Top Line: Does axillary lymph node dissection improve outcomes in breast cancer patients with 1-2 positive sentinel lymph nodes (SLN).
The Study: The Z0011 trial questioned the benefit of axillary lymph node dissection (ALND) in women with 1-2 positive sentinel lymph nodes. SINODAR-ONE was a randomized noninferiority trial comparing recurrence and survival outcomes with or without ALND. Eligible patients (n=889) were between 45 and 75 with T1-2 invasive breast cancer who were clinically node negative and had 1 or 2 sentinel lymph node macrometastases. They were randomized to no further surgery or axillary lymph node dissection with removal of 10 or more nodes. In both arms, patients received standard adjuvant therapy, which consisted of whole breast radiation in those who had breast conservation surgery (75.2%), but no nodal radiation. A small number (17.4%) of mastectomy patients received radiation. Nearly half (48.7%) received adjuvant chemotherapy. In the ALND arm, 44% had additional positive non-sentinel nodes including 22.1% with one, 8.9% with two, 3.2% with three, and 9.8% with more than three. At 5 years, survival was non-inferior with SLNB alone (98.8% v 98.9%). There was also no difference in the cumulative incidence in recurrence with SLNB (3.3% v 6.9%). Recurrences were primarily distant with only one regional lymph node failure in each arm.
TBL: Overall and axillary recurrence is exceedingly low in patients with T1-2 breast cancer with 1-2 positive SLN who receive mastectomy or lumpectomy and whole breast radiation. | Tinterri, Ann Surg Oncol 2022