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Gastrointestinal tumours, colorectal 1

1433 - Neoadjuvant FOLFOX 4 versus FOLFOX 4 plus Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a phase II multicentre randomised controlled trial (PRODIGE 22)


09 Sep 2017


Gastrointestinal tumours, colorectal 1


Cytotoxic Therapy;  Colon and Rectal Cancer


Mehdi Karoui


Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393


M. Karoui1, A. Rullier2, C. Mariette3, E. Maillard4, A. Bardier5, F. Poizat6, A. Luciani7, A. Sarran8, J. Legoux9, C. De Chaisemartin10, C. Lecaille11, O. Bouche12, F. Mauvais13, F. Brunetti14, M. Prudhomme15, J. Seitz16, C. Lepage17, J. Taieb18

Author affiliations

  • 1 Department Of Digestive Surgery, CHU Pitié-Salpétrière, 75651 - Paris/FR
  • 2 Department Of Anatomopathology, Pellegrin Hospital, Bordeaux/FR
  • 3 Department Of Digestive And Oncological Surgery, Lille University Hospital, France, 59037 - Lille/FR
  • 4 Biostatistics, FFCD, Burgundy University, INSERM U866, Dijon/FR
  • 5 Department Of Pathological Anatomy, CHU Pitié-Salpétrière, 75651 - Paris/FR
  • 6 Department Of Anatomopathology, Institut Paoli Calmettes, Marseille/FR
  • 7 Department Of Medical Imaging, CHU Henri Mondor, Créteil/FR
  • 8 Department Of Radiology, Institut Paoli Calmettes, Marseille/FR
  • 9 Department Of Gastroenterology, CHR La Source, 45100 - Orléans/FR
  • 10 Department Of Digestive Surgery, Institut Paoli Calmettes, Marseille/FR
  • 11 Department Of Oncology, Polyclinique Bordeaux Nord, Bordeaux/FR
  • 12 Department Of Medicine-oncology, CHU Robert Debré, Reims/FR
  • 13 Department Of Digestive Surgery, CH Beauvais, Beauvais/FR
  • 14 Department Of Digestive Surgery, CHU Henri Mondor, Créteil/FR
  • 15 Department Of Digestive Surgery, CHU Carémeau, Nîmes/FR
  • 16 Department Of Gastroenterology And Oncology, CHU La Timone, 13385 - Marseille/FR
  • 17 Department Of Gastroenterology, CHU Le Bocage, FFCD, Burgundy University, INSERM U866, 21079 - Dijon/FR
  • 18 Department Of Gastroenterology, European Georges Pompidou Hospital, 75015 - Paris/FR


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Abstract 1433


Neoadjuvant chemotherapy has proven valuable in several tumors, but not in colon cancer (CC). The present randomized phase II trial addressed this issue in patients (pts) with locally advanced CC.


Pts with resectable CC deemed as high risk T3 (extramural tumor invasion > 5 mm), T4 and/or N2 (3 or more visible lymph nodes or 1 node >10mm diameter) on initial abdominopelvic CT-scan were randomized to either receive 6 months of adjuvant FOLFOX after colectomy (arm A control), or neoadjuvant FOLFOX for 4 cycles before surgery and 8 cycles after (arm B). In RAS wild-type pts a third arm testing peri-operative FOLFOX + cetuximab has been added prior to colectomy (arm C). The primary endpoint of the study was the rate of major pathological Tumor Regression Grade (TRG) as defined by Ryan centrally assessed by 2 pathologists blinded to the pts treatment. The secondary endpoints included toxicity, perioperative morbidity, carcinologic quality and completeness of the surgery. Analysis was by intention to treat.


120 pts from 37 French centres were enrolled, 94% completed preoperative chemotherapy. All but 5 pts (disease progression n = 2, metastatic disease at inclusion n = 1, non resectable tumor n = 1, death n = 1) in the preoperative arms were resected. 95% and 98% of patients underwent R0 resection in the preoperative arms and control arm, respectively. No significant differences in severe postoperative morbidity rates (Dindo Grade >3) were seen between arm A (13.7%), B (8.2%) and C (14.3%) (p = 0.64). Major pathological responses (TRG 1-2) were observed in 7.7%, 44.2%, and 6.3% in arm A, B and C respectively (p 


Preoperative FOLFOX for locally advanced resectable CC is feasible with acceptable toxicity/morbidity and high TRG. A phase III trial to establish whether these encouraging results translate into improved long-term oncological outcome is now warranted.

Clinical trial identification


Legal entity responsible for the study



Merck, PHRC 2010


O. Bouche: Roche, Merck-Serono, Amgen, Lilly, Boehringer Ingelheim, Bayer J-F. Seitz: Merck, Sanofi. J. Taieb: Abbvie, Amgen, Baxalta, Celgene, Lilly, Merck, Roche. All other authors have declared no conflicts of interest.

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