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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Wednesday, January 17, 2024
Findings from the SENOMAC trial, presented at the 2023 San Antonio Breast Cancer Symposium (SABCS; Abstract GS02-06), suggest the omission of completion axillary lymph node dissection (ALND) may not impact recurrence-free survival in patients with clinically node-positive breast cancer. The noninferiority trial sought to build knowledge regarding patients who undergo mastectomy, have large tumors, or experience sentinel lymph node extracapsular extension.
“Despite extended inclusion criteria, there was no difference in recurrence-free survival whether completion ALND was omitted (intervention) or not (standard),” noted Jana de Boniface, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues. “Patients undergoing mastectomy will specifically be addressed in subgroup analyses.”
Between January 2015 and December 2021, the trial enrolled 2,766 patients at 67 sites across five countries. Enrollment criteria included a diagnosis of cT1–3cN0 primary breast cancer and one to two sentinel lymph node macrometastases. The per-protocol population consisted of 2,539 patients who were randomly assigned to undergo completion ALND in the standard group (n = 1,204) or to avoid completion ALND in the intervention group (n = 1,335). Recurrence-free survival was comparable between the groups (country-adjusted hazard ratio [HR] = 0.89, 95% confidence interval [CI] = 0.65–1.20).
Median patient age was 61 years; median follow-up was 37.1 months. The majority of tumors were luminal (93.6%), and most tumors were either stage T1 (53.5%) or T2 (40.7%). Roughly one-third of participants had sentinel lymph node extracapsular extension (34.1%). Overall, 918 patients (36.2%) underwent mastectomy. A total of 104 recurrences were noted, split nearly evenly across the standard (n = 54) and intervention (n = 50) groups.
“Long-term follow-up is crucial considering the high proportion of luminal cancers,” concluded the authors.
Disclosure: Dr. de Boniface reported no conflicts of interest.
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