Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya.
Department of Gastroenterology, Saitama Cancer Center, Saitama.
ESMO Open. 2023 Dec;8(6):102071. doi: 10.1016/j.esmoop.2023.102071. Epub 2023 Nov 27.
Nivolumab therapy is a standard-of-care treatment for heavily pretreated patients with advanced gastric cancer (AGC). Previous studies have reported improvement in the objective response rate to chemotherapy after nivolumab therapy for other types of cancer. This study evaluated the efficacy and safety of chemotherapy after nivolumab therapy in AGC.
We conducted a prospective, multicenter, observational study in pretreated patients with nivolumab-refractory or -intolerant AGC. Patients received irinotecan, oxaliplatin-containing regimens, or trifluridine/tipiracil. The primary endpoint was overall survival.
A total of 199 patients were included (median age: 69 years; male: 70%; female: 30%). Median overall survival and progression-free survival were 7.5 months [95% confidence interval (CI): 6.7-9.7 months] and 2.9 months (95% CI: 2.2-3.5 months), respectively. Objective response and disease control rates were 16.8% (95% CI: 11.6% to 23.6%) and 18.9% (95% CI: 38.9% to 54.6%), respectively. A prognostic index using alkaline phosphatase and the Glasgow Prognostic Score was generated to classify patients into three risk groups (good, moderate, and poor). The hazard ratios of the moderate and poor groups to the good group were 1.88 (95% CI: 1.22-2.92) and 3.29 (95% CI: 1.92-5.63), respectively. At the initiation of chemotherapy, 42 patients had experienced immune-related adverse events due to prior nivolumab therapy. The most common grade 3-4 adverse events were neutropenia (7.5%), anemia (8.0%), and anorexia (7.5%).
The administration of cytotoxic chemotherapy after nivolumab therapy may give rise to a synergistic antitumor effect in AGC. Further investigation is warranted to confirm these findings.
纳武利尤单抗治疗是晚期胃癌（AGC）大量预处理患者的标准治疗方法。先前的研究报告称，纳武利尤单抗治疗其他类型的癌症后，化疗的客观缓解率有所提高。本研究评估了纳武利尤单抗治疗后在 AGC 中化疗的疗效和安全性。
我们在纳武利尤单抗难治或不耐受的 AGC 预处理患者中进行了一项前瞻性、多中心、观察性研究。患者接受伊立替康、含奥沙利铂的方案或三氟尿苷/替匹嘧啶。主要终点是总生存期。
共纳入 199 例患者（中位年龄：69 岁；男性：70%；女性：30%）。中位总生存期和无进展生存期分别为 7.5 个月[95%置信区间（CI）：6.7-9.7 个月]和 2.9 个月（95% CI：2.2-3.5 个月）。客观缓解率和疾病控制率分别为 16.8%（95% CI：11.6%-23.6%）和 18.9%（95% CI：38.9%-54.6%）。生成了一个使用碱性磷酸酶和格拉斯哥预后评分的预后指数，将患者分为三个风险组（良好、中度和差）。中度和差组与良好组的风险比分别为 1.88（95% CI：1.22-2.92）和 3.29（95% CI：1.92-5.63）。在开始化疗时，由于先前的纳武利尤单抗治疗，42 例患者发生了免疫相关不良事件。最常见的 3-4 级不良事件是中性粒细胞减少症（7.5%）、贫血（8.0%）和厌食症（7.5%）。
纳武利尤单抗治疗后给予细胞毒性化疗可能在 AGC 中产生协同抗肿瘤作用。需要进一步研究来证实这些发现。
