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. 2023 Apr 6;15(7):2188.
doi: 10.3390/cancers15072188.

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

Caroline Gronnier  1 , Christophe Mariette  2   3 , Come Lepage  4   5 , Carole Monterymard  6 , Marine Jary  7 , Aurélie Ferru  8 , Mathieu Baconnier  9 , Xavier Adhoute  10 , David Tavan  11 , Hervé Perrier  12 , Véronique Guerin-Meyer  13 , Cédric Lecaille  14 , Nathalie Bonichon-Lamichhane  15 , Didier Pillon  16 , Oana Cojocarasu  17 , Joëlle Egreteau  18 , Xavier Benoit D'journo  19 , Laétitia Dahan  20 , Christophe Locher  21 , Patrick Texereau  22 , Denis Collet  1 , Pierre Michel  23 , Meher Ben Abdelghani  24 , Rosine Guimbaud  25 , Marie Muller  26 , Olivier Bouché  27 , Guillaume Piessen  2   3
Affiliations

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

Caroline Gronnier et al. Cancers (Basel). .

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.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Therapeutic strategy. GEJ tumours were classified according to the Siewert classification [15].* The clinical tumor–node–metastasis (cTNM) classification we used was based on usTNM classifications for carcinoma of the esophagus [19] and the stomach [20]. Non-traversable tumors were considered cT3N+ as previously published [16].** CT-scans were centrally reviewed according to the RECIST V1.1 criteria by an independent observer blinded to the outcomes prospectively in one center.
Figure 2
Figure 2
Flow chart of the study.
Figure 3
Figure 3
Waterfall graph: percentage change in tumor size according to RECIST criteria.
See this image and copyright information in PMC

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