Cosmetic Results and Side Effects of Accelerated Partial-Breast Irradiation Versus Whole-Breast Irradiation for Low-Risk Invasive Carcinoma of the Breast: The Randomized Phase III IRMA Trial.

Autor:	Meduri B; Department of Radiation Oncology, University Hospital of Modena, Modena, Italy., Baldissera A; Department of Radiation Oncology, Bellaria Hospital-AUSL Bologna, Bologna, Italy., Iotti C; Department of Radiation Oncology, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy., Scheijmans LJEE; Department of Radiation Oncology, Instituut Verbeeten, Tilburg, the Netherlands., Stam MR; Radiotherapiegroep, Arnhem/Ede, the Netherlands., Parisi S; Department of Radiation Oncology, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy., Boersma LJ; Department of Radiation Oncology (Maastro), Maastricht University Medical Centre+-GROW School for Oncology and Reproduction, Maastricht, the Netherlands., Ammendolia I; Department of Radiation Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Koiter E; Department of Radiation Oncology, Medisch Spectrum Twente, Enschede, the Netherlands., Valli M; Department of Radiation Oncology, IOSI (Oncology Institute of Italian Switzerland), Bellinzona, Switzerland., Scandolaro L; Department of Radiation Oncology, Presidio Ospedaliero S.Anna-ASST Lariana, San Fermo della Battaglia-Como, Italy., Busz D; Department of Radiation Oncology, University of Groningen-University Medical Center Groningen, Groningen, the Netherlands., Stenfert Kroese MC; Radiotherapiegroep, Deventer/Apeldoorn, the Netherlands., Ciabatti S; Department of Radiation Oncology, Bellaria Hospital-AUSL Bologna, Bologna, Italy., Giacobazzi P; Department of Radiation Oncology, University Hospital of Modena, Modena, Italy., Ruggieri MP; Department of Radiation Oncology, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy., Engelen A; Department of Radiation Oncology, Instituut Verbeeten, Tilburg, the Netherlands., Munafò T; Department of Radiation Oncology, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy., Westenberg AH; Radiotherapiegroep, Arnhem/Ede, the Netherlands., Verhoeven K; Department of Radiation Oncology (Maastro), Maastricht University Medical Centre+-GROW School for Oncology and Reproduction, Maastricht, the Netherlands., Vicini R; Department of Methodological and Statistical Support for Clinical Research, University Hospital of Modena, Modena, Italy., D'Amico R; Department of Methodological and Statistical Support for Clinical Research, University Hospital of Modena, Modena, Italy.; Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy., Lohr F; Department of Radiation Oncology, University Hospital of Modena, Modena, Italy., Bertoni F; Department of Radiation Oncology, University Hospital of Modena, Modena, Italy., Poortmans P; Department of Radiation Oncology, Iridium Netwerk, Wilrijk-Antwerp, Belgium.; Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk-Antwerp, Belgium., Frezza GP; Department of Radiation Oncology, Bellaria Hospital-AUSL Bologna, Bologna, Italy.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Apr 20; Vol. 41 (12), pp. 2201-2210. Date of Electronic Publication: 2023 Jan 09.
DOI:	10.1200/JCO.22.01485
Abstrakt:	Purpose: The results in terms of side effects vary among the published accelerated partial-breast irradiation (APBI) studies. Here, we report the 5-year results for cosmetic outcomes and toxicity of the IRMA trial. Methods: We ran this randomized phase III trial in 35 centers. Women with stage I-IIA breast cancer treated with breast-conserving surgery, age ≥ 49 years, were randomly assigned 1:1 to receive either whole-breast irradiation (WBI) or external beam radiation therapy APBI (38.5 Gy/10 fraction twice daily). Patients and investigators were not masked to treatment allocation. The primary end point was ipsilateral breast tumor recurrence. We hereby present the analysis of the secondary outcomes, cosmesis, and normal tissue toxicity. All side effects were graded with the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer Radiation Morbidity Scoring Schema. Analysis was performed with both intention-to-treat and as-treated approaches. Results: Between March 2007 and March 2019, 3,309 patients were randomly assigned to 1,657 WBI and 1,652 APBI; 3,225 patients comprised the intention-to-treat population (1,623 WBI and 1,602 APBI). At a median follow-up of 5.6 (interquartile range, 4.0-8.4) years, adverse cosmesis in the APBI patients was higher than that in the WBI patients at 3 years (12.7% v 9.2%; P = .009) and at 5 years (14% v 9.8%; P = .012). Late soft tissue toxicity (grade ≥ 3: 2.8% APBI v 1% WBI, P < .0001) and late bone toxicity (grade ≥ 3: 1.1% APBI v 0% WBI, P < .0001) were significantly higher in the APBI arm. There were no significant differences in late skin and lung toxicities. Conclusion: External beam radiation therapy-APBI with a twice-daily IRMA schedule was associated with increased rates of late moderate soft tissue and bone toxicities, with a slight decrease in patient-reported cosmetic outcomes at 5 years when compared with WBI, although overall toxicity was in an acceptable range.
Databáze:	MEDLINE
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