Efficacy of trastuzumab in Japanese patients with HER2-positive advanced gastric or gastroesophageal junction cancer: a subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study.
Efficacy of trastuzumab in Japanese patients with HER2-positive advanced gastric or gastroesophageal junction cancer: a subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study.
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DOI：
10.1007/s10120-011-0118-1
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发表时间：
2012-07
期刊：
影响因子：
7.4
通讯作者：
Ohtsu, Atsushi
中科院分区：
文献类型：
--
作者：
Sawaki, Akira;Ohashi, Yasuo;Omuro, Yasushi;Satoh, Taroh;Hamamoto, Yasuo;Boku, Narikazu;Miyata, Yoshinori;Takiuchi, Hiroya;Yamaguchi, Kensei;Sasaki, Yasutsuna;Nishina, Tomohiro;Satoh, Atsushi;Baba, Eishi;Tamura, Takao;Abe, Takashi;Hatake, Kiyohiko;Ohtsu, Atsushi
曲妥珠单抗治疗胃癌（ToGA）研究是首项纳入日本人表皮生长因子2（HER 2）阳性晚期/转移性胃癌或胃食管交界处癌患者的国际试验。ToGA显示曲妥珠单抗联合化疗（卡培他滨/顺铂或5-氟尿嘧啶/顺铂）改善了总体人群的总生存期（风险比0.74）。在其他研究中观察到有利于日本人群结局的地区差异;因此，ToGA亚组分析可能有助于评价该方案在日本患者中的潜在获益。我们对入组ToGA的101例日本患者进行了亚组分析（曲妥珠单抗+化疗，n = 51;化疗，n = 50）。日本亚组中曲妥珠单抗联合化疗的中位总生存期为15.9个月（95%置信区间12-25），化疗为17.7个月（95%置信区间12-24）（风险比1.00; 95%置信区间0.59-1.69）。调整预先设定的协变量后，总生存期的估计风险比为0.68（95%置信区间0.36-1.27）。进一步的事后和探索性检查支持调整后风险比的稳健性。在调整组间不平衡的患者背景后，接受曲妥珠单抗联合化疗的日本人表皮生长因子2阳性晚期/转移性胃癌或胃食管连接部癌患者的总生存期比接受单药化疗的患者有所改善。
The Trastuzumab for Gastric Cancer (ToGA) study is the first international trial to include Japanese patients with human epidermal growth factor 2 (HER2) positive advanced/metastatic gastric or gastroesophageal junction cancer. ToGA showed that trastuzumab plus chemotherapy (capecitabine/cisplatin or 5-fluorouracil/cisplatin) improved overall survival in the overall population (hazard ratio 0.74). Regional differences in outcome in favor of Japanese populations were observed in other studies; therefore, subgroup analyses of ToGA may contribute to the evaluation of the potential benefits of this regimen in Japanese patients. We performed subgroup analyses on 101 Japanese patients enrolled into ToGA (trastuzumab plus chemotherapy, n = 51; chemotherapy, n = 50). Median overall survival in the Japanese subgroup was 15.9 months (95% confidence interval 12–25) for trastuzumab plus chemotherapy and 17.7 months (95% confidence interval 12–24) for chemotherapy (hazard ratio 1.00; 95% confidence interval 0.59–1.69). After adjusting for prespecified covariates, the estimated hazard ratio for overall survival was 0.68 (95% confidence interval 0.36–1.27). Further post hoc and exploratory examinations supported the robustness of the adjusted hazard ratios. After adjusting for imbalanced patient backgrounds between arms, overall survival of Japanese patients with human epidermal growth factor 2 positive advanced/metastatic gastric or gastroesophageal junction cancer who received trastuzumab plus chemotherapy was improved compared with patients who received chemotherapy alone.
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