Evidence map›Paper›PMID 33050920›Full record

Trial reportRadiation oncology (London, England)2020

Acute toxicity of normofractionated intensity modulated radiotherapy with simultaneous integrated boost compared to three-dimensional conformal radiotherapy with sequential boost in the adjuvant treatment of breast cancer.

David Krug, Christine Köder, Matthias F Häfner, Nathalie Arians, Semi B Harrabi, Stefan A Koerber, Tobias Forster, Ingmar Schlampp, Christof Sohn, Joerg Heil and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Radiation oncology (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01322854 (Randomized Phase III Trial Comparing Intensity Modulated Radiotherapy With Integrated Boost to Conventional Radiotherapy With Consecutive Boost in Patients With Breast Cancer After Breast Conserving Surgery), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 27% 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.

NCT01322854 phase3unknown statusnot on this map

Randomized Phase III Trial Comparing Intensity Modulated Radiotherapy With Integrated Boost to Conventional Radiotherapy With Consecutive Boost in Patients With Breast Cancer After Breast Conserving Surgery

TypeinterventionalSponsorHeidelberg UniversityRan2011 to 2018Enrolled502ConditionsBreast CancerArmsIMRT with an simultaneous integrated boost
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Intraoperative radiotherapy boost as part of breast-conservation therapy for breast cancer: a single-institution retrospective analysis.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2021
    Article
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 2 institutions in 1 country.

David KrugDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany. david.krug@uksh.de.ORCID http://orcid.org/0000-0001-8811-5416
Christine KöderDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Matthias F HäfnerDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Nathalie AriansDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Semi B HarrabiDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Stefan A KoerberDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Tobias ForsterDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Ingmar SchlamppDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Christof SohnDepartment of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.
Joerg HeilDepartment of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.
Holger HofDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Juliane Hörner-RieberDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Jürgen DebusDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg University · DEGerman Cancer Research Center · DE

Funding

German Aerospace Center (DLR)/Federal Ministry of Education and Research (BMBF) 01ZP0504
6 · The paper itself

Abstract

backgroundIntensity-modulated radiotherapy (IMRT) improves dose homogeneity and late toxicity compared to simple tangential techniques in adjuvant whole-breast radiotherapy for patients with breast cancer. Simultaneous-integrated boost (SIB) radiotherapy shortens the overall treatment time and improves dose homogeneity. However, prospective randomized trials regarding IMRT with SIB for adjuvant radiotherapy in breast cancer are lacking.

methodsThe IMRT-MC2 (MINT) trial is a phase III prospective randomized controlled trial comparing IMRT with SIB (Arm A: whole breast 28 × 1.8 Gy, Boost 28 × 2.3 Gy) to 3D-conformal radiotherapy with a sequential boost (Arm B: whole breast 28 × 1.8 Gy, boost 8 × 2 Gy) in patients with breast cancer after BCS. Indication for boost radiotherapy was defined as age < 70 years or age > 70 years with presence of additional risk factors. This is a retrospective analysis of acute toxicity at one of two trial sites.

resultsFive hundred two patients were randomized, of which 446 patients were eligible for this analysis. There was no statistically significant difference in terms of any grade radiation dermatitis between the two treatment arms at the end of treatment (p = 0.26). However, radiation dermatitis grade 2/3 (29.1% vs. 20.1 and 3.5% vs. 2.3%) occurred significantly more often in Arm A (p = 0.02). Breast/chest wall pain at the first follow-up visit was significantly more common in patients treated on Arm B (p = 0.02).

conclusionsTreatment on both arms was well tolerated, however there were some differences regarding radiodermatitis and breast pain. Further analyses are ongoing.

trial registrationclinicaltrials.gov , NCT01322854 , registered 24th March 2011.

Indexed as

Breast NeoplasmsFemaleHumansMastodyniaMiddle AgedProspective StudiesRadiodermatitisRadiotherapy, AdjuvantRadiotherapy, ConformalRadiotherapy, Intensity-ModulatedRe-IrradiationRetrospective StudiesBoost irradiationBreast-conserving surgeryBreast painRadiation dermatitis

Identifiers

PMID33050920
PMCPMC7557053
OpenAlexW3092626250

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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.