Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459)

Autor: Gerd Fastner, Roland Reitsamer, Christoph Gaisberger, Wolfgang Hitzl, Bartosz Urbański, Dawid Murawa, Christiane Matuschek, Wilfried Budach, Antonella Ciabattoni, Juliann Reiland, Marie Molnar, Cristiana Vidali, Claudia Schumacher, Felix Sedlmayer, on behalf of the HIOB Trialist Group
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Cancers, Vol 14, Iss 6, p 1396 (2022)
Druh dokumentu: article
ISSN: 2072-6694
DOI: 10.3390/cancers14061396
Popis: Background and purpose: To investigate intraoperative electron radiation therapy (IOERT) as a tumor bed boost during breast conserving surgery (BCS) followed by hypofractionated whole breast irradiation (HWBI) on age-correlated in-breast recurrence (IBR) rates in patients with low- to high-risk invasive breast cancer. Material and methods: BCS and IOERT (11.1 Gy) preceded a HWBI (40.5 Gy) in 15 fractions. Five-year IBR-rates were compared by a sequential ratio test (SQRT) with best evidences in three age groups (35–40 y and 41–50 y: 3.6%, >50 y: 2%) in a prospective single arm design. Null hypothesis (H0) was defined to undershoot these benchmarks for proof of superiority. Results: Of 1445 enrolled patients, 326 met exclusion criteria, leaving 1119 as eligible for analysis. After a median follow-up of 50 months (range 0.7–104), we detected two local recurrences, both in the age group >50 y. With no observed IBR, superiority was demonstrated for the patient groups 41–50 and >50 y, respectively. For the youngest group (35–40 y), no appropriate statistical evaluation was yet possible due to insufficient recruitment. Conclusions: In terms of five-year IBR-rates, Boost-IOERT followed by HWBI has been demonstrated to be superior in patients older than 50 and in the age group 41–50 when compared to best published evidence until 2010.
Databáze: Directory of Open Access Journals
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