Evidence map›Paper›PMID 32043193›Full record

Trial reportBreast cancer research and treatment2020

Nomogram-based estimate of axillary nodal involvement in ACOSOG Z0011 (Alliance): validation and association with radiation protocol variations.

Matthew S Katz, Linda McCall, Karla Ballman, Reshma Jagsi, Bruce G Haffty, Armando E Giuliano

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2020. 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 NCT00003854 (A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT00003854 phase3completednot on this map

A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan1999 to 2011Enrolled4,590ConditionsBreast CancerArmsimmunohistochemistry staining method, lymphangiography, sentinel lymph node biopsy, therapeutic conventional surgery, whole breast irradiation
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Matthew S KatzDepartment of Radiation Medicine, Lowell General Hospital, 295 Varnum Avenue, Lowell, MA, 01854, USA. Matthew.Katz@lowellgeneral.org.ORCID http://orcid.org/0000-0002-0239-9807
Linda McCallAlliance Statistics and Data Center, Duke University, Durham, NC, USA.
Karla BallmanAlliance Statistics and Data Center, Weill Cornell Medicine, New York, NY, USA.
Reshma JagsiDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Bruce G HafftyDepartment of Radiation Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Armando E GiulianoDepartment of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
Foundation for the National Institutes of Health (US) U10CA180821NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA233160
6 · The paper itself

Abstract

purposeA substantial proportion of patients enrolled on ACOSOG Z0011 received protocol-deviant radiation treatment. It is currently unknown whether these deviations involved the use of more extensive fields in patients at higher nomogram-predicted risk.

methodsWe used the M.D. Anderson (MDA) and Memorial Sloan-Kettering (MSK) nomograms to estimate risk of additional positive axillary nodes using surgical pathology information. In the control arm, we compared axillary dissection (AD) findings to nomogram-predicted estimates for validation. We used logistic regression to evaluate whether nomogram-estimated higher risk of nodal involvement was associated with high tangent (HT) or supraclavicular (SCV) radiation fields for patients with known radiation field design.

results552/856 (64.5%) had complete details for the MDA nomogram. Mean MDA risk estimate in both treatment arms was 23.8%. Estimated risk for patients on the AD arm with positive nodes was 25.9%. Higher risk estimate was associated with additional positive nodes in the AD arm (OR 1.04, 95% CI 1.02-1.06, p < 0.0001). We observed significant association with higher MDA nomogram-estimated risk and SCV radiation (OR 1.07, 95% CI 1.04-1.10, p < 0.0001) but not HT (OR 0.99, 95% CI 0.96-1.02, p = 0.52) The MSK nomogram had similar associations.

conclusionMDA and MSK nomogram risk estimates were associated with lymph node risk in ACOSOG Z0011. Radiation oncologists' use of differing radiation fields were associated with treating higher risk patients. ClinicalTrials.gov id: NCT00003854.

Indexed as

NomogramsAdultAgedAged, 80 and overAxillaBreast NeoplasmsFemaleGuideline AdherenceHumansLogistic ModelsLymphatic MetastasisLymph Node ExcisionMiddle AgedRadiotherapyRetrospective StudiesRisk AssessmentAxillary lymph nodeBreast cancerNomogramRadiation therapySentinel lymph node

Identifiers

PMID32043193
PMCPMC7138254

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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.