Evidence map›Paper›PMID 22374460›Full record

Trial reportBritish journal of cancer2012

Multicentre phase II trial of trastuzumab and capecitabine in patients with HER2 overexpressing metastatic pancreatic cancer.

J Harder, G Ihorst, V Heinemann, R Hofheinz, M Moehler, P Buechler, G Kloeppel, C Röcken, M Bitzer, S Boeck and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 89 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 3% 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

89 citing papers in PubMed, 2 syntheses or guidelines pooled it, 181 citations in OpenAlex.

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  12. Updates in Molecular Profiling of Pancreatic Ductal Adenocarcinoma.The Surgical clinics of North America · 2024
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29 more citing papers are in PubMed but not listed here.

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

14 authors at 11 institutions in 1 country.

J HarderMedizinische Klinik II, Hegau- Bodensee Klinikum, Virchowstraße 10, D-78224 Singen, Germany. jan.harder@hbh-kliniken.de
G Ihorst
V Heinemann
R Hofheinz
M Moehler
P Buechler
G Kloeppel
C Röcken
M Bitzer
S Boeck
E Endlicher
A Reinacher-Schick
C Schmoor
M Geissler
Kiel University · DELMU Klinikum · DEUniversity Medical Center Freiburg · DEHegau-Bodensee-Klinikum Singen · DEHeidelberg University · DEJohannes Gutenberg University Mainz · DEKlinikum Esslingen · DEUniversitätsklinikum Knappschaftskrankenhaus Bochum · DEUniversitätsklinikum Tübingen · DEUniversity Medical Centre Mannheim · DEUniversity of Regensburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew therapeutic options for metastatic pancreatic cancer are urgently needed. In pancreatic cancer, overexpression of the epidermal growth factor receptor 2 (HER2) has been reported in up to 45%. This multicentre phase II study investigated the efficacy and toxicity of the HER2 antibody trastuzumab combined with capecitabine in the patients with pancreatic cancer and HER2 overexpression.

methodsPrimary endpoint was progression-free survival (PFS) after 12 weeks. A total of 212 patients were screened for HER2 expression.

resultsImmunohistochemical (IHC) HER2 expression was: 83 (40%) grade 0, 71 (34%) grade 1, 31 (15%) grade 2, 22 (11%) grade 3. A total of 17 patients with IHC +3 HER2 expression or gene amplification could be assessed for the treatment response. Grade 3/4 treatment toxicities were: each 7% leucopenia, diarrhoea, nausea and hand-foot syndrome. Progression-free survival after 12 weeks was 23.5%, median overall survival (OS) 6.9 months.

conclusionThis study demonstrates +3 HER2 expression or gene amplification in 11% of patients. Contrary to breast and gastric cancer, only 7 out of 11 (64%) patients with IHC +3 HER2 expression showed gene amplification. Although the therapy was well tolerated, PFS and OS did not perform favourably compared with standard chemotherapy. Together, we do not recommend further evaluation of anti-HER2 treatment in patients with metastatic pancreatic cancer.

Indexed as

AdenocarcinomaAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDeoxycytidineDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleFluorouracilGene ExpressionHumansKaplan-Meier EstimateMaleMiddle AgedAntibodies, Monoclonal, HumanizedCapecitabineDeoxycytidineERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesFluorouracilTrastuzumab

Identifiers

PMID22374460
PMCPMC3304403
OpenAlexW2049522382

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.