CHICAGO — “Routine use of axillary lymph node dissection (ALND) should be abandoned.”

That’s the conclusion based on 10-year survival data from the American College of Surgeons Oncology Group (ACOSOG) Z0011 randomized study comparing sentinel lymph node dissection (SLND) alone to ALND in women with clinical T1-2 N0 M0 breast cancer and a positive sentinel node presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.1

Continue Reading

The study’s hypothesis was that SLND alone achieves similar locoregional control and survival as level I and II ALND for patients treated with breast conserving therapy and adjuvant systemic therapy. Previously, no significant difference in 5-year locoregional recurrence or survival was observed between ALND and SLND; however the study was criticized for its short follow-up, 6.3 years , said Armando E. Giuliano, MD, Cedars-Sinai Medical Center, Los Angeles, California.

Patients with clinically node negative breast cancer with 1 or 2 sentinel nodes with immunohistochemically detected metastases were randomly assigned to receive SLND (n = 446) or SLND plus ALND  (n = 445). All patients were scheduled to received whole breast irradiation and systemic therapy.

Baseline patient characteristics were similar for age, tumor size, Bloom-Richardson score, estrogen receptor status, adjuvant systemic therapy, tumor type, and stage.

Those in the SLND alone arm had a median of 2 lymph nodes removed; in contrast, those randomly assigned to ALND had a median of 17 nodes removed (P < .001). A total of 17.6% of patients in the ALND arm had 3 or more involved nodes, compared with 5.0% of those in the SNLD arm (P < .001). A total of 106 patients (27.4%) treated with ALND had additional positive nodes removed beyond the sentinel node(s).

At a median follow-up of 9.25 years, by treatment arm, there were no statistically significant differences in local (P = .13, ALND vs SLND) or regional recurrence (P = .28; ALND vs SLND), Dr. Giuliano said. Only 2 nodal regional recurrences were observed in the ALND arm, while there were 5 in the SLND alone arm.

“Only 1 additional regional recurrence was seen after 5 years,” Dr. Giuliano said.

The 10-year locoregional recurrence-free survival was 93.8% for the ALND arm and 94.7% for the SNLD alone arm (P = .36). The 10-year overall survival for patients undergoing SLND plus ALND was 83.6% vs 86.3% for sentinel node biopsy (HR, 0.85; 95% CI, 0.59-1.24; P = .40), and disease-free survival was 78.2% vs 80.2% (HR, 0.85; 95% CI, 0.62-1.17; P = .32).

Hormone receptor status, Bloom-Richardson score, and tumor size were associated with locoregional recurrence, not the operation itself, he said. Multivariable analysis found that age, estrogen receptor, tumor size, and adjuvant systemic chemotherapy — not type of operation — were associated with 10-year overall survival.

Of the 605 radiation case reports reviewed, 11% of patients had received no radiation. Review of 228 detailed radiation therapy records found that in 18.9% of patients, a third field had been used, a protocol deviation. However, this third field use was equal between ALND and SLND. An unplanned analysis found that if a patient did not receive irradiation, local recurrence increased significantly (P = .004), and overall survival decreased (P = .03). However, radiation therapy was not associated with node recurrence (P = .80) nor was a third field associated with overall survival (P = .35).



1. Giuliano AE, Hunt K, Ballman KV, et al. Ten-year survival results of ACOSOG Z0011: a randomized trial of axillary node dissection in women with clinical T1-2 N0 M0 breast cancer who have a positive sentinel node (Alliance). Oral presentation at: 2016 ASCO Annual Meeting; June 3-7, 2016; Chicago, IL.