Caroline Gronnier, Christophe Mariette, Come Lepage, Carole Monterymard, Marine Jary, Aurélie Ferru, Mathieu Baconnier, Xavier Adhoute, David Tavan, Hervé Perrier, Véronique Guerin-Meyer, Cédric Lecaille, Nathalie Bonichon-Lamichhane, Didier Pillon, Oana Cojocarasu, Joëlle Egreteau, Xavier Benoit D'journo, Laëtitia Dahan, Christophe Locher, Patrick Texereau, Denis Collet, Pierre Michel, Meher Ben Abdelghani, Rosine Guimbaud, Marie Muller, Olivier Bouché, Guillaume Piessen.
Abstract
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).
KEYWORDS
EGFR-1; cetuximab; efficacy; esogastric adenocarcinoma; neoadjuvant chemotherapy; safety; surgery.
Gronnier C, Mariette C, Lepage C, Monterymard C, Jary M, Ferru A, Baconnier M, Adhoute X, Tavan D, Perrier H, Guerin-Meyer V, Lecaille C, Bonichon-Lamichhane N, Pillon D, Cojocarasu O, Egreteau J, D’journo XB, Dahan L, Locher C, Texereau P, Collet D, Michel P, Ben Abdelghani M, Guimbaud R, Muller M, Bouché O, Piessen G. Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study. Cancers (Basel). 2023 Apr 6;15(7):2188. doi: 10.3390/cancers15072188. PMID: 37046849; PMCID: PMC10093434.
