P5057 - Efficacy and Safety of Sintilimab in Patients With Gastric or Gastroesophageal Junction Cancer: A Systematic Review and Meta-Analysis

Faryal Altaf, MD¹, Eeshal Fatima, MBBS², Mikail Khanzada, MBBS³, Adnan Safi, MBBS⁴, Zaheer Qureshi, MD^5
1BronxCare Health System, Bronx, NY; ²Services Institute of Medical Sciences, Lahore, Punjab, Pakistan; ³Lahore Medical and Dental College, Lahore, Punjab, Pakistan; ⁴Lahore General Hospital, Lahore, Punjab, Pakistan; ⁵The Frank H. Netter M.D. School of Medicine at Quinnipiac University, Bronx, NY

Introduction: Gastric cancer is the 5th most common cancer worldwide. The majority of patients are diagnosed at advanced stages when relying just on surgery may not be adequate because, despite surgical resection, the prognosis remains poor, and most patients relapse after surgery. Immune checkpoint inhibitors such as anti-programmed cell death protein-1/programmed death-ligand 1 (PD-1/PD-L1) antibodies are primarily approved for the treatment of inoperable or metastatic solid cancers. Sintilimab is a highly selective monoclonal anti-PD-1/PD-L1 antibody with a robust anti-tumor response. The primary aim of this study is to assess the efficacy and safety of sintilimab in gastric or gastro-esophageal junction cancer.

Methods: A thorough search was conducted on PubMed, Scopus, and Google Scholar from inception till May 2024. OpenMeta[Analyst] was used to perform statistical analysis. The pooled disease control rate, objective response rate, stable disease rate, and partial disease rate with 95% confidence interval (CI) were assessed using the random-effects model. Heterogeneity was evaluated using the Higgins I² index. In all cases, p-value < 0.05 was indicative of significant results. This review has been registered with PROSPERO (CRD42024521560).

Results: A total of 16 studies, consisting of 932 patients who received sintilimab therapy, were included in our study. The majority of the patients (649) were male. The mean age of the participants ranged from 21 to 86 years. The pooled proportion revealed a disease control rate of 73% (95% CI = 66.2% - 79.3%; p-value < 0.001), an objective response rate of 40% (95% CI = 24.3% - 57.2%; p-value < 0.001), and a stable disease rate of 34.6% (95% CI = 22.8% - 47.4%; p-value < 0.001), and a partial disease rate of 31.6% (95% CI = 18.1% - 45.1%; p-value < 0.001). However, high heterogeneity was observed. Commonly reported adverse events included anemia, neutropenia, vomiting, and an increase in the levels of liver enzymes, but none of these adverse events showed a significant association with sintilimab therapy.

Discussion: Sintilimab shows promising efficacy and a well-tolerated safety profile. Our results suggest its potential as an innovative therapeutic option for individuals with gastric or gastro-esophageal junction cancer; however, significant heterogeneity was observed in some results, making it difficult to come to a solid conclusion. Therefore, large-scale randomized trials are required to confirm our findings.


Disclosures:


Faryal Altaf, MD¹, Eeshal Fatima, MBBS², Mikail Khanzada, MBBS³, Adnan Safi, MBBS⁴, Zaheer Qureshi, MD⁵. P5057 - Efficacy and Safety of Sintilimab in Patients With Gastric or Gastroesophageal Junction Cancer: A Systematic Review and Meta-Analysis, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.