随着医生获得多吉美的经验，肝癌的治疗效果有所改善

StephenW

Liver cancer outcomes improving as physicians gain experience with Nexavar

Tovoli F, et al. J Hepatol. 2019;doi:10.1016/j.jhep.2019.08.015.
August 29, 2019

Increasing physician experience in the management of Nexavar-related adverse events has led to longer treatment duration and improved overall survival rates in patients with hepatocellular carcinoma, according to results from a nearly 10-year retrospective study.

Francesco Tovoli , MD, from the University of Bologna in Italy, and colleagues wrote that while dose reduction and temporary interruptions can mediate adverse events related to treatment with Nexavar (sorafenib, Bayer), some patients are unable to avoid intolerable or severe adverse events even with modification.
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To analyze the change in sorafenib management over time, Tovoli and colleagues reviewed data from 338 patients treated between January 2008 and December 2017. The researchers divided the patients into two groups: 154 patients who received sorafenib between 2008 and 2012, and 184 patients treated between 2013 and 2017.

All patient reported at least one adverse event after treatment initiation.

Compared with the first time period group, the second group had a longer median duration of treatment (5.8 vs. 4.1 months; P = .021), a lower median daily dose (425 vs. 568 mg per day; P < .001) and lower rates of permanent discontinuation (9.2% vs. 20.8%; P < .001).

Additionally, patients in the second time period group had higher rates of overall survival (12 vs. 11 months; P = .002) and higher rates of 2-year (28.1% vs. 18.4%; P = .003) and 3-year survival (14.6% vs. 6.8%; P = .037).

Multivariate analysis revealed Child-Pugh B status (HR = 2.093; 95% CI, 1.364-3.211), performance status (HR = 1.357; 95% CI, 1.043-1.765), macrovascular invasion (HR = 1.722; 95% CI, 1.331-2.622), alpha-fetoprotein of 400 ng/mL or higher (HR = 1.328; 95% CI, 1.024-1.724), the appearance of dermatological adverse events (HR = 0.624; 95% CI, 0.482-0.808), and period of treatment (HR = 0.728; 95% CI, 0.581-0.937) as independent predictors of overall survival for both groups.

“[Future] trials will be of critical importance in shaping the future therapeutic algorithms for the systemic treatment of HCC in the next future, and their results are eagerly awaited,” Tovoli and colleagues concluded. “Therefore, we suggest that the increased survival under sorafenib should be considered in the design of future trials, to minimize the risk of unintentional failure due to an underestimated sample size.” – by Talitha Bennett

Disclosures: Tovoli reports he is a consultant for Bayer AG. Please see the full study for all other authors’ relevant financial disclosures.

StephenW

随着医生获得多吉美的经验，肝癌的治疗效果有所改善

Tovoli F，et al。 J Hepatol。 2019; doi：10.1016 / j.jhep.2019.08.015。
2019年8月29日

根据近10年回顾性研究的结果，医生在治疗多吉美相关不良事件方面的经验越来越多，导致肝细胞癌患者的治疗时间延长，总体生存率提高。

来自意大利博洛尼亚大学的医学博士Francesco Tovoli及其同事写道，虽然减少和暂时中断可以调节与多吉美（索拉非尼，拜耳）治疗相关的不良事件，但有些患者甚至无法避免无法忍受的严重不良事件。修改。
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通过AASLD标准排除HBV治疗通常会导致不良后果
Stivarga在多吉美治疗期间改善HCC预后
减少多吉美剂量产生成本效益，不影响HCC的OS

为了分析索拉非尼管理随时间的变化，Tovoli及其同事回顾了2008年1月至2017年12月期间接受治疗的338名患者的数据。研究人员将患者分为两组：2008年至2012年期间接受索拉非尼治疗的154名患者，以及2013年和2017年的184名患者。

所有患者在治疗开始后报告至少一种不良事件。

与第一时间段组相比，第二组治疗中位时间更长（5.8对4.1个月; P = .021），中位日剂量较低（425对比568 mg /天; P <.001）永久停产率较低（9.2％对20.8％; P <.001）。

此外，第二时间段患者的总生存率较高（12对11个月; P = .002），2年患者较高（28.1％对18.4％; P = .003）和3年存活率（14.6％vs。6.8％; P = .037）。

多变量分析显示Child-Pugh B状态（HR = 2.093; 95％CI，1.364-3.211），表现状态（HR = 1.357; 95％CI，1.043-1.765），大血管侵犯（HR = 1.722; 95％CI，1.331） -2.622），甲胎蛋白400 ng / mL或更高（HR = 1.328; 95％CI，1.024-1.724），出现皮肤病学不良事件（HR = 0.624; 95％CI，0.482-0.808）和期治疗（HR = 0.728; 95％CI，0.581-0.937）作为两组总生存期的独立预测因子。

“[未来]试验对于制定未来治疗HCC的系统治疗算法至关重要，并且热切期待他们的研究结果，”Tovoli及其同事总结道。 “因此，我们建议在未来试验的设计中应考虑索拉非尼的存活率增加，以尽量减少由于低估样本量而导致的意外失败的风险。” - 作者：Talitha Bennett

披露：Tovoli报告说他是拜耳公司的顾问。有关所有其他作者的相关财务披露，请参阅完整的研究。