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Methylene blue 1% as a sensitive and safe alternative for sentinel lymph node biopsy in early stage breast cancer