Efficacy and safety of camrelizumab-based regimens in advanced squamous cell carcinoma patients: a prospective...

Camrelizumab-based regimens show promising efficacy in esophageal cancer patients, according to previous pivotal trials. Given the strict eligibility criteria in pivotal trials, real-world studies are essential to evaluate the efficacy and safety of camrelizumab-based regimens in a broader patient population under routine clinical practice. Therefore, this study aimed to explore the efficacy and safety of camrelizumab-based regimens for the treatment of advanced esophageal cancer patients in real world settings.

A total of 192 advanced esophageal cancer patients receiving camrelizumab-based regimens were included in this study. The specific camrelizumab-based regimens were decided by the investigators according to the patients' physical condition. For efficacy assessment, treatment response and survival were assessed. For safety assessment, adverse events were collected. The median (range) follow-up duration was 7.2 (0.7-58.8) months.

Objective response rate and disease control rate were 18.8% and 84.4%, respectively. Camrelizumab-based regimens achieved the median [95% confidence interval progression-free survival (PFS) and overall survival (OS) of 6.8 (5.4-8.2) and 17.4 (12.8-21.9) months, respectively. Compared to patients receiving camrelizumab monotherapy, progression-free survival was prolonged in patients receiving camrelizumab combination therapy (P = 0.007), especially in patients receiving camrelizumab plus chemotherapy (P = 0.017), camrelizumab plus apatinib (P = 0.041), and camrelizumab plus chemotherapy and apatinib (P = 0.014). overall survival was not different between patients with camrelizumab combination therapy and camrelizumab monotherapy (all P > 0.05). Multivariable Cox regression analysis suggested that camrelizumab plus apatinib (vs. camrelizumab monotherapy) was independently associated with prolonged PFS (hazard ratio = 0.493, P = 0.049). The incidence of total adverse events was 71.4%. Most adverse events were grade 1-2 (64.0%). Common adverse events included fatigue (20.8%), anorexia (19.3%), and leukopenia (15.6%).

Camrelizumab shows satisfactory efficacy and safety in advanced esophageal cancer patients, and the camrelizumab combination regimens seem to bring prolonged PFS than its monotherapy. The real-world design reflects routine clinical practice, supporting the generalizability of these findings. However, potential confounders may exist and the broad range of follow-up durations may contribute to variability in survival data. Therefore, our results should be interpreted cautiously.