Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Department of Biostatistics, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):900-909. doi: 10.1016/j.ijrobp.2018.04.011. Epub 2018 Apr 12.
To assess the baseline albumin-bilirubin (ALBI) score as a predictor of toxicity and survival in a prospective cohort of Western patients with hepatocellular carcinoma (HCC) treated with stereotactic body radiation therapy (SBRT) in 2 prospective trials.
The study included 102 patients with Child-Pugh class A liver disease who received 6-fraction SBRT for HCC. Univariate and multivariable logistic regression investigated factors associated with toxicity, defined as an increase in Child-Pugh score ≥ 2 within 3 months of SBRT. Univariate and multivariable Cox regression analyses investigated factors predictive of overall survival (OS). The ALBI score was analyzed as a continuous and binary variable in separate analyses.
On multivariable analysis of toxicity, including the ALBI score as a continuous variable, the ALBI score (odds ratio [OR] per 0.1-unit increase, 1.51; 95% confidence interval [CI] 1.23-1.85; P = .00074), mean liver dose (OR, 1.31; 95% CI 1.02-1.68; P = .036), and dose received by 800 cm of normal liver (OR, 1.10; 95% CI 1.01-1.20; P = .028) were significant. When the ALBI score was included as a dichotomous variable, the ALBI grade remained a significant predictor of toxicity (OR, 7.44; 95% CI 2.34-23.70; P = .00069). On multivariable analysis of OS, including the ALBI score as a continuous variable, the ALBI score (hazard ratio [HR] per 0.1-unit increase, 1.09; 95% CI 1.03-1.17; P = .004), tumor thrombus (HR, 1.94; 95% CI 1.23-3.07; P = .004), and treatment in trial 1 versus trial 2 (HR, 1.92; 95% CI 1.23-3.03; P = .004) were significant. Similarly, when the ALBI score was included as a binary variable, the ALBI grade, tumor thrombus, and trial were significant predictors of OS. When the ALBI score was considered, the Child-Pugh score (A6 vs A5) was not significant in multivariable models analyzing toxicity or survival. Concordance statistics indicated models containing the ALBI score were superior to those containing the Child-Pugh score.
The baseline ALBI score was more discriminating than the Child-Pugh score in predicting OS and toxicity in patients with Child-Pugh class A liver disease. The ALBI score should be used as a factor for stratification in future HCC SBRT trials.
在两项前瞻性临床试验中,评估基线白蛋白-胆红素(ALBI)评分作为接受立体定向体部放射治疗(SBRT)的西方 HCC 患者毒性和生存的预测因子。
该研究纳入了 102 例 Child-Pugh 肝功能 A 级的 HCC 患者,接受了 6 个分次 SBRT。单变量和多变量逻辑回归分析了与毒性相关的因素,定义为 SBRT 后 3 个月内 Child-Pugh 评分增加≥2。单变量和多变量 Cox 回归分析了与总生存(OS)相关的因素。ALBI 评分分别作为连续变量和二分类变量进行分析。
在包括 ALBI 评分作为连续变量的毒性多变量分析中,ALBI 评分(每增加 0.1 单位的比值比[OR],1.51;95%置信区间[CI],1.23-1.85;P =.00074)、平均肝脏剂量(OR,1.31;95%CI,1.02-1.68;P =.036)和 800cm2 正常肝脏接受的剂量(OR,1.10;95%CI,1.01-1.20;P =.028)是显著的。当 ALBI 评分作为二分类变量纳入时,ALBI 分级仍然是毒性的显著预测因子(OR,7.44;95%CI,2.34-23.70;P =.00069)。在包括 ALBI 评分作为连续变量的 OS 多变量分析中,ALBI 评分(每增加 0.1 单位的风险比[HR],1.09;95%CI,1.03-1.17;P =.004)、肿瘤血栓(HR,1.94;95%CI,1.23-3.07;P =.004)和试验 1 与试验 2 的治疗(HR,1.92;95%CI,1.23-3.03;P =.004)是显著的。同样,当 ALBI 评分作为二分类变量纳入时,ALBI 分级、肿瘤血栓和试验是 OS 的显著预测因子。当考虑 ALBI 评分时,Child-Pugh 评分(A6 与 A5)在多变量分析毒性或生存时并不显著。一致性统计表明,包含 ALBI 评分的模型优于包含 Child-Pugh 评分的模型。
在预测 Child-Pugh 肝功能 A 级患者的 OS 和毒性方面,基线 ALBI 评分比 Child-Pugh 评分更具判别力。ALBI 评分应作为未来 HCC SBRT 试验分层的因素。