Efficacy and safety analysis of first-line tirelizumab combined with paclitaxel-containing chemotherapy regimen in 30 cases of real-world advanced gastric cancer in China.

e14643 Background: According to the latest global cancer statistics, gastric cancer is the 6th most common tumor with the highest incidence rate and the 5th highest mortality rate in the world. The primary treatment for advanced gastric cancer is still based on chemotherapy, and the median overall survival (OS) of patients treated with conventional chemotherapy is only 12 months. Recently, the rapid rise of immunotherapy has also brought new hope to gastric cancer patients. Many trials related to chemotherapy combined with immunotherapy for advanced gastric cancer are currently underway, which has been a hot research topic in recent years and has had auspicious positive results, such as the KEYNOTE-059 and CHECKMATE649 study. To reduce the burden of disease, the accessibility of innovative drugs has been significantly improved, providing more new clinical treatment ideas and options for Chinese patients with advanced gastric cancer. Methods: The study enrolled advanced gastric cancer (HER-2 negative) was treated with immune combination paclitaxel for first-line treatment, as follows: receiving intravenous albumin-conjugated paclitaxel (260 mg/m 2 ) every 3 weeks; in combination with Tirelizumab (200 mg every three weeks), and after 4-6 cycles of treatment, Tirelizumab was maintained until disease progression or intolerance. The primary study endpoints were progression-free survival (PFS) and overall survival (OS), and the secondary endpoints were objective remission rate (ORR) and safety. Results: From July 2020 to August 2023, 30 patients received first-line immunization and paclitaxel-containing chemotherapy regimens at our center. The objective remission rate (ORR) was 40.9%, and the disease control rate (DCR) was 77.3%. The incidence of treatment-related grade 1-2 adverse reactions was: vomiting in 5 cases (16.7%), loss of appetite in 22 cases (73.3%), diarrhea in 10 cases (33.3%), transaminase elevation in 5 cases (16.7%), numbness of the hands and feet in 25 cases (83.3%), leukopenia in 7 cases (23.3%), and hemoglobin reduction in 16 cases (53.3%). hyperbilirubinemia in 2 cases (6.7%). Grade 3-4 adverse events and their incidence were: vomiting in 4 cases (13.3%), loss of appetite in 4 cases (13.3%), diarrhea in 1 case (3.3%), transaminase elevation in 2 cases (6.7%), leukopenia in 3 cases (10.0%), and hemoglobin reduction in 2 cases (6.7%). There were 3 cases of immunosuppressant-related adverse reactions (1 case of immunosuppressant-associated thyroiditis, 1 case of immunosuppressant-associated acute myocardial infarction, Conclusions: The first-line treatment of advanced gastric cancer with immune checkpoint inhibitors combined with paclitaxel-containing chemotherapy has a high rate of disease control, prolongs overall survival, has more clinical adverse reactions, is favored by grade 1-2 adverse reactions, and has a high degree of safety, and provides a new clinical idea for the first-line treatment of patients with advanced gastric cancer. Clinical trial information: KY2022-189-02.