Efficacy and safety of disitamab vedotin in treatment of advanced gastric cancer based on real-world

Objective To evaluate the efficacy and safety of disitamab vedotin (RC48) in the treatment of advanced gastric cancer in real-world. Methods A retrospective analysis was conducted on clinical data of patients with human epidermal growth factor receptor 2 (HER2)-expressing advanced gastric cancer who were treated with disitamab vedotin at our institution between October 2021 and October 2024. Clinical efficacy and adverse events were assessed. Factors influencing the efficacy of disitamab vedotin were evaluated using the Log-rank test for intergroup analysis. Results A total of 58 patients with HER2-expressing advanced gastric cancer who received RC48 treatment were included in this study. The objective response rate (ORR) was 10.3%, and the disease control rate (DCR) was 63.8%. The median progression-free survival (mPFS) for all patients was 4.2 months (95% CI = 3.002-5.398), with a 1-year progression-free survival rate of 13.0%. Subgroup analysis revealed that DCR was significantly higher in patients receiving RC48 as third-line therapy compared to those receiving it as later-line therapy (75.0% vs . 50.0%, P = 0.049). The DCR was also significantly higher in patients who experienced adverse drug reactions (ADRs) than in those who did not (76.7% vs . 50.0%, P = 0.035). Male patients had a significantly longer mPFS than female patients (4.9 months vs. 2.6 months, Log-rank P = 0.006). Common RC48-related ADRs included neutropenia, hemoglobin reduction, and liver impairment. The incidence of grade III or higher ADRs was 17.2% (10/58). Univariate analysis indicated that the presence of underlying diseases and the line of RC48 therapy were significantly associated with the occurrence of ADRs. Conclusions In the real-world setting, RC48 shows some clinical efficacy and a manageable safety profile in patients with HER2-expressing advanced gastric cancer. These findings provide useful information for clinical practice.