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【2017ASCO GI】雷莫芦单抗（RAM）治疗晚期胃癌：年龄亚组分析显示一致性良好

2017年01月25日

整理：医脉通

来源：医脉通

在1月19日的口头报告上，由来自日本爱知县癌症中心的Kei Muro教授为主要研究者的研究团队以“Efficacy and safety of ramucirumab(RAM)for metastatic gastric or gastroesophageal junction(GEJ)adenocarcinoma across age subgroups in two global phase 3 trials”为题，报道了雷莫芦单抗（Ramucirumab）在两项Ⅲ期临床研究（REGARD和RAINBOW）中的年龄亚组分析。

雷莫芦单抗（Ramucirumab、RAM)是一种对VEGFR-2高度亲和的人源化IgG-1单克隆抗体，可阻断VEGF的活化。美国FDA已批准雷莫芦单抗用于进展期胃癌。

REGARD和RAINBOW两项Ⅲ期研究的目标人群均为进展期胃/胃食管结合部癌患者，证实了雷莫芦单抗二线治疗对比安慰剂可以为此类患者带来显著的生存获益，且毒性可控。本次亚组分析聚焦不同年龄段患者的获益情况（≤45岁，45~70岁，≥70岁，≥75岁）。

研究内容

REGARD研究中患者2:1随机进入雷莫芦单抗（8mg/kg）+最佳支持治疗（BSC）或安慰剂+BSC；RAINBOW研究中患者1:1随机进入雷莫芦单抗（8mg/kg）+紫杉醇（PTX）或安慰剂+PTX。

采用Kaplan-Meier分析和Cox比例风险模型评估不同年龄段患者的总生存（OS）和无进展生存（PFS），采用亚组疗效模式图（STEPP）评估不同年龄亚组的治疗有效性和不良事件发生率。

几乎所有年龄段患者的基线特征都得到了良好的平衡，治疗有效性数据如下图所示。

根据年龄的STEPP分析没有发现不同亚组间有效性和不良事件存在明显的风险差异。

结论

与安慰剂相比，雷莫芦单抗的有效性在所有年龄亚组保持一致，毒性相近。尽管部分年龄亚组患者数量较少，但该探索性分析支持了无论年龄大小，雷莫芦单抗均可用于进展期胃癌治疗。

【原文】

Efficacy and safety of ramucirumab (RAM) for metastatic gastric orgastroesophageal junction (GEJ) adenocarcinoma across age subgroupsin two global phase 3 trials.

First Author: Kei Muro, Aichi Cancer CenterHospital, Nagoya, Japan

Background:

REGARD and RAINBOW are two phase 3 studies which dem-onstrated significant survival benefits and manageable toxicity in patientswith advanced gastric cancer (GC) randomized in the second-line setting toreceive RAM or placebo. We examined outcomes by age (#45, 45-70, $70, $75 years).

Methods:

Patients were randomized 2:1 to receive RAM8 mg/kg + best-supportive care (BSC) or placebo (PL) + BSC (REGARD); or 1:1RAM 8 mg/kg + paclitaxel (PTX) or PL + PTX (RAINBOW). Kaplan-Meieranalysis and Cox proportional hazards regression were performed for over-all survival (OS) and progression-free survival (PFS). Subpopulation treatmenteffect pattern plot (STEPP) assessed efficacy and the incidence of adverseevents (AEs) across age subgroups. Results: Baseline characteristics weregenerally well balanced between arms amongst the age subgroups. Efficacyoutcomes are summarized in the Table. STEPP analysis revealed no obviouspatterns for differential risks in terms of efficacy and AEs (any grade orgrade $3) according to age.

Conclusions:

Compared with PL, the efficacy ofRAM was maintained in all age groups, with similar rates of toxicity. Despitesome limitations regarding patient numbers in some age subgroups, thisexploratory subgroup analysis supports the use of RAM for the treatment ofGC, irrespective of age. Clinical trial information: NCT00917384 andNCT01170663.

参考文献：

Kei Muro.et al. J Clin Oncol 35, 2017 (suppl 4S; abstract 3)

编辑：肿瘤资讯-小编