Evidence map›Paper›PMID 22571859›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2012

Neoadjuvant cetuximab, twice-weekly gemcitabine, and intensity-modulated radiotherapy (IMRT) in patients with pancreatic adenocarcinoma.

J M Pipas, B I Zaki, M M McGowan, M J Tsapakos, G H Ripple, A A Suriawinata, G J Tsongalis, T A Colacchio, S R Gordon, J E Sutton and 9 more

Open access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 9% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  5. Review
  6. Article
  7. Review
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  11. Article
  12. Article
  13. Preoperative Therapy and Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma: a 25-Year Single-Institution Experience.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2017
    Article
  14. Neoadjuvant therapy for pancreatic cancer: an ongoing debate.Therapeutic advances in gastroenterology · 2016
    Article
  15. Review
  16. Review
  17. Review
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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

19 authors at 5 institutions in 2 countries.

J M PipasSection Hematology/Oncology, Department of Medicine. Electronic address: J.Marc.Pipas@Hitchcock.org.
B I ZakiSection Radiation Oncology, Department of Medicine.
M M McGowanSection Hematology/Oncology, Department of Medicine.
M J TsapakosDepartment of Radiology.
G H RippleSection Hematology/Oncology, Department of Medicine.
A A SuriawinataDepartment of Pathology.
G J TsongalisDepartment of Pathology.
T A ColacchioSection Surgical Oncology, Department of Surgery.
S R GordonSection Gastroenterology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon.
J E SuttonDepartment of Surgery, Veterans Administration Medical Center, White River Junction.
A SrivastavaDepartment of Pathology, Brigham & Women's Hospital, Boston.
K D SmithSection Surgical Oncology, Department of Surgery.
T B GardnerSection Gastroenterology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon.
M KorcDepartment of Medicine, Indiana University School of Medicine, Indianapolis.
T H DavisSection Hematology/Oncology, Department of Medicine.
M PreisSection Hematology/Oncology, Department of Medicine.
S M TarczewskiOffice of Clinical Research, Norris Cotton Cancer Center, Lebanon.
T A MacKenzieDepartment of Epidemiology & Biostatistics, Dartmouth-Hitchcock Medical Center, Lebanon, USA.
R J BarthSection Surgical Oncology, Department of Surgery.
American University of Beirut Medical Center · LBBrigham and Women's Hospital · USDartmouth–Hitchcock Medical Center · USIndiana University – Purdue University Indianapolis · USWhite River Junction VA Medical Center · US

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
NCI NIH HHS P30 CA023108NCI NIH HHS P30 CA023108-34
6 · The paper itself

Abstract

backgroundNeoadjuvant therapy has been investigated for localized and locally advanced pancreatic ductal adenocarcinoma (PDAC) but no standard of care exists. Combination cetuximab/gemcitabine/radiotherapy demonstrates encouraging preclinical activity in PDAC. We investigated cetuximab with twice-weekly gemcitabine and intensity-modulated radiotherapy (IMRT) as neoadjuvant therapy in patients with localized or locally advanced PDAC. EXPERIMENTAL

designTreatment consisted of cetuximab load at 400 mg/m(2) followed by cetuximab 250 mg/m(2) weekly and gemcitabine 50 mg/m(2) twice-weekly given concurrently with IMRT to 54 Gy. Following therapy, patients were considered for resection.

resultsThirty-seven patients were enrolled with 33 assessable for response. Ten patients (30%) manifested partial response and 20 (61%) manifested stable disease by RECIST. Twenty-five patients (76%) underwent resection, including 18/23 previously borderline and 3/6 previously unresectable tumors. Twenty-three (92%) of these had negative surgical margins. Pathology revealed that 24% of resected tumors had grade III/IV tumor kill, including two pathological complete responses (8%). Median survival was 24.3 months in resected patients. Outcome did not vary by epidermal growth factor receptor status.

conclusionsNeoadjuvant therapy with cetuximab/gemcitabine/IMRT is tolerable and active in PDAC. Margin-negative resection rates are high and some locally advanced tumors can be downstaged to allow for complete resection with encouraging survival. Pathological complete responses can occur. This combination warrants further investigation.

Indexed as

Radiotherapy, Intensity-ModulatedAdenocarcinomaAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntimetabolites, AntineoplasticAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCetuximabDeoxycytidineErbB ReceptorsFemaleGemcitabineHumansAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntimetabolites, AntineoplasticAntineoplastic AgentsCetuximabDeoxycytidineEGFR protein, humanErbB ReceptorsGemcitabine

Identifiers

PMID22571859
PMCPMC3577039
OpenAlexW2120333793

What OpenQuestion holds

Textmetadata
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.