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SHR Neuro Krebs Kardio Lipid Stoffw Microb

Hoeppner, J; Brunner, T; Schmoor, C; Bronsert, P; Kulemann, B; Claus, R; Utzolino, S; Izbicki, JR; Gockel, I; Gerdes, B; Ghadimi, M; Reichert, B; Lock, JF; Bruns, C; Reitsamer, E; Schmeding, M; Benedix, F; Keck, T; Folprecht, G; Thuss-Patience, P; Neumann, UP; Pascher, A; Imhof, D; Daum, S; Strieder, T; Krautz, C; Zimmermann, S; Werner, J; Mahlberg, R; Illerhaus, G; Grimminger, P; Lordick, F.
Perioperative Chemotherapy or Preoperative Chemoradiotherapy in Esophageal Cancer.
N Engl J Med. 2025; 392(4):323-335 Doi: 10.1056/NEJMoa2409408
Web of Science PubMed FullText FullText_MUG

Co-Autor*innen der Med Uni Graz: Brunner Thomas Baptist
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Abstract:: BACKGROUND: The best multimodal approach for resectable locally advanced esophageal adenocarcinoma is unclear. An important question is whether perioperative chemotherapy is preferable to preoperative chemoradiotherapy. METHODS: In this phase 3, multicenter, randomized trial, we assigned in a 1:1 ratio patients with resectable esophageal adenocarcinoma to receive perioperative chemotherapy with FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) plus surgery or preoperative chemoradiotherapy (radiotherapy at a dose of 41.4 Gy and carboplatin and paclitaxel) plus surgery. Eligibility criteria included a primary tumor with a clinical stage of cT1 cN+, cT2-4a cN+, or cT2-4a cN0 disease, in which T indicates the size and extent of the tumor (higher numbers indicate a more advanced tumor), and N indicates the presence (N+) or absence (N0) of cancer spread to the lymph nodes, without evidence of metastatic spread. The primary end point was overall survival. RESULTS: From February 2016 through April 2020, we assigned 221 patients to the FLOT group and 217 patients to the preoperative-chemoradiotherapy group. With a median follow-up of 55 months, overall survival at 3 years was 57.4% (95% confidence interval [CI], 50.1 to 64.0) in the FLOT group and 50.7% (95% CI, 43.5 to 57.5) in the preoperative-chemoradiotherapy group (hazard ratio for death, 0.70; 95% CI, 0.53 to 0.92; P = 0.01). Progression-free survival at 3 years was 51.6% (95% CI, 44.3 to 58.4) in the FLOT group and 35.0% (95% CI, 28.4 to 41.7) in the preoperative-chemoradiotherapy group (hazard ratio for disease progression or death, 0.66; 95% CI, 0.51 to 0.85). Among the patients who started the assigned treatment, grade 3 or higher adverse events were observed in 120 of 207 patients (58.0%) in the FLOT group and in 98 of 196 patients (50.0%) in the preoperative-chemoradiotherapy group. Serious adverse events were observed in 98 of 207 patients (47.3%) in the FLOT group and in 82 of 196 patients (41.8%) in the preoperative-chemoradiotherapy group. Mortality at 90 days after surgery was 3.1% in the FLOT group and 5.6% in the preoperative-chemoradiotherapy group. CONCLUSIONS: Perioperative chemotherapy with FLOT led to improved survival among patients with resectable esophageal adenocarcinoma as compared with preoperative chemoradiotherapy. (Funded by the German Research Foundation; ESOPEC ClinicalTrials.gov number, NCT02509286.).
Find related publications in this database (using NLM MeSH Indexing): Humans - administration & dosage; Esophageal Neoplasms - therapy, mortality, pathology; Male - administration & dosage; Female - administration & dosage; Middle Aged - administration & dosage; Aged - administration & dosage; Adenocarcinoma - therapy, mortality, pathology; Antineoplastic Combined Chemotherapy Protocols - therapeutic use, adverse effects; Fluorouracil - administration & dosage; Chemoradiotherapy - administration & dosage; Docetaxel - administration & dosage, therapeutic use; Oxaliplatin - administration & dosage, therapeutic use; Paclitaxel - administration & dosage; Carboplatin - administration & dosage; Leucovorin - administration & dosage; Adult - administration & dosage; Kaplan-Meier Estimate - administration & dosage; Esophagectomy - administration & dosage; Preoperative Care - administration & dosage; Survival Analysis - administration & dosage; Neoadjuvant Therapy - administration & dosage; Perioperative Care - administration & dosage; Neoplasm Staging - administration & dosage