CSCO 2017:令人振奋:曲妥珠单抗治疗晚期胃癌生存期可达30个月

2017-09-29 肿瘤资讯编辑部 肿瘤资讯

9月28日下午,在CSCO年会胃癌论坛上,解放军八一医院肿瘤内科秦叔逵教授报告了一项有关曲妥珠单抗真实世界的研究,即前瞻性、多中心、非干预的EVIDENCE研究。研究结果显示,曲妥珠单抗治疗中国HER2阳性转移性胃癌中位OS高达30个月,中位PFS 9.5个月。该结果从临床实践角度证明了曲妥珠单抗在晚期胃癌中的卓越疗效。

9月28日下午,在CSCO年会胃癌论坛上,解放军八一医院肿瘤内科秦叔逵教授报告了一项有关曲妥珠单抗真实世界的研究,即前瞻性、多中心、非干预的EVIDENCE研究。研究结果显示,曲妥珠单抗治疗中国HER2阳性转移性胃癌中位OS高达30个月,中位PFS 9.5个月。该结果从临床实践角度证明了曲妥珠单抗在晚期胃癌中的卓越疗效。

中国是胃癌大国,因缺乏有效筛查手段,确诊时多数患者已达中晚期,细胞毒药物治疗的中位OS为11个月左右。ToGA研究作为第一项曲妥珠单抗治疗HER2阳性胃癌的大型Ⅲ期临床研究,首次证实化疗联合靶向药物可显着延长晚期胃癌的OS。曲妥珠单抗于2012年在我国上市胃癌适应症,是HER2阳性晚期胃癌唯一的标准一线治疗。


ToGA为经典的临床随机对照试验(RCT),RCT作为最高等级的临床证据标准,试验条件严格,但是不能完全反映真实世界的复杂性。真实世界研究数据来自真实的医疗环境,反映实际诊疗过程和真实条件下的患者健康状况的研究,可精确地满足患者的需要,使研究证据有更强的外推性,更具临床实用价值。

目前在真实世界,曲妥珠单抗治疗我国HER2阳性转移性胃癌疗效和安全性方面数据有限。

研究详情

EVIDENCE研究是一项5队列前瞻性、多中心、非干预登记研究 (NCT01839500)。队列1纳入接受曲妥珠单抗治疗的HER2阳性(IHC3+ or IHC2+/ISH+) 转移性胃癌,此中期分析报告队列 I 中前95例患者的疗效及安全性数据。

2013年4月至2016年8月纳入中国33家中心95例患者,要求入组前6个月内诊断的HER2阳性(IHC3+ or IHC2+/ISH+) 转移性胃癌,且正在接受或即将接受曲妥珠单抗的治疗。患者中位年龄61岁,男性71例(74.7%),ECOG评分0~1分62例(65.3%)。绝大部分患者基线期无心脑血管相关病史,其中24例(25.3%)有高血压。肿瘤远处转移80例(84.2%) ,区域或局部复发15例(15.8%),转移部位以淋巴结、肝和肺为主。HER2免疫组化3+患者80例,FISH阳性患者17例。

疗效方面,中位PFS 9.5个月(95% CI 7.6-11.8个月),见图1。中位OS 30个月(95% CI 18.6-38.7个月),见图2。中位TTP 7.6个月(95% CI 5.7-9.1个月)。

图1:曲妥珠单抗治疗的PFS曲线

图2:曲妥珠单抗治疗的OS曲线

治疗方案方面,与曲妥珠单抗联合的一线化疗方案中,最常见为卡培他滨联合奥沙利铂 (28例[31.1%]),其次为卡培他滨单药(20例 [22.2%]),以及卡培他滨联合顺铂 (16例 [17.8%])。与曲妥珠单抗联合的二/三线化疗方案中,最常见的是以紫杉醇为基础的方案。治疗期间曲妥珠单抗治疗疾病进展后二线继续使用曲妥珠单抗21例,二线进展后继续使用曲妥珠单抗7例。并且在新辅助和辅助治疗阶段,分别有7例和8例患者接受曲妥珠单抗治疗。

安全性方面,曲妥珠单抗相关不良事件共26例(27.4%),其中中性粒细胞减少10例(10.5%)、血小板减少9例(9.5%)、白细胞计数减7例(7.4%)。≥3级治疗相关不良事件出现6例(中性粒细胞减少和血小板减少)。基线时及随访期间平均最低LVEF分别为66.7%和64.2%,随访期间未发现LVEF自基线>50%改变至≤50%,曲妥珠单抗心脏安全性良好。

研究表明在中国的常规临床实践中,曲妥珠单抗联合各种化疗均显示了很好的疗效和安全性。除在姑息治疗中使用曲妥珠单抗外,在围手术期也有使用。

本研究是中国首个曲妥珠单抗治疗转移性胃癌的前瞻性观察研究,目前整个研究5个队列1600余例患者已全部入组完成,正在进行随访和数据分析,相信不久的将来会展现更完整的中国胃癌诊治真实世界图景。

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    0

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    2017-09-29 Julie W

    本研究是中国首个曲妥珠单抗治疗转移性胃癌的前瞻性观察研究.目前整个研究5个队列1600余例患者已全部入组完成.正在进行随访和数据分析.相信不久的将来会展现更完整的中国胃癌诊治真实世界图景.

    0

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    2017-09-29 1e1a50a1m36(暂无匿称)

    谢谢分享知识学习

    0

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