The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University and Clinical Cancer Institute of Nanjing University, Nanjing, China.
The Department of Pathology of Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.
Cancer Med. 2023 Apr;12(8):9517-9526. doi: 10.1002/cam4.5722. Epub 2023 Mar 13.
Previous clinical trials indicated the addition of anti-PD-1 antibody remarkably improved the efficacy of trastuzumab and chemotherapy in patients with HER2-positive gastric/gastroesophageal junction (GEJ) cancer. However, no real-world experiences have been reported yet.
We retrospectively analyzed 1212 patients with gastric/GEJ cancer treated at Nanjing Drum Tower Hospital between 2019 and 2022. Among 138 patients with HER2-positive gastric/GEJ cancer, 47 patients receiving at least two doses of the combination regimen with anti-PD-1 antibody, trastuzumab, and chemotherapy were recruited in the study population, and 38 out of 47 patients with measurable disease were included in the efficacy population. Progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and toxicity profiles were reported.
In the study population, 37 (78.7%) received the study therapy as a first-line treatment. In the efficacy population, the ORR and DCR were 76.3% and 94.7%, respectively. The overall median PFS was 9.1 months (95% confidence interval [CI] 6.3-11.9 months). For the first-line treatment, the mPFS was 10 months, and 7 months for the second-line. Among 14 patients who failed the study treatment, three (21.4%) developed brain metastasis as the first failure site. No significant association was found between PFS and the expression of PD-L1. 22.2% of patients developed grade 3 treatment-related adverse events (TRAEs). No treatment-related grade ≥4 adverse events or deaths occurred.
This real-world study validated the combination regimen's high efficacy and good tolerance in patients with HER2-positive gastric/GEJ cancer. An increased incidence of brain metastasis was observed in patients who failed this regimen.
先前的临床试验表明，抗 PD-1 抗体的加入显著提高了曲妥珠单抗和化疗在 HER2 阳性胃/胃食管交界处（GEJ）癌患者中的疗效。然而，目前尚未有真实世界的数据报道。
我们回顾性分析了 2019 年至 2022 年在南京鼓楼医院接受治疗的 1212 例胃癌/GEJ 患者。在 138 例 HER2 阳性胃癌/GEJ 患者中，纳入了 47 例至少接受两剂抗 PD-1 抗体、曲妥珠单抗和化疗联合方案治疗的患者，其中 38 例可测量疾病患者纳入疗效人群。报告了无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）和毒性谱。
在研究人群中，37 例（78.7%）患者将研究治疗作为一线治疗。在疗效人群中，ORR 和 DCR 分别为 76.3%和 94.7%。总体中位 PFS 为 9.1 个月（95%置信区间 [CI] 6.3-11.9 个月）。对于一线治疗，mPFS 为 10 个月，二线治疗为 7 个月。在 14 例未能接受研究治疗的患者中，有 3 例（21.4%）以脑转移为首次失败部位。未发现 PFS 与 PD-L1 表达之间存在显著相关性。22.2%的患者发生 3 级治疗相关不良事件（TRAEs）。未发生与治疗相关的≥4 级不良事件或死亡。
这项真实世界的研究验证了该联合方案在 HER2 阳性胃/GEJ 癌患者中的高疗效和良好耐受性。在该方案失败的患者中观察到脑转移的发生率增加。
