Evidence map›Paper›PMID 30312434›Full record

Trial reportJournal of the National Cancer Institute2019

Presence of Circulating Tumor Cells in High-Risk Early Breast Cancer During Follow-Up and Prognosis.

Elisabeth Trapp, Wolfgang Janni, Christian Schindlbeck, Julia Jückstock, Ulrich Andergassen, Amelie de Gregorio, Marianna Alunni-Fabbroni, Marie Tzschaschel, Arkadius Polasik, Julian G Koch and 11 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of the National Cancer Institute, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 3 pooled it
5.0field-weighted citation impact, top 3% 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

77 citing papers in PubMed, 3 syntheses or guidelines pooled it, 137 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 6 institutions in 2 countries.

Elisabeth TrappDepartment of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.
Wolfgang JanniDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Christian SchindlbeckDepartment of Gynecology and Obstetrics, Clinical Center Traunstein, Traunstein, Germany.
Julia JückstockDepartment of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.
Ulrich AndergassenDepartment of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.
Amelie de GregorioDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Marianna Alunni-FabbroniDepartment of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.
Marie TzschaschelDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Arkadius PolasikDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Julian G KochDepartment of Gynecology and Obstetrics, University Hospital, Ludwig-Maximilians-University, Munich, Germany.
Thomas W P FriedlDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Peter A FaschingDepartment of Obstetrics and Gynecology, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-Nuremberg, Erlangen, Germany.
Lothar HaeberleDepartment of Obstetrics and Gynecology, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-Nuremberg, Erlangen, Germany.
Tanja FehmDepartment of Gynecology and Obstetrics, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany.
Andreas SchneeweissNational Center for Tumor Diseases, Ruprecht-Karls-University Hospital Heidelberg, Heidelberg, Germany.
Matthias W BeckmannDepartment of Obstetrics and Gynecology, Friedrich-Alexander University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-Nuremberg, Erlangen, Germany.
Klaus PantelDepartment of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Volkmar MuellerDepartment of Gynecology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Brigitte RackDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Christoph ScholzDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
SUCCESS Study Group
University Hospital Ulm · DELudwig-Maximilians-Universität München · DEComprehensive Cancer Center Erlangen · DEUniversität Hamburg · DEHeidelberg University · DEHeinrich Heine University Düsseldorf · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prognostic relevance of circulating tumor cells (CTCs) at the time of primary diagnosis has been well established. However, little information is available regarding their prognostic relevance to follow-up care.

methodsThe multicenter, open-label, phase III SUCCESS A trial compared two adjuvant chemotherapy regimens followed by 2 vs 5 years of zoledronate for early-stage, high-risk breast cancer patients. The presence of CTCs was assessed before and 2 years after chemotherapy using the FDA-approved CellSearch System. Overall survival (OS) and disease-free survival (DFS) were analyzed using univariate log-rank tests and multivariable Cox regressions. OS and DFS were measured starting from an assessment of CTCs 2 years after the completion of chemotherapy. All statistical tests were two-sided.

resultsThe sample included 1087 patients who participated in the translational research program of the SUCCESS A trial and for whom sufficient translational data were available regarding CTC status at baseline and at the 2-year follow-up visit. Two years after chemotherapy, 198 (18.2%) patients were CTC-positive. The median follow-up after this timepoint was 37 months. Cox regressions that included CTC status at baseline revealed that CTC status 2 years after chemotherapy had statistically significant and independent prognostic relevance for OS (hazard ratio [HR] = 3.91, 95% confidence interval [CI] = 2.04 to 7.52, P < .001) and DFS (HR = 2.31, 95% CI = 1.50 to 3.55, P < .001).

conclusionThe presence of CTCs 2 years after chemotherapy was associated with decreased OS and DFS. Based on these results, active individualized surveillance strategies for breast cancer survivors based on biomarkers should be reconsidered.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularFemaleFollow-Up StudiesHumansMiddle AgedNeoplastic Cells, CirculatingPrognosisProspective StudiesRisk FactorsSurvival RateYoung Adult

Identifiers

PMID30312434
OpenAlexW2897267414

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.