Evidence map›Paper›PMID 25225907›Full record

Trial reportBritish journal of cancer2014

Intra- and postoperative catumaxomab in patients with epithelial ovarian cancer: safety and two-year efficacy results from a multicentre, single-arm, phase II study.

J Sehouli, A Reinthaller, C Marth, D Reimer, T Reimer, W Stummvoll, L Angleitner-Boubenizek, B Brandt, R Chekerov

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Review
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  3. Contemporary Management of Malignant Ascites.The Journal of surgical research · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

J Sehouli1] 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.
A ReinthallerDepartment of Gynaecology and Gynecologic Oncology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria.
C MarthDepartment of Obstetrics and Gynaecology, Innsbruck Medical University, Anichstraße 35, A-6020 Innsbruck, Austria.
D ReimerDepartment of Gynaecology, Charité University Hospital, Campus Virchow Clinic, Augustenburger Platz 1, 13353 Berlin, Germany.
T ReimerDepartment of Obstetrics and Gynaecology, Klinikum Suedstadt, University of Rostock, Südring 81, D-18059 Rostock, Germany.
W StummvollDepartment of Obstetrics and Gynaecology, Landesfrauenklinik Linz, Krankenhausstraße 26-30, A-4020 Linz, Austria.
L Angleitner-BoubenizekDepartment of Obstetrics and Gynaecology, Landesfrauenklinik Linz, Krankenhausstraße 26-30, A-4020 Linz, Austria.
B BrandtNeovii (formerly Fresenius) Biotech GmbH, Frankfurter Ring 193a, 80807 Munich, Germany.
R ChekerovDepartment of Gynaecology, Charité University Hospital, Campus Virchow Clinic, Augustenburger Platz 1, 13353 Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis 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).

methodsPatients 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.

resultsForty-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.

conclusionsIntra- 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.

Indexed as

AdultAgedAntibodies, BispecificCarcinoma, Ovarian EpithelialFemaleHumansIntraoperative CareMiddle AgedNeoplasms, Glandular and EpithelialOvarian NeoplasmsPostoperative CareAntibodies, Bispecificcatumaxomab

Identifiers

PMID25225907
PMCPMC4200087

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.