Xu Mengli, Meng Xiangrui, Lu Yao, Wang Feng
Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
J Gastrointest Oncol. 2022 Apr;13(2):548-558. doi: 10.21037/jgo-21-897.
Trastuzumab plus chemotherapy is the standard-of-care (SoC) first-line therapy for HER2-positive advanced gastric cancer. Combining PD-1 antibody with SoC first-line therapy showed encouraging results in the KEYNOTE-811 study. The retrospective study aims to evaluate the efficacy and safety of SoC SoC plus camrelizumab (PD-1 antibody) as a first-line treatment for HER2-positive advanced gastric cancer in a real-world setting.
This study included 41 patients with HER2-positive advanced gastric cancer who received SoC or SoC plus camrelizumab from June 2017 to December 2020. The endpoints were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Thirteen patients received SoC (SoC group) and 28 patients received SoC plus camrelizumab (camrelizumab group). As of December 2020, the median follow-up time was 10.0 months. In the camrelizumab and SoC groups, the ORRs were 75.0% and 46.2% (P=0.032), respectively. The DCR was 96.4% in the camrelizumab group and 69.2% in the SoC group (P=0.003). The median OS was 18.4 in the camrelizumab group and 13.2 months in the SoC group [hazard ratio (HR) =0.343; 95% confidence interval (CI): 0.151-0.783; P=0.008]. The median PFS was 3.78 in the camrelizumab group and 1.74 months in the SoC group (HR =0.416; 95% CI: 0.186-0.932; P=0.027). In the HER2 subgroups in the camrelizumab group, the median PFS of immunohistochemistry (IHC) 3+ IHC 2+ fluorescence in situ hybridization (FISH) was 11.3 9.0 months (HR =1.684; 95% CI: 0.710-3.994; P=0.047). The incidence rates of reactive cutaneous capillary endothelial proliferation (RCCEP) (P<0.001), abnormal liver function (P=0.040), and hypothyroidism (P=0.039) between the two groups were significantly different. RCCEP and hypothyroidism were considered to be related to camrelizumab.
First-line treatment with camrelizumab combined with SoC showed significant clinical benefits and good tolerance compared with SoC for HER2-positive advanced gastric cancer.
曲妥珠单抗联合化疗是HER2阳性晚期胃癌的标准一线治疗方案。在KEYNOTE-811研究中，将PD-1抗体与标准一线治疗方案联合显示出令人鼓舞的结果。这项回顾性研究旨在评估在真实世界中，标准一线治疗方案联合卡瑞利珠单抗（一种PD-1抗体）作为HER2阳性晚期胃癌一线治疗的疗效和安全性。
本研究纳入了41例HER2阳性晚期胃癌患者，这些患者在2017年6月至2020年12月期间接受了标准一线治疗方案或标准一线治疗方案联合卡瑞利珠单抗。研究终点包括客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和安全性。
13例患者接受标准一线治疗方案（标准一线治疗方案组），28例患者接受标准一线治疗方案联合卡瑞利珠单抗（卡瑞利珠单抗组）。截至2020年12月，中位随访时间为10.0个月。在卡瑞利珠单抗组和标准一线治疗方案组中，ORR分别为75.0%和46.2%（P=0.032）。卡瑞利珠单抗组的DCR为96.4%，标准一线治疗方案组为69.2%（P=0.003）。卡瑞利珠单抗组的中位OS为18.4个月，标准一线治疗方案组为13.2个月[风险比（HR）=0.343；95%置信区间（CI）：0.151-0.783；P=0.008]。卡瑞利珠单抗组的中位PFS为3.78个月，标准一线治疗方案组为1.74个月（HR =0.416；95% CI：0.186-0.932；P=0.027）。在卡瑞利珠单抗组的HER2亚组中，免疫组化（IHC）3+ IHC 2+荧光原位杂交（FISH）的中位PFS为11.3 9.0个月（HR =1.684；95% CI：0.710-3.994；P=0.047）。两组之间反应性皮肤毛细血管内皮增殖（RCCEP）（P<0.001）、肝功能异常（P=0.040）和甲状腺功能减退（P=0.039）的发生率有显著差异。RCCEP和甲状腺功能减退被认为与卡瑞利珠单抗有关。
与标准一线治疗方案相比，卡瑞利珠单抗联合标准一线治疗方案用于HER2阳性晚期胃癌的一线治疗显示出显著的临床益处和良好的耐受性。
