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标题: 2期试验比较索拉非尼，普伐他汀，它们的组合或在HCC与Child-P [打印本页]

作者: StephenW 时间: 2021-2-18 18:33 标题: 2期试验比较索拉非尼，普伐他汀，它们的组合或在HCC与Child-P

Phase 2 trial comparing sorafenib, pravastatin, their combination or supportive care in HCC with Child–Pugh B cirrhosis

Jean-Frédéric Blanc, Faiza Khemissa, Jean-Pierre Bronowicki, Carole Monterymard, Jean-Marc Perarnau, Vincent Bourgeois, Stéphane Obled, Meher Ben Abdelghani, Isabelle Mabile-Archambeaud, Roger Faroux, Jean-François Seitz, Christophe Locher, Hélène Senellart, Anne-Laure Villing, Franck Audemar, Charlotte Costentin, Gaël Deplanque, Sylvain Manfredi & Julien Edeline for the PRODIGE 21 collaborators

Hepatology International volume 15, pages93–104(2021)Cite this article

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Abstract
Background and aims

There is limited data regarding the role for systemic treatment in patients with Hepatocellular Carcinoma with Child–Pugh B cirrhosis.
Methods

PRODIGE 21 was a multicentric prospective non-comparative randomized trial. Patients were randomized to receive sorafenib (Arm A), pravastatin (Arm B), sorafenib–pravastatin (Arm C) combination, or best supportive care (Arm D). Primary endpoint was time to progression (TTP), secondary endpoints included safety and overall survival (OS).
Results

160 patients were randomized and 157 patients were included in the final analysis. 86% of patients were BCLC C and 55% had macrovascular invasion. The safety profiles of the drugs were as expected. Median TTP was 3.5, 2.8, 2.0 and 2.2 months in arms A, B, C and D, respectively, but analysis was limited by the number of patients deceased without radiological progression (59%). Median OS was similar between the four arms: 3.8 [95% CI: 2.4–6.5], 3.1 [95% CI: 1.9–4.3], 4.0 [95% CI: 3.2–5.5] and 3.5 months [95% CI: 2.2–5.4] in arms A, B, C and D, respectively. Median OS was 4.0 months [95% CI: 3.3–5.5] for patients treated with sorafenib, vs 2.9 months [95% CI: 2.2–3.9] for patients not treated with sorafenib. In patients with ALBI grade 1/2, median OS was 6.1 months [95% CI: 3.8–8.3] in patients treated with sorafenib vs 3.1 months [95% CI: 1.9–4.8] for patients not treated with sorafenib.
Conclusion

In the overall Child–Pugh B population, neither sorafenib nor pravastatin seemed to provide benefit. In the ALBI grade 1/2 sub-population, our trial suggests potential benefit of sorafenib.
Clinical trial registration

The study was referenced in clinicaltrials.gov (NCT01357486).

作者: StephenW 时间: 2021-2-18 18:33

2期试验比较索拉非尼，普伐他汀，它们的组合或在HCC与Child-Pugh B肝硬化中的支持治疗

Jean-FrédéricBlanc，Faiza Khemissa，Jean-Pierre Bronowicki，Carole Monterymard，Jean-Marc Perarnau，Vincent Bourgeois，StéphaneObled，Meher Ben Abdelghani，Isabelle Mabile-Archambeaud，Roger Faroux，Jean-FrançoisSeitz，Christophe Locher，Hélèère PRODIGE 21合作者的Anne-Laure Villing，Franck Audemar，Charlotte Costentin，GaëlDeplanque，Sylvain Manfredi和Julien Edeline

国际肝病杂志第15卷，93-104（2021）页

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抽象的
背景和目标

关于全身治疗在Child-Pugh B肝硬化肝细胞癌中的作用的数据有限。
方法

PRODIGE 21是一项多中心前瞻性非比较随机试验。患者被随机分配接受索拉非尼（Arm A），普伐他汀（Arm B），索拉非尼–普伐他汀（Arm C）组合或最佳支持治疗（Arm D）。主要终点是进展时间（TTP），次要终点包括安全性和总生存期（OS）。
结果

160名患者被随机分组，其中157名患者被纳入最终分析。 86％的患者为BCLC C，55％的患者为大血管浸润。药物的安全性符合预期。 A，B，C和D组的TTP中位数分别为3.5、2.8、2.0和2.2个月，但分析受到死于无放射进展的患者数量的限制（59％）。四个部门之间的OS中位数相似：3.8 [95％CI：2.4-6.5]，3.1 [95％CI：1.9-4.3]，4.0 [95％CI：3.2-5.5]和3.5个月[95％CI：2.2 –5.4]分别在A，B，C和D组中。索拉非尼治疗的患者中位OS为4.0个月[95％CI：3.3-5.5]，而非索拉非尼治疗的患者中位OS为2.9个月[95％CI：2.2-3.9]。在ALBI 1/2级患者中，索拉非尼治疗的患者的中位OS为6.1个月[95％CI：3.8-8.3]，而未经索拉非尼治疗的患者的中位OS为3.1个月[95％CI：1.9-4.8]。
结论

在整个Child-Pugh B人群中，索拉非尼和普伐他汀似乎都不能提供益处。在ALBI 1/2级亚人群中，我们的研究表明索拉非尼具有潜在的益处。
临床试验注册

该研究在Clinicaltrials.gov（NCT01357486）中进行了引用。

作者: StephenW 时间: 2021-2-18 18:33

https://link.springer.com/articl ... c_springer_20210217

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