advanced liver cirrhosis (BCLC stage D) and in those with intermediate tumours (BCLC stages B-C), regardless of the nodule number-size criteria (ie, Milan criteria), provided that macroscopic vascular invasion and extra-hepatic disease are absent.

FUNDING

None.

摘要

背景

通过优先考虑具有 5 年肝移植生存获益的患者，可提高对慢性肝功能衰竭患者的已故供肝分配。巴塞罗那临床肝癌（BCLC）分期已被提议作为评估肝细胞癌患者预后的标准方法。我们旨在创建一个将 BCLC 分期与患者的 5 年肝移植获益联系起来的预测模型。

方法

来自 ITA.LI.CA 数据库（n=2951）的大量连续肝细胞癌患者队列（n=1328），根据以下标准被判定为潜在适合肝移植：无肉眼血管侵犯或转移，年龄 70 岁以下，无相关肝外合并症。为了评估 BCLC 分期与非肝移植生存之间的相关性，我们进行了 Cox 单因素和多因素分析，包括以下协变量：BCLC 分期、诊断年份、年龄、性别、肝硬化病因、终末期肝病模型评分、α-胎蛋白浓度和治疗。使用蒙特卡罗模拟分析计算患者的肝移植生存获益，即患者接受肝移植后的 5 年预期寿命（通过 Metroticket 模型估计）减去根据 BCLC 分期的无肝移植的 5 年预期寿命。

结果

1328 例患者中，83 例（6%）为 BCLC0 期疾病，614 例（46%）为 BCLC A 期，500 例（38%）为 BCLC B-C 期，131 例（10%）为 BCLC D 期。在 Cox 非肝移植生存多因素模型中，与 BCLC 分期升高相关的风险比为：BCLC A 期相对于 BCLC0 期为 1.530（95%CI 1.107-2.116），BCLC B-C 期相对于 BCLC A 期为 1.572（1.350-1.830），BCLC D 期相对于 BCLC B-C 期为 1.470（1.164-1.856）。蒙特卡罗模拟分析的结果证实了 BCLC 分类对移植获益的显著影响；在调整后的模型中，BCLC0 期的中位 5 年移植获益为 11.19 个月（IQR 10.73-11.67），BCLC A 期为 13.49 个月（11.51-15.57），BCLC B-C 期为 17.36 个月（15.06-19.28），BCLC D 期为 28.46 个月（26.38-30.34）。