OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL) : a randomized open label trial
Algara, Manuel (Institut Hospital del Mar d'Investigacions Mèdiques)
Rodríguez García, Elvira (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Beato Tortajada, Inmaculada (Consorci Hospitalari Provincial de Castelló)
Martínez Arcelus, Francisco José (Hospital Universitari i Politècnic La Fe (València))
Salinas Ramos, Juan (Hospital General Universitario Santa Lucía (Cartagena, Múrcia))
Rodríguez garrido, José Reyes (Hospital Universitario de León)
Sanz Latiesas, Xavier (Institut Hospital del Mar d'Investigacions Mèdiques)
Soler Rodríguez, Ana (Hospital Universitari de la Ribera (València))
Juan Rijo, Germán (Hospital Universitario de Cabueñes (Gijón))
Flaquer García, Amanda (Arabako Unibertsitate Ospitalea (Vitoria, País Basc))
Universitat Autònoma de Barcelona

Data:	2020
Resum:	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. 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. 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. ClinicalTrial. gov, NCT02335957;.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; altres ; Versió publicada
Matèria:	Breast cancer ; Conserving surgery ; OSNA ; Nodal irradiation ; Incidental dose
Publicat a:	Radiation oncology, Vol. 15 (october 2020) , ISSN 1748-717X

DOI: 10.1186/s13014-020-01672-7
PMID: 33008422

9 p, 1.2 MB

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