Learning sentinel node biopsy: Results of a prospective randomized trial of two techniques

doi:10.1016/S0039-6060(99)70127-3

Surgery

Volume 126, Issue 4, October 1999, Pages 714-722

Presented at the 56th Annual Meeting of the Central Surgical Association, St Louis, Mo, Mar 4-6, 1999.

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Abstract

Background: Evidence indicates that sentinel node (SN) biopsy can accurately predict axillary nodal status. Debate exists as to the optimal method of SN identification. Methods: Patients with clinical T1 or T2 tumors and negative axillae were randomized to SN localization with blue dye (B) alone (n = 50) or blue dye plus radioactivity (B+R) (n = 42). Patients undergoing needle localization (n = 47) were assigned to blue dye. Results: The SN was identified in 110 patients (79%) and contained metastases in 28. The SN predicted the axillary nodal status in 96% of cases. The SN identification rate did not differ between B (88%) or B+R (86%) but was significantly lower in patients requiring localization (64%). The time to SN identification also did not differ between B and B+R. The number of cases done by an individual surgeon was a significant predictor of SN identification. A stepwise logistic regression analysis of factors influencing the success of SN identification identified tumor location, needle localization, number of operations, and body mass index as significant predictors. Conclusions: Our study does not identify any advantage for the use of the more expensive and complex method of SN identification using B+R compared with B alone, even for surgeons learning the techniques. (Surgery 1999;126:714-22.)

Section snippets

Methods

Patients were enrolled between February 20, 1997, and January 31, 1999. Eligibility criteria included a T1 or T2 invasive breast carcinoma and clinically negative axillary lymph nodes. Patients with multicentric tumors, prior axillary operation, and those who were pregnant were excluded. Before randomization, patients were stratified on the basis of tumor size (T1 versus T2) and, using random assignment lists held by the study coordinator, were randomized to lymphatic mapping with 1% isosulfan

Results

One hundred thirty-nine patients entered the study including 92 who were randomized, 50 to blue dye and 42 to radioactivity plus blue dye, and 47 undergoing needle localization who were assigned to receive blue dye alone. All patients had breast-conserving surgery. The mean (standard deviation) patient age was 53.4 (10.0) years, and patient body mass index ranged from 17.8 to 50.1 with a mean of 27.2 (6.5). Fifty-seven patients had a prior excisional breast biopsy. The mean pathologic tumor

Discussion

In 1994 Giuliano et al¹ reported a 66% rate of sentinel node identification using isosulfan blue dye alone for lymphatic mapping. Other early studies of lymphatic mapping using radioactive colloid alone2, 3 or the combination of blue dye plus colloid⁴ had higher rates of sentinel node identification, ranging from 82% to 98%. These studies were interpreted3, 4 as proof that the use of a radiocolloid made the procedure easier to learn and thus more widely applicable. However, these conclusions

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^☆: Supported by the Northwestern Memorial Foundation and the Lynn Sage Foundation of Northwestern Memorial Hospital.

^☆☆: Reprint requests: Monica Morrow, MD, 675 N St Clair St, Suite 13-174, Chicago, IL 60611.

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Central Surgical AssociationLearning sentinel node biopsy: Results of a prospective randomized trial of two techniques☆,☆☆

Abstract

Section snippets

Methods

Results

Discussion

Lancet

Lymphatic mapping and sentinel lymphadenectomy for breast cancer

Ann Surg

Surgical resection and radiolocalization of the sentinel node in breast cancer using a gamma probe

Surg Oncol

Lymphatic mapping and sentinel node biopsy in the patient with breast cancer

JAMA

Lymphatic mapping in the treatment of breast cancer

Oncology

Biostatistics: a foundation for analysis in the health sciences

Central Surgical Association
Learning sentinel node biopsy: Results of a prospective randomized trial of two techniques☆,☆☆