Lancet Oncol:为Braf突变的晚期肺癌患者提供一条新的诊疗思路

2017-10-23 佚名 桓兴医讯

据估计,全球每年约有3.6万人(约占肺癌患者总数的1-3%)被诊断为BRAF V600阳性NSCLC。2017年4月5日,欧盟委员会批准了诺华的Tafinlar(dabrafenib)与Mekinist(trametinib)组合用于治疗BRAF V600阳性晚期或转移性非小细胞肺癌(NSCLC)患者。该批准标志着欧盟所有28个成员国以及冰岛和挪威的此类患者首次得到针对性治疗方案,而以前几乎没有方

据估计,全球每年约有3.6万人(约占肺癌患者总数的1-3%)被诊断为BRAF V600阳性NSCLC。2017年4月5日,欧盟委员会批准了诺华的Tafinlar(dabrafenib)与Mekinist(trametinib)组合用于治疗BRAF V600阳性晚期或转移性非小细胞肺癌(NSCLC)患者。该批准标志着欧盟所有28个成员国以及冰岛和挪威的此类患者首次得到针对性治疗方案,而以前几乎没有方法治疗。

在既往未治疗过的BRAFV 600E突变的转移性非小细胞肺癌患者中用达拉非尼(dabrafenib)+曲美替尼(trametinib)治疗:一项开放标签的2期临床试验。

背景

BRAF V600E突变发挥致癌基因的作用,约有1-2%的肺腺癌会出现BRAF V600E突变,单独使用达拉非尼(dabrafenib)或联合曲美替尼(trametinib)用于既往未治疗过的BRAFV600E突变的转移性非小细胞肺癌患者,已显示出明显的抗肿瘤活性。在此,我们在既往未治疗过的BRAF V600E突变的转移性非小细胞肺癌患者中旨在评价达拉非尼(dabrafenib)+曲美替尼(trametinib)的有效性和安全性。

方法

在这项2期、连续入组、多队列、多中心、非随机化、开放标签的研究中,将既往未治疗过的BRAFV600E突变的转移性非小细胞肺癌成年患者(≥18岁)入组到C队列,这些患者来自北美、欧洲、亚洲的8个国家19家医疗中心。患者每日两次口服达拉非尼150mg+每日一次曲美替尼2mg,直至出现疾病进展、不可耐受的不良反应、患者要求终止试验或死亡。主要终点为研究人员评价的总缓解率,总缓解率为按照“实体瘤疗效评价标准1.1版”确认为完全缓解或部分缓解患者的百分比。通过意向性治疗在研究方案确定的患者群(既往未治疗过的患者)中进行主要分析和安全性分析。研究仍在进行,但不再招募患者,这项临床试验已在ClinicalTrials.gov网站注册,注册号NCT01336634。

结果

2014年4月16日至2014年12月28日,入组并用达拉非尼+曲美替尼一线治疗了36名患者,数据锁定日(2017年4月28日)的中位随访时间15.9个月(IQR,7.8–22.0),研究人员评价的确切总缓解患者的比例为23名(64%,95%CI,46–79),其中2名患者(6%)获得完全缓解、21名(58%)部分缓解。所有患者有一种及一种以上的各种级别的不良反应,25名(69%)有3、4级不良反应,最常见(超过2名患者出现)的3、4级不良反应为发热(4名[11%])、丙氨酸转氨酶升高(4名[11%])、高血压(4名[11%])和呕吐(3名[8%])。超过2名患者出现的严重不良反应包括丙氨酸转氨酶升高(5名[14%])、发热(4名[11%)、天冬氨酸转氨酸升高(3名[8%])、射血分数下降(3名[8%])。报告了1次致命性不良反应(呼吸心跳骤停),判定与研究性治疗不相关。

解释

在既往未治疗过的BRAFV 600E突变的转移性非小细胞肺癌患者中,达拉非尼+曲美替尼是一种新的治疗方案,临床抗肿瘤效果佳、安全可控。

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    2018-02-17 howi
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    2017-11-19 minlingfeng
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    2017-10-25 zhaojie88
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    2017-10-24 xuexin53

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