Journal Article DKFZ-2023-01063

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Non-inferiority of local control and comparable toxicity of intensity-modulated radiotherapy with simultaneous integrated boost in breast cancer: 5-year results of the IMRT-MC2 phase III trial: IMRT-SIB is non-inferior to 3-D-CRT-seqB in RT for BC patients.

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2023
Elsevier Science Amsterdam [u.a.]

International journal of radiation oncology, biology, physics 117(4), 857-868 () [10.1016/j.ijrobp.2023.05.035]
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Abstract: The IMRT-MC2 trial was conducted to demonstrate non-inferiority of conventionally fractionated intensity-modulated radiotherapy with simultaneous integrated boost (IMRT-SIB) to 3-D-conformal radiotherapy with sequential boost (3-D-CRT-seqB) for adjuvant breast radiotherapy.A total of 502 patients were randomized between 2011 and 2015 for the prospective, multicenter, phase-III-trial (NCT01322854). 5-year results of late toxicity (LENT-SOMA), overall survival, disease-free survival, distant disease-free survival, cosmesis (Harvard scale) and local control (non-inferiority margin at hazard ratio of 3.5) were analyzed after a median follow-up of 62 months.The 5-year LC rate for the IMRT-SIB arm was non-inferior to the control arm (98.7% vs. 98.3%, respectively; HR 0.582, 95%-CI: [0.119-2.375], p=0.4595). Furthermore, there was no significant difference in overall survival (97.1% versus 98.3%, respectively; HR 1.235, 95%-CI: [0.472-3.413], p=0.6697), disease-free survival (95.8% versus 96.1%, respectively; HR 1.130, 95%-CI: [0.487-2.679], p=0.7758) and distant disease-free survival (97.0% versus 97.8%, respectively; HR 1.667, 95%-CI: [0.575-5.434], p=0.3601). After 5 years, late toxicity evaluation and cosmetic assessment further showed no significant differences between treatment arms.The 5-year results of the IMRT-MC2 trial provide strong evidence, that the application of conventionally fractionated simultaneous integrated boost irradiation for breast cancer patients is both safe and effective with non-inferior local control compared to 3-D-conformal radiotherapy with sequential boost.

Keyword(s): 3-D-conformal radiotherapy ; 5-year follow-up ; Breast cancer ; intensity-modulated radiotherapy (IMRT) ; local control ; overall survival ; sequential boost irradiation ; simultaneously integrated boost (SIB)

Classification:

Note: 2023 Nov 15;117(4):857-868 / #LA:E050#

Contributing Institute(s):
  1. E050 KKE Strahlentherapie (E050)
  2. DKTK HD zentral (HD01)
Research Program(s):
  1. 315 - Bildgebung und Radioonkologie (POF4-315) (POF4-315)

Appears in the scientific report 2023
Database coverage:
Medline ; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Ebsco Academic Search ; Essential Science Indicators ; IF >= 5 ; JCR ; NationallizenzNationallizenz ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection
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 Record created 2023-05-30, last modified 2024-02-29



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