Nivolumab plus chemotherapy in metastatic gastric cancer with low combined positive score

초록

Background: A combination of immune checkpoint inhibitors and chemotherapy has emerged as standard therapy in advanced human epidermal growth factor receptor 2-negative advanced gastric cancer (AGC). However, the clinical benefit in patients with a low combined positive score (CPS) of 1–4 remains controversial. Objectives: To evaluate the efficacy and safety of nivolumab plus chemotherapy in AGC patients with low CPS (1–4) in a real-world clinical setting. Design: A retrospective single-center study conducted at Samsung Medical Center. Methods: We analyzed outcomes in AGC patients with CPS 1–4 who received nivolumab in combination with capecitabine and oxaliplatin (XELOX) or fluorouracil, oxaliplatin, and leucovorin (FOLFOX) as first-line therapy between April 2021 and December 2024. Tumor response was assessed using Response Evaluation Criteria in Solid Tumor version 1.1. Progression-free survival (PFS) and overall survival (OS) were estimated using Kaplan–Meier methods. Results: Of 336 patients receiving first-line nivolumab plus XELOX or FOLFOX, 63 had a CPS of 1–4. Median age was 61 years, and the most common CPS was 1, found in 26 patients (41%). One patient achieved a complete response (2%), and 25 patients achieved partial response (40%), for an overall response rate of 42%. Stable disease was observed in 23 patients, a disease control rate of 76%. Median PFS was 5.8 months (95% confidence interval (CI), 4.9–6.7), and median OS was 15.0 months (95% CI, 13.2–18.7). Any-grade adverse events were reported in 92% of patients, while grade 3 or 4 treatment-related adverse events occurred in 61% of patients, most commonly anemia and neutropenia. Conclusion: This real-world retrospective study suggests modest efficacy of AGC patients with low CPS treated with nivolumab with chemotherapy. Further studies are needed to determine the optimal treatment strategy and to identify predictive biomarkers for therapy selection in patients with low-CPS AGC. © The Author(s), 2025. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).

키워드