, Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan.
Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Gastric Cancer. 2021 Nov;24(6):1320-1329. doi: 10.1007/s10120-021-01199-0. Epub 2021 May 28.
This study evaluated the safety and effectiveness of ramucirumab monotherapy and combination therapy for advanced gastric cancer in the real-world setting.
This single-arm, prospective, multicenter, non-interventional, observational, post-marketing study was conducted in Japan from August 2015 to March 2019. Patients with unresectable advanced or recurrent gastric cancer and newly prescribed ramucirumab were followed for up to 12 months after first treatment. Data on adverse events and survival were collected via Electronic Data Capture.
Of 687 enrolled patients, 658 were eligible for analysis. Most patients received either ramucirumab monotherapy (123/658; 18.7%) or ramucirumab plus paclitaxel combination therapy (528/658; 80.2%). The majority of patients reported ≥ 1 adverse events in both the combination therapy (any grade, 479/528; 90.7%; ≥ Grade 3, 321/528; 60.8%) and monotherapy groups (any grade, 77/123; 62.6%; ≥ Grade 3, 42/123; 34.2%). The most common any grade adverse events were neutropenia (combination: 49.6%; monotherapy: 8.9%), fatigue (combination: 19.5%; monotherapy: 13.8%), and decreased appetite (combination: 18.2%; monotherapy: 10.6%). Grade 5 adverse events were reported in 4 patients, including metastases to meninges, pneumonia aspiration, death, and gastric perforation; of these, gastric perforation was deemed treatment-related. Median survival time was 5.7 months (95% confidence interval: 4.1-6.8 months) following monotherapy and 11.0 months (95% confidence interval: 9.8-12.2 months) following combination therapy.
This analysis adds to the limited data available on ramucirumab use in a real-world setting, demonstrating similar safety and effectiveness for ramucirumab in treating advanced gastric cancer in routine clinical practice in Japan to that of global clinical trials.
本研究评估了雷莫芦单抗单药及联合治疗在真实世界环境下用于晚期胃癌的安全性和有效性。
本项单臂、前瞻性、多中心、非干预性、观察性、上市后研究于 2015 年 8 月至 2019 年 3 月在日本开展。对新诊断为不可切除的晚期或复发性胃癌且接受雷莫芦单抗治疗的患者进行随访，随访时间截至首次治疗后 12 个月。通过电子数据采集系统收集不良事件和生存数据。
在 687 例入组患者中，658 例患者符合分析条件。大多数患者接受雷莫芦单抗单药治疗（123/658；18.7%）或雷莫芦单抗联合紫杉醇联合治疗（528/658；80.2%）。联合治疗组（任何级别：479/528；90.7%；≥3 级：321/528；60.8%）和单药治疗组（任何级别：77/123；62.6%；≥3 级：42/123；34.2%）中均有大多数患者报告发生≥1 次不良事件。最常见的任何级别不良事件为中性粒细胞减少（联合治疗组：49.6%；单药治疗组：8.9%）、疲劳（联合治疗组：19.5%；单药治疗组：13.8%）和食欲下降（联合治疗组：18.2%；单药治疗组：10.6%）。报告了 4 例 5 级不良事件，包括脑膜转移、肺炎吸入、死亡和胃穿孔；其中，胃穿孔被认为与治疗相关。单药治疗后中位生存时间为 5.7 个月（95%置信区间：4.1-6.8 个月），联合治疗后为 11.0 个月（95%置信区间：9.8-12.2 个月）。
本分析增加了雷莫芦单抗在真实世界环境下应用的有限数据，证实了雷莫芦单抗在日本常规临床实践中治疗晚期胃癌的安全性和有效性与全球临床试验结果一致。
