Department of Surgery, Queen's University, Kingston, Ontario, Canada.
Division of Cancer Care and Epidemiology, Queen's Cancer Research Institute, Kingston, Ontario, Canada.
Clin Oncol (R Coll Radiol). 2021 Mar;33(3):202-207. doi: 10.1016/j.clon.2020.07.013. Epub 2020 Aug 1.
In the pivotal Trastuzumab for Gastric Cancer (ToGA) trial, trastuzumab improved median survival in patients with advanced HER-2-positive gastric and gastroesophageal cancer from 11.1 to 13.8 months; however, its effectiveness in routine clinical practice has not been evaluated. Our objective was to evaluate the uptake and outcomes of trastuzumab in a population-based cohort of patients with oesophageal, gastroesophageal and gastric cancer in Ontario, Canada.
The Ontario Cancer Registry and linked treatment records were used to identify all patients with oesophageal, gastroesophageal and gastric cancer treated with trastuzumab during 2012-2017. Outcomes were analysed from the time of first trastuzumab cycle and included a primary outcome (survival) and secondary outcomes (uptake, delivery, 30-day hospital admission and 30-day mortality). Trends over the study period and survival were evaluated.
In total, 476 patients with oesophageal, gastroesophageal and gastric cancer received trastuzumab during the study period. The mean age was 62 years, 78% (370/476) were male, and 65% (312/476) had gastric cancer. The annual number of patients receiving trastuzumab increased over the study period (53 in 2012 and 101 in 2017). The median number of cycles of trastuzumab delivered was six. Thirty-day hospital admission and mortality rates were 17% and 4%, respectively. The median overall survival was 282 days (9.3 months).
The median survival of patients treated with trastuzumab for advanced oesophageal, gastroesophageal and gastric cancer in routine practice is substantially less than that observed in the pivotal clinical trial. Studies of comparative effectiveness using real-world data offer insight into outcomes achieved in routine practice.
在关键的曲妥珠单抗治疗胃癌（ToGA）试验中，曲妥珠单抗将晚期 HER-2 阳性胃癌和胃食管交界癌患者的中位生存期从 11.1 个月提高到 13.8 个月；然而，其在常规临床实践中的有效性尚未得到评估。我们的目的是评估曲妥珠单抗在加拿大安大略省接受治疗的食管、胃食管和胃癌患者的人群队列中的应用情况和结果。
利用安大略癌症登记处和相关治疗记录，确定了 2012 年至 2017 年期间所有接受曲妥珠单抗治疗的食管、胃食管和胃癌患者。从第一次曲妥珠单抗周期开始分析结果，包括主要结局（生存）和次要结局（应用、给药、30 天住院和 30 天死亡率）。评估了研究期间的趋势和生存情况。
在研究期间，共有 476 名食管、胃食管和胃癌患者接受了曲妥珠单抗治疗。平均年龄为 62 岁，78%（370/476）为男性，65%（312/476）患有胃癌。接受曲妥珠单抗治疗的患者数量在研究期间逐年增加（2012 年为 53 例，2017 年为 101 例）。曲妥珠单抗给药的中位数为 6 个周期。30 天住院率和死亡率分别为 17%和 4%。中位总生存期为 282 天（9.3 个月）。
在常规实践中，接受曲妥珠单抗治疗的晚期食管、胃食管和胃癌患者的中位生存期明显短于关键临床试验中的观察结果。使用真实世界数据进行的比较有效性研究提供了对常规实践中获得的结果的深入了解。
