Metronomic capecitabine versus best supportive care as second-line treatment in hepatocellular carcinoma: a retrospective study.

Metronomic capecitabine versus best supportive care as second-line treatment in hepatocellular carcinoma: a retrospective study.
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DOI:
10.1038/srep42499
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发表时间:
2017-02-13
期刊:
影响因子:
4.6
通讯作者:
Frassineti GL
Frassineti GL
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Casadei Gardini A;Foca F;Scartozzi M;Silvestris N;Tamburini E;Faloppi L;Brunetti O;Rudnas B;Pisconti S;Valgiusti M;Marisi G;Foschi FG;Ercolani G;Tassinari D;Cascinu S;Frassineti GL

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初步研究表明卡培他滨对HCC患者可能是安全有效的。本研究的目的是回顾性评价节拍器卡培他滨作为二线治疗的安全性和有效性。这项多中心研究回顾性分析了对索拉非尼联合节拍卡培他滨或最佳支持治疗(BSC)无反应或不耐受的HCC患者的数据。卡培他滨治疗的患者中位无进展生存期为3.1个月(95%CI: 2.7-3.5)。接受卡培他滨的患者中位总生存期为12.0个月(95% CI: 10.7-15.8),而接受BSC的患者中位总生存期为9.0个月(95% CI: 6.5-13.9)。单因素未加权Cox回归模型的结果显示,与单独接受BSC的患者相比,卡培他滨组患者的死亡风险降低46% (95%CI: 0.357-0.829; p =0.005)。在对潜在混杂因素进行加权后,死亡风险基本保持不变(45%;95%CI: 0.354-0.883; p = 0.013)。节拍卡培他滨在不良事件管理方面似乎是HCC患者的安全二线治疗,显示出潜在的抗肿瘤活性,需要在III期研究中进一步评估。
Preliminary studies suggest that capecitabine may be safe and effective in HCC patients. The aim of this study was to retrospectively evaluate the safety and efficacy of metronomic capecitabine as second-line treatment. This multicentric study retrospectively analyzed data of HCC patients unresponsive or intolerant to sorafenib treatment with metronomic capecitabine or best supportive care (BSC).Median progression free survival was 3.1 months in patients treated with capecitabine (95%CI: 2.7–3.5). Median overall survival was 12.0 months (95% CI: 10.7–15.8) in patients receiving capecitabine, while 9.0 months (95% CI: 6.5–13.9) in patients receiving BSC. The result of univariate unweighted Cox regression model shows a 46% reduction in death risk for patients on capecitabine (95%CI: 0.357–0.829; p  =0.005) compared to patients receiving BSC alone. After weighting for potential confounders, death risk remained essentially unaltered (45%; 95%CI: 0.354–0.883; p = 0.013). Metronomic capecitabine seems a safe second-line treatment for HCC patients in terms of management of adverse events, showing a potential anti-tumour activity which needs further evaluation in phase III studies.