Discussion
EVENTS
Over the past two decades, the management of early BC has focused on less radical surgeries and axillary management has undergone a paradigm shift along this path. The results of the SINODAR-ONE and ACOSOG Z0011 clinical trials have suggested that ALND can be avoided in cN0 patients with up to two macroscopically positive SLNs who undergo BCS. For patients treated with mastectomy, the clinical value of ALND has not been well defined. There is still controversy over the de-escalation of axillary surgery in patients receiving mastectomy with one to two macrometastatic SLNs, and it remains unclear whether these results can be safely applied to these patientsRetrospective analyses have, however, evaluated the outcomes of BC patients selected for mastectomy with omission of ALND, despite one to two SLN macrometastasesThe available data on axillary management in cN0 T1–2 BC patients undergoing mastectomy with one to two positive SLNs is thus limited to a small number of patients in retrospective studies. To overcome these limitations and evaluate the oncological results of ALND omission, some clinical trials have included cN0 BC patients with positive SLNs selected for mastectomy in their protocols. The BOOG 2013-07 trialThe present sub-analysis of the SINODAR-ONE trial evaluated 218 patients with cN0 T1–2 BC and one to two SLN macrometastases treated with mastectomy. Out of these, 107 patients were assigned to the experimental treatment arm and received SLNB only. Similar to the authors’ previous resultsThe present study has limitations. A subgroup analysis could have led to false-negative results because of the two treatment groups being much smaller than the original study population. The statistical power could, moreover, have been influenced by poor accrual rates and fewer than anticipated events. Additionally, even if post-mastectomy RT rates were significantly different between the treatment arms, no additional or more detailed adjuvant RT data are currently available. Finally, the present trial has a relatively short follow-up time. To strengthen the conclusion of the trial, enrolment of BC patients with one to two positive SLNs and selected for mastectomy was reopened.