Abstract:Background and Aims: Surgical resection is the preferred treatment for breast cancer. The use of sentinel lymph node biopsy (SLNB) in place of axillary lymph node dissection (ALND) can reduce the incidence of postoperative complications. The success (or not) of SLNB is closely related to the selection of tracer. At present, methylene blue and 99mTc sulfur colloid or the combination of the two are the most commonly used in clinical practice, however, both tracer agents have their drawbacks. A number of clinical trials have been performed to assess the new tracer agents, such as indocyanine green (ICG), superparamagnetic iron oxide (SPIO), indigocarmine, carbon nanoparticles, among which ICG has been most extensively studied. Nevertheless, there are few Meta-analysis on the clinical value of combining multiple tracers. Therefore, this study was designated to evaluate the application value of dual-tracer method of ICG combined with methylene blue in SLNB of breast cancer in China by Meta-analysis.
Methods: The publicly published studies comparing using dual-tracer method of ICG combined with methylene blue and single-tracer method of methylene blue performed by Chinese medical institutes were searched in China National Knowledge Infrastructure, Wanfangdata, VIP database, PubMed and Cochrane Library, encompassing the time period from the dates of inception to August 2019. The search results were screened in accordance with exclusion criteria, and the methodological qualities of the included studies were assessed. The differences in detection rate of sentinel lymph nodes (SLNs), number of detected SLNs, false negative rate, sensitivity and specificity between the two tracer methods were compared. Publication bias analysis was assessed by funnel plot.
Results: A total of 15 studies were finally included, including 12 articles in Chinese and 3 articles in English, and all of them were domestic studies. Meta-analysis results showed that the detection rate of SLNs (OR=5.39, 95% CI=3.46–8.39, P<0.000 01), number of detected SLNs (SMD=1.06, 95% CI=0.76–1.36, P<0.000 01), sensitivity (OR=5.31, 95% CI=2.68–10.55, P<0.000 01) and specificity (OR=2.71, 95% CI=1.35–5.45, P=0.005) were significantly increased and the false negative rate (OR=0.15, 95% CI=0.08–0.29, P<0.000 01) was significantly decreased by using dual -tracer method of ICG plus methylene blue compared with single-tracer method of methylene blue. The detection rates of SLNs reported in the 15 articles were used to assess publication bias, and the funnel plot showed that the possibility of publication bias was low.
Conclusion: The dual-tracer method of ICG combined with methylene blue has a high application value in SLNB of breast cancer in China. With the progress of research, more clinical studies will be included for Meta-analysis in the future, so that this method can be expected to be widely used in clinical practice.