OPTimizing Irradiation Through Molecular Assessment of Lymph Node (OPTIMAL): a Randomized Open Label Trial

Overview

Journal Radiat Oncol

Publisher Biomed Central

Specialties Oncology
Radiology

Date 2020 Oct 3

PMID 33008422

Citations 2

Authors

Manuel Algara Lopez

Elvira Rodriguez Garcia

Inmaculada Beato Tortajada

Francisco Jose Martinez Arcelus

Juan Salinas Ramos

Jose Reyes Rodriguez Garrido

Xavier Sanz Latiesas

Ana Soler Rodriguez

German Juan Rijo

Amanda Flaquer Garcia

Affiliations

Soon will be listed here.

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.

Trial Registration: ClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957.

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Survival and recurrence with or without axillary dissection in patients with invasive breast cancer and sentinel node metastasis.

Monteiro Sanvido V, Elias S, Facina G, Bromberg S, Nazario A Sci Rep. 2021; 11(1):19893.

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