This article is more than 5 years old. Information may no longer be current.
Axillary node dissection may not improve breast cancer outcomes
Giuliano AE. JAMA. 2011;305:569-575.
Click Here to Manage Email Alerts
Axillary lymph node dissection did not improve survival outcomes in a cohort of women with T1-T2 breast cancer who had received sentinel node dissection, according to study results.
Eligible women had no palpable adenopathy and one to two sentinel lymph nodes containing metastases. Lumpectomy and whole-breast irradiation was performed in all patients. Women with sentinel lymph node metastases that had been identified by sentinel lymph node dissection were randomly assigned axillary lymph node dissection of 10 or more nodes, or no further axillary treatment. Patients were treated with systemic therapy at the discretion of the clinician.
There were 445 patients in the axillary node dissection arm and 446 patients in the sentinel node dissection alone arm.
Five-year OS rates were 91.8% (95% CI, 89.1%-94.5%) for axillary node dissection and 92.5% (95% CI, 90.0%-95.1%) for sentinel node dissection alone. Five-year DFS rates were 82.2% (95% CI, 78.3%-86.3%) in the axillary node group and 83.9% (95% CI, 80.2%-87.9%) in the sentinel node only group.
The unadjusted HR for treatment-related OS was 0.79 (90% CI, 0.56-1.11). After adjusting for age and adjuvant therapy, the HR was 0.87 (90% CI, 0.62-1.23).
Researchers from The American College of Surgeons Oncology Group conducted the phase 3 trial at 115 sites in the US from May 1999 to December 2004. The initial enrollment target was 1,900 women with final analysis occurring after 500 deaths. The trial was halted due to lower mortality rates than expected.
Eligibility criteria were identified by frozen section, touch preparation or hematoxylin-eosin staining on permanent section, according to the results.
The primary outcome measure was OS, which the researchers defined as a noninferiority margin of a one-sided HR of less than 1.3 indicating that sentinel node dissection alone is noninferior to axillary node dissection. The key secondary endpoint was DFS.
Women receiving axillary dissection had a median of 17 nodes removed, compared with two nodes in the sentinel node dissection arm.
The median follow-up duration was 6.3 years, with the last follow-up occurring on March 4, 2010.
 |
Follow HemOncToday.com on Twitter. |