Evidence map›Paper›PMID 19349544›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer.

Stewart J Anderson, Irene Wapnir, James J Dignam, Bernard Fisher, Eleftherios P Mamounas, Jong-Hyeon Jeong, Charles E Geyer, D Lawrence Wickerham, Joseph P Costantino, Norman Wolmark

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 162 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
162citing papers in PubMed, 10 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.

NCT02386371 nacompletednot on this mapstarted 2014, after this paper: background citation

Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2014 to 2023Enrolled66ConditionsBreast CarcinomaArmstumorectomy, Intra Operative Radiotherapy
NCT03820830 phase3active not recruitingnot on this mapstarted 2019, after this paper: background citation

A Phase III Open-label, Multicenter, Randomized Trial of Adjuvant Palbociclib in Combination With Endocrine Therapy Versus Endocrine Therapy Alone for Patients With Hormone Receptor Positive / HER2-negative Resected Isolated Locoregional Recurrence of Breast Cancer

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan2019 to 2029Enrolled405ConditionsBreast Cancer RecurrentArmsPalbociclib 125mg, Standard endocrine therapy
3 · Its place in the literature

Who cites it

162 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Guideline
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  6. DEGRO practical guidelines for radiotherapy of breast cancer VI: therapy of locoregional breast cancer recurrences.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2016
    Guideline
  7. Body mass index and survival in women with breast cancer-systematic literature review and meta-analysis of 82 follow-up studies.Annals of oncology : official journal of the European Society for Medical Oncology · 2014
    Pooled it
  8. Pooled it
  9. Guideline
  10. DEGRO practical guidelines: radiotherapy of breast cancer I: radiotherapy following breast conserving therapy for invasive breast cancer.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2013
    Guideline
  11. Identifying Locally Recurrent Versus Second Primary Breast Cancer: Genomic Versus Clinical Criteria from Carolina Breast Cancer Study Phase III.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2026
    Trial
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  16. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
    Trial
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102 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Stewart J AndersonDepartment of Biostatistics, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA 15261, USA. sja@pitt.edu
Irene Wapnir
James J Dignam
Bernard Fisher
Eleftherios P Mamounas
Jong-Hyeon Jeong
Charles E Geyer
D Lawrence Wickerham
Joseph P Costantino
Norman Wolmark

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

purposeLocoregional failure (LRF) after breast-conserving therapy (BCT) is associated with increased risk of distant disease and death. The magnitude of this risk has not been adequately characterized in patients with lymph node-negative disease. PATIENTS AND

methodsOur study population included 3,799 women randomly assigned to five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative disease (ie, B-13, B-14, B-19, B-20, and B-23) who underwent lumpectomy and whole breast irradiation with or without adjuvant systemic therapy. Cumulative incidences of ipsilateral breast tumor recurrence (IBTR) and other locoregional recurrence (oLRR) were calculated, along with distant-disease-free interval (DDFI) and overall survival (OS) after these events. Cox models were employed to model mortality by using clinical and pathologic factors jointly with these events.

resultsFour hundred nineteen patients (11.0%) experienced LRF: 342 (9.0%) experienced IBTR, and 77 (2.0%) experienced oLRR. The 12-year cumulative incidences of IBTR and oLRR in patients treated with adjuvant systemic therapy were 6.6% and 1.8%, respectively. Overall, 37.1% of IBTRs and 72.7% of oLRRs occurred within 5 years of diagnosis. Older age, black race, higher body mass index (BMI), larger tumors, and occurrence of IBTR or oLRR were significantly associated with increased mortality. The 5-year OS after IBTR and oLRR were 76.6% and 34.9%, respectively. Adjusted hazard ratios for mortality associated with IBTR and oLRR were significantly higher in estrogen receptor (ER)-negative patients than in ER-positive patients (P = .002 and P < .0001, respectively). Patients with early LRF had worse OS and DDFI than those with later-occurring LRF.

conclusionAlthough LRF is uncommon in patients with node-negative breast cancer who are treated with lumpectomy, radiation, and adjuvant systemic therapy, those who do develop LRF have substantially worse OS and DDFI.

Indexed as

AgedBreast NeoplasmsChemotherapy, AdjuvantCombined Modality TherapyFemaleHumansKaplan-Meier EstimateMastectomy, SegmentalMiddle AgedNeoplasm Recurrence, LocalPrognosisRadiotherapy

Identifiers

PMID19349544
PMCPMC2684852

What OpenQuestion holds

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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.