LAUSR

OBJECTIVE 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. BACKGROUND 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. METHODS 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). RESULTS 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. CONCLUSIONS 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.