> Detailanzeige

Lorenzen, Sylvie; Götze, Thorsten Oliver; Thuss-Patience, Peter; Biebl, Matthias; Homann, Nils; Schenk, Michael; Lindig, Udo; Heuer, Vera; Kretzschmar, Albrecht; Goekkurt, Eray; Haag, Georg Martin; Riera-Knorrenschild, Jorge; Bolling, Claus; Hofheinz, Ralf-Dieter; Zhan, Tianzuo; Angermeier, Stefan; Ettrich, Thomas Jens; Siebenhuener, Alexander Reinhard; Elshafei, Moustafa; Bechstein, Wolf Otto; Gaiser, Timo; Loose, Maria; Sookthai, Disorn; Kopp, Christina; [...]

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

Literatur-
verwaltung

Zur
Merkliste

Lösche von
Merkliste

Per Whatsapp teilen

Schließen

Merkliste



Sie können Bookmarks mittels Listen verwalten, loggen Sie sich dafür bitte in Ihr SLUB Benutzerkonto ein.
  • Medientyp: E-Artikel
  • Titel: 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
  • Beteiligte: Lorenzen, Sylvie; Götze, Thorsten Oliver; Thuss-Patience, Peter; Biebl, Matthias; Homann, Nils; Schenk, Michael; Lindig, Udo; Heuer, Vera; Kretzschmar, Albrecht; Goekkurt, Eray; Haag, Georg Martin; Riera-Knorrenschild, Jorge; Bolling, Claus; Hofheinz, Ralf-Dieter; Zhan, Tianzuo; Angermeier, Stefan; Ettrich, Thomas Jens; Siebenhuener, Alexander Reinhard; Elshafei, Moustafa; Bechstein, Wolf Otto; Gaiser, Timo; Loose, Maria; Sookthai, Disorn; Kopp, Christina; [...]
  • Erschienen: American Society of Clinical Oncology (ASCO), 2024
  • Erschienen in: Journal of Clinical Oncology
  • Sprache: Englisch
  • DOI: 10.1200/jco.23.00975
  • ISSN: 0732-183X; 1527-7755
  • Schlagwörter: Cancer Research ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>PURPOSE</jats:title><jats:p> 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). </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> 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). </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> 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%) and MSI (A, 63%; B, 27%) subpopulations. Complete margin-free (R0) resection rates were relatively high in both arms (A, 96%; B, 95%). The incidence and severity of adverse events were similar in both groups. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Within the limitations of the exploratory nature of the data, the addition of ATZ to perioperative FLOT is safe and improved postoperative stage and histopathologic regression. </jats:p></jats:sec>