Evidence map›Paper›PMID 20697084›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

HER2 and chromosome 17 effect on patient outcome in the N9831 adjuvant trastuzumab trial.

Edith A Perez, Monica M Reinholz, David W Hillman, Kathleen S Tenner, Matthew J Schroeder, Nancy E Davidson, Silvana Martino, George W Sledge, Lyndsay N Harris, Julie R Gralow and 7 more

Open access · bronzeAbstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 110 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 3 pooled it
9.5field-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.

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

110 citing papers in PubMed, 3 syntheses or guidelines pooled it, 235 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 1 institution in 1 country.

Edith A PerezSerene M. and Frances C. Durling Professor of Medicine, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL 32224, USA. perez.edith@mayo.edu
Monica M Reinholz
David W Hillman
Kathleen S Tenner
Matthew J Schroeder
Nancy E Davidson
Silvana Martino
George W Sledge
Lyndsay N Harris
Julie R Gralow
Amylou C Dueck
Rhett P Ketterling
James N Ingle
Wilma L Lingle
Peter A Kaufman
Daniel W Visscher
Robert B Jenkins
Mayo Clinic in Florida · US

Funding

TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
North Central Cancer Treatment Group (NCCTG) Biospecimen ResourceU24CA114740 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 2005 to 2014
$8.6M
Predictive Biomarkers of Adjuvant Trastuzumab in the HER2+N9831 Intergroup TrialR01CA129949 · NCI · MAYO CLINIC JACKSONVILLE · PI PEREZ, EDITH A. · 2008 to 2011
$1.3M
NCI NIH HHS CA114740NCI NIH HHS CA129949NCI NIH HHS CA25224NCI NIH HHS R01 CA129949NCI NIH HHS U10 CA025224NCI NIH HHS U24 CA114740
6 · The paper itself

Abstract

purposeWe examined associations between tumor characteristics (human epidermal growth factor receptor 2 [HER2] protein expression, HER2 gene and chromosome 17 copy number, hormone receptor status) and disease-free survival (DFS) of patients in the N9831 adjuvant trastuzumab trial. PATIENTS AND

methodsAll patients (N = 1,888) underwent chemotherapy with doxorubicin and cyclophosphamide, followed by weekly paclitaxel with or without concurrent trastuzumab. HER2 status was determined by immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH) at a central laboratory, Mayo Clinic, Rochester, MN. Patients with conflicting local positive HER2 expression results but normal central laboratory testing were included in the analyses (n = 103).

resultsPatients with HER2-positive tumors (IHC 3+, FISH HER2/centromere 17 ratio ≥ 2.0, or both) benefited from trastuzumab, with hazard ratios (HRs) of 0.46, 0.49, and 0.45, respectively (all P < .0001). Patients with HER2-amplified tumors with polysomic (p17) or normal (n17) chromosome 17 copy number also benefited from trastuzumab, with HRs of 0.52 and 0.37, respectively (P < .006). Patients who received chemotherapy alone and had HER2-amplified and p17 tumors had a longer DFS than those who had n17 (78% v 68%; P = .04), irrespective of hormone receptor status or tumor grade. Patients with HER2-normal tumors by central testing (n = 103) seemed to benefit from trastuzumab, but the difference was not statistically significant (HR, 0.51; P = .14). Patients with hormone receptor-positive or -negative tumors benefited from the addition of trastuzumab, with HRs of 0.42 (P = .005) and 0.60 (P = .0001), respectively.

conclusionThese results confirm that IHC or FISH HER2 testing is appropriate for patient selection for adjuvant trastuzumab therapy. Trastuzumab benefit seemed independent of HER2/centromere 17 ratio and chromosome 17 copy number.

Indexed as

Chromosomes, Human, Pair 17AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase III as TopicCyclophosphamideDisease-Free SurvivalDoxorubicinErb-b2 Receptor Tyrosine KinasesFemaleHumansImmunohistochemistryIn Situ Hybridization, FluorescenceLaboratoriesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCyclophosphamideDoxorubicinErb-b2 Receptor Tyrosine KinasesPaclitaxelTrastuzumab

Identifiers

PMID20697084
PMCPMC2954132
OpenAlexW2104558660

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.