为了确定在局部晚期食管腺癌中将抗PD-1抗体杜瓦卢单抗添加至诱导FOLFOX和术前化疗的安全性和有效性。诱导FOLFOX后进行PET引导化学放疗已经显示出对食管腺癌的生存率提高。目前，在早期和晚期疾病中添加免疫检查点抑制剂有明显的益处。鉴于这些结果，我们调查了将杜瓦卢单抗添加至诱导FOLFOX和术前化疗的安全性和有效性。患有局部晚期可切除的食管/ GEJ腺癌的患者在食管切除术前接受PET引导化学放疗并接受杜瓦卢单抗治疗。拥有R0切除的患者接受每4周1,500毫克的杜瓦卢单抗治疗进行辅助疗程，共6次。该研究的主要终点是病理完全缓解（pCR）。我们招募了36名患者，其中33名完成了所有术前治疗并接受了手术。术前治疗耐受性良好，没有手术延迟或出现新的安全信号。pCR在8名患者中被确定出来（22％【单侧90％下限：13.3％】），有22名患者的mPR（61％【单侧90％下限：50％】）。12和24个月的总生存率分别为92％和85％。在手术前将杜瓦卢单抗添加到诱导FOLFOX和PET引导化学放疗中是安全的，并具有高的病理反应率以及鼓舞人心的生存数据。版权所有©2023 Wolters Kluwer Health，Inc. 保留所有权利。

To determine the safety and efficacy of adding the anti-PD-1 antibody durvalumab to induction FOLFOX and preoperative chemotherapy in locally advanced esophageal adenocarcinoma.Neoadjuvant induction FOLFOX followed by PET directed chemoradiation has demonstrated improved survival for esophageal adenocarcinoma. There is clear benefit now for the addition of immune checkpoint inhibitors both in early and advanced stage disease. Given these results we investigated the safety and efficacy of adding durvalumab to induction FOLFOX and preoperative chemoradiotherapy.Patients with locally advanced resectable esophageal/GEJ adenocarcinoma received PET directed chemoradiation with durvalumab prior to esophagectomy. Patients who had R0 resections received adjuvant durvalumab 1,500 mg every 4 weeks for 6 treatments. The primary endpoint of the study was pathologic complete response (pCR).We enrolled 36 patients, 33 of whom completed all preoperative treatment and underwent surgery. Preoperative treatment was well tolerated, with no delays to surgery nor new safety signals. pCR was identified in 8 (22% [one-sided 90% lower bound: 13.3%]) patients with mPR in 22 (61% [one sided 90% lower bound: 50%]) patients. Twelve and 24-month OS was 92% and 85% respectively.The addition of durvalumab to induction FOLFOX and PET directed CRT prior to surgery is safe, with a high rate of pathologic response, as well as encouraging survival data.Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.