Evidence map›Paper›PMID 24220557›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Validation of the 12-gene colon cancer recurrence score in NSABP C-07 as a predictor of recurrence in patients with stage II and III colon cancer treated with fluorouracil and leucovorin (FU/LV) and FU/LV plus oxaliplatin.

Greg Yothers, Michael J O'Connell, Mark Lee, Margarita Lopatin, Kim M Clark-Langone, Carl Millward, Soonmyung Paik, Saima Sharif, Steven Shak, Norman Wolmark

Erratum issued Registry-linked trialOpen access · greenAbstract readValidation Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06314958 (Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment), which is not on this map. Cited by 78 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 4 pooled it
9.7field-weighted citation impact, top 1% 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.

NCT06314958 recruitingnot on this mapstarted 2023, after this paper: background citation

Predicting Recurrence-Free Survival in Stage III and High-Risk Stage II Colorectal Cancer After Curative-Intent Treatment

TypeobservationalSponsorCity of Hope Medical CenterRan2023 to 2028Enrolled400ConditionsColorectal Cancer, Colorectal Adenocarcinoma, Colorectal Cancer Stage II, Colorectal Cancer Stage IIIArmsCENSURE
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 4 syntheses or guidelines pooled it, 173 citations in OpenAlex.

  1. Pooled it
  2. Rectal Cancer, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2018
    Guideline
  3. Pooled it
  4. Updated guidelines for biomarker testing in colorectal carcinoma: a national consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2015
    Guideline
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Machine Learning Predicts Oxaliplatin Benefit in Early Colon Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Greg YothersGreg Yothers, Michael J. O'Connell, Soonmyung Paik, Saima Sharif, and Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations and Biostatistical Centers; Greg Yothers, University of Pittsburgh Graduate School of Public Health; Saima Sharif and Norman Wolmark, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA; Mark Lee, Margarita Lopatin, Kim M. Clark-Langone, and Steven Shak, Genomic Health, Redwood City, CA.
Michael J O'Connell
Mark Lee
Margarita Lopatin
Kim M Clark-Langone
Carl Millward
Soonmyung Paik
Saima Sharif
Steven Shak
Norman Wolmark
NSABP Foundation · US

Funding

PRIMARY CANCER THERAPY GROUP--NSABP (HEADQUARTERS)U10CA012027 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2012
$117.2M
NSABP Foreign AccrualsU10CA037377 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2014
$116.5M
STUDY TO ASSESS RALOXIFENE FOR PREVENTING BREAST CANCERU10CA069974 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2013
$62.4M
PRIMARY BREAST CANCER THERAPY--BIOSTATISTICS CENTERU10CA069651 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2012
$52.1M
NCI NIH HHS U10 CA012027NCI NIH HHS U10 CA037377NCI NIH HHS U10 CA069651NCI NIH HHS U10 CA069974NCI NIH HHS U10-CA-12027NCI NIH HHS U10-CA-37377NCI NIH HHS U10-CA-69651NCI NIH HHS U10-CA-69974
6 · The paper itself

Abstract

purposeAccurate assessments of recurrence risk and absolute treatment benefit are needed to inform colon cancer adjuvant therapy. The 12-gene Recurrence Score assay has been validated in patients with stage II colon cancer from the Cancer and Leukemia Group B 9581 and Quick and Simple and Reliable (QUASAR) trials. We conducted an independent, prospectively designed clinical validation study of Recurrence Score, with prespecified end points and analysis plan, in archival specimens from patients with stage II and III colon cancer randomly assigned to fluorouracil (FU) or FU plus oxaliplatin in National Surgical Adjuvant Breast and Bowel Project C-07.

methodsRecurrence Score was assessed in 892 fixed, paraffin-embedded tumor specimens (randomly selected 50% of patients with tissue). Data were analyzed by Cox regression adjusting for stage and treatment.

resultsContinuous Recurrence Score predicted recurrence (hazard ratio for a 25-unit increase in score, 1.96; 95% CI, 1.50 to 2.55; P < .001), as well as disease-free and overall survival (both P < .001). Recurrence Score predicted recurrence risk (P = .001) after adjustment for stage, mismatch repair, nodes examined, grade, and treatment. Recurrence Score did not have significant interaction with stage (P = .90) or age (P = .76). Relative benefit of oxaliplatin was similar across the range of Recurrence Score (interaction P = .48); accordingly, absolute benefit of oxaliplatin increased with higher scores, most notably in patients with stage II and IIIA/B disease.

conclusionThe 12-gene Recurrence Score predicts recurrence risk in stage II and stage III colon cancer and provides additional information beyond conventional clinical and pathologic factors. Incorporating Recurrence Score into the clinical context may better inform adjuvant therapy decisions in stage III as well as stage II colon cancer.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsColonic NeoplasmsDisease-Free SurvivalDNA Mismatch RepairFemaleFluorouracilGene Expression Regulation, NeoplasticHumansLeucovorinMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingOrganoplatinum CompoundsFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID24220557
PMCPMC3871512
OpenAlexW2131072420

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.