Evidence map›Paper›PMID 21693655›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011

p53 Expression in node-positive breast cancer patients: results from the Cancer and Leukemia Group B 9344 Trial (159905).

Jonathan F Lara, Ann D Thor, Lynn G Dressler, Gloria Broadwater, Ira J Bleiweiss, Susan Edgerton, David Cowan, Lori J Goldstein, Silvana Martino, James N Ingle and 8 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

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

  1. Guideline
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  14. Review
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  16. Article
  17. Prognostic effect of p53 expression in patients with completely resected colorectal cancer.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014
    Article
  18. Article
  19. Article
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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

18 authors.

Jonathan F LaraDepartment of Pathology, Saint Barnabas Medical Center, Livingston, NJ 07039, USA. jlara@sbhcs.com
Ann D Thor
Lynn G Dressler
Gloria Broadwater
Ira J Bleiweiss
Susan Edgerton
David Cowan
Lori J Goldstein
Silvana Martino
James N Ingle
I Craig Henderson
Larry Norton
Eric P Winer
Clifford A Hudis
Matthew J Ellis
Donald A Berry
Daniel F Hayes
Cancer and Leukemia Group B

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
UNIVERSITY OF ILLINOIS MINORITY BASED CCOPU10CA074811 · NCI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI PEACE, DAVID J · 1997 to 2011
$8.5M
NORTH SHORE UNIV COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035279 · NCI · NORTH SHORE UNIVERSITY HOSPITAL · PI VINCIGUERRA, VINCENT P · 1985 to 2014
$7.3M
CANCER &LEUKEMIA GROUP BU10CA032291 · NCI · DANA-FARBER CANCER INSTITUTE · PI BURSTEIN, HAROLD J. · 1985 to 2013
$5.8M
WUSM CANCER AND LEUKEMIA GROUP BU10CA077440 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L · 1998 to 2013
$4.4M
CANCER AND LEUKEMIA GROUP B--RPCI/SUNYABU10CA059518 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI LEVINE, ELLIS G · 1993 to 2013
$4.0M
CANCER AND LEUKEMIA GROUP B GRANT REVISED APPLICATIONU10CA041287 · NCI · UNIVERSITY OF CHICAGO · PI KINDLER, HEDY L · 1986 to 2013
$3.9M
MEMORIAL HOSPITAL AND CANCER AND ACUTE LEUKEMIA GROUP BU10CA077651 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI HUDIS, CLIFFORD A · 1998 to 2013
$3.2M
CANCER AND LEUKEMIA GROUP BU10CA047577 · NCI · DUKE UNIVERSITY · PI CRAWFORD, JEFFREY · 1988 to 2013
$2.2M
CANCER AND LEUKEMIA GROUP B (CALGB)U10CA003927 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI HURD, DAVID D. · 1985 to 2008
$2.2M
NCI NIH HHS CA03927NCI NIH HHS CA04326NCI NIH HHS CA04457NCI NIH HHS CA07968NCI NIH HHS CA12046NCI NIH HHS CA16450NCI NIH HHS CA26806NCI NIH HHS CA31983NCI NIH HHS CA32291NCI NIH HHS CA35279NCI NIH HHS CA37135NCI NIH HHS CA47555NCI NIH HHS CA47559NCI NIH HHS CA47577NCI NIH HHS CA47642NCI NIH HHS CA59518NCI NIH HHS CA74811NCI NIH HHS CA77298NCI NIH HHS CA77406NCI NIH HHS CA77440NCI NIH HHS CA77651NCI NIH HHS R01 CA092461NCI NIH HHS U10 CA003927NCI NIH HHS U10 CA007968NCI NIH HHS U10 CA021060NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032291NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA035279NCI NIH HHS U10 CA041287NCI NIH HHS U10 CA047559NCI NIH HHS U10 CA047577NCI NIH HHS U10 CA047642NCI NIH HHS U10 CA059518NCI NIH HHS U10 CA074811NCI NIH HHS U10 CA077440NCI NIH HHS U10 CA077651
6 · The paper itself

Abstract

purposep53 as a prognostic and predictive factor in early-stage breast cancer has had mixed results. We studied p53 protein expression, by immunohistochemistry, in a randomized clinical trial of stage II patients treated with adjuvant doxorubicin and cyclophosphamide with or without paclitaxel [Cancer and Leukemia Group B (CALGB) 9344, INT0148]. PATIENTS AND

methodsEpithelial p53 expression was evaluated using two immunohistochemical antibodies (DO7 and 1801) in formalin-fixed, paraffin-embedded tissue from patients with node-positive breast cancer who were randomized to four cycles of cyclophosphamide and one of three doses of doxorubicin (60, 75, or 90 mg/m(2); AC) and to receive four subsequent cycles of paclitaxel (T) or not. Prognostic and predictive value of p53 protein expression was assessed, independent of treatment assignment, for escalating doses of doxorubicin or addition of T with endpoints of relapse-free (RFS) and overall survival (OS).

resultsOf 3,121 patients, 1,887 patient specimens treated on C9344 were obtained, passed quality control, and evaluated for p53 expression. Expression was 23% and 27% for mAbs 1801 and D07, respectively, with 92% concordance. In univariate analysis, p53 positivity was associated with worse OS with either antibody, but only p53 staining with monoclonal antibody 1801 had significantly worse RFS. In multivariate analysis, p53 was not predictive of RFS or OS from either doxorubicin dose escalation or addition of paclitaxel regardless of the antibody.

conclusionNuclear staining of p53 by immunohistochemistry is associated with worse prognosis in node-positive patients treated with adjuvant doxorubicin-based chemotherapy but is not a useful predictor of benefit from doxorubicin dose escalation or the addition of paclitaxel.

Indexed as

AdultBreast NeoplasmsCyclophosphamideDoxorubicinFemaleHumansImmunohistochemistryLymphatic MetastasisMiddle AgedPaclitaxelPredictive Value of TestsPrognosisTumor Suppressor Protein p53CyclophosphamideDoxorubicinPaclitaxelTumor Suppressor Protein p53

Identifiers

PMID21693655
PMCPMC3149770

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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.