Evidence map›Paper›PMID 26494415›Full record

Trial reportLancet (London, England)2016

5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial.

Vratislav Strnad, Oliver J Ott, Guido Hildebrandt, Daniela Kauer-Dorner, Hellen Knauerhase, Tibor Major, Jaroslaw Lyczek, Jose Luis Guinot, Jürgen Dunst, Cristina Gutierrez Miguelez and 21 more

6 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 247 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
247citing papers in PubMed, 16 pooled it
27.4field-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.

NCT00402519 phase3unknown statusnot on this map

Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ (DCIS) of the Female Breast

TypeinterventionalSponsorUniversity of Erlangen-Nürnberg Medical SchoolRan2004 to 2019Enrolled1,300ConditionsBreast CancerArmsAccelerated partial breast irradiation, External beam whole breast irradiation
NCT04282122 recruitingnot on this mapstarted 2019, after this paper: background citation

Establishment of a Prospective Evaluation of Daily Practice Including the Individual Radiosensitivity Test to the Decision of Daily Practice

TypeobservationalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2019 to 2026Enrolled500ConditionsBreast CancerArmsRadiotherapy
NCT04669873 narecruitingnot on this mapstarted 2021, after this paper: background citation

Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery

TypeinterventionalSponsorInstituto Brasileiro de Controle do CancerRan2021 to 2026Enrolled36ConditionsMalignant Neoplasm of BreastArmsActive Comparator: Standard, Experimental 1: Hypofractionated radiotherapy, Experimental 2: Accelerated Partial Breast Irradiation
NCT05142202 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Doubly Accelerated Partial Breast Irradiation After Breast-Conserving Surgery for Early Breast Cancer - High Five (HiFi) APBI Study

TypeinterventionalSponsorThe Greater Poland Cancer CentreRan2021 to 2025Enrolled147ConditionsBreast CancerArmsBreast Irradiation after Breast-Conserving Surgery
NCT05591547 phase2active not recruitingnot on this mapstarted 2022, after this paper: background citation

SH APBI RISE: Evaluating the Safety and Efficacy of a Novel IMRT/VMAT-based Accelerated Partial Breast Irradiation Regimen for patIents With Favorable Risk breaSt cancEr

TypeinterventionalSponsorSanford HealthRan2022 to 2027Enrolled91ConditionsBreast CancerArmsIMRT/VMAT-Based Accelerated Partial Breast Irradiation
NCT06946238 narecruitingnot on this mapstarted 2025, after this paper: background citation

Accelerated Partial Breast Irradiation in One Fraction for Patients With Early-stage Disease and Favorable Histological Subtypes (Breast-1F).

TypeinterventionalSponsorIRCCS San RaffaeleRan2025 to 2035Enrolled311ConditionsBreast CancerArmsAdjuvant single-fraction accelerated partial breast irradiation
3 · Its place in the literature

Who cites it

247 citing papers in PubMed, 16 syntheses or guidelines pooled it, 654 citations in OpenAlex.

  1. Pooled it
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  10. DEGRO practical guideline for partial-breast irradiation.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2020
    Guideline
  11. Pooled it
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  13. Systematic Review of Intensity-Modulated Brachytherapy (IMBT): Static and Dynamic Techniques.International journal of radiation oncology, biology, physics · 2019
    Pooled it
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  16. Guideline
  17. Trial
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  19. 5-year results of accelerated partial breast irradiation (APBI) with SBRT (stereotactic body radiation therapy) and exactrac adaptive gating (NovalisClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors at 19 institutions in 7 countries.

