• Darren Cowzer, Abraham Jing-Ching Wu, Smita Sihag, Henry S Walch, Bernard J Park, David R Jones, Ping Gu, Steven B Maron, Ryan Sugarman, Sree Bhavani Chalasani, Marina Shcherba, Marinela Capanu, Joanne F Chou, Jennie K Choe, Anton Nosov, Prasad S Adusumilli, Randy Yeh, Laura H Tang, David H Ilson, Yelena Y Janjigian, Daniela Molena, and Geoffrey Y Ku.
• Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
• Ann. Surg. 2023 Sep 1; 278 (3): e511e518e511-e518.

ObjectiveTo determine the safety and efficacy of adding the anti-PD-L1 antibody durvalumab to induction FOLFOX and preoperative chemotherapy in locally advanced esophageal adenocarcinoma.BackgroundNeoadjuvant induction FOLFOX followed by positron emission tomography (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.MethodsPatients with locally advanced resectable esophageal/gastroesophageal junction adenocarcinoma received PET-directed chemoradiation with durvalumab before esophagectomy. Patients who had R0 resections received adjuvant durvalumab 1500 mg every 4 weeks for 6 treatments. The primary endpoint of the study was pathologic complete response.ResultsWe 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. Pathologic complete response was identified in 8 [22% (1-sided 90% lower bound: 13.3%)] patients with major pathologic response in 22 [61% (1-sided 90% lower bound: 50%)] patients. Twelve and 24-month overall survival was 92% and 85%, respectively.ConclusionsThe addition of durvalumab to induction FOLFOX and PET-directed chemoradiotherapy before 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.

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