Multicenter Trial of Sentinel Node Biopsy for Breast Cancer Using Both Technetium Sulfur Colloid and Isosulfan Blue Dye

Abstract

Objective

To determine the factors associated with false-negative results

on sentinel node biopsy and sentinel node localization

(identification rate) in patients with breast cancer enrolled in a

multicenter trial using a combination technique of isosulfan

blue with technetium sulfur colloid (Tc99).

Summary Background Data

Sentinel node biopsy is a diagnostic test used to detect

breast cancer metastases. To test the reliability of this

method, a complete lymph node dissection must be performed

to determine the false-negative rate. Single-institution

series have reported excellent results, although one multicenter

trial reported a false-negative rate as high as 29% using

radioisotope alone. A multicenter trial was initiated to test

combined use of Tc99 and isosulfan blue.

Methods

Investigators (both private-practice and academic surgeons)

were recruited after attending a course on the technique of

sentinel node biopsy. No investigator participated in a learning

trial before entering patients. Tc99 and isosulfan blue were

injected into the peritumoral region.

Results

Five hundred twenty-nine patients underwent 535 sentinel

node biopsy procedures for an overall identification rate in

finding a sentinel node of 87% and a false-negative rate of

13%. The identification rate increased and the false-negative

rate decreased to 90% and 4.3%, respectively, after investigators

had performed more than 30 cases. Univariate analysis

of tumor showed the poorest success rate with older patients

and inexperienced surgeons. Multivariate analysis identified

both age and experience as independent predictors of failure.

However, with older patients, inexperienced surgeons, and

patients with five or more metastatic axillary nodes, the falsenegative

rate was consistently greater.

Conclusions

This multicenter trial, from both private practice and academic

institutions, is an excellent indicator of the general

utility of sentinel node biopsy. It establishes the factors that

play an important role (patient age, surgical experience,

tumor location) and those that are irrelevant (prior surgery,

tumor size, Tc99 timing). This widens the applicability of

the technique and identifies factors that require further

investigation. originally published Annals of Surgery, Vol. 233, No. 1, Jan 2001