Evidence map›Paper›PMID 25605582›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2015

Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial.

Lorenzo Livi, Icro Meattini, Livia Marrazzo, Gabriele Simontacchi, Stefania Pallotta, Calogero Saieva, Fabiola Paiar, Vieri Scotti, Carla De Luca Cardillo, Paolo Bastiani and 6 more

6 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2015. 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 200 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
200citing papers in PubMed, 17 pooled it
16.2field-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.

NCT02104895 phase3completednot on this map

Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria CareggiRan2005 to 2014Enrolled520ConditionsBreast CancerArmsAccelerated partial breast irradiation (APBI), Whole breast irradiation (WBI)
NCT02386371 nacompletednot on this map

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
NCT03520894 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Radiotherapy in Preoperative Setting With CyberKnife as Treatment in Early Breast Cancer: an Explorative Study

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria CareggiRan2018 to 2024Enrolled25ConditionsEarly Breast CancerArmsNeoadjuvant radiotherapy
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
NCT05071105 narecruitingnot on this mapstarted 2021, after this paper: background citation

Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone

TypeinterventionalSponsorUniversity of Rome Tor VergataRan2021 to 2026Enrolled30ConditionsBreast Neoplasm FemaleArmsStereotactic Body Radiation Therapy
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
3 · Its place in the literature

Who cites it

200 citing papers in PubMed, 17 syntheses or guidelines pooled it, 462 citations in OpenAlex.

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  14. DEGRO practical guideline for partial-breast irradiation.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2020
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  17. Partial breast irradiation for early breast cancer.The Cochrane database of systematic reviews · 2016
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140 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 3 institutions in 1 country.

Lorenzo LiviDepartment of Radiation Oncology, University of Florence, Florence, Italy.
Icro MeattiniDepartment of Radiation Oncology, University of Florence, Florence, Italy. Electronic address: icro.meattini@unifi.it.
Livia MarrazzoMedical Physics Unit, University of Florence, Florence, Italy.
Gabriele SimontacchiDepartment of Radiation Oncology, University of Florence, Florence, Italy.
Stefania PallottaMedical Physics Unit, University of Florence, Florence, Italy.
Calogero SaievaMolecular and Nutritional Epidemiology Unit, ISPO (Cancer Research and Prevention Institute), University of Florence, Florence, Italy.
Fabiola PaiarDepartment of Radiation Oncology, University of Florence, Florence, Italy.
Vieri ScottiDepartment of Radiation Oncology, University of Florence, Florence, Italy.
Carla De Luca CardilloDepartment of Radiation Oncology, University of Florence, Florence, Italy.
Paolo BastianiRadiotherapy Unit, Azienda Sanitaria 10, University of Florence, Florence, Italy.
Lorenzo OrzalesiDepartment of Surgery, University of Florence, Florence, Italy.
Donato CasellaDepartment of Surgery, University of Florence, Florence, Italy.
Luis SanchezDepartment of Surgery, University of Florence, Florence, Italy.
Jacopo NoriDiagnostic Senology Unit, University of Florence, Florence, Italy.
Massimiliano FambriniGynecologic and Obstetrics Unit, University of Florence, Florence, Italy.
Simonetta BianchiDivision of Pathological Anatomy, Department of Medical and Surgical Critical Care, University of Florence, Florence, Italy.
University of Florence · ITAzienda Sanitaria di Firenze · ITPiedmont Reference Center for Epidemiology and Cancer Prevention · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccelerated partial breast irradiation (APBI) has been introduced as an alternative treatment method for selected patients with early stage breast cancer (BC). Intensity-modulated radiotherapy (IMRT) has the theoretical advantage of a further increase in dose conformity compared with three-dimensional techniques, with more normal tissue sparing. The aim of this randomised trial is to compare the local recurrence and survival of APBI using the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation (WBI) in early stage BC.

methodsThis study was performed at the University of Florence (Florence, Italy). Women aged more than 40years affected by early BC, with a maximum pathological tumour size of 25mm, were randomly assigned in a 1:1 ratio to receive either WBI or APBI using IMRT. Patients in the APBI arm received a total dose of 30 Gy to the tumour bed in five daily fractions. The WBI arm received 50Gy in 25 fractions, followed by a boost on the tumour bed of 10Gy in five fractions. The primary end-point was occurrence of ipsilateral breast tumour recurrences (IBTRs); the main analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT02104895.

findingsA total of 520 patients were randomised (260 to external WBI and 260 to APBI with IMRT) between March 2005 and June 2013. At a median follow-up of 5.0 years (Interquartile Range (IQR) 3.4-7.0), the IBTR rate was 1.5% (three cases) in the APBI group (95% confidence interval (CI) 0.1-3.0) and in the WBI group (three cases; 95% CI 0.0-2.8). No significant difference emerged between the two groups (log rank test p=0.86). We identified seven deaths in the WBI group and only one in the APBI group (p=0.057). The 5-year overall survival was 96.6% for the WBI group and 99.4% for the APBI group. The APBI group presented significantly better results considering acute (p=0.0001), late (p=0.004), and cosmetic outcome (p=0.045).

interpretationTo our knowledge, this is the first randomised study using the IMRT technique for APBI delivery. No significant difference in terms of IBTR and overall survival was observed between the two arms. APBI displayed a significantly better toxicity profile.

Indexed as

Radiotherapy, Intensity-ModulatedAdultAgedBreastBreast NeoplasmsFemaleHumansMiddle AgedAccelerated partial breast irradiationIMRTIntensity-modulated radiotherapyPhase 3 trialWhole breast irradiation

Identifiers

PMID25605582
OpenAlexW2146227526

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.