Evidence map›Paper›PMID 25214034›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2015

A phase II study of catumaxomab administered intra- and postoperatively as part of a multimodal approach in primarily resectable gastric cancer.

Carsten Bokemeyer, Alexander Stein, Karsten Ridwelski, Djordje Atanackovic, Dirk Arnold, Ewald Wöll, Alexis Ulrich, Ramona Fischer, Colin Krüger, Christoph Schuhmacher

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.4field-weighted citation impact, top 17% of its field
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

13 citing papers in PubMed, 21 citations in OpenAlex.

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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

10 authors at 9 institutions in 2 countries.

Carsten BokemeyerDepartment of Internal Medicine II (Hematology, Oncology, Bone Marrow Transplantation), University Medical Center Hamburg-Eppendorf, Hamburg, Germany. c.bokemeyer@uke.uni-hamburg.de.
Alexander SteinDepartment of Internal Medicine II (Hematology, Oncology, Bone Marrow Transplantation), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Karsten RidwelskiDepartment of Surgery, Städtisches Klinikum Magdeburg, Magdeburg, Germany.
Djordje AtanackovicDepartment of Internal Medicine II (Hematology, Oncology, Bone Marrow Transplantation), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Dirk ArnoldDepartment of Medical Oncology, Tumour Biology Institute, Freiburg, Germany.
Ewald WöllDepartment for Internal Medicine Zams, Saint Vincent Hospital Zams, Zams, Austria.
Alexis UlrichDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, Germany.
Ramona FischerNeovii (formerly Fresenius) Biotech GmbH, Munich, Germany.
Colin KrügerDepartment of Surgery, Visceral, Thoracic and Vascular Surgery, Vivantes Hospital of Neukoelln, Berlin, Germany.
Christoph SchuhmacherDepartment of Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
University Medical Center Hamburg-Eppendorf · DEBiolog Life Science Institute · DEKlinikum Magdeburg · DEKlinikum rechts der Isar · DENeovii Biotech (Germany) · DESaint Vincent Hospital · USUniversität Hamburg · DEUniversity Hospital Heidelberg · DEVivantes Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative 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.

methodsThis 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.

resultsOf 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 %.

conclusionIntra- 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.

Indexed as

AdenocarcinomaAdultAgedAntibodies, BispecificAntineoplastic AgentsCombined Modality TherapyFemaleGastrectomyHumansIntraoperative PeriodMaleMiddle AgedNeoadjuvant TherapyPostoperative PeriodStomach NeoplasmsAntibodies, BispecificAntineoplastic AgentscatumaxomabCatumaxomabGastric cancerIntraoperativeMultimodal treatmentPostoperative

Identifiers

PMID25214034
OpenAlexW2145542303

What OpenQuestion holds

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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.