Clinical course of sorafenib treatment in patients with hepatocellular carcinoma

Clinical course of sorafenib treatment in patients with hepatocellular carcinoma
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DOI:
10.3109/00365521.2012.683040
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发表时间:
2012-07-01
影响因子:
1.9
通讯作者:
Cho, Mong
Cho, Mong
中科院分区:
医学4区
文献类型:
--
作者:
Woo, Hyun Young;Heo, Jeong;Cho, Mong

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目标。索拉非尼已被证明可以提高晚期肝细胞癌(HCC)患者的存活率。然而,它在临床实践中的耐受性还没有得到很好的评估,在肿瘤进展或不耐受的情况下是否应该继续使用索拉非尼也没有确定。作者回顾评估了索拉非尼的耐受性,并评估了在索拉非尼治疗期间有进展的患者的临床病程。材料和方法。2008年3月至2010年7月,80例晚期肝癌患者接受索拉非尼治疗。结果。治疗的中位数为78.5天,15%的人因不良事件而停止使用索拉非尼。肝功能ChildPugh A级患者的持续时间(233+/-240d)明显长于ChildPugh-B级患者(100+/-136d;p=0.006)。总的进展率为53%(43/80),进展的中位时间为105天(95%可信区间为59-150天)。进展后14例单纯保守治疗(组1),14例继续索拉非尼治疗(组2),6例改用非索拉非尼治疗(组3),9例加用索拉非尼治疗(组4)。2、3和4组进展后生存率明显好于1组(p=0.001)。结论。索拉非尼在临床实践中对大多数患者都是耐受的,在索拉非尼治疗期间出现进展的患者可能会继续使用索拉非尼。然而,在肝功能Child-Pugh B级的患者中耐受性较差,在这些患者中应谨慎使用。
Objective. Sorafenib has been shown to improve survival of patients with advanced hepatocellular carcinoma (HCC). However, its tolerance in clinical practice has not been well evaluated, and whether sorafenib should be continued in cases of tumor progression or intolerance has not been established. The authors retrospectively assessed sorafenib tolerability, and evaluated the clinical course in patients who showed progression during sorafenib treatment. Material and methods. Between March 2008 and July 2010, 80 patients with advanced HCC were treated with sorafenib. Results. With a median of 78.5 days of treatment, 15% discontinued sorafenib due to adverse events. The duration was significantly longer in patients with Child-Pugh class A liver function (233 +/- 240 days) than in those with Child-Pugh class B (100 +/- 136 days; p = 0.006). The overall progression rate was 53% (43/80), with a median time to progression of 105 days (95% confidence interval, 59-150 days). After progression, 14 patients received conservative care only (group 1), 14 continued sorafenib monotherapy (group 2), 6 changed to treatment without sorafenib (group 3) and 9 underwent additional treatment with concomitant sorafenib (group 4). Survival after progression was significantly better in groups 2, 3 and 4 than in group 1 (p = 0.001). Conclusions. Sorafenib was tolerable for most patients in clinical practice and may be continued in patients who show progression during sorafenib therapy. However, it was less well tolerated in patients with Child-Pugh class B liver function and should be used with caution in these patients.