Evidence map›Paper›PMID 24231454›Full record

Trial reportJournal of the National Cancer Institute2013

Predictive and prognostic analysis of PIK3CA mutation in stage III colon cancer intergroup trial.

Shuji Ogino, Xiaoyun Liao, Yu Imamura, Mai Yamauchi, Nadine J McCleary, Kimmie Ng, Donna Niedzwiecki, Leonard B Saltz, Robert J Mayer, Renaud Whittom and 9 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 5 pooled it
3.3field-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.

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

25 citing papers in PubMed, 5 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Molecular Biomarkers for the Evaluation of Colorectal Cancer.American journal of clinical pathology · 2017
    Guideline
  3. Guideline
  4. Prognostic role of tumor PIK3CA mutation in colorectal cancer: a systematic review and meta-analysis.Annals of oncology : official journal of the European Society for Medical Oncology · 2016
    Pooled it
  5. Pooled it
  6. Trial
  7. International journal of molecular sciences · 2025
    Review
  8. Association ofOncoimmunology · 2021
    Article
  9. Article
  10. Review
  11. Observational
  12. Nut Consumption and Survival in Patients With Stage III Colon Cancer: Results From CALGB 89803 (Alliance).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
    Observational
  13. Marine ω-3 Polyunsaturated Fatty Acid and Fish Intake after Colon Cancer Diagnosis and Survival: CALGB 89803 (Alliance).Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2018
    Article
  14. World journal of gastroenterology · 2018
    Article
  15. Article
  16. DNA methylation markers for diagnosis and prognosis of common cancers.Proceedings of the National Academy of Sciences of the United States of America · 2017
    Article
  17. Article
  18. Article
  19. Review
  20. Mutation of theOncology letters · 2015
    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

19 authors at 8 institutions in 2 countries.

Shuji OginoAffiliations of authors: Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA (SO, XL, YI, MY, NJM, KN, RJM, JAM, CSF); Department of Pathology (SO), Channing Division of Network Medicine, Department of Medicine (DS, CSF), and Department of Surgery (MMB), Brigham and Women's Hospital and Harvard Medical School, Boston, MA (SO); Department of Epidemiology (SO, DS) and Department of Biostatistics (DS) , Harvard School of Public Health, Boston, MA; Alliance Statistics and Data Center, Duke University Medical Center, Durham, NC (DN); Memorial Sloan-Kettering Cancer Center, New York, NY (LBS); Hôpital du Sacré-Coeur de Montréal, Montreal, Canada (RW); Loyola University Stritch School of Medicine, Maywood, IL (AH); current: Edward Cancer Center, Naperville, IL (AH); Northwestern University, Chicago, IL (ABB); Toledo Community Hospital Oncology Program, Toledo, OH (RBM); Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH (RMG).
Xiaoyun Liao
Yu Imamura
Mai Yamauchi
Nadine J McCleary
Kimmie Ng
Donna Niedzwiecki
Leonard B Saltz
Robert J Mayer
Renaud Whittom
Alexander Hantel
Al B Benson
Rex B Mowat
Donna Spiegelman
Richard M Goldberg
Monica M Bertagnolli
Jeffrey A Meyerhardt
Charles S Fuchs
Alliance for Clinical Trials in Oncology
Harvard University Press · USCommunity Hospital · USDuke University · USLoyola University Chicago · USMemorial Sloan Kettering Cancer Center · USPalmetto Hematology Oncology · USThe Ohio State University · USUniversité de Montréal · CA