Vratislav StrnadDepartment of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany. Electronic address: vratislav.strnad@uk-erlangen.de.
Oliver J OttDepartment of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.
Guido HildebrandtDepartment of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
Daniela Kauer-DornerDepartment of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria.
Hellen KnauerhaseDepartment of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
Tibor MajorCenter of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
Jaroslaw LyczekBrachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskej, Warsaw, Poland; Podkarpacki Hospital Cancer Center Brzozów, Brzozów, Poland.
Jose Luis GuinotDepartment of Radiation Oncology, Valencian Institute of Oncology, Valencia, Spain.
Jürgen DunstDepartment of Radiation Oncology, University Hospital Kiel, Germany.
Cristina Gutierrez MiguelezDepartment of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
Pavel SlampaDepartment of Radiation Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic.
Michael AllgäuerDepartment of Radiation Oncology, Hospital Barmherzige Brüder Regensburg, Regensburg, Germany.
Kristina LösslDepartment of Radiation Oncology, University Hospital Bern, Inselspital, Bern, Switzerland.
Bülent PolatDepartment of Radiation Oncology, University Hospital Würzburg, Würzburg, Germany.
György KovácsInterdisciplinary Brachytherapy Unit, University of Lübeck/UKSH Campus Lübeck, Lübeck, Germany.
Arnt-René FischedickDepartment of Radiation Oncology, Clemens Hospital, Münster, Germany.
Thomas G WendtDepartment of Radiation Oncology, University Hospital Jena, Jena, Germany.
Rainer FietkauDepartment of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
Marion HindemithDepartment of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.
Alexandra ReschDepartment of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria.
Anna KulikBrachytherapy Department, Centrum Onkologii-Instytut im Marii Skłodowskej, Warsaw, Poland.
Leo ArribasDepartment of Radiation Oncology, Valencian Institute of Oncology, Valencia, Spain.
Peter NiehoffDepartment of Radiation Oncology, University Hospital Kiel, Germany; Department of Radiotherapy, Municipal Hospital Cologne, University Witten-Herdecke, Witten, Germany.
Fernando GuedeaDepartment of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
Annika SchlamannDepartment of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.
Richard PötterDepartment of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria.
Christine GallDepartment of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany.
Martina MalzerDepartment of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany.
Wolfgang UterDepartment of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany.
Csaba PolgárCenter of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
Groupe Européen de Curiethérapie of European Society for Radiotherapy and Oncology (GEC-ESTRO)
Friedrich-Alexander-Universität Erlangen-Nürnberg · DEUniversitätsklinikum Erlangen · DEUniversity Hospital Leipzig · DEVienna General Hospital · ATCentrum Onkologii · PLFundación Instituto Valenciano de Oncología · ESNational Institute of Oncology · HUClemenshospital Münster · DEInstitut Català d'Oncologia · ESInstitut Català d'Ornitologia · ESJena University Hospital · DEKrankenhaus Barmherzige Brüder · DEMasaryk Memorial Cancer Institute · CZUniversitätsklinikum Würzburg · DEUniversity Hospital of Bern · CHUniversity Hospital Schleswig-Holstein · DEUniversity of Lübeck · DEUniversity of Rostock · DEWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn a phase 3, randomised, non-inferiority trial, accelerated partial breast irradiation (APBI) for patients with stage 0, I, and IIA breast cancer who underwent breast-conserving treatment was compared with whole-breast irradiation. Here, we present 5-year follow-up results.

methodsWe did a phase 3, randomised, non-inferiority trial at 16 hospitals and medical centres in seven European countries. 1184 patients with low-risk invasive and ductal carcinoma in situ treated with breast-conserving surgery were centrally randomised to either whole-breast irradiation or APBI using multicatheter brachytherapy. The primary endpoint was local recurrence. Analysis was done according to treatment received. This trial is registered with ClinicalTrials.gov, number NCT00402519.

findingsBetween April 20, 2004, and July 30, 2009, 551 patients had whole-breast irradiation with tumour-bed boost and 633 patients received APBI using interstitial multicatheter brachytherapy. At 5-year follow-up, nine patients treated with APBI and five patients receiving whole-breast irradiation had a local recurrence; the cumulative incidence of local recurrence was 1.44% (95% CI 0.51-2.38) with APBI and 0.92% (0.12-1.73) with whole-breast irradiation (difference 0.52%, 95% CI -0.72 to 1.75; p=0.42). No grade 4 late side-effects were reported. The 5-year risk of grade 2-3 late side-effects to the skin was 3.2% with APBI versus 5.7% with whole-breast irradiation (p=0.08), and 5-year risk of grade 2-3 subcutaneous tissue late side-effects was 7.6% versus 6.3% (p=0.53). The risk of severe (grade 3) fibrosis at 5 years was 0.2% with whole-breast irradiation and 0% with APBI (p=0.46).

interpretationThe difference between treatments was below the relevance margin of 3 percentage points. Therefore, adjuvant APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is not inferior to adjuvant whole-breast irradiation with respect to 5-year local control, disease-free survival, and overall survival.

fundingGerman Cancer Aid.

Indexed as

AdultAgedBrachytherapyBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma in SituCatheters, IndwellingCombined Modality TherapyFemaleHumansMastectomy, SegmentalMiddle AgedRadiotherapy DosageTreatment Outcome

Identifiers

PMID26494415
OpenAlexW2178502550

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.