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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.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.issn 1748-717X
dc.identifier.uri http://hdl.handle.net/10230/52410
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.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.uri http://creativecommons.org/licenses/by/4.0/
dc.title OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1186/s13014-020-01672-7
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.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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