Impact of baseline characteristics on outcomes of advanced HCC patients treated with sorafenib: a secondary analysis of a phase III study
Impact of baseline characteristics on outcomes of advanced HCC patients treated with sorafenib: a secondary analysis of a phase III study
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DOI：
10.1007/s00432-018-2610-z
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发表时间：
2018-05-01
影响因子：
3.6
通讯作者：
Abdel-Rahman, Omar
中科院分区：
文献类型：
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作者：
Abdel-Rahman, Omar
背景本研究旨在探讨索拉非尼治疗的晚期肝细胞癌（HCC）患者的基线特征对预后的影响，在设置的临床trial.Methods这是一个二次分析的比较臂（索拉非尼臂）的NCT 00699374研究，这是一个III期多中心研究在2008年和2010年之间进行。通过Kaplan-Meier分析和对数秩检验评估不同患者亚组的总生存期和无进展生存期的单变量概率。多因素分析影响总生存期和无进展生存期的因素，然后通过考克斯回归analysis.Results内的比较（索拉非尼）手臂的所有患者都包括在分析（N = 544例患者）。在多变量分析中，（P = 0.028），既往局部区域治疗（P = 0.048），1级ALBI评分（P <0.001），ECOG体力评分为0（P <0.001）、BMI>= 25（P = 0.026）、AFP <200（P = 0.001）和无肝外扩散（P = 0.007）与较好的总生存率相关。同样，在多变量分析中，非亚洲人种（P = 0.004）、1级ALBI评分（P = 0.001）、ECOG体能评分为0（P = 0.006）和无肝外扩散（P = 0.005）与更好的无进展生存期相关。此外，高级别手足皮肤反应的发生与总生存率的统计学显著改善相关（P = 0.003），这在调整其他相关基线因素的多变量分析中得到进一步证实结论在高度选择的晚期HCC患者队列中，基线患者，肝脏，以疾病为中心的变量在预测患者结果中起重要作用。这些信息在治疗决策和患者咨询方面非常重要。
Background The current study aims to investigate the impact of baseline characteristics on the outcomes of sorafenib-treated advanced Hepatocellular carcinoma (HCC) patients in the setting of a clinical trial.Methods This is a secondary analysis of the comparator arm (sorafenib arm) of the NCT00699374 study which is a phase III multicenter study conducted between 2008 and 2010. The univariate probability of overall and progression-free survival was assessed among different patient subsets through Kaplan-Meier analysis and log-rank testing. Multivariate analysis of factors affecting overall and progression-free survival was then conducted through Cox regression analysis.Results All patients within the comparator (sorafenib) arm were included in the analysis (N = 544 patients). In multivariate analysis, prior hepatectomy (P = 0.028), prior locoregional treatment (P = 0.048), grade 1 ALBI score (P < 0.001), ECOG performance score of 0 (P < 0.001), BMI >= 25 (P = 0.026), AFP < 200 (P = 0.001), and no extra-hepatic spread (P = 0.007) were associated with better overall survival. Likewise, in multivariate analysis, non-Asian race (P = 0.004), grade 1 ALBI score (P = 0.001), ECOG performance score of 0 (P = 0.006), and no extra-hepatic spread (P = 0.005) were associated with better progression-free survival. Moreover, development of high-grade hand-foot skin reaction was associated with a statistically significant improvement in overall survival (P = 0.003), which was further confirmed in a multivariate analysis adjusted for other relevant baseline factors (P = 0.002).Conclusion Within a cohort of highly selected advanced HCC patients, baseline patient-, liver-, and disease-centered variables play an important role in predicting patient outcomes. This information is important in terms of therapeutic decision-making and patient counseling.