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

Abstract

ObjectiveTo 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 DataSentinel 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. MethodsInvestigators (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. ResultsFive 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. ConclusionsThis 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.Since the description of sentinel lymph node biopsy (SNB) in the early 1990s, results for breast cancer have been reported in several single-institution series.1-4 These results were promising, and the sentinel node predicted the presence or absence of disease in the remaining axillary lymph

ICG fluorescence-guided sentinel node biopsy for axillary nodal staging in breast cancer

“…The detection rate of 98% for the SLN in 43 patients was comparable to that of the standard technique using a combination of radioisotope scanning and blue dye staining. Detection rate (97.7%), sensitivity (94.4%), and falsenegative rate (5.6%) in this study were also similar to that reported for the combined method with a detection rate approximating 95% [3,28].…”

Sentinel lymphnode biopsy in early breast cancer using methylene blue dye and radioactive sulphur colloid — a single institution Indian experience

“…Complete fi nal results of two large randomized trials (NSABP B-32, ALMANAC) are awaited in this regard [78,79]. Outside clinical trials, patients who are found to have a positive sentinel lymph node by H and E should undergo a completion axillary dissection, since a number of studies have shown that nonsentinel nodes can also be involved in 30-50% of cases [59,71,80].…”

Efficacy of Methylene Blue in Sentinel Lymph Node Biopsy for Early Breast Cancer

“…at least 90% sentinel lymph node detection rate and less than 5% false-negative rate indicates that only sentinel lymph node biopsy without axillary dissection can be made. Tafra et al (21) reported that 30 cases are adequate for the learning phase. In the ALMANAC study, it has been reported that at least 40 patients are required (22).…”