医脉通编译，转载请务必注明出处。
2015年ASCO GI研讨会于1月15日～17日在美国旧金山举行。Ramucirumab（RAM）是一种人类IgG1单克隆抗体VEGF-R2的拮抗剂。RAINBOW试验证明，RAM增加到RTX方案可以显著提高二线胃和胃食管交界处（GEJ）腺癌患者（pts）的总生存期（OS），无进展生存期（PFS）和客观缓解率（ORR）。在此次会议上，展出了一项RAINBOW试验的一个年龄组分析结果。
研究方法：
晚期胃和GEJ腺癌患者接受以铂类+氟尿嘧啶为基础化疗，疾病进展后，按照1:1随机分配，在第1和15天接受RAM（8mg/kg）或者安慰剂（PL），联合紫杉醇（RTX）80mg/m2，在第1，8和15天静脉注射，28天为一个周期。符合条件的患者ECOG PS≤1，以及适当的器官功能。OS是主要终点。次要终点包括PFS，ORR和安全性。
研究结果：
基线特征总体均衡。在下表中对预后进行了总结。对于两个年龄组和类似的各年龄组来说，≥3级不良事件（AEs）发生率在RAM+RTX组较高。≥3级AEs发生在＞10%的患者中，而且在RAM+RTX组比例更高，发热中性粒细胞减少情况如下表所示。
研究结论：
在两个年龄组中，OS，PFS，和ORR经过RAM+PTX治疗有相似的改善，且高于PL+PTX。两个年龄组的毒性特征相似，但值得注意的是，在≥65岁患者中，≥3级中性粒细胞减少和白细胞减少症的发生率相对较高。
英文摘要：
RAINBOW: A global, phase 3, double-blind study of ramucirumab (RAM) plus paclitaxel (PTX) versus placebo (PL) plus PTX in the treatment of advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma following disease progression on first-line platinum- and fluoropyrimidine-containing combination therapy—An age-group analysis.（Abstract11）
Background：RAM is a human IgG1 monoclonal antibody VEGF-R2 antagonist. The RAINBOW trial demonstrated that RAM added to PTX significantly improved overall survival (OS), progression free survival (PFS), and objective response rates (ORR) in 2nd-line gastric and GEJ adenocarcinoma patients (pts). Outcomes are reported by pts aged <65 and ≥65 yrs.
Methods：Pts with advanced gastric and GEJ adenocarcinoma after disease progression on platinum- and fluoropyrimidine-based chemotherapy were randomized 1:1 to receive RAM (8 mg/kg) or placebo (PL) on days 1 and 15 plus PTX 80 mg/m2IV on days 1, 8, and 15 of a 28-day cycle. Eligible pts had ECOG PS ≤ 1 and adequate organ function. OS was the primary endpoint. Secondary endpoints included PFS, ORR, and safety.
Results：Baseline characteristics were generally well balanced. Outcomes are summarized in the Table. The incidence of Grade ≥3 adverse events (AEs) was higher in the RAM+PTX arms for both age groups and similar across age groups. Grade ≥3 AEs occurring in ≥10% of pts and at higher rate in the RAM+PTX arm, and febrile neutropenia are shown in the Table.
Conclusions：RAM+PTX conferred similar improvements over PL+PTX for OS, PFS, and ORR in both age groups. Toxicity profiles were similar in both groups, although a relatively higher incidence of Grade ≥3 neutropenia and leukopenia in pts ≥65 years was noted.
查看会议专题》》》2015 ASCO胃肠肿瘤(GI)研讨会
