Uboha Nataliya V, Basree Mustafa M, Eickhoff Jens C, Deming Dustin A, Matkowskyj Kristina, Maloney James, McCarthy Daniel, DeCamp Malcolm, LoConte Noelle, Emmerich Philip B, Kraus Sean, Patel Monica A, Kratz Jeremy D, Lubner Sam J, Hurst Newton, Bassetti Michael F
Division of Hematology, Medical Oncology and Palliative Care, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
Carbone Cancer Center, Madison, Wisconsin, USA.
J Surg Oncol. 2025 Jun;131(7):1293-1301. doi: 10.1002/jso.28070. Epub 2025 Jan 5.
Standard treatment of patients with stage II/III esophageal or gastroesophageal junction (E/GEJ) cancer involves neoadjuvant chemoradiation (nCRT), resection, and immunotherapy. Our trial evaluated the addition of perioperative avelumab to standard treatments.
Patients with resectable E/GEJ cancers received avelumab with nCRT and adjuvant avelumab after resection. Primary endpoints for phase I and II portions were safety and pathologic complete response (pCR) rate, respectively. Secondary endpoints included recurrence-free survival (RFS), surgical complication prevalence, and R0 resection rate.
Twenty-two patients enrolled in the study. Median follow-up during data cutoff was 23.9 months. There were no dose-limiting toxicities during the run-in phase. Nineteen patients (86.4%) underwent resection with R0 resection rate of 78.9% and with pCR rate of 26%. Most common treatment-related adverse events (TRAE) were cytopenias from chemoradiation. Aside from one grade ≥ 3 avelumab-related hypersensitivity, no grade ≥ 3 avelumab TRAEs were seen. Median RFS was not reached, and 1-year RFS and overall survival were 71% and 81%, respectively. The study was terminated before full planned accrual due to standard practice change based on the CheckMate 577 trial.
The addition of perioperative avelumab to nCRT was tolerable and demonstrated promising outcomes.
II/III期食管癌或食管胃交界（E/GEJ）癌患者的标准治疗包括新辅助放化疗（nCRT）、手术切除和免疫治疗。我们的试验评估了围手术期添加阿维鲁单抗至标准治疗中的效果。
可切除的E/GEJ癌患者在nCRT期间接受阿维鲁单抗治疗，并在切除术后接受辅助性阿维鲁单抗治疗。I期和II期部分的主要终点分别为安全性和病理完全缓解（pCR）率。次要终点包括无复发生存期（RFS）、手术并发症发生率和R0切除率。
22名患者入组本研究。数据截止时的中位随访时间为23.9个月。导入期未出现剂量限制性毒性。19名患者（86.4%）接受了手术切除，R0切除率为78.9%，pCR率为26%。最常见的治疗相关不良事件（TRAE）是放化疗引起的血细胞减少。除1例≥3级阿维鲁单抗相关超敏反应外，未观察到≥3级阿维鲁单抗TRAE。未达到中位RFS，1年RFS和总生存率分别为71%和81%。由于基于CheckMate 577试验的标准治疗方案改变，该研究在计划的全部入组前终止。
围手术期添加阿维鲁单抗至nCRT是可耐受的，并显示出有前景的结果。
