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

Radiation Oncology

Amanda Flaquer García¹  Germán Juan Rijo²  Inmaculada Beato Tortajada³  Ana Soler Rodríguez⁴  Manuel Algara López⁵  Xavier Sanz Latiesas⁶  Francisco José Martínez Arcelus⁷  Juan Salinas Ramos⁸  José Reyes Rodríguez garrido⁹  Elvira Rodríguez García^1,10 

[1] Araba Txagorritxu University Hospital, Vitoria, Spain;Radiation Oncology Department, Cabueñes University Hospital, Gijón, Spain;Radiation Oncology Department, Castellón Provincial Hospital, Castellón de La Plana, Spain;Radiation Oncology Department, De La Ribera Hospital, Alzira, Spain;Radiation Oncology Department, Del Mar Hospital, Autonomous University of Barcelona, Hospital del Mar Medical Research Institute, Passeig Maritim, 25, 08003, Barcelona, Spain;Radiation Oncology Department, Del Mar Hospital, Pompeu Fabra University, Hospital del Mar Medical Research Institute, Barcelona, Spain;Radiation Oncology Department, La Fe Polytechnic University Hospital La Fe, Valencia, Spain;Radiation Oncology Department, Santa Lucia General University Hospital, Cartagena, Spain;Radiation Oncology Department, University Hospital of Leon, León, Spain;Radiation Oncology Department, Virgen del Rocío University Hospital, Seville, Spain;

关键词: Breast cancer;    Conserving surgery;    OSNA;    Nodal irradiation;    Incidental dose;   

DOI  :  10.1186/s13014-020-01672-7

来源: Springer

【 摘 要 】

BackgroundConservative 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.MethodsBC 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.DiscussionStandardizing 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.Trial registrationClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957

【 授权许可】

CC BY