Evidence map›Paper›PMID 32375735›Full record

Trial reportBMC cancer2020

Primary surgery versus no surgery in synchronous metastatic breast cancer: patient-reported quality-of-life outcomes of the prospective randomized multicenter ABCSG-28 Posytive Trial.

V Bjelic-Radisic, F Fitzal, M Knauer, G Steger, D Egle, R Greil, P Schrenk, M Balic, Ch Singer, R Exner and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01015625 (Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 5% 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.

NCT01015625 nacompletednot on this map

Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy

TypeinterventionalSponsorAustrian Breast & Colorectal Cancer Study GroupRan2010 to 2022Enrolled90ConditionsSynchronous Metastasized Breast Cancer, Circulating Tumor CellsArmsSurgery, Surgery on Demand
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
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  3. Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
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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

13 authors at 6 institutions in 3 countries.

V Bjelic-RadisicBreast Unit, University Hospital Wuppertal, Heusnerstraße 40, 42283, Wuppertal, Germany. vesna.bjelic-radisic@helios-gesundheit.de.ORCID http://orcid.org/0000-0002-3749-4775
F FitzalDepartment of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
M KnauerBreast Unit, Kantonsspital St. Gallen, St. Gallen, Switzerland.
G StegerDepartment of Internal Medicine, Medical University of Vienna, Vienna, Austria.
D EgleDepartment of Gynecology and Obstetrics, Medical University Innsbruck, Inssbruck, Austria.
R GreilDepartment of Internal Medicine III with Hematology, Medical Oncology, Hemostaseology, Infectious Disease, Rheumatology, Oncologic Center, Laboratory for Immunological and Molecular cancer Reseasrch, Paracelsus Medical University Salzburg, Salzburg, Austria.
P SchrenkDepartment of Surgery, Medical University Linz, Linz, Austria.
M BalicDivision of Oncology, Department of Internal Medicine and Comprehensive Cancer Center, Medical University Graz, Graz, Austria.
Ch SingerDepartment of Gynecology and Obstetrics, Medical University Vienna, Vienna, Austria.
R ExnerDepartment of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
L SoelknerStatistics Department, Austrian Breast and Colorectal Cancer Study Group (ABCSG), Vienna, Austria.
Michael GnantDepartment of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
ABCSG
Comprehensive Cancer Center Vienna · ATMedical University of Graz · ATInnsbruck Medical University · ATKantonsspital St. Gallen · CHParacelsus Medical University · ATUniversity of Wuppertal · DE

Funding

ABCSG naBürgermeister Fond of City Vienna naCancer Aid Styria na
6 · The paper itself

Abstract

backgroundThe ABCSG-28 trial compared primary surgery followed by systemic therapy versus primary systemic therapy without surgery in patients with de novo stage IV BC. The present report describes QoL results of this trial.

methodsNinety patients with primary operable MBC were randomised to surgery of the primary tumor followed by systemic therapy or to primary systemic therapy without surgery. QoL analyses covering the results at baseline, 6,12,18 and 24 months follow up of 79 (88%) patients, was assessed with the EORTC QLQ-C30 and QLQ-BR23 questionnaires.

resultsThere were no statistically significant differences in any of the scales of the QLQ-C30 and QLQ-BR23 questionnaires between the two groups over the time. Baseline global health status and physical functioning were predictors for OS (patients with a higher score lived longer (p=0.0250, p=0.0225; p=0.0355, p=0.0355)). Global health status, social functioning scale, breast symptoms and future perspective were predictors for longer TTPd (p=0.0244; p=0.0140, p=0.020; p=0.0438, p=0.0123). Patients in both arms reported significant improvement on the emotional functioning scale. Cognitive functioning decreased over time in both groups. Younger women had clinically relevant better physical and sexual functioning scores (p=0.039 and 0.024).

conclusionPrimary surgery does not improve nor alter QoL of patients with de novo stage IV BC. Global health status and physical functioning were predictors for OS and could be use as additional marker for prediction of OS and TTTd in patients with de novo stage IV BC.

trial registrationThe trial is registered on clinicaltrial.gov (NCT01015625, date of registration:18/11/2009).

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAdultAgedAged, 80 and overBreast NeoplasmsFemaleFollow-Up StudiesHumansMastectomyMiddle AgedNeoplasm MetastasisPrognosisProspective StudiesSurvival RateYoung Adultbreast cancercancer managementmetastatic cancerquality of life

Identifiers

PMID32375735
PMCPMC7204290
OpenAlexW3021159086

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.