title: Intra- and postoperative catumaxomab in patients with epithelial ovarian cancer: safety and two-year efficacy results from a multicentre, single-arm, phase II study.
abstract: BACKGROUND
  This is the first study investigating the safety and efficacy of the trifunctional antibody catumaxomab administered i.p. at the end of cytoreductive surgery and postoperatively prior to standard chemotherapy in patients with primary epithelial ovarian cancer (EOC).
  
  
  METHODS
  Patients received i.p. catumaxomab 10 μg intraoperatively and 10, 20, 50 and 150 μg on days 7, 10, 13 and 16, respectively, postoperatively. After the study, patients received standard chemotherapy and were followed for 23 months. The primary endpoint was the rate of postoperative complications.
  
  
  RESULTS
  Forty-one patients entered the study and were evaluable for safety and 34 were alive at 24 months. Complete tumour resection rate was 68%. Postoperative complications were observed in 51%, the most common anastomotic leakage (7%) and wound infections (5%). The most common catumaxomab-related adverse events were abdominal pain, nausea, vomiting and pyrexia. Thirty-nine percent discontinued catumaxomab therapy, and 98% received chemotherapy post study. Kaplan-Meier estimates of disease-free and overall survival after 24 months were 56% and 85%, respectively.
  
  
  CONCLUSIONS
  Intra- and close postoperative catumaxomab seems feasible, but efficacy and safety were limited by postsurgical complications. In the future prospective trials are needed to investigate the best schedule of integration of catumaxomab into current treatment strategies for EOC.
authors.affiliation: 1] NOGGO, Ovarian cancer study group of the North-Eastern German Society of Gynaecological Oncology (NOGGO), Berlin, Germany [2] Department of Gynaecology, Charité University Hospital, Campus Virchow Clinic, Augustenburger Platz 1, 13353 Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Sehouli
authors.affiliation: Department of Gynaecology and Gynecologic Oncology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Reinthaller
authors.affiliation: Department of Obstetrics and Gynaecology, Innsbruck Medical University, Anichstraße 35, A-6020 Innsbruck, Austria.
authors.forename: C
authors.initials: C
authors.lastname: Marth
authors.affiliation: Department of Gynaecology, Charité University Hospital, Campus Virchow Clinic, Augustenburger Platz 1, 13353 Berlin, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Reimer
authors.affiliation: Department of Obstetrics and Gynaecology, Klinikum Suedstadt, University of Rostock, Südring 81, D-18059 Rostock, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Reimer
authors.affiliation: Department of Obstetrics and Gynaecology, Landesfrauenklinik Linz, Krankenhausstraße 26-30, A-4020 Linz, Austria.
authors.forename: W
authors.initials: W
authors.lastname: Stummvoll
authors.affiliation: Department of Obstetrics and Gynaecology, Landesfrauenklinik Linz, Krankenhausstraße 26-30, A-4020 Linz, Austria.
authors.forename: L
authors.initials: L
authors.lastname: Angleitner-Boubenizek
authors.affiliation: Neovii (formerly Fresenius) Biotech GmbH, Frankfurter Ring 193a, 80807 Munich, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Brandt
authors.affiliation: Department of Gynaecology, Charité University Hospital, Campus Virchow Clinic, Augustenburger Platz 1, 13353 Berlin, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Chekerov
mesh_terms: D000328:Adult; D000368:Aged; D018033:Antibodies, Bispecific / Q000008:administration & dosage / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D005260:Female; D006801:Humans; D007430:Intraoperative Care; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000601:surgery; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000601:surgery; D011182:Postoperative Care
chemical_list: D018033:Antibodies, Bispecific; C522419:catumaxomab