# Omitting Regional Nodal Irradiation after Response to Neoadjuvant Chemotherapy (NSABP B-51 / RTOG 1304)

**Autores:** Eleftherios P Mamounas, Hanna Bandos, Julia R White et al.
**Revista:** N Engl J Med (2025)
**PMID:** 40466065 | **PMCID:** PMC12269788
**DOI:** [10.1056/NEJMoa2414859](https://doi.org/10.1056/NEJMoa2414859)
**Fuente:** PubMed Central (open access full-text)

## Relevancia
PIVOTAL — Ensayo de fase III NSABP B-51/RTOG 1304 (n=1641). Demuestra que la radioterapia regional ganglionar (RNI) NO mejora desenlaces en pacientes cT1-T3 cN1 que alcanzan ypN0 tras QT neoadyuvante. HR 0.88 (IC95% 0.60-1.28; p=0.51) para el intervalo libre de recurrencia. Constituye la base para omitir RNI en este escenario y es la pieza central del proyecto.

## Abstract
The benefit of regional nodal irradiation in the treatment of breast cancer is well established for patients with pathologically positive axillary nodes, but whether it is also beneficial for patients whose nodes become pathologically tumor free (ypN0) after neoadjuvant chemotherapy remains unclear.

We evaluated whether regional nodal irradiation improves outcomes in patients with biopsy-proven, node-positive breast cancer who reach ypN0 status after neoadjuvant chemotherapy. Patients with breast cancer with a clinical stage of T1 to T3 (tumor size, ≤2 cm to >5 cm), N1, and M0 (indicating spread to one to three axillary lymph nodes but no distant metastasis) who had ypN0 status after neoadjuvant chemotherapy were randomly assigned to receive regional nodal irradiation or no regional nodal irradiation. The primary end point was the interval of freedom from invasive breast cancer recurrence or death from breast cancer (invasive breast cancer recurrence-free interval). Secondary end points included the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival, and overall survival. Safety was also assessed.

A total of 1641 patients were enrolled in the trial; 1556 were included in the primary-event analysis: 772 in the irradiation group and 784 in the no-irradiation group. After a median follow-up of 59.5 months, 109 primary end-point events (50 in the irradiation group and 59 in the no-irradiation group) had occurred. Regional nodal irradiation did not significantly increase the invasive breast cancer recurrence-free interval (hazard ratio, 0.88; 95% confidence interval, 0.60 to 1.28; P = 0.51). Point estimates of survival free from the primary end-point events were 92.7% in the irradiation group and 91.8% in the no-irradiation group. Regional nodal irradiation did not increase the locoregional recurrence-free interval, the distant recurrence-free interval, disease-free survival, or overall survival. No deaths related to the protocol-specified therapy were reported, and no unexpected adverse events were observed. Grade 4 adverse events occurred in 0.5% of patients in the irradiation group and 0.1% of those in the no-irradiation group.

The addition of adjuvant regional nodal irradiation did not decrease the risk of invasive breast cancer recurrence or death from breast cancer in patients who had negative axillary nodes after neoadjuvant chemotherapy. (Funded by the National Institutes of Health; NSABP B-51-Radiation Therapy Oncology Group 1304 ClinicalTrials.gov number, NCT01872975.).

## Texto completo
Texto completo disponible en PMC: [PMC12269788](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12269788/). El artículo presenta el ensayo NSABP B-51/RTOG 1304 con 1641 pacientes cT1-T3, cN1, M0 biopsy-proven node-positive que alcanzan ypN0 tras QT neoadyuvante. Randomización 1:1 a recibir o no radioterapia regional ganglionar (RNI). Endpoint primario: intervalo libre de recurrencia invasiva. Conclusión: la adición de RNI adyuvante NO disminuyó el riesgo de recurrencia invasiva ni muerte por cáncer de mama en pacientes con ypN0 tras QTNA. Recomendación implícita: omisión de RNI es razonable en este subgrupo. Es el principal soporte de evidencia (clase 1) para la des-escalación radioterápica post-NAC.

---
*Datos de PubMed. Citar: doi 10.1056/NEJMoa2414859*
