RT Journal Article
T1 OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized clinical trial.
A1 Algara, Manuel
A1 Rodríguez, Elvira
A1 Martínez-Arcelus, Francisco José
A1 Salinas, Juan
A1 Sanz, Xavier
A1 Beato, Inmaculada
A1 Manso, Aurea
A1 Soler, Ana
A1 Rodríguez, José Reyes
A1 Frías, Andere
A1 Calín, Ana
A1 Juan, Germán
A1 Meireles, Pedro
A1 Flaquer, Amanda
A1 OPTIMAL investigators, 
K1 Breast cancer
K1 Breast-conserving surgery
K1 Incidental irradiation
K1 Nodal irradiation
K1 OSNA
K1 Sentinel lymph node
AB In breast cancer (BC) patients, the involvement of four or more lymph nodes (LN) is an indication of regional irradiation. The optimal treatment strategy remains unclear when fewer nodes are involved and lymphadenectomy is not performed. We designed a clinical trial to show the non-inferiority of Incidental (INC) compared to intentional (INT) irradiation of axillary nodes in patients with early-stage BC and low burden LN involvement. BC patients, cN0 (n = 487) undergoing breast conservation surgery and sentinel node biopsy, with total tumor load assessed by OSNA (One-Step Nucleic Acid Amplification) of 250-15,000 copies mRNA CK19/µL in sentinel LN were randomized to receive INC or INT nodal irradiation. The primary endpoint was 5-year disease-free survival (DFS). Secondary endpoints were locoregional recurrence (LRR), distant recurrence (DR), and acute and chronic toxicity (CT). Five-years DFS were 93.7% (INC) and 93.8% (INT) (difference 0.1% [one-sided 95% CI  Intentional does not outperform incidental irradiation by more than 5.7% in terms of 5-year DFS, 4.8% for LRR, and 6% for DR. ClinicalTrials.gov Identifier: NCT02335957.
YR 2022
FD 2022-09-19
LK http://hdl.handle.net/10668/22481
UL http://hdl.handle.net/10668/22481
LA en
DS RISalud
RD Apr 11, 2025