Abstract PD2-03: Sentinel lymph node mapping with dual tracer combination: Fluorescent fluorescein with methylene blue compared to radio active sulphur colloid with methylene blue: A randomised comparison
Authors: Srivasatava A , Suresh J , Ranjan P , Kumar A , Kataria K , Dhar A , Vathulru S 
Published: February 2018

Abstract
Objective-Fluorescein and methylene blue (FWMB) combined tracer is non-inferior to Tc99- Sulphur colloid and methylene blue (TWMB) in identification of sentinel lymph nodes in women with operable breast cancer.
Rationale-Sentinel node biopsy (SNB) is the standard procedure for axillary nodal evaluation. Most authors recommend dual tracers, a radioactive dye tagged with large particulate matter like albumin or sulphur colloid and blue dye like lymphazurin, methylene blue or patent blue for identification of sentinel lymph nodes. In Asian countries like India, the availability of radioactive pharamaceutical and gamma probe facility are sparse. Hence, we have compared a combination of fluorescein and methylene blue with technetium and methylene blue in a two arm randomized controlled trial with non-inferiority hypothesis and 1:1 allocation ratio on 81 patients with operable breast cancer. The non inferiority margin was set at 5 %.The study was conducted in All India Institute of Medical Sciences, New Delhi from June 2015 to November 2016. The study included ladies with operable breast cancer of all histological types after getting informed written consent.
Novelty- This is the first randomized trial comparing fluorescein with technetium sulphur colloid in sentinel lymph node biopsy in breast cancer .
In the fluorescein and methylene blue arm, one ml of 20% fluorescein diluted with 4 ml of normal saline was injected in the periareolar region, half the dye injected intradermally and half in the sub areolar plane. One ml of 1% Methylene blue dye diluted in 4 ml normal saline was also injected in similar manner. It was followed by gentle massage for 5 minutes. An incision was made on lateral axillary skin crease and fluorescent or blue lymphatics dissected to the level of sentinel lymph nodes. Fluorescent lymphatics were identified with a blue light lamp (480 nm). Sentinel lymph node(s) were excised and sent for histopathological examination. Radioactive node was picked up by gamma probe.
Results- The base line patient and tumour characteristics of the two groups showed no significant difference. Since it was a non inferiority trial, we performed per protocol analysis revealing the identification of sentinel nodes = 84.6% in both arms (effect size-zero and 90% confidence interval -13.4 to +13.4.). Results of subgroup analysis before and after chemotherapy and SNB done under local and general anaesthesia has been given in tables 1 and 2.
Table 1. Identification of sentinel nodes (Per protocol analysis) TWMBFWMBEffect size (ninety percent confidence interval)Total33/39(84.6)33/39(84.6)0.0(-13.4,13.4)Prechemo patients26/29(89.7)26/30(86.7) Postchemo patients7/10(70)7/9(77.8)7.8(-25.2,+40.8)Local Anaesthesia23/25(92.0)22/23(95.7)3.7(-7.7,+14.9)General Anaesthesia10/14(71.4)11/16(68.8)

Table 2. Identification of sentinel nodes (Intention to treat analysis) TWMBFWMBTotal33/39(84.6)33/40(82.5)Prechemo patients26/29(89.7)26/31(83.9)Postchemo patients7/10(70)7/9(77.8)Local Anaesthesia23/25(92.0)22/24(91.7)General Anaesthesia10/14(71.4)11/16(68.8)
Conclusion- Fluorescein + methylene blue offer an attractive cheap method of SNB.
Citation Format: Srivasatava A, Suresh J, Ranjan P, Kumar A, Kataria K, Dhar A, Vathulru S. Sentinel lymph node mapping with dual tracer combination: Fluorescent fluorescein with methylene blue compared to radio active sulphur colloid with methylene blue: A randomised comparison [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr PD2-03.