Perioperative Atezolizumab Plus Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel for Resectable Esophagogastric Cancer: Interim Results From the Randomized, Multicenter, Phase II/III DANTE/IKF-s633 Trial

作者：Sylvie Lorenzen, Thorsten Oliver Götze, Peter C Thuss-Patience, Matthias Biebl, Nils Homann, Michael Schenk, Udo Lindig, Vera Heuer, Albrecht Kretzschmar, Eray Goekkurt, Georg Martin Haag, Jorge Riera‐Knorrenschild, Claus Bolling, Ralf‐Dieter Hofheinz, Tianzuo Zhan, Stefan Angermeier, Thomas Jens Ettrich, Alexander Siebenhüner, Moustafa Elshafei, Wolf O. Bechstein, Timo Gaiser, Maria Loose, Disorn Sookthai, Christina Kopp, Claudia Pauligk, Salah‐Eddin Al‐Batran, for the AIO and SAKK Study Working Groups · 发表于：Journal of Clinical Oncology · 年份：2023 · DOI：10.1200/jco.23.00975 · 被引用次数：224 · 研究领域：Esophageal Cancer Research and Treatment、Gastric Cancer Management and Outcomes、Cancer Immunotherapy and Biomarkers

PURPOSE This trial evaluates the addition of the PD-L1 antibody atezolizumab (ATZ) to standard-of-care fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) as a perioperative treatment for patients with resectable esophagogastric adenocarcinoma (EGA). METHODS DANTE started as multicenter, randomized phase II trial, which was subsequently converted to a phase III trial. Here, we present the results of the phase II proportion, focusing on surgical pathology and safety outcomes on an exploratory basis. Patients with resectable EGA (≥cT2 or cN+) were assigned to either four preoperative and postoperative cycles of FLOT combined with ATZ, followed by eight cycles of ATZ maintenance (arm A) or FLOT alone (arm B). RESULTS Two hundred ninety-five patients were randomly assigned (A, 146; B, 149) with balanced baseline characteristics between arms. Twenty-three patients (8%) had tumors with microsatellite instability (MSI), and 58% patients had tumors with a PD-L1 combined positive score (CPS) of ≥1. Surgical morbidity (A, 45%; B, 42%) and 60-day mortality (A, 3%; B, 2%) were comparable between arms. Downstaging favored arm A versus arm B (ypT0, 23% v 15% [one-sided P = .044]; ypT0-T2, 61% v 48% [one-sided P = .015]; ypN0, 68% v 54% [one-sided P = .012]). Histopathologic complete regression rates (pathologic complete response or TRG1a) were higher after FLOT plus ATZ (A, 24%; B, 15%; one-sided P = .032), and the difference was more pronounced in the PD-L1 CPS ≥10 (A, 33%; B, 12%...