Evidence map›Paper›PMID 19904267›Full record

Trial reportBritish journal of cancer2009

Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials.

A D Wagner, P Buechner-Steudel, M Moehler, H Schmalenberg, R Behrens, J Fahlke, A Wein, S Behl, O Kuss, G Kleber and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01383746 (Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.8field-weighted citation impact, top 7% 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.

NCT01383746 phase1 / phase2terminatednot on this mapstarted 2011, after this paper: background citation

Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2011 to 2012Enrolled5ConditionsCholestasis, Progressive Familial Intrahepatic 3ArmsYttrium microsphere injection
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 57 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Therapy of Primary Liver Cancer.Innovation (Cambridge (Mass.)) · 2020
    Review
  10. Article
  11. Article
  12. Article
  13. Signaling pathways as therapeutic targets in biliary tract cancer.Expert opinion on therapeutic targets · 2017
    Review
  14. Article
  15. Therapeutic options for intrahepatic cholangiocarcinoma.Hepatobiliary surgery and nutrition · 2017
    Review
  16. Review
  17. Review
  18. Article
  19. Gallbladder Cancer in the 21st Century.Journal of oncology · 2015
    Review
  20. Article
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

11 authors at 7 institutions in 1 country.

A D WagnerFirst Department of Medicine, University Hospital, Halle 06097 (Saale), Germany. Dorothea.wagner@chuv.ch
P Buechner-Steudel
M Moehler
H Schmalenberg
R Behrens
J Fahlke
A Wein
S Behl
O Kuss
G Kleber
W E Fleig
University Hospital in Halle · DEJena University Hospital · DEMartin Luther University Halle-Wittenberg · DEUniversitätsklinikum Erlangen · DEUniversity Hospital Leipzig · DEUniversity Hospital Magdeburg · DEUniversity of Applied Sciences Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGemcitabine, oxaliplatin and 5-fluorouracil (5-FU) are active in biliary tract cancer and have a potentially synergistic mode of action and non-overlapping toxicity. The objective of these trials was to determine response, survival and toxicity separately in patients with bile duct cancer (BDC) and gallbladder cancer (GBC) treated with gemcitabine/oxaliplatin/5-FU chemotherapy.

methodsEligible patients with histologically proven, advanced or metastatic BDC (n=37) or GBC (n=35) were treated with gemcitabine (900 mg m(-2) over 30 min), oxaliplatin (65 mg m(-2)) and 5-FU (1500 mg m(-2) over 24 h) on days 1 and 8 of a 21-day cycle. Tumour response was the primary outcome measure.

resultsResponse rates were 19% (95% CI: 6-32%) and 23% (95% CI: 9-37%) for BDC and GBC, respectively. Median survivals were 10.0 months (95% CI: 8.6-12.4) and 9.9 months (95% CI: 7.5-12.2) for BDC and GBC, respectively, and 1- and 2-year survival rates were 40 and 23% in BDC and 34 and 6% in GBC (intention-to-treat analysis). Major grade III and IV adverse events were neutropenia, thrombocytopenia, elevated bilirubin and anorexia.

conclusionTriple-drug chemotherapy achieves comparable results for response and survival to previously reported regimens, but with more toxicity.

Indexed as

AdenocarcinomaAdolescentAdultAgedAntimetabolites, AntineoplasticBile Duct NeoplasmsDeoxycytidineFemaleFluorouracilGallbladder NeoplasmsGemcitabineHumansMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsAntimetabolites, AntineoplasticDeoxycytidineFluorouracilGemcitabineOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID19904267
PMCPMC2788250
OpenAlexW1989236133

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.