Krankenhaus Nordwest, Institute of Clinical Cancer Research (IKF), Frankfurt am Main, Germany.
Zentrum für Hämatologie und Onkologie MVZ GmbH, Porta Westfalica, Germany.
Oncologist. 2020 Aug;25(8):e1181-e1187. doi: 10.1634/theoncologist.2020-0109. Epub 2020 Jun 4.
The observational study HerMES collected primary data on effectiveness and safety of trastuzumab in patients with human epidermal growth receptor 2 (HER2)-positive cancer of the stomach or gastroesophageal junction (GEJ) in routine clinical practice, exploring the treatment with trastuzumab, chemotherapy backbones used, and the HER2 testing in a real-world setting in Germany.
SUBJECTS, MATERIALS, AND METHODS: This noninterventional study observed patients with histologically confirmed, HER2-positive metastatic adenocarcinoma of the stomach or GEJ, who were treated with trastuzumab according to the physicians' judgement and clinical practice. The observation phase per patient took as long as the duration of the trastuzumab therapy, but for a maximum of 12 months. A subsequent extended follow-up phase lasted until the patient's death or the end of the study, that is, 2 years from start of the follow-up phase of the last patient. All data were analyzed descriptively.
Between February 2010 and July 2016, 364 patients were observed at 171 sites throughout Germany. The median overall survival was 14.1 months and the median progression-free survival was 7.9 months. The overall response rate was 43%. Safety was in line with previous reports. This study observed a high diversity of chemotherapy regimens that were combined with trastuzumab. Post hoc subgroup analyses showed differences in outcomes according to the chemotherapy regimen used.
Trastuzumab treatment in everyday practice as observed in HerMES confirmed the positive results of the pivotal study ToGA in an observational, real-world setting.
Real-world data of trastuzumab treatment of patients with gastroesophageal or gastric metastatic adenocarcinoma confirmed the positive results of the pivotal clinical trial. The observed median overall survival was 14.1 months and the median progression-free survival was 7.9 months. Although recommendations concerning administration of trastuzumab were well implemented, a high diversity of chemotherapy regimens were combined with trastuzumab. Regimens other than the in-label regimens, especially oxaliplatin-based doublets or 5-fluorouracil, leucovorin, oxaliplatin, taxane triplets, were used in 29% of patients. Observation of a second, marginal HER2-positivity population confirmed the benefit of trastuzumab predominantly for well-confirmed human epidermal growth receptor 2 (HER2)-positive tumors and the requirement of reliable HER2 testing.
观察性研究 HerMES 收集了在德国常规临床实践中曲妥珠单抗治疗人表皮生长因子受体 2（HER2）阳性胃癌或胃食管交界处（GEJ）癌症患者的有效性和安全性的原始数据，探索曲妥珠单抗的治疗方法、使用的化疗骨干药物以及真实环境中的 HER2 检测。
受试者、材料和方法：这项非干预性研究观察了经组织学证实的 HER2 阳性转移性胃或 GEJ 腺癌患者，这些患者根据医生的判断和临床实践接受曲妥珠单抗治疗。每位患者的观察期与曲妥珠单抗治疗的持续时间相同，但最长不超过 12 个月。随后的扩展随访期持续到患者死亡或研究结束，即最后一位患者随访期开始后 2 年。所有数据均进行描述性分析。
2010 年 2 月至 2016 年 7 月，在德国的 171 个地点观察了 364 名患者。中位总生存期为 14.1 个月，中位无进展生存期为 7.9 个月。总缓解率为 43%。安全性与以往报告一致。本研究观察到与曲妥珠单抗联合使用的化疗方案具有高度多样性。事后亚组分析显示，根据使用的化疗方案，结果存在差异。
HerMES 观察到的曲妥珠单抗治疗日常实践证实了关键性 ToGA 研究在观察性真实世界环境中的积极结果。
胃食管或胃转移性腺癌患者曲妥珠单抗治疗的真实世界数据证实了关键性临床试验的积极结果。观察到的中位总生存期为 14.1 个月，中位无进展生存期为 7.9 个月。尽管曲妥珠单抗给药的建议得到了很好的实施，但仍有高度多样化的化疗方案与曲妥珠单抗联合使用。除标签方案外，尤其是奥沙利铂为基础的二联或氟尿嘧啶、亚叶酸、奥沙利铂、紫杉烷三联方案，在 29%的患者中使用。对第二个人群的次要 HER2 阳性观察证实了曲妥珠单抗主要对明确的人表皮生长因子受体 2（HER2）阳性肿瘤有益，并且需要可靠的 HER2 检测。
