Phase Ib/Ii Trial Of Durvalumab And Chemoradiation (Crt) With Carboplatin/Paclitaxel For Esophageal And Gastroesophageal Junction (Gej) Adenocarcinoma.

JOURNAL OF CLINICAL ONCOLOGY(2018)

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172Background: Pre-op CRT with carboplatin (C)/paclitaxel (P) and radiation (RT) for locally advanced esophageal cancer is a standard of care, based on the CROSS trial (NEJM 2012;366:2074). However, outcomes remain poor. Early data suggest activity of durvalumab (D) in GEJ/gastric cancer [Ann Oncol 25:iv361-372; 2014]. In a pilot study, we assessed safety of D + C/P + RT as pre-op therapy. Methods: Patients (Pts) had TanyN+ or T3-4NanyM0 esophageal and Siewert Type I/II GEJ adenocarcinoma staged by EUS, PET/CT and CT. Pts received D 1500mg x 1 dose and 4 weeks later C AUC2 and P 50mg/m2 weekly x 5 with RT (1.8Gy daily fractions to 50.4Gy). Pts also received D 1,500mg at first dose of C/P and RT. PET/CT was repeated 21-27 days post D and 4-6 weeks post CRT. Esophagectomy was planned 6-8 weeks after CRT. Pts who had R0 resections received adjuvant D 1,500mg 4 weekly x 6 doses. Initially, 6 patients were treated and followed for 30 days after surgery to assess for unacceptable toxicities. Results: 6 pts were...
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