Evidence map›Paper›PMID 26425688›Full record

Trial reportEBioMedicine2015

TP53 Mutational Status and Prediction of Benefit from Adjuvant 5-Fluorouracil in Stage III Colon Cancer Patients.

Daniela Kandioler, Martina Mittlböck, Sonja Kappel, Harald Puhalla, Friedrich Herbst, Cord Langner, Brigitte Wolf, Jörg Tschmelitsch, Walter Schippinger, Günther Steger and 6 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in EBioMedicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–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

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Association ofGenetics research · 2022
    Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. TP53 mutations in Romanian patients with colorectal cancer.Genes and environment : the official journal of the Japanese Environmental Mutagen Society · 2023
    Article
  12. Review
  13. Review
  14. Article
  15. Presence of ConcurrentCancers · 2022
    Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Daniela KandiolerDepartment of Surgery, Medical University of Vienna, 1090 Vienna, Austria.
Martina MittlböckCenter for Medical Statistics, Informatics, and Intelligent Systems, Section for Clinical Biometrics, Medical University of Vienna, 1090 Vienna, Austria.
Sonja KappelDepartment of Surgery/Surgical Research, Medical University of Vienna, 1090 Vienna, Austria.
Harald PuhallaDepartment of Surgery, Medical University of Vienna, 1090 Vienna, Austria.
Friedrich HerbstDepartment of Surgery, Hospital Barmherzige Brüder, 1020 Vienna, Austria.
Cord LangnerInstitute for Pathology, Medical University of Graz, 8036 Graz, Austria.
Brigitte WolfDepartment of Surgery/Surgical Research, Medical University of Vienna, 1090 Vienna, Austria.
Jörg TschmelitschDepartment of Surgery, Hospital Barmherzige Brüder, 9300 St Veit/Glan, Austria.
Walter SchippingerDepartment of Internal Medicine, Albert Schweitzer Clinic, 8020 Graz, Austria.
Günther StegerDepartment of Internal Medicine, Medical University of Vienna, 1090 Vienna, Austria.
Friedrich HofbauerDepartment of Surgery, Hospital Oberpullendorf, 7350 Oberpullendorf, Austria.
Hellmut SamoniggDepartment of Internal Medicine, Medical University of Graz, 8036 Graz, Austria.
Michael GnantDepartment of Surgery, Medical University of Vienna, 1090 Vienna, Austria.
Bela TelekyDepartment of Surgery, Medical University of Vienna, 1090 Vienna, Austria.
Irene KührerDepartment of Internal Medicine, Medical University of Vienna, 1090 Vienna, Austria.
p53 Research Group and the Austrian Breast and Colorectal Study Group (ABCSG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We investigated the hypothesis that the varying treatment efficacy of adjuvant 5-fluorouracil (5FU) in stage III colon cancer is linked to the TP53 mutational status. ABCSG-90 was a prospective randomized trial in which effect of adjuvant 5FU was studied in stage III colon cancer patients. Tumor material of 70% of these patients (389/572) was available for analysis of the biomarker TP53 using a TP53-gene-specific Sanger sequencing protocol. Median follow-up was 88 months. TP53 mutation frequency was 33%. A significant interaction between TP53 status, outcomes and nodal category was found (P = 0.0095). In the N1 category, TP53 wildtype patients had significantly better overall survival than TP53 mutated (81.0% vs. 62.0% overall survival at 5 years; HR = 2.131; 95% CI: 1.344-3.378; P = 0.0010). In the N2 category, the TP53 status did not affect survival (P = 0.4992). In TP53 wildtype patients, the prognostic significance of N category was significantly enhanced (P = 0.0002). In TP53 mutated patients, survival curves of N1 and N2 patients overlapped and nodal category was no longer prognostic. The biomarker TP53 independently predicted effect of adjuvant 5FU in N1 colon cancer patients. TP53 was not predictive in N2 patients, in whom 5FU is known to have no effect.

Indexed as

Colonic NeoplasmsMutationAdolescentAdultAgedAged, 80 and overBiomarkers, TumorDisease-Free SurvivalFemaleFluorouracilHumansMaleMiddle AgedNeoplasm StagingProspective StudiesSurvival RateBiomarkers, TumorFluorouracilTP53 protein, humanTumor Suppressor Protein p535FU, 5-fluorouracilABCSG, Austrian Breast and Colorectal Cancer Study GroupAdjuvant 5-fluorouracilCI, confidence intervalsFFPE, formalin-fixed paraffin-embeddedHR, hazard ratiosINF, interferonLEV, levamisolePredictive biomarkerStage III colon cancerTP53Varying treatment efficacy

Identifiers

PMID26425688
PMCPMC4563117

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.