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
Tumor Environment and Metastasis (TEAM) Research ProgramP30CA060553 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Daniela E Matei · 1993 to 2026
$153.9M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
Tissue and Pathology ResourcesP50CA127003 · NCI · DANA-FARBER CANCER INST · PI EL-BARDEESY, NABEEL, SELLERS, WILLIAM R · 2007 to 2023
$33.2M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
MEDICAL CENTER OF DELAWARE CCOPU10CA045418 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GRUBBS, STEPHEN S. · 1987 to 2014
$14.5M
Multidisciplinary Clinical and Translational Science (MCTS) Program (UL1)UL1TR000150 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LLOYD-JONES, DONALD M · 2012 to 2013
$10.1M
TOLEDO COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035415 · NCI · TOLEDO COMMUNITY HOSPITAL ONCOLOGY PROG · PI MOWAT, REX BRADLEY · 1985 to 2014
$9.9M
SOUTHERN NEVADA CANCER RESEARCH FOUNDATION-CCOPU10CA035421 · NCI · SOUTHERN NEVADA CANCER RESEARCH FDN · PI ELLERTON, JOHN A · 1985 to 2014
$9.8M
NCATS NIH HHS UL1 TR000150NCI NIH HHS CA031946NCI NIH HHS CA03927NCI NIH HHS CA04326NCI NIH HHS CA04457NCI NIH HHS CA077658NCI NIH HHS CA07968NCI NIH HHS CA08025NCI NIH HHS CA11028NCI NIH HHS CA114558-02NCI NIH HHS CA11789NCI NIH HHS CA12046NCI NIH HHS CA12449NCI NIH HHS CA16450NCI NIH HHS CA17145NCI NIH HHS CA21060NCI NIH HHS CA21115NCI NIH HHS CA26806NCI NIH HHS CA29165NCI NIH HHS CA31983NCI NIH HHS CA32102NCI NIH HHS CA32291NCI NIH HHS CA33601NCI NIH HHS CA35279NCI NIH HHS CA35415NCI NIH HHS CA35421NCI NIH HHS CA37135NCI NIH HHS CA41287NCI NIH HHS CA45389NCI NIH HHS CA45418NCI NIH HHS CA45564NCI NIH HHS CA45808NCI NIH HHS CA46282NCI NIH HHS CA47555NCI NIH HHS CA47559NCI NIH HHS CA47577NCI NIH HHS CA47642NCI NIH HHS CA60138NCI NIH HHS CA71323NCI NIH HHS CA74811NCI NIH HHS CA77298NCI NIH HHS CA77406NCI NIH HHS CA77440NCI NIH HHS CA77597NCI NIH HHS CA77651NCI NIH HHS CA77658NCI NIH HHS K07 CA148894NCI NIH HHS N01 CA032102NCI NIH HHS P30 CA016058NCI NIH HHS P30 CA060553NCI NIH HHS P50 CA127003NCI NIH HHS R01 CA118553NCI NIH HHS R01 CA149222NCI NIH HHS R01 CA151993NCI NIH HHS R01 CA169141NCI NIH HHS U10 CA017145NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA035415NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA077651NCI NIH HHS U10 CA077658
6 · The paper itself

Abstract

backgroundSomatic mutations in PIK3CA (phosphatidylinositol-4,5-bisphosphonate 3-kinase [PI3K], catalytic subunit alpha gene) activate the PI3K-AKT signaling pathway and contribute to pathogenesis of various malignancies, including colorectal cancer.

methodsWe examined associations of PIK3CA oncogene mutation with relapse, survival, and treatment efficacy in 627 stage III colon carcinoma case subjects within a randomized adjuvant chemotherapy trial (5-fluorouracil and leucovorin [FU/LV] vs irinotecan [CPT11], fluorouracil and leucovorin [IFL]; Cancer and Leukemia Group B 89803 [Alliance]). We detected PIK3CA mutation in exons 9 and 20 by polymerase chain reaction and pyrosequencing. Cox proportional hazards model was used to assess prognostic and predictive role of PIK3CA mutation, adjusting for clinical features and status of routine standard molecular pathology features, including KRAS and BRAF mutations and microsatellite instability (mismatch repair deficiency). All statistical tests were two-sided.

resultsCompared with PIK3CA wild-type cases, overall status of PIK3CA mutation positivity or the presence of PIK3CA mutation in either exon 9 or 20 alone was not statistically significantly associated with recurrence-free, disease-free, or overall survival (log-rank P > .70; P > .40 in multivariable regression models). There was no statistically significant interaction between PIK3CA and KRAS (or BRAF) mutation status in survival analysis (P(interaction) > .18). PIK3CA mutation status did not appear to predict better or worse response to IFL therapy compared with FU/LV therapy (P(interaction) > .16).

conclusionsOverall tumor PIK3CA mutation status is not associated with stage III colon cancer prognosis. PIK3CA mutation does not appear to serve as a predictive tumor molecular biomarker for response to irinotecan-based adjuvant chemotherapy.

Indexed as

MutationAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinChemotherapy, AdjuvantClass I Phosphatidylinositol 3-KinasesColonic NeoplasmsDisease-Free SurvivalFemaleFluorouracilHumansIrinotecanKaplan-Meier EstimateLeucovorinMaleBRAF protein, humanCamptothecinClass I Phosphatidylinositol 3-KinasesFluorouracilIrinotecanKRAS protein, humanLeucovorinPhosphatidylinositol 3-KinasesPIK3CA protein, humanProto-Oncogene ProteinsProto-Oncogene Proteins B-rafProto-Oncogene Proteins p21(ras)ras Proteins

Identifiers

PMID24231454
PMCPMC3848984
OpenAlexW2144496040

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.