曲妥珠单抗联合S-1及顺铂用于HER2阳性不可测量病灶的晚期胃癌：OGSG 1202研究
Trastuzumab With S-1 Plus Cisplatin in HER2-positive Advanced Gastric Cancer Without Measurable Lesions: OGSG 1202.
作者信息
Endo Shunji, Kurokawa Yukinori, Gamoh Makio, Kimura Yutaka, Matsuyama Jin, Taniguchi Hirokazu, Takeno Atsushi, Kawabata Ryohei, Kawada Junji, Masuzawa Toru, Yamamoto Kazuyoshi, Kobayashi Kouji, Sakai Daisuke, Shimokawa Toshio, Satoh Taroh
机构信息
Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Osaka, Japan.
Department of Surgery, Yao Municipal Hospital, Osaka, Japan.
出版信息
Anticancer Res. 2019 Feb;39(2):1059-1065. doi: 10.21873/anticanres.13213.
BACKGROUND/AIM: Trastuzumab with S-1 plus cisplatin was proved to be effective for human epidermal growth factor receptor type 2 (HER2)-positive advanced gastric cancer with measurable lesions. However, the efficacy and safety of this regimen in the absence of measurable lesions are unknown.
PATIENTS AND METHODS
Patients with HER2-positive gastric cancer without measurable lesions received cisplatin plus trastuzumab intravenously on day 1 and oral S-1 on days 1-14 of a 21-day cycle. The primary end-point was overall survival, and 40 patients were planned to be enrolled.
RESULTS
Fifteen patients were enrolled. The median overall survival was 14.4 months. The 1- and 3-year overall survival rates were 66.7 % and 26.7 %, respectively. Major grade 3-4 adverse events included neutropenia (47%), anemia (40%), diarrhea (20%), nausea (20%), and anorexia (20%).
CONCLUSION
Trastuzumab with S-1 plus cisplatin might be effective and tolerable for HER2-positive advanced gastric cancer without measurable lesions.
背景/目的：曲妥珠单抗联合S-1及顺铂已被证明对具有可测量病灶的人表皮生长因子受体2（HER2）阳性晚期胃癌有效。然而，该方案在无可测量病灶情况下的疗效和安全性尚不清楚。
患者与方法
无可测量病灶的HER2阳性胃癌患者在21天周期的第1天静脉注射顺铂加曲妥珠单抗，并在第1 - 14天口服S-1。主要终点为总生存期，计划入组40例患者。
结果
共入组15例患者。中位总生存期为14.4个月。1年和3年总生存率分别为66.7%和26.7%。主要的3 - 4级不良事件包括中性粒细胞减少（47%）、贫血（40%）、腹泻（20%）、恶心（20%）和厌食（20%）。
结论
曲妥珠单抗联合S-1及顺铂可能对无可测量病灶的HER2阳性晚期胃癌有效且耐受性良好。
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