Source: DGNews  |  Posted 7 years ago

By Charlene Laino

SAN ANTONIO, TX -- December 13, 2004 -- Sentinel node biopsy is a highly viable and safe alternative to standard axillary node dissection in women with breast cancer, according to the largest prospective randomized trial to compared the two methods.

Thomas B. Julian, MD, medical oncologist, Allegheny Cancer Center, Pittsburgh, Pennsylvania, United States, reported the results during a general session on December 9[^]th[] at the 27[^]th[] Annual San Antonio Breast Cancer Symposium.

The aim of the study was to find out if sentinel node biopsy is equivalent to axillary dissection in terms of prognosis, regional control, and survival, he said.

Dr. Julian and coworkers evaluated 5000 women with operable invasive breast cancer and clinical negative nodes. The researchers randomized 2583 women to sentinel node resection followed by axillary node dissection; 2,627 women were randomized to sentinel node resection, and underwent axillary node dissection only if they had positive nodes on intraoperative cytology and histological examination.

Results show that sentinel node biopsy had an overall accuracy rate of 97.2% and a negative predictive value of 96.1%, while the false negative rate was 9.7% and the sensitivity was 90.3%, Dr. Julian reported. For the women who underwent intraoperative cytology and histological examination, the accuracy was 89.8%, with a false negative rate of 38.5% and the false-positive rate was 0.4%.

Overall, 26% of patients were sentinel lymph node-positive in both groups. In 61.5% of node-positive patients, the sentinel node was the only positive node, Dr. Julian said. Only eight patients (0.6%) had sentinel nodes located outside of the axilla, he said.

Dr. Julian noted in an interview that the false negative rate was not affected by a surgeon's experience. However, patients who underwent excisional or incisional biopsies had a significantly higher false negative rate -- 15.2% and 14.3%, respectively -- compared with the 8% rate among those receiving core biopsies (P <.02), he said.

The technical success rate when tumors were located in the outer central segment of the breast was 98.7%, compared with 93.9% when tumors were found in the lower inner segment, he added. There was no difference in false negatives as a function of tumor location.

Fewer than 1% of patients had an allergic reaction during the procedure, Dr. Julian said. "Anaphylaxis is rare but does require monitoring."

[Presentation title: "Preliminary Technical Results of NSABP B-32, a Randomized Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients." Abstract 14]