Shitara Kohei, Muro Kei, Shimada Yasuhiro, Hironaka Shuichi, Sugimoto Naotoshi, Komatsu Yoshito, Nishina Tomohiro, Yamaguchi Kensei, Segawa Yoshihiko, Omuro Yasushi, Tamura Takao, Doi Toshihiko, Yukisawa Seigo, Yasui Hirofumi, Nagashima Fumio, Gotoh Masahiro, Esaki Taito, Emig Michael, Chandrawansa Kumari, Liepa Astra M, Wilke Hansjochen, Ichimiya Yukako, Ohtsu Atsushi
Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Aichi Cancer Center, Nagoya, Japan.
Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.
We evaluated the safety and efficacy of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients previously treated for advanced gastric or gastroesophageal junction adenocarcinoma in Japanese and Western subgroups from the RAINBOW trial.
Patients received ramucirumab at 8 mg/kg or placebo (days 1 and 15) plus paclitaxel at 80 mg/m(2) (days 1, 8, and 15 of a 28-day cycle). End points were compared between treatment arms within Japanese (N = 140) and Western (N = 398) populations.
The incidence of adverse events of grade 3 or higher was higher for ramucirumab plus paclitaxel in both populations (Japanese population, 83.8 % vs 52.1 %; Western population, 79.1 % vs 61.9 %). Neutropenia was the commonest adverse event of grade 3 or higher, with a higher incidence for ramucirumab plus paclitaxel (Japanese population, 66.2 % vs 25.4 %; Western population, 32.1 % vs 14.7 %). The incidence of febrile neutropenia was low and was similar between treatment arms in both populations. The overall survival hazard ratio was 0.88 (95 % confidence interval, 0.60-1.28) in the Japanese population and 0.73 (95 % confidence interval, 0.58-0.91) in the Western population. The progression-free survival hazard ratio was 0.50 (95 % confidence interval, 0.35-0.73) in the Japanese population and 0.63 (95 % confidence interval, 0.51-0.79) in the Western population. The objective response rate was higher for ramucirumab plus paclitaxel in both populations (Japanese population, 41.2 % vs 19.4 %; Western population, 26.8 % vs 13.0 %), as was the 6-month survival rate (Japanese population, 94.1 % vs 71.4 %; Western population, 66.0 % vs 49.0 %).
Safety profiles of the ramucirumab plus paclitaxel arm were similar between populations, though there was a higher incidence of neutropenia in Japanese patients. Progression-free survival and objective response rate improvements were observed for ramucirumab plus paclitaxel in both populations. CLINICALTRIALS.
NCT01170663.
我们在RAINBOW试验的日本和西方亚组中，评估了雷莫西尤单抗联合紫杉醇对比安慰剂联合紫杉醇用于先前接受过治疗的晚期胃或胃食管交界腺癌患者的安全性和疗效。
患者接受8mg/kg雷莫西尤单抗或安慰剂（第1天和第15天）联合80mg/m²紫杉醇（28天周期的第1、8和15天）治疗。对日本人群（N = 140）和西方人群（N = 398）中各治疗组的终点指标进行比较。
在两个人群中，雷莫西尤单抗联合紫杉醇组3级及以上不良事件的发生率均更高（日本人群，83.8%对52.1%；西方人群，79.1%对61.9%）。中性粒细胞减少是最常见的3级及以上不良事件，雷莫西尤单抗联合紫杉醇组的发生率更高（日本人群，66.2%对25.4%；西方人群，32.1%对14.7%）。发热性中性粒细胞减少的发生率较低，且在两个人群的各治疗组之间相似。日本人群的总生存风险比为0.88（95%置信区间，0.60 - 1.28），西方人群为0.73（95%置信区间，0.58 - 0.91）。日本人群的无进展生存风险比为0.50（95%置信区间，0.35 - 0.73），西方人群为0.63（95%置信区间，0.51 - 0.79）。在两个人群中，雷莫西尤单抗联合紫杉醇组的客观缓解率均更高（日本人群，41.2%对19.4%；西方人群，26.8%对13.0%），6个月生存率也是如此（日本人群，94.1%对71.4%；西方人群，66.0%对49.0%）。
尽管日本患者中性粒细胞减少的发生率较高，但雷莫西尤单抗联合紫杉醇组在两个人群中的安全性概况相似。在两个人群中均观察到雷莫西尤单抗联合紫杉醇可改善无进展生存和客观缓解率。临床试验。
NCT01170663
