Abstract
Abstract Introduction The advent of multimodal and targeted breast cancer treatment has seen a radical shift from aggressive surgical intervention to a more minimalist approach, both within the breast and axilla. Primary among these changes is the utilisation of the sentinel lymph node biopsy (SLNB) to detect disease within the axilla and a move away from an obligatory axillary clearance when the sentinel node is positive. This depends on the accurate identification of the SLN and initial studies describe a higher identification rate and a lower false negative rate with a dual tracer identification technique. This encompasses a combination of a blue / green dye and radio-labelled isotope. The use of blue dye has been, of itself, associated with significant morbidity and therefore many clinicians may opt for single tracer identification. Aims The aim of the current study was to determine whether the addition of blue dye to radio-isotope increased the positive SLN detection rate, where the SLN was identified pre-operatively on a lymphoscintigram. Methods A prospective randomised controlled trial comparing the combined techniques of isosulphan blue dye and isotope scanning versus isotope scanning alone was performed at a single tertiary referral centre. Ethical approval was obtained prior to commencing the study from the hospital ethics committee. Enrolment commenced in March 2010 and ceased in September 2012. The study design was a randomised open label controlled parallel group trial. The primary outcome measure was the effect of the omission of the blue dye on the identification of SLN if the lymphoscintigram was positive (1 -3 nodes identified). Results A total of 673 patients were included in the final analysis with 344 patients receiving the combination (blue dye and radio-isotope) and 329 patients who received radio-isotope scanning alone. The groups were evenly matched both demographically and pathologically. The mean age was 48 years (48.3 versus 47.7 years; P = 0.47), the mean tumour size was 23.1mm (23.2mm versus 23.0mm; p = 0.89) and there was no statistically significant difference in the grade of the tumours between the two groups (p = 0.58). Overall, there was no difference in the number of nodes retrieved between the two groups (563 versus 523; p = 0.30). Similarly, there was no difference in the number of positive lymph nodes that were identified between the two groups (107 versus 98; 23.8% versus 22%; p = 0.65). Conclusions The addition of isosulphan blue dye does not aid in the identification of the SLN in patients who have a positive lymphoscintigram when radioisotope colloid is used. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P1-01-01.
Published Version
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