Real-world effectiveness and safety of first-line serplulimab in patients with metastatic or locally advanced esophageal carcinoma.

Abstract

e14609 Background: Serplulimab has demonstrated promising efficacy as a first-line treatment for esophageal squamous cell carcinoma (ESCC) with a combined positive score (CPS) ≥1 in clinical trials. However, real-world evidence regarding its effectiveness and safety in advanced esophageal cancer remains limited. This study aimed to evaluate the real-world outcomes of serplulimab-based therapy in patients with metastatic or locally advanced esophageal carcinoma (EC). Methods: This multicenter, retrospective study included patients diagnosed with metastatic or unresectable locally advanced EC who received first-line serplulimab-containing therapy between March 2022 and December 2023. Data were collected from medical records, including patient demographics, disease characteristics, treatment regimens, therapeutic response, and adverse events (AEs). Key endpoints included objective response rate (ORR), disease control rate (DCR), real-world progression-free survival (rwPFS), real-world overall survival (rwOS), and safety outcomes. Results: A total of 104 patients were included, with a mean age of 68 years (81 [77.9%] male). Histological subtypes comprised ESCC (80.8%), combined small cell and adenocarcinoma (9.6%), mixed neuroendocrine–non-neuroendocrine neoplasms (5.8%), and neuroendocrine neoplasm (3.8%). Of these, 97 patients (93.3%) received concurrent chemotherapy, 10 (9.6%) underwent targeted therapy, and 21 (20.2%) received radiotherapy. Among 90 evaluable patients, the ORR was 40.0% (95% CI: 29.8–50.9), while the DCR was 97.8% (95% CI: 92.2–99.7). After a median follow-up of 6.8 months (range: 0.6–25.4), the median rwPFS was 12.0 months (95% CI: 8.9–NE), and the median rwOS was not reached (95% CI: 13.3–NE). The estimated 12-month survival rate was 73.5% (95% CI: 60.4–89.3). Subgroup analysis revealed a significantly longer median PFS in patients aged ≥65 compared to those < 65 years (12.0 vs. 6.9 months, P = 0.022). Overall, 55.8% of patients (n = 58) experienced AEs, 18.3% (n = 19) reported treatment-related adverse events (TRAEs), and 1.9% (n = 2) experienced serious adverse events (SAEs), including hyperkalemia and leukopenia. Conclusions: This real-world study supports the efficacy of serplulimab as a first-line treatment for metastatic or locally advanced EC, encompassing a wide range of histological subtypes and diverse patient populations. The observed outcomes align with those from randomized controlled trials. The safety profile was consistent with previous findings, with no new safety concerns identified.