Thématique :
- Cancers autres (hors CCR et CHC)
Originalité :
Solidité :
A confirmer
Doit faire évoluer notre pratique :
Pas encore
Nom du veilleur :
Professeur Sylvain MANFREDI
Coup de coeur :
British journal of Cancer
  2018 Jul .  
  doi: 10.1038/s41416-018-0150-6  
  Randomised phase II trial to investigate catumaxomab (anti-EpCAM × anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric cancer  
  Knödler M, Körfer J, Kunzmann V, Trojan J, Daum S, Schenk M, Kullmann F, Schroll S, Behringer D, Stahl M, Al-Batran SE, Hacker U, Ibach S, Lindhofer H, Lordick F  



Peritoneal carcinomatosis (PC) represents an unfavourable prognostic factor for patients with gastric cancer (GC). Intraperitoneal treatment with the bispecific and trifunctional antibody catumaxomab (EpCAM, CD3), in addition to systemic chemotherapy, could improve elimination of PC.


This prospective, randomised, phase II study investigated the efficacy of catumaxomab followed by chemotherapy (arm A, 5-fluorouracil, leucovorin, oxaliplatin, docetaxel, FLOT) or FLOT alone (arm B) in patients with GC and PC. Primary endpoint was the rate of macroscopic complete remission (mCR) of PC at the time of second diagnostic laparoscopy/laparotomy prior to optional surgery.


Median follow-up was 52 months. Out of 35 patients screened, 15 were allocated to arm A and 16 to arm B. mCR rate was 27% in arm A and 19% in arm B (p = 0.69). Severe side effects associated with catumaxomab were nausea, infection, abdominal pain, and elevated liver enzymes. Median progression-free (6.7 vs. 5.4 months, p = 0.71) and overall survival (13.2 vs. 13.0 months, p = 0.97) were not significantly different in both treatment arms.


Addition of catumaxomab to systemic chemotherapy was feasible and tolerable in advanced GC. Although the primary endpoint could not be demonstrated, results are promising for future investigations integrating intraperitoneal immunotherapy into a multimodal treatment strategy.


Question posée
Evaluation du Catumaxonab en intra-péritonéal, en association avec une chimiothérapie de type FLOT pour les cancers gastriques avec carcinose.
Question posée
Etude négative : pas d’augmentation des réponses complètes, pas d’amélioration significative de la PFS et de l’OS.