Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459)
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 inva...
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MDPI AG
2022-03-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/14/6/1396 |
| _version_ | 1797472527258222592 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Gerd Fastner |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-09T20:02:56Z |
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| id | doaj.art-77a78186c4c24de0bb9235e80a735541 |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-09T20:02:56Z |
| publishDate | 2022-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-77a78186c4c24de0bb9235e80a7355412023-11-24T00:40:21ZengMDPI AGCancers2072-66942022-03-01146139610.3390/cancers14061396Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459)Gerd Fastner0Roland Reitsamer1Christoph Gaisberger2Wolfgang Hitzl3Bartosz Urbański4Dawid Murawa5Christiane Matuschek6Wilfried Budach7Antonella Ciabattoni8Juliann Reiland9Marie Molnar10Cristiana Vidali11Claudia Schumacher12Felix Sedlmayer13on behalf of the HIOB Trialist GroupDepartment of Radiotherapy and Radio-Oncology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, 5020 Salzburg, AustriaDepartment of Gynecology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, 5020 Salzburg, AustriaDepartment of Radiotherapy and Radio-Oncology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, 5020 Salzburg, AustriaResearch Office—Biostatistics, Paracelsus Medical University, 5020 Salzburg, AustriaDepartment of Radiotherapy and Gynecological Oncology, Greater Poland Cancer Centre, 61-866 Poznań, PolandClinic of General Surgery and Surgical Oncology, Faculty of Medicine and Health Sciences, University of Zielona Góra, 65-046 Zielona Gora, PolandDepartment of Radiation Oncology, Medical Faculty, Heinrich Heine University, 40225 Düsseldorf, GermanyDepartment of Radiation Oncology, Medical Faculty, Heinrich Heine University, 40225 Düsseldorf, GermanyU.O.C. Radioterapia, San Filippo Neri Hospital, ASL Roma 1, 00135 Rome, ItalyAvera McKennan Hospitals and University Health System, Avera Medical Group Comprehensive Breast Care, Sioux Falls, SD 57105, USADepartment of Radiotherapy and Radiooncology, Landeskrankenhaus Klagenfurt, 9020 Klagenfurt, AustriaDepartment of Radiation Oncology, Azienda Sanitaria Universitaria Integrata di Trieste, 34128 Trieste, ItalyBreast Center, Department of Senology, St. Elisabeth Hospital Cologne-Hohenlind, 50935 Cologne, GermanyDepartment of Radiotherapy and Radio-Oncology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, 5020 Salzburg, AustriaBackground 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.https://www.mdpi.com/2072-6694/14/6/1396hypofractionationwhole breast irradiationintraoperative radiation therapyboostelectronsIOERT |
| spellingShingle | 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 Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459) Cancers hypofractionation whole breast irradiation intraoperative radiation therapy boost electrons IOERT |
| title | Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459) |
| title_full | Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459) |
| title_fullStr | Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459) |
| title_full_unstemmed | Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459) |
| title_short | Hypofractionated Whole Breast Irradiation and Boost-IOERT in Early Stage Breast Cancer (HIOB): First Clinical Results of a Prospective Multicenter Trial (NCT01343459) |
| title_sort | hypofractionated whole breast irradiation and boost ioert in early stage breast cancer hiob first clinical results of a prospective multicenter trial nct01343459 |
| topic | hypofractionation whole breast irradiation intraoperative radiation therapy boost electrons IOERT |
| url | https://www.mdpi.com/2072-6694/14/6/1396 |
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