OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial

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• dc.contributor.author Algara López, Manuel-Ignacio
• dc.contributor.author Rodríguez García, Elvira
• dc.contributor.author Beato Tortajada, Inmaculada
• dc.contributor.author Martínez Arcelus, Francisco José
• dc.contributor.author Salinas Ramos, Juan
• dc.contributor.author Rodríguez Garrido, José Reyes
• dc.contributor.author Sanz Latiesas, Javier, 1967-
• dc.contributor.author Soler Rodríguez, Ana
• dc.contributor.author Juan Rijo, Germán
• dc.contributor.author Flaquer Garcí, Amanda
• dc.date.accessioned 2022-02-03T07:35:22Z
• dc.date.available 2022-02-03T07:35:22Z
• dc.date.issued 2020
• dc.description.abstract Background: Conservative surgery followed by breast and nodal irradiation is the standard loco-regional early breast cancer (BC) treatment for patients with four or more involved lymph nodes. However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive nodal status assessment molecular techniques as the One-Step Nucleic Acid Amplification (OSNA) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN. Methods: BC patients who underwent conservative surgery and whose SLN total tumour load assessed with OSNA ranged between 250-15,000 copies/µL will be eligible. Patients will be randomized to receive irradiation on the breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on the breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity and loco-regional and distant disease recurrence rates. Discussion: Standardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus. Hence, the quantitative score for the metastatic burden of SLN provided by OSNA can contribute by improving the discrimination of which BC patients with limited nodal involvement can benefit from incidental radiation as an adjuvant treatment strategy.
• dc.format.mimetype application/pdf
• dc.identifier.citation Algara López M, Rodríguez García E, Beato Tortajada I, Martínez Arcelus FJ, Salinas Ramos J, Rodríguez Garrido JR, et al. OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial. Radiat Oncol. 2020 Oct 2; 15(1): 229. DOI: 10.1186/s13014-020-01672-7
• dc.identifier.doi http://dx.doi.org/10.1186/s13014-020-01672-7
• dc.identifier.issn 1748-717X
• dc.identifier.uri http://hdl.handle.net/10230/52410
• dc.language.iso eng
• dc.publisher BioMed Central
• dc.rights Copyright © The Author(s) 2020. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Breast cancer
• dc.subject.keyword Conserving surgery
• dc.subject.keyword Incidental dose
• dc.subject.keyword Nodal irradiation
• dc.subject.keyword OSNA
• dc.title OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion