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Article Dans Une Revue Cancers Année : 2023

Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study

Come Lepage
Marine Jary
  • Fonction : Auteur
Didier Pillon
  • Fonction : Auteur
Denis Collet
  • Fonction : Auteur
Pierre Michel
  • Fonction : Auteur
Meher Ben Abdelghani
  • Fonction : Auteur
Rosine Guimbaud
  • Fonction : Auteur
Marie Muller
Olivier Bouché

Résumé

Purpose: While perioperative chemotherapy provides a survival benefit over surgery alone in gastric and gastroesophageal junction (G/GEJ) adenocarcinomas, the results need to be improved. This study aimed to evaluate the efficacy and safety of perioperative cetuximab combined with 5-fluorouracil and cisplatin. Patients and Methods: Patients received six cycles of cetuximab, cisplatin, and simplified LV5FU2 before and after surgery. The primary objective was a combined evaluation of the tumor objective response (TOR), assessed by computed tomography, and the absence of major toxicities resulting in discontinuation of neoadjuvant chemotherapy (NCT) (45% and 90%, respectively). Results: From 2011 to 2013, 65 patients were enrolled. From 64 patients evaluable for the primary endpoint, 19 (29.7%) had a morphological TOR and 61 (95.3%) did not stop NCT prematurely due to major toxicity. Sixty patients (92.3%) underwent resection. Sixteen patients (/56 available, 28.5%) had histological responses (Mandard tumor regression grade ≤3). After a median follow-up of 44.5 months, median disease-free and overall survival were 24.4 [95% CI: 16.4-39.4] and 40.3 months [95% CI: 27.5-NA], respectively. Conclusion: Adding cetuximab to the NCT regimen in operable G/GEJ adenocarcinomas is safe, but did not show enough efficacy in the present study to meet the primary endpoint (NCT01360086).

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Cancer
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hal-04521848 , version 1 (23-05-2024)

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Caroline Gronnier, Christophe Mariette, Come Lepage, Carole Monterymard, Marine Jary, et al.. Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study. Cancers, 2023, 15 (7), pp.2188. ⟨10.3390/cancers15072188⟩. ⟨hal-04521848⟩
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