Abstract
Use of both patent blue and a radioisotope to locate, and reduce the risk of sentinel lymph node (SLN) detection failure in breast cancer is recommended, but drawbacks commonly lead to using only a radioisotope. An alternative method would therefore be valuable. This randomized, controlled study in 99 patients compared SLN detection using 99mtechnetium (Tc) alone versus Tc combined with indocyanine green (ICG). The primary endpoint was the SLN identification rate. The primary outcome measure was the number of patients with <2 SLN detected. One SLN was detected in 44.0% of patients in the dual detection group and 40.8% in the 99mTc alone group (RR = 1.08 (95% CI 0.68; 1.72), p = 0.84). A mean (±SD) of 2.14 ± 1.23 SLN were identified in the dual detection group vs. 1.77 ± 0.85 using Tc alone (p = 0.09). Eight-five (78.7%) SLN were both ICG+ and TC+, 15 (13.9%) ICG+ and Tc−, and 7 (6.5%) ICG− and Tc+. SLN detected were ICG-positive in 92.6% of patients and 99mTc-positive in 85.2% with. No adverse event related to ICG injection was recorded. Dual detection of SLN using ICG and radioisotope is reliable and sensitive but was not superior to isotope alone in successfully locating SLN in our pilot randomized trial.
Highlights
Initial surgery comprising excision of the mammary tumor and sentinel lymph node biopsy (SLNB) is currently the standard of care for early-stage breast cancer[1,2]
The primary outcome measure was the number of patients with fewer than two (i.e. 0 or 1) SLN detected with the indocyanine green (ICG) + 99mTc method versus the 99mTc method alone
A total of 100 patients with clinically lymph node-negative breast cancer were randomized to receive a subareolar injection of either ICG + 99mTc (20 MBq) or 99mTc alone for SLNB
Summary
Initial surgery comprising excision of the mammary tumor and sentinel lymph node biopsy (SLNB) is currently the standard of care for early-stage breast cancer[1,2]. Various markers are available for identification of SLN in patients with breast cancer, tracing methods being based on radioactivity, colorimetry or both techniques combined. Each of these three approaches presents specific advantages and drawbacks. The drawbacks of the radioisotope method using radioactive technetium (99mTc), are mainly cost and organizational limitations, the use of patent blue carrying a risk of anaphylactic shock and of persistent tattoos[3,4] These problems have led numerous teams to abandon the dual detection method, with the consequent risk of an increased rate of false negatives. This primary endpoint, rather than retrieval of at least one SLN (the global definition of detection rate), was chosen in view of our ultimate aim to increase, by use of the dual detection method, the number of SLN retrieved to a mean of 2–4 SLN per patient in accordance with French guidelines
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