Journal Article

The real-world efficacy and safety of nivolumab plus chemotherapy in patients with HER2-negative advanced gastric cancer

Liu, Ting-Ting, Liu, Yu-Yin, Chen, Yen-Hao, Liu, Yueh-Wei, Yeh, Cheng-Hsi, Lin, Yu-Cheng, Lin, Yu-Hung, Tsai, Ming-Yen

2024

Overview

Background The aim of this study is to investigate the real-world efficacy and safety of nivolumab in combination with chemotherapy for patients with advanced human epidermal growth factor receptor 2 (HER2)-negative gastric cancer (GC). Methods We enrolled patients diagnosed with unresectable advanced or metastatic GC who received nivolumab plus chemotherapy as first-line systemic treatment. The combined positive score (CPS), indicating the number of programmed cell death-ligand 1 (PD-L1)-stained cells, was utilized. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan–Meier method. Adverse events (AEs) were graded, and treatment was ceased upon disease progression or intolerance. Results A total of 27 patients were included in the study, comprising 15 patients with CPS ≥ 5 and 12 patients with CPS < 5. The objective response rate (ORR) was 55.6%, with a disease control rate (DCR) of 74.1%. Patients in the CPS ≥ 5 group exhibited higher ORR and DCR compared to those in the CPS < 5 group. Median PFS and OS were 6.1 months and 14.6 months, respectively; patients with CPS ≥ 5 showed a trend towards better PFS and OS than those with CPS < 5. Most AEs were grade 1–2, with a few instances of grade 3–4 toxicities reported, including neutropenia, thrombocytopenia, diarrhea, and anemia. There were no grade 5 AEs reported in our cohort. Furthermore, 64.7% of patients received subsequent anticancer treatment following disease progression on nivolumab plus chemotherapy. Conclusions The results of our study demonstrate the efficacy and safety of nivolumab plus chemotherapy in real-world practice support its adoption as a new standard first-line treatment for patients with advanced HER2-negative GC, particularly those with CPS ≥ 5.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Aged / Antineoplastic Combined Chemotherapy Protocols - adverse effects / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Apoptosis / Biomedical and Life Sciences / Biomedicine / Breast cancer / Cancer Research / Cancer therapies / Cell death / Cell survival / Chemotherapy / Chemotherapy, Combination / Diagnosis / Diarrhea / Disease / Disease control / Dosage and administration / Drug therapy / ErbB-2 protein / Esophagus / Female / Gastric cancer / Health Promotion and Disease Prevention / Humans / Immune system / Immunotherapy / Male / Medicine/Public Health / Metastases / Metastasis / Middle Aged / Monoclonal antibodies / Neutropenia / Nivolumab / Nivolumab - administration & dosage / Nivolumab - adverse effects / Nivolumab - therapeutic use / Oncology / Patient outcomes / Patients / PD-L1 protein / Progression-Free Survival / Receptor, ErbB-2 - metabolism / Retrospective Studies / Review boards / Stomach Neoplasms - drug therapy / Stomach Neoplasms - mortality / Stomach Neoplasms - pathology / Surgical Oncology / Targeted cancer therapy / Testing / Thrombocytopenia / Treatment Outcome