Quality of life after simultaneously integrated boost with intensity-modulated versus conventional radiotherapy with sequential boost for adjuvant treatment of breast cancer: 2-year results of the multicenter randomized IMRT-MC2 trial.

3-D-conformal radiotherapy Breast cancer Intensity-modulated radiotherapy (IMRT) Quality of life Sequential boost irradiation Simultaneously integrated boost (SIB)

Journal

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
ISSN: 1879-0887
Titre abrégé: Radiother Oncol
Pays: Ireland
ID NLM: 8407192

Informations de publication

Date de publication:
10 2021
Historique:
received: 30 03 2021
revised: 24 08 2021
accepted: 26 08 2021
pubmed: 5 9 2021
medline: 31 12 2021
entrez: 4 9 2021
Statut: ppublish

Résumé

We recently published 2-year results of the prospective, randomized IMRT-MC2 trial, showing non-inferior local control and cosmesis in breast cancer patients after conventionally fractionated intensity-modulated radiotherapy with simultaneously integrated boost (IMRT-SIB), compared to 3D-conformal radiotherapy with sequential boost (3D-CRT-seqB). Here, we report on 2-year quality of life results. 502 patients were enrolled and randomized to IMRT-SIB (50.4 Gy in 1.8 Gy fractions with a 64.4 Gy SIB to the tumor bed) or to 3D-CRT-seqB (50.4 Gy in 1.8 Gy fractions, followed by a sequential boost of 16 Gy in 2 Gy fractions). For quality of life (QoL) assessment, patients completed the QLQ-C30 and QLQ-BR23 questionnaires at baseline, 6 weeks and 2 years after radiotherapy. Significant differences between treatment arms were seen 6 weeks after radiotherapy for pain (22.3 points for IMRT vs. 27.0 points for 3D-CRT-seqB; p = 0.033) and arm symptoms (18.1 points for IMRT vs. 23.6 points for 3D-CRT-seqB; p = 0.013), both favoring IMRT-SIB. Compared to baseline values, both arms showed significant improvement in global score (IMRT: p = 0.009; 3D-CRT: p = 0.001) after 2 years, with slight deterioration on the role (IMRT: p = 0.008; 3-D-CRT: p = 0.001) and social functioning (IMRT: p = 0.013, 3D-CRT: p = 0.001) as well as the future perspectives scale (IMRT: p = 0.003; 3D-CRT: p = 0.0034). This is the first randomized phase III trial demonstrating that IMRT-SIB was associated with slightly superior QoL compared to 3-D-CRT-seqB. These findings further support the clinical implementation of SIB in adjuvant breast cancer treatment.

Sections du résumé

BACKGROUND
We recently published 2-year results of the prospective, randomized IMRT-MC2 trial, showing non-inferior local control and cosmesis in breast cancer patients after conventionally fractionated intensity-modulated radiotherapy with simultaneously integrated boost (IMRT-SIB), compared to 3D-conformal radiotherapy with sequential boost (3D-CRT-seqB). Here, we report on 2-year quality of life results.
PATIENTS AND METHODS
502 patients were enrolled and randomized to IMRT-SIB (50.4 Gy in 1.8 Gy fractions with a 64.4 Gy SIB to the tumor bed) or to 3D-CRT-seqB (50.4 Gy in 1.8 Gy fractions, followed by a sequential boost of 16 Gy in 2 Gy fractions). For quality of life (QoL) assessment, patients completed the QLQ-C30 and QLQ-BR23 questionnaires at baseline, 6 weeks and 2 years after radiotherapy.
RESULTS
Significant differences between treatment arms were seen 6 weeks after radiotherapy for pain (22.3 points for IMRT vs. 27.0 points for 3D-CRT-seqB; p = 0.033) and arm symptoms (18.1 points for IMRT vs. 23.6 points for 3D-CRT-seqB; p = 0.013), both favoring IMRT-SIB. Compared to baseline values, both arms showed significant improvement in global score (IMRT: p = 0.009; 3D-CRT: p = 0.001) after 2 years, with slight deterioration on the role (IMRT: p = 0.008; 3-D-CRT: p = 0.001) and social functioning (IMRT: p = 0.013, 3D-CRT: p = 0.001) as well as the future perspectives scale (IMRT: p = 0.003; 3D-CRT: p = 0.0034).
CONCLUSION
This is the first randomized phase III trial demonstrating that IMRT-SIB was associated with slightly superior QoL compared to 3-D-CRT-seqB. These findings further support the clinical implementation of SIB in adjuvant breast cancer treatment.

Identifiants

pubmed: 34480960
pii: S0167-8140(21)06713-X
doi: 10.1016/j.radonc.2021.08.019
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT01322854']

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

165-176

Informations de copyright

Copyright © 2021 Elsevier B.V. All rights reserved.

Auteurs

Tobias Forster (T)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Adriane Hommertgen (A)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Matthias Felix Häfner (MF)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Nathalie Arians (N)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Laila König (L)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Semi Ben Harrabi (SB)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Ingmar Schlampp (I)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Clara Köhler (C)

Department of Radiation Oncology, Heidelberg University Hospital, Germany.

Eva Meixner (E)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.

Vanessa Heinrich (V)

Department of Radiation Oncology, Eberhard-Karls-University Tuebingen, Germany.

Nicola Weidner (N)

Department of Radiation Oncology, Eberhard-Karls-University Tuebingen, Germany.

Johannes Hüsing (J)

Division of Biostatistics, Coordination Centre for Clinical Trials, University of Heidelberg, Germany.

Christof Sohn (C)

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

Jörg Heil (J)

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

Michael Golatta (M)

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

Holger Hof (H)

Strahlentherapie Rhein-Pfalz, Neustadt, Germany.

David Krug (D)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany; Department of Radiation Oncology, University Hospital Schleswig Holstein, Kiel, Germany.

Jürgen Debus (J)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany; Department of Radiation Oncology, University Hospital Schleswig Holstein, Kiel, Germany; Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg Ion-Beam Therapy Center (HIT), Department of Radiation Oncology, Heidelberg University Hospital, Germany.

Juliane Hörner-Rieber (J)

Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany; Department of Radiation Oncology, University Hospital Schleswig Holstein, Kiel, Germany; German Cancer Consortium (DKTK), partner site, Heidelberg, Germany. Electronic address: juliane.hoerner-rieber@med.uni-heidelberg.de.

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Classifications MeSH