Abstract
To evaluate the impact of regional nodal irradiation (RNI) on the loco-regional recurrence free survival (LRFS), distant metastases free survival (DMFS) and overall survival (OS) in breast cancer patients with node positive disease who received neoadjuvant chemotherapy (NAC) and became ypN0.From January 1st 2016 till December 31st 2019, 231 patients with node positive breast cancer who received NAC and became ypN0 were randomized to receive whole breast irradiation/post mastectomy irradiation with or without RNI. One hundred and twelve patients were included in the regional nodal irradiation arm (RNI+) and 119 patients were included in the no regional nodal irradiation arm (RNI-).Median follow up was 24 months (range, 1-55 months). No regional nodal failures were recorded in both groups. The actuarial LRFS was 98.2% in the RNI+ arm and 100% in the RNI- arm (P 0.28). The actuarial DMFS was 93.6% in the RNI+ arm and 97.4% in the RNI- arm (P 0.93). The actuarial OS was 96.3% in the RNI+ arm and 99.1% in the RNI- arm (P 0.75). Cox univariate regression analysis revealed initial tumor size > 5 cm (HR 1.276, CI 1.054-1.543, P 0.012) was the only factor associated with increased incidence of distant metastases. Age younger than 35 years was associated with worsened survival (HR 0.866, CI 0.760-0.986, P 0.03).In the current interim analysis, omission of regional nodal irradiation did not compromise the outcomes in clinically node positive patients who received NAC and had ypN0 disease.
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