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.


Journal

Radiation oncology (London, England)
ISSN: 1748-717X
Titre abrégé: Radiat Oncol
Pays: England
ID NLM: 101265111

Informations de publication

Date de publication:
13 Oct 2020
Historique:
received: 22 06 2020
accepted: 20 08 2020
entrez: 14 10 2020
pubmed: 15 10 2020
medline: 31 7 2021
Statut: epublish

Résumé

Intensity-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. The 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. Five 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). Treatment on both arms was well tolerated, however there were some differences regarding radiodermatitis and breast pain. Further analyses are ongoing. clinicaltrials.gov , NCT01322854 , registered 24th March 2011.

Sections du résumé

BACKGROUND BACKGROUND
Intensity-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.
METHODS METHODS
The 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.
RESULTS RESULTS
Five 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).
CONCLUSIONS CONCLUSIONS
Treatment on both arms was well tolerated, however there were some differences regarding radiodermatitis and breast pain. Further analyses are ongoing.
TRIAL REGISTRATION BACKGROUND
clinicaltrials.gov , NCT01322854 , registered 24th March 2011.

Identifiants

pubmed: 33050920
doi: 10.1186/s13014-020-01652-x
pii: 10.1186/s13014-020-01652-x
pmc: PMC7557053
doi:

Banques de données

ClinicalTrials.gov
['NCT01322854']

Types de publication

Clinical Trial, Phase III Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

235

Subventions

Organisme : German Aerospace Center (DLR)/Federal Ministry of Education and Research (BMBF)
ID : 01ZP0504

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Auteurs

David Krug (D)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany. david.krug@uksh.de.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany. david.krug@uksh.de.
Department of Radiation Oncology, University Hospital Schleswig-Holstein, Campus Kiel, Arnold-Heller-Str. 3, 24105, Kiel, Germany. david.krug@uksh.de.

Christine Köder (C)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.

Matthias F Häfner (MF)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.

Nathalie Arians (N)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.

Semi B Harrabi (SB)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.

Stefan A Koerber (SA)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.

Tobias Forster (T)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.

Ingmar Schlampp (I)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.

Christof Sohn (C)

Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.

Joerg Heil (J)

Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.

Holger Hof (H)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.
Strahlentherapie Rhein-Pfalz, Neustadt, Germany.

Juliane Hörner-Rieber (J)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.

Jürgen Debus (J)

Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Research in Oncology (NCRO), Heidelberg, Germany.
German Cancer Consortium (DKTK), Partner site Heidelberg, Heidelberg, Germany.

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