Metronomic capecitabine vs. best supportive care in Child-Pugh B hepatocellular carcinoma: a proof of concept.

Metronomic capecitabine vs. best supportive care in Child-Pugh B hepatocellular carcinoma: a proof of concept.
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DOI:
10.1038/s41598-018-28337-6
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发表时间:
2018-07-03
期刊:
影响因子:
4.6
通讯作者:
Brandi G
Brandi G
中科院分区:
综合性期刊3区
文献类型:
--
作者:
De Lorenzo S;Tovoli F;Barbera MA;Garuti F;Palloni A;Frega G;Garajovà I;Rizzo A;Trevisani F;Brandi G

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关于肝细胞癌(HCC)合并中度肝功能不全(Child - Pugh B级)患者的系统治疗,相关证据相对缺乏。在这项多中心研究中,我们回顾性分析了未接受过系统治疗的Child - Pugh B级HCC患者的数据,这些患者接受了分子靶向药物(MC)治疗或最佳支持治疗(BSC)。为降低选择偏倚的风险,采用了治疗权重逆概率法。倾向评分的产生包括:肝外转移;大血管侵犯;体能状态,甲胎蛋白>400 ng/ml,Child - Pugh评分(B7与B8 - 9)。我们确定了35例接受MC治疗的患者和70例对照患者。MC治疗患者的中位总生存期为7.5个月[95%置信区间:3.733 - 11.267],BSC组为5.1个月[95%置信区间:4.098 - 6.102](p = 0.013)。在接受MC治疗的患者中,中位无进展生存期为4.5个月(95%置信区间:2.5 - 6.5)。单变量未加权Cox回归显示,接受MC治疗的患者死亡风险降低42%(95%置信区间:0.370 - 0.906;p = 0.017)。在对潜在混杂因素进行加权后,死亡风险基本未改变。在MC组中,12例患者(34.3%)至少出现一种不良事件,其中最常见的是:疲劳(17.1%)、手足综合征(8.5%)、血小板减少症(8.5%)和中性粒细胞减少症(5.7%)。对于Child - Pugh B级HCC患者,MC似乎是一种安全的选择。其潜在的抗肿瘤活性值得进行前瞻性评估。
There is a relative lack of evidence about systemic treatments in patients with hepatocellular carcinoma (HCC) and moderate liver dysfunction (Child-Pugh B). In this multicenter study we retrospectively analyzed data from Child-Pugh B-HCC patients naïve to systemic therapies, treated with MC or best supportive care (BSC). To reduce the risk of selection bias, an inverse probability of treatment weighting approach was adopted. Propensity score was generated including: extrahepatic spread; macrovascular invasion; performance status, alphafetoprotein > 400 ng/ml, Child- Pugh score [B7 vs. B8–9]. We identified 35 MC-treated patients and 70 controls. Median overall survival was 7.5 [95% CI: 3.733–11.267]in MC-patients and 5.1 months [95% CI: 4.098–6.102] in the BSC group (p = 0.013). In patients treated with MC, median progression-free survival was 4.5 months (95% CI: 2.5–6.5). The univariate unweighted Cox regression showed a 42% reduction in death risk for patients on MC (95%CI: 0.370–0.906; p = 0.017). After weighting for potential confounders, death risk remained essentially unaltered. In the MC group, 12 patients (34.3%) experienced at least one adverse event, the most common of which were: fatigue (17.1%), hand-foot syndrome (8.5%), thrombocytopenia (8.5%), and neutropenia (5.7%). MC seems a safe option for Child-Pugh B-HCC patients. Its potential antitumour activity warrants prospective evaluations.
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