Zhenghua Wu

and 5 more

Introduction:Siltuximab is a monoclonal antibody approved by the US Food and Drug Administration for interleukin-6 (IL-6). Numerous preclinical and clinical studies have revealed the pathological role of the IL-6 pathway in inflammation, autoimmune diseases, and cancer. The drug was approved in 2014 for the treatment of multicentric Castleman’s disease (MCD) and currently has a wide range of applications in the treatment of hematologic diseases. However, no previous studies have evaluated the safety of this drug in the treatment of hematologic disorders, and therefore the present study primarily reassessed the hematologic safety of this drug. Method:PubMed, EMBASE, and ClinicalTrials.gov were searched per the Preferred Reporting Items for Systematic reviews and Meta-Analyses statements for safety assessment while real-world pharmacovigilance data were mined via OpenVigil. Result:In all, four RCTs with 589 pooled patients were included. The safety evaluation revealed that treatment with siltuximab was associated with a propensity for thrombocytopenia (odds ratio [OR]: 1.67; 95% confidence interval [CI]: 1.16-2.40; p < 0.01), while the incidences of anemia and neutropenia were not significant. Regarding the analysis of real-world pharmacovigilance databases, siltuximab use was associated with a significant proclivity for anemia, neutropenia, and thrombocytopenia. Conclusion: The findings indicate that siltuximab is associated with a relatively high risk of anemia, neutropenia, and thrombocytopenia. Both clinicians and patients should exercise caution regarding these potential adverse events and make wise decisions.

Li Wang

and 9 more

Purpose: Although the presence of Kirsten rat sarcoma virus (KRAS) mutations predicts of a lack of benefit from epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) therapy for none small cell cancer (NSCLC), it may be more sensitive to programmed combination therapy with cell death 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors + anti-angiogenesis. Recent treatment guidelines and clinical studies related to adenocarcinoma in NSCLC have indicated that in patients with inoperable stage IV lung adenocarcinoma, immune checkpoint inhibitors in combination with anti-angiogenic drugs may exert a synergistic effect and significantly improve the efficacy of near-term treatment, but quantification and long-term follow-up of specific clinical indicators are still lacking. No previous cases of long-term good results with camrelizumab combined with anti-angiogenic agents for KRAS-mutated NSCLC have been described. Methods: This manuscript reports a case where patients with advanced NSCLC with pleural effusion and KRAS mutations treated poorly with conventional chemotherapy had long-term (more than 18 months) benefit with immunotherapy combined with an anti-angiogenic inhibitor. In this case, pharmaceutical care of the patient was carried out through therapeutic drug adjustment, compliance, efficacy assessment, and safety evaluation to provide a reference for improving the efficacy and safety of drug therapy in clinical practice. Results: As of the last follow-up date (December 2023), overall survival was 27 months and the patient is currently in good general condition with no significant complaints of discomfort. Conclusion: ICLs in combination with antiangiogenic therapy may be a therapeutic option for patients with KRAS mutations in advanced non-small cell lung cancer with good persistence.

guorong Fan

and 7 more

Background Proton pump inhibitors (PPIs) are widely used to treat digestive system diseases. Previous studies have suggested conflicting results between PPIs treatment and digestive tract cancers (DTCs). We utilized the FDA Adverse Event Reporting System (FAERS) database to assess the effect of PPIs use on DTCs through data mining. Method This study examined the association between six PPI agents and DTCs by mining the FAERS database from January 2004 to September 2021 by using Open Vigil 2.1. The reporting odds ratio (ROR) with 95% confidence intervals (CIs) was used to detect statistically significant associations between PPIs and DTCs. High Level Terms (HLTs) and Preferred Terms (PTs) were defined by the Medical Dictionary for Regulatory Activities 24.0 (MedDRA24.0). Result A total of 2553 DTCs adverse event reports were screened, with positive signals obtained from gastric neoplasms malignant (GNM) (ROR: 1.09, 95% CI: 1.01-1.18) and bile duct neoplasms malignant (BDNM) (ROR: 1.80, 95% CI: 1.44-2.25). Esomeprazole showed the strongest signal (ROR: 1.85, 95% CI: 1.66-2.06) for GNM, while rabeprazole for BDNM (ROR: 2.94, 95% CI: 1.32-6.56), and female PPI users had a higher risk of BDNM (ROR: 2.44, 95% CI: 1.77-3.35). Among Subordinate PTs, adenocarcinoma gastric, and the combination of “bile duct cancer” and “cholangiocarcinoma” were highly associated with PPIs use. Conclusion By mining the FAERS database, we provided important clues for the association between PPIs use and DTCs risk.