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ESMO Asia 2017:舒尼替尼的个体化治疗

2017-11-19 佚名 肿瘤资讯

在2017年ESMO Asia和ESMO会议上,分别有两项研究评估了舒尼替尼个体化治疗方案在亚洲患者和中国患者的疗效和安全性。

舒尼替尼是一个口服的多靶点小分子激酶抑制剂,目前已经推荐作为转移性肾细胞癌患者的一线标准治疗方案,推荐的剂量为舒尼替尼50mg/天,服药4周,停药2周方案(4/2方案)。但4/2方案的不良反应发生率较高,且既往的研究显示,使用2/1方案(服药2周,停药1周),不但可以降低不良反应的发生率,还可以提高药物疗效。因此,探索舒尼替尼个体化的治疗方案尤为重要。在2017年ESMO Asia和ESMO会议上,分别有两项研究评估了舒尼替尼个体化治疗方案在亚洲患者和中国患者的疗效和安全性。

2017 ESMO Asia摘要号281P:荟萃分析-在亚裔和非亚裔的转移性肾细胞癌患者中对比舒尼替尼替代方案的安全性和疗效

背景:

目前,舒尼替尼用于转移性肾细胞癌(mRCC)的使用方案主要有两种:传统方案(TS,服药4周、停药2周方案)和替代方案(AS,服药2周、停药1周;或先采用TS方案后转化为AS方案)。这一荟萃分析旨比较亚裔和非亚裔人群中AS方案的安全性和疗效。

方法:

研究系统性的检索了Embase,Medline和Cochrane Library三大数据库近5年发表的相关研究,采用随机效应模型进行分析。

结果:

纳入所有采用舒尼替尼AS方案治疗mRCC的研究,要求以英文形式发表。共检索到1132篇文章,其中14篇文章符合评估标准,最终9篇文章纳入分析。这9个研究中,有7个采用舒尼替尼转化方案,即从TS转化为AS方案,1个研究直接采用AS方案,另1个研究两个方案均有,既包括了直接采用AS方案的患者,也包括接受转化方案治疗的患者。对比亚裔和非亚裔人群采用舒尼替尼AS方案治疗的安全性,结果显示,两个人群中,总的常见的不良事件发生数目没有显着差异。采用Kruskal Wallis分别对比两组患者不同的不良事件发生率,结果显示两组人群常见不良事件的发生率无统计学差异:贫血(P=0.58),疲劳(P=0.49),高血压(P=0.37),甲状腺功能减低(P=0.59),厌食(P=0.55),手足综合症(P=0.30)。疗效对比,亚裔人群和非亚裔人群接受舒尼替尼AS方案治疗的总生存无统计学差异(亚裔人群:31.25 个月,95% CI :22.85-39.66;非亚裔人群:24.97个月,95% CI:14.18-35.59;P?=?0.40);两个人群的无进展生存期也没有显着差异(亚裔人群:14.51个月,95% CI:9.55-19.48;非亚裔人群:15.80个月, 95% CI:10.77-20.59; P?=?0.43)。

结论:

无论是亚裔人群还是非亚裔人群,接受舒尼替尼替代方案治疗的安全性是一致的。

2017 ESMO摘要号893P:舒尼替尼4/2方案改为2/1方案治疗转移性肾细胞癌可改善长期临床结局和安全性谱

背景:

不良事件是舒尼替尼标准剂量方案治疗中伴随的关键问题。本研究旨在比较3个舒尼替尼剂量方案用于转移性肾细胞癌(mRCC)患者的生存获益和安全性

方法:

对接受舒尼替尼一线治疗患者的临床病理学和生存数据进行回顾性分析。患者分为3组:标准剂量方案组(4/2方案);起始替代剂量方案组(2/1方案);转换剂量方案组(4/2-2/1方案)。记录和评价治疗相关不良事件,并分析无进展生存(PFS)、总生存(OS)和潜在危险因素。

结果:

共纳入99例患者,75例(75.8%)患者起始接受舒尼替尼4/2方案,24例患者起始接受舒尼替尼2/1方案。治疗过程中起始4/2方案组有45例(60%)患者因严重不良事件或耐受性较差而转为2/1方案(4/2-2/1方案)。中位随访时间为37个月。与4/2方案组相比,2/1方案组的3/4级不良事件发生率明显降低(69.6% vs 40.6%,P = 0.001)。总体来看,4/2-2/1方案组患者的生存获益最大。4/2方案组、2/1方案组和4/2-2/1方案的中位PFS分别为12.5个月、11.0个月和25.0个月(P = 0.003),中位OS分别为21.0个月、28.0个月和52.0个月(P=0.030)。多因素分析证实,4/2-2/1方案是PFS改善的独立预测因素。4/2-2/1方案能降低55%的死亡风险,虽然差异无统计学意义。此外,IMDC预后风险不良的患者更有可能从4/2-2/1方案达到较大获益。

结论:

与起始舒尼替尼标准剂量4/2方案和起始2/1方案比较,4/2-2/1方案可显着改善mRCC患者的安全性和临床疗效;IMDC风险预后不良或肿瘤负担较大的mRCC患者似乎更有可能从舒尼替尼转换剂量方案中达到更大的生存获益;本研究的结论还需开展前瞻性研究进一步确认。

总结

两项研究回顾性分析和总结了舒尼替尼2/1方案的疗效和安全性,特别是在亚洲患者和中国患者中,结果显示,这一替代方案疗效确切,在安全性优于4/2方案的同时,获得更好的疗效以及长期生存获益。期待后续大样本量的前瞻性研究结果,为舒尼替尼个体化治疗增加新增加。

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    2018-05-09 luwei00
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    2018-10-01 liuhuangbo
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    2017-11-21 zhang92560
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盘点:欧洲泌尿外科学《European Urology》期刊九月文章一览。

此研究结果表明:相比无病生存的患者,转移性复发患者的ctDNA水平显著升高(P<0.001)。 从开始进行血浆ctDNA检测到术后转移复发的中位时间为101天(0–932 天)。因此,液体活检作为一种新的、敏感度较高的技术可早期检测转移复发和监测治疗反应,同时能够支持临床工作开展和指导医生的治疗决策

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NEJM:舒尼替尼可显著延长高危肾细胞癌患者肾切除术后的无病生存期

舒尼替尼(一种血管内皮生长因子通路抑制剂)是转移性肾细胞癌的有效治疗方法。 该研究试图确定舒尼替尼对于肾脏切除术后肿瘤复发高风险的局部肾细胞癌患者的疗效和安全性。

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