纳米白蛋白结合紫杉醇联合雷莫芦单抗对比紫杉醇联合雷莫芦单抗二线治疗晚期胃癌的回顾性队列研究。
Retrospective cohort study of nanoparticle albumin-bound paclitaxel plus ramucirumab versus paclitaxel plus ramucirumab as second-line treatment in patients with advanced gastric cancer.
机构信息
Department of Pharmacy, National Cancer Center Hospital East, Kashiwa, Japan.
Department of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
出版信息
BMC Cancer. 2020 Nov 16;20(1):1111. doi: 10.1186/s12885-020-07614-6.
BACKGROUND
Nanoparticle albumin-bound paclitaxel (nab-PTX) has shown non-inferiority to paclitaxel (PTX) as second-line therapy for advanced gastric cancer (AGC) with fewer infusion-related reactions. The efficacy and safety of nab-PTX plus ramucirumab (RAM) was reported in a phase II trial; however, there is no randomized trial comparing this regimen with PTX plus RAM in patients with AGC. This retrospective study aimed to investigate the efficacy and safety of nab-PTX plus RAM versus PTX plus RAM in patients with AGC.
METHODS
This study included patients with AGC who received nab-PTX plus RAM from September 2017 to January 2019 or PTX plus RAM from June 2015 to August 2017 as second-line chemotherapy in our hospital.
RESULTS
A total of 113 and 138 patients who received nab-PTX plus RAM and PTX plus RAM, respectively, were analyzed. Median progression-free survival (PFS) was 3.9 months (95% confidence interval [CI]: 3.4-4.3) in the nab-PTX plus RAM group and 3.9 months (95% CI: 3.1-4.7) in the PTX plus RAM group (hazard ratio [HR]: 1.08; 95% CI: 0.83-1.40; P = 0.573). Median overall survival (OS) was 10.9 months (95% CI: 9.3-12.7) in the nab-PTX plus RAM group and 10.3 months (95% CI: 8.5-12.0) in the PTX plus RAM group (hazard ratio: 0.82; 95% CI: 0.61-1.10; P = 0.188). In patients with moderate/massive ascites, favorable outcomes for progression-free survival were observed in the nab-PTX plus RAM group compared with the PTX plus RAM group. Although anemia and fatigue (any grade) were more frequent in the nab-PTX plus RAM group, discontinuation of study treatment was not increased in the nab-PTX plus RAM group. There was no occurrence of hypersensitivity reaction in the nab-PTX plus RAM group, while two patients (1.4%) experienced grade 3 hypersensitivity reactions in the PTX plus RAM group.
CONCLUSIONS
The combination of nab-PTX plus RAM showed a similar efficacy and safety profile to PTX plus RAM as second-line treatment for patients with AGC.
背景
纳米白蛋白结合紫杉醇（nab-PTX）作为晚期胃癌（AGC）二线治疗药物，其在输注相关不良反应方面优于紫杉醇（PTX）。一项 II 期试验报道了 nab-PTX 联合雷莫芦单抗（RAM）的疗效和安全性；然而，尚无随机试验比较该方案与 PTX 联合 RAM 在 AGC 患者中的疗效。本回顾性研究旨在探讨 nab-PTX 联合 RAM 与 PTX 联合 RAM 治疗 AGC 患者的疗效和安全性。
方法
本研究纳入了 2017 年 9 月至 2019 年 1 月期间在我院接受 nab-PTX 联合 RAM 二线化疗或 2015 年 6 月至 2017 年 8 月期间接受 PTX 联合 RAM 二线化疗的 AGC 患者。
结果
共分析了 113 例接受 nab-PTX 联合 RAM 和 138 例接受 PTX 联合 RAM 的患者。nab-PTX 联合 RAM 组和 PTX 联合 RAM 组的中位无进展生存期（PFS）分别为 3.9 个月（95%置信区间[CI]：3.4-4.3）和 3.9 个月（95% CI：3.1-4.7）（风险比[HR]：1.08；95% CI：0.83-1.40；P=0.573）。nab-PTX 联合 RAM 组和 PTX 联合 RAM 组的中位总生存期（OS）分别为 10.9 个月（95% CI：9.3-12.7）和 10.3 个月（95% CI：8.5-12.0）（风险比：0.82；95% CI：0.61-1.10；P=0.188）。在中/大量腹水患者中，nab-PTX 联合 RAM 组的 PFS 结果优于 PTX 联合 RAM 组。尽管 nab-PTX 联合 RAM 组贫血和乏力（任何级别）更为常见，但 nab-PTX 联合 RAM 组并未增加研究治疗的停药率。nab-PTX 联合 RAM 组未发生过敏反应，而 PTX 联合 RAM 组有 2 例（1.4%）患者发生 3 级过敏反应。
结论
nab-PTX 联合 RAM 作为二线治疗晚期胃癌患者，疗效和安全性与 PTX 联合 RAM 相当。
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