title: A phase II study of catumaxomab administered intra- and postoperatively as part of a multimodal approach in primarily resectable gastric cancer.
abstract: BACKGROUND
  Postoperative relapse rate after gastrectomy and perioperative chemotherapy remain high in patients with advanced gastric cancer due to the spread of disseminated tumour cells in the peritoneal cavity. Perioperative administration of catumaxomab could potentially eliminate residual tumour cells after intended curative resection of the primary tumour.
  
  
  METHODS
  This open-label, phase II study investigated the safety and efficacy of catumaxomab following neoadjuvant chemotherapy and subsequent surgery in patients with resectable (T2-4, N+, M0) gastric adenocarcinoma. Patients received catumaxomab intra- (single 10 μg dose) and postoperatively (10, 20, 50 and 150 μg on days 7, 10, 13 and 16, respectively). The primary endpoint was the postoperative complication rate (maximum rate defined as <62 %) within 30 days after surgery in patients who received at least the first catumaxomab dose.
  
  
  RESULTS
  Of 64 patients treated with neoadjuvant chemotherapy, 58 underwent surgery and 54 received at least the first catumaxomab dose. Postoperative complications were reported in 18 of 54 evaluable patients (complication rate 33 %; 95 % confidence interval: 21-48 %); thus, the primary endpoint was met. The most frequent complications were pulmonary infection (17 %) and anastomosis insufficiency requiring surgery (11 %). The most common catumaxomab-related adverse events were pyrexia (67 %), leucocytosis (19 %), abdominal pain (17 %) and chills (17 %). The 4-year disease-free and overall survival rates were 38 and 50 %.
  
  
  CONCLUSIONS
  Intra- and postoperative administration of catumaxomab as part of a multimodal treatment approach was feasible and tolerable in patients with advanced gastric cancer and should be further investigated in a randomised trial.
authors.affiliation: Department of Internal Medicine II (Hematology, Oncology, Bone Marrow Transplantation), University Medical Center Hamburg-Eppendorf, Hamburg, Germany. c.bokemeyer@uke.uni-hamburg.de.
authors.forename: Carsten
authors.initials: C
authors.lastname: Bokemeyer
authors.affiliation: Department of Internal Medicine II (Hematology, Oncology, Bone Marrow Transplantation), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Stein
authors.affiliation: Department of Surgery, Städtisches Klinikum Magdeburg, Magdeburg, Germany.
authors.forename: Karsten
authors.initials: K
authors.lastname: Ridwelski
authors.affiliation: Department of Internal Medicine II (Hematology, Oncology, Bone Marrow Transplantation), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Djordje
authors.initials: D
authors.lastname: Atanackovic
authors.affiliation: Department of Medical Oncology, Tumour Biology Institute, Freiburg, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Arnold
authors.affiliation: Department for Internal Medicine Zams, Saint Vincent Hospital Zams, Zams, Austria.
authors.forename: Ewald
authors.initials: E
authors.lastname: Wöll
authors.affiliation: Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Alexis
authors.initials: A
authors.lastname: Ulrich
authors.affiliation: Neovii (formerly Fresenius) Biotech GmbH, Munich, Germany.
authors.forename: Ramona
authors.initials: R
authors.lastname: Fischer
authors.affiliation: Department of Surgery, Visceral, Thoracic and Vascular Surgery, Vivantes Hospital of Neukoelln, Berlin, Germany.
authors.forename: Colin
authors.initials: C
authors.lastname: Krüger
authors.affiliation: Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Schuhmacher
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D018033:Antibodies, Bispecific / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D005260:Female; D005743:Gastrectomy; D006801:Humans; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011184:Postoperative Period; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery
chemical_list: D018033:Antibodies, Bispecific; D000970:Antineoplastic Agents; C522419:catumaxomab
keywords: Catumaxomab; Gastric cancer; Intraoperative; Multimodal treatment; Postoperative