In a retrospective study (OPBC-05/ICARO) reported in the Journal of Clinical Oncology, Montagna et al found that nodal burden in patients with breast cancer with residual isolated tumor cells after neoadjuvant chemotherapy (ypN0[i1]) was low and that axillary recurrence after omission of axillary lymph node dissection (ALND) was uncommon.
As stated by the investigators: “The nodal burden of patients with residual … [isolated tumor cells] in the sentinel lymph nodes [SLNs] after … [neoadjuvant chemotherapy] (ypN0i1) is unknown, and axillary management is not standardized. We investigated rates of additional positive lymph nodes at …ALND and oncologic outcomes in patients with ypN0i1 treated with and without ALND.”
Study Details and Key Findings
The study included 583 patients from sites in 18 countries who had stage I to III breast cancer with residual isolated tumor cells in sentinel lymph nodes after neoadjuvant chemotherapy. The primary outcome measure was the 3-year rate of any axillary recurrence. Among the 583 patients, 182 (31%) had completion ALND, and 401 (69%) did not have ALND.
Median patient age was 48 years. A total of 74% of patients were clinically node-positive at diagnosis, and 41% had hormone receptor–positive/HER2-negative disease. Patients undergoing ALND vs those not undergoing ALND were more likely to have cN2/3 disease (17% vs 7%, P < .001), isolated tumor cells detected on frozen section (62% vs 8%, P < .001), lymphovascular invasion (38% vs 24%, P < .001), and receive adjuvant chest wall (89% vs 78%, P = .024) and nodal radiation (82% vs 75%, P = .038). The mean number of sentinel lymph nodes with isolated tumor cells was 1.2.
The 3-year rates in the entire cohort were 2.0% for any axillary recurrence (isolated or combined with local or distant recurrence), 0.58% for isolated axillary recurrence, and 11% for any invasive (locoregional or distant) recurrence. At 3 years, no significant differences between patients receiving vs not receiving ALND were observed for any (1.5% vs 3.1%, P = .8) and isolated axillary recurrence (0.58% vs 1.7%, P = .7) or any invasive (locoregional or distant) recurrence (8.1% vs 12%, P = .13).
Exploratory analysis of 5-year outcomes in the entire cohort showed any and isolated axillary recurrence in 4.4% and 1.3% of patients, respectively, and any invasive recurrence in 18%. No significant differences between the ALND group vs the no-ALND group were found for any (4.1% vs 4.6%, P = .8) and isolated axillary recurrence (1.7% vs 1.1%, P = .7) or any invasive recurrence (16% vs 19%, P = .13).
The investigators concluded: “The nodal burden in patients with ypN0(i1) was low, and axillary recurrence after ALND omission was rare in patients selected for this approach. These results do not support routine ALND in all patients with ypN0(i1).”
Walter P. Weber, MD, of University Hospital Basel, Basel, Switzerland, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by a NIH/NCI Cancer Center Support Grant to Memorial Sloan Kettering Cancer Center. For full disclosures of the study authors, visit http://ascopubs.org.
