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

Weijia Jiang¹Wanren Peng²Dong Qian³Genhe Wang⁴Hong Qian⁵Wenxia Deng⁶Zishu Wang⁷Zhiyong Wei²Tai Ma²Dong Zhao⁸Yifu He⁹Chenghui Li¹⁰Gang Wang⁹Zhongxian Zheng¹¹Xinglai Guo¹²Shaojin Zhu¹³Liming Xia¹⁴Xiangde Jiang¹⁵Jie Wei¹⁶Xinzhong Li¹⁷Guoping Sun^18*

• ¹Department of Oncology, Anhui Medical University, Hefei, China
• ²Department of Oncology, the First Affiliated Hospital of Anhui Medical University, Hefei, China
• ³Department of Radiation Oncology, The First Affiliated Hospital of USTC, Anhui Provincial Hospital, Hefei, China
• ⁴Department of Oncology, Huangshan City People’s Hospital, Huangshan, China
• ⁵Department of Oncology, Anqing 116 Hospital, Anqing, China
• ⁶Department of Oncology, Tongling People’s Hospital, Tongling, China
• ⁷Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China
• ⁸Department of Oncology, Lixin County People’s Hospital, Bozhong, China
• ⁹Department of Medical Oncology, The First Affiliated Hospital of USTC, Anhui Provincial Hospital, Hefei, China
• ¹⁰Department of Oncology, Anqing Municipal Hospital, Anqing, China
• ¹¹Department of Oncology, The People’s Hospital of Chizhou, Chizhou, China
• ¹²Department of Oncology, Fuyang Tumor Hospital, Fuyang, China
• ¹³Department of Thoracic Surgery, Yijishan Hospital of Wannan Medical College, Wuhu, China
• ¹⁴Department of Oncology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China
• ¹⁵Department of Oncology, The People’s Hospital of Bozhou, Bozhou, China
• ¹⁶Department of Radiation Oncology, Chuzhou City First People's Hospital, Chuzhou, China
• ¹⁷Department of Oncology, Huaibei City People’s Hospital, Huaibei, China
• ¹⁸Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Department of Oncology, The First Affiliated Hospital of Anhui Medical University, China

Objective: 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. Methods: 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. Results: Objective response rate and disease control rate were 18.8% and 84.4%, respectively. Camrelizumab-based regimens achieved the median [95% confidence interval (CI)] 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, PFS 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). OS 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%). Conclusion: 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.