Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea.
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Cancer Chemother Pharmacol. 2019 Mar;83(3):501-508. doi: 10.1007/s00280-018-3753-y. Epub 2018 Dec 8.
To investigate the safety and efficacy of 30-min maintenance infusions of trastuzumab in advanced gastric cancer positive for human epidermal growth factor receptor 2 (HER2).
This was a retrospective study conducted across five Korean hospitals in patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma treated with first-line, 3-weekly trastuzumab plus chemotherapy. The first dose of trastuzumab (8 mg/kg) was administered as a 90-min infusion, with all subsequent maintenance infusions (6 mg/kg) given over 30 min. The primary aim was to investigate infusion-related reactions and cardiac events with 30-min infusions of trastuzumab. Objective response rate, progression-free survival, and overall survival were secondary endpoints.
The study included 128 patients (efficacy population), of whom 123 received both induction and maintenance infusions and formed the safety population. The median age was 63 years; 80% were presenting for the first time with metastatic disease, and 94% were treated with trastuzumab plus capecitabine/cisplatin. Infusion-related reactions were observed in 32 of 123 patients (26%). There were no cardiac events. The most frequent adverse events were anorexia and nausea, followed by vomiting, fatigue, mucositis, sensory neuropathy, and hand-foot syndrome. Most events were grade 1-2 and were manageable. No patient discontinued study treatment due to adverse events. The objective response rate was 63%, and included 6 complete responses.
Trastuzumab 30-min maintenance infusions were well tolerated with a good safety profile, and resulted in sustained efficacy in patients with HER2-positive advanced gastric cancer.
研究曲妥珠单抗 30 分钟维持输注在人表皮生长因子受体 2（HER2）阳性晚期胃癌中的安全性和疗效。
这是一项在韩国五家医院进行的回顾性研究，纳入了接受一线、每 3 周曲妥珠单抗联合化疗治疗的 HER2 阳性胃或胃食管交界腺癌患者。曲妥珠单抗的首剂量（8mg/kg）以 90 分钟输注，所有后续维持输注（6mg/kg）均在 30 分钟内完成。主要目的是研究曲妥珠单抗 30 分钟输注的输注相关反应和心脏事件。客观缓解率、无进展生存期和总生存期为次要终点。
该研究纳入了 128 例患者（疗效人群），其中 123 例患者接受了诱导和维持输注，构成了安全性人群。中位年龄为 63 岁；80%的患者首次出现转移性疾病，94%的患者接受了曲妥珠单抗联合卡培他滨/顺铂治疗。123 例患者中有 32 例（26%）出现了输注相关反应。无心脏事件。最常见的不良反应为厌食和恶心，其次为呕吐、疲劳、黏膜炎、感觉神经病变和手足综合征。大多数事件为 1-2 级，且可管理。无患者因不良反应而停止研究治疗。客观缓解率为 63%，包括 6 例完全缓解。
曲妥珠单抗 30 分钟维持输注耐受性良好，安全性良好，在 HER2 阳性晚期胃癌患者中具有持续疗效。
