Wang Jianzheng, He Yunduan, Zhang Baiwen, Lv Huifang, Nie Caiyun, Chen Beibei, Xu Weifeng, Zhao Jing, Cheng Xiaojiao, Li Qingli, Tu Shuiping, Chen Xiaobing
Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou, University and Henan Cancer Hospital, Zhengzhou, China.
Department of Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Front Oncol. 2022 Jun 1;12:924149. doi: 10.3389/fonc.2022.924149. eCollection 2022.
Unresectable advanced or recurrent gastric cancer patients have a poor prognosis. PD-1 monotherapy regimen and PD-1 combined chemotherapy regimen have become the standard third- and first-line treatment for advanced gastric cancer, respectively. However, the status of immune checkpoint inhibitors in the second-line treatment for advanced gastric cancer has not been established. The combination of chemotherapy and anti-PD-1 antibody has been demonstrated to have a synergistic effect. In this study, we aimed to evaluate the efficacy and safety of sintilimab combined with nab-paclitaxel in the second-line treatment for advanced gastric cancer (GC)/gastroesophageal junction (GEJ) cancer patients.
We retrospectively analyzed patients with advanced GC/GEJ cancer that progressed after first-line systemic therapies with sintilimab combined with nab-paclitaxel from April 1, 2019 to December 31, 2021. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.
Thirty-nine patients were enrolled and eligible for response assessment. Complete response (CR) was not observed, 15 patients achieved partial response (PR), 16 patients had stable disease (SD) and 9 patients had progressive disease (PD). The ORR and DCR were 15 (38.5%) and 31 (79.5%), respectively. Median PFS was 5.4 months (95%CI: 3.072-7.728). PFSs between different subgroups were analyzed. The results showed that gender, age, Human epidermal growth factor receptors 2 (HER2) status, PD-L1 expression, primary tumor site and chemotherapy cycles had no significant effect on PFS. Most of the adverse events (AEs) were of grade 1-2 and manageable. The common treatment-related adverse events of grade 3 or 4 included anemia (12.8%), neutropenia (12.8%), leukopenia (10.3%), hand-foot syndrome (7.7%), thrombocytopenia (7.7%). The potential immune-related adverse events (irAEs) were grade 1 pneumonia (1 pts [2.6%]) and grade 4 hepatitis (1 pts [2.6%]). There were no treatment-related deaths.
These results indicate that sintilimab combined with nab-paclitaxel exhibits good anti-tumor activity and an acceptable safety profile as a second-line treatment for advanced or metastatic gastric cancer. These results warrant further investigation and evaluation to identify patients who can benefit more from the combined treatment strategy.
无法切除的晚期或复发性胃癌患者预后较差。PD-1单药治疗方案和PD-1联合化疗方案分别已成为晚期胃癌的标准三线和一线治疗方案。然而，免疫检查点抑制剂在晚期胃癌二线治疗中的地位尚未确立。化疗与抗PD-1抗体联合已被证明具有协同作用。在本研究中，我们旨在评估信迪利单抗联合白蛋白结合型紫杉醇在晚期胃癌（GC）/胃食管交界（GEJ）癌患者二线治疗中的疗效和安全性。
我们回顾性分析了2019年4月1日至2021年12月31日期间接受信迪利单抗联合白蛋白结合型紫杉醇一线全身治疗后病情进展的晚期GC/GEJ癌患者。主要终点为无进展生存期（PFS）。次要终点包括客观缓解率（ORR）、疾病控制率（DCR）和安全性。
39例患者入组并符合疗效评估标准。未观察到完全缓解（CR），15例患者达到部分缓解（PR），16例患者病情稳定（SD），9例患者病情进展（PD）。ORR和DCR分别为15例（38.5%）和31例（79.5%）。中位PFS为5.4个月（95%CI：3.072 - 7.728）。分析了不同亚组之间的PFS。结果显示，性别、年龄、人表皮生长因子受体2（HER2）状态、PD-L1表达、原发肿瘤部位和化疗周期对PFS均无显著影响。大多数不良事件（AE）为1 - 2级且可控。3/4级常见的治疗相关不良事件包括贫血（12.8%）、中性粒细胞减少（12.8%）、白细胞减少（10.3%）、手足综合征（7.7%）、血小板减少（7.7%）。潜在的免疫相关不良事件（irAE）为1级肺炎（1例[2.6%]）和4级肝炎（1例[2.6%]）。无治疗相关死亡。
这些结果表明，信迪利单抗联合白蛋白结合型紫杉醇作为晚期或转移性胃癌的二线治疗方案具有良好的抗肿瘤活性和可接受的安全性。这些结果值得进一步研究和评估，以确定能从联合治疗策略中更多获益的患者。
