Effectiveness and safety of camrelizumab in advanced esophageal cancer: A prospective multicenter observational cohort studies (ESCORT-RWS)

4049 Background: Camrelizumab, an anti-programmed death 1 (PD-1) monoclonal antibody, has demonstrated survival benefits in patients with advanced or metastatic esophageal squamous cell carcinoma. However, the real-world effectiveness and safety of camrelizumab in patients with advanced esophageal cancer are largely unknown. Methods: In this prospective multicenter observational cohort study (NCT04616040), patients with advanced esophageal cancer who were scheduled to receive camrelizumab at the discretion of the physicians in charge were screened for inclusion. Clinical outcomes were treatment emergent adverse events (TEAEs), objective response rate (ORR), disease control rate (DCR), time to treatment discontinuation (TTD), progression free survival (PFS), and overall survival (OS). Results: Between Dec. 24, 2020 and Dec. 30, 2022, data were available for 624 patients (median age: 64.5 years; 74 [11.9%] aged ≥75 years; 515 [82.5%] men; 20 [3.2%] ECOG PS ≥2; 602 [96.5%] esophageal squamous cell carcinoma) from 42 institutions in China. All patients received at least one dose of camrelizumab-containing therapy, including 305 (48.9%) in the first-line, 238 (38.1%) in the second-line, and 81 (13.0%) in the third or later line settings. Most patients were treated with camrelizumab plus chemotherapy (487 [78.0%], primarily taxane and platinum-based chemotherapy in 284 [45.5%] patients), followed by camrelizumab plus antiangiogenic therapy (64 [10.3%]), camrelizumab monotherapy (46 [7.4%]), and camrelizumab plus antiangiogenic therapy and chemotherapy (27 [4.3%]). TEAEs occurred in 541 (86.7%) patients, most commonly anemia (41.2%), decreased white blood cell (38.5%), and decreased neutrophil count (28.5%). No new safety signals were noted. At the data cutoff (Dec. 30, 2022), 152 (24.4%) patients were still on treatment. The median follow-up estimated by the reverse Kaplan-Meier method and effectiveness outcomes are summarized in the Table. Conclusions: The real-world effectiveness and safety profiles of camrelizumab in advanced esophageal cancer patients are generally consistent with those observed in pivotal clinical trials. [Table: see text]