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Randomised phase II trial to investigate catumaxomab (anti-EpCAM × anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric cancer

by Knödler, Maren , Schenk, Michael , Lordick, Florian , Lindhofer, Horst , Hacker, Ulrich , Kunzmann, Volker , Körfer, Justus , Daum, Severin , Al-Batran, Salah-Eddin , Schroll, Sebastian , Behringer, Dirk , Trojan, Jörg , Kullmann, Frank , Ibach, Stefan , Stahl, Michael

in 5-Fluorouracil / CD3 antigen / Chemotherapy / Clinical trials / Gastric cancer / Guanylate cyclase / Immunotherapy / Investigations / Laparoscopy / Liver / Monoclonal antibodies / Nausea / Oxaliplatin / Pain / Patients / Peritoneum / Remission / Surgery / Targeted cancer therapy

2018

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Randomised phase II trial to investigate catumaxomab (anti-EpCAM × anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric cancer

2018

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Randomised phase II trial to investigate catumaxomab (anti-EpCAM × anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric cancer

2018

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Journal Article

Randomised phase II trial to investigate catumaxomab (anti-EpCAM × anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric cancer

Knödler, Maren,

Schenk, Michael,

Lordick, Florian,

Lindhofer, Horst,

Hacker, Ulrich,

Kunzmann, Volker,

Körfer, Justus,

Daum, Severin,

Al-Batran, Salah-Eddin,

Schroll, Sebastian,

Behringer, Dirk,

Trojan, Jörg,

Kullmann, Frank,

Ibach, Stefan,

Stahl, Michael

2018

Overview

BackgroundPeritoneal 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.MethodsThis 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.ResultsMedian 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.ConclusionsAddition 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.

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