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NESC Multicenter Phase II Trial in the Preoperative Treatment of Gastric Adenocarcinoma with Chemotherapy (Docetaxel-Cisplatin-5FU+Lenograstim) Followed by Chemoradiation Based 5FU and Oxaliplatin and Surgery.

Authors
  • Mineur, Laurent1
  • Plat, Frederi1
  • Desseigne, Françoise2
  • Deplanque, Gael3
  • Belkacemi, Mohamed4
  • Moureau-Zabotto, Laurence5
  • Beyrne, Carlos D6
  • Jalali, Khadija7
  • Obled, Stéphane8
  • Smith, Denis9
  • Vazquez, Léa1
  • Boustany, Rania1
  • 1 Institut Sainte Catherine, Avignon, France. , (France)
  • 2 Centre Léon Berard, Lyon, France. , (France)
  • 3 Hopital Saint Joseph, Paris, France. , (France)
  • 4 INSERM, Montpellier, France. , (France)
  • 5 Institut Paoli Calmettes, Marseille, France. , (France)
  • 6 Hopital Henri Duffaut, Avignon, France. , (France)
  • 7 Hopital Sud, Amiens, France. , (France)
  • 8 CHU de Nimes, Nimes, France. , (France)
  • 9 Hopital Saint-André, Bordeaux, France. , (France)
Type
Published Article
Journal
Cancer research and treatment
Publication Date
Apr 01, 2024
Volume
56
Issue
2
Pages
580–589
Identifiers
DOI: 10.4143/crt.2023.812
PMID: 37817565
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Preoperative chemoradiation (CRT) is expected to increase the rate of curative resection and complete histological response. In this trial, we investigated the efficacy of a neoadjuvant CRT regimen in gastric adenocarcinoma (NCT01565109 trial). Patients with stage IB to IIIC gastric adenocarcinoma, endoscopy ultrasound and computed tomography-scan diagnosed, were eligible for this phase II trial. Neoadjuvant treatment consisted of 2 cycles of chemotherapy with DCF (docetaxel, cisplatin, and 5-fluorouracil [5FU]) followed by preoperative CRT with oxaliplatin, continuous 5FU and radiotherapy (45 Gy in 25 fractions of 1.8 Gy, 5 fractions per week for 5 weeks) administered before surgery. R0-resection rate, pathological complete response (pathCR) rate, and survival (progression-free survival [PFS] and overall survival [OS]) were evaluated as primary endpoints. Among 33 patients included, 32 patients (97%) received CRT and 26 (78.8%) were resected (R0 resection for all patients resected). Among resected patients, we report pathCR in 23,1% and pathologic major response (tumor regression grade 2 according to Mandard's classification) in 26,9%. With a median follow-up duration of 5.82 years (range, 0.4 to 9.24 years), the estimated median OS for all 33 patients was not reached; 1-, 3-, and 5-year OS rates were 85%, 61%, and 52%, respectively. Among resected patients, those whose histological response was tumor grade regression (TRG) 1-2 had significantly better OS and PFS rates than those with a TRG 3-4-5 response (p=0.019 and p=0.016, respectively). Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer need to be further evaluated in a phase III trial.

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