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

person Zhihao Lu Peking University Cancer Hospital, Beijing, China info_outline Zhihao Lu, Jun Zhao, Zhe Yang, Na Li, Junsheng Wang, Shuanghu Yuan, Yusheng Wang, Suyi Li, Fengming Ran, Yinghua Ji, Yanqiao Zhang, Chen Wang, Lixin Wan, Ming Wang, Liang Liang, Xiaofang Dai, Guanghui Cheng, Wei Li, Peng Zhen, Lin Shen

Authors person Zhihao Lu Peking University Cancer Hospital, Beijing, China info_outline Zhihao Lu, Jun Zhao, Zhe Yang, Na Li, Junsheng Wang, Shuanghu Yuan, Yusheng Wang, Suyi Li, Fengming Ran, Yinghua Ji, Yanqiao Zhang, Chen Wang, Lixin Wan, Ming Wang, Liang Liang, Xiaofang Dai, Guanghui Cheng, Wei Li, Peng Zhen, Lin Shen Organizations Peking University Cancer Hospital, Beijing, China, Changzhi People's Hospital Affiliated to Changzhi Medical College, Changzhi, China, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China, The First Affiliated Hospital of Shihezi University School of Medicine, Xinjiang, China, Anyang Tumor Hospital, Anyang, China, Shandong Cancer Hospital and Institute, Jinan, China, Affiliated Cancer Hospital of Shanxi Medical University, Taiyuan, China, Anhui Provincial Cancer Hospital, Hefei, China, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China, Harbin Medical University Cancer Hospital, Harbin, China, Ganzhou People's Hospital, Ganzhou, China, Nanyang Central Hospital, Nanyang, China, Cangzhou Central Hospital, Cangzhou, China, Sichuan Province Hospital, Chengdu, China, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, China-Japan Union Hospital of Jilin University, Changchun, China, The First Hospital of Jilin University, Changchun, China, Chifeng Cancer Hospital, Chifeng, China Abstract Disclosures Research Funding No funding received None. 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. ESCORT-RWS 1 st line 2 nd line ≥3 rd line Median follow-up (95% CI), months 7.0 (6.2, 8.5) 10.6 (9.3, 12.1) 9.1 (7.0, 12.8) ORR (95% CI) 54.2 (47.5, 60.8) 31.4 (24.6, 38.9) 28.1 (17.0, 41.5) DCR (95% CI) 96.0 (92.6, 98.2) 80.0 (73.3, 85.7) 68.4 (54.8, 80.1) Median TTD (95% CI), months 6.0 (5.1, 7.1) 5.9 (5.1, 6.6) 5.1 (3.4, 6.7) Median PFS (95% CI), months 10.1 (7.4, 15.5) 7.9 (5.3, 9.1) 7.9 (5.2, 11.1) Median OS (95% CI), months 17.5 (13.3, NR) 14.0 (10.0, 16.7) 12.9 (7.9, 20.3)

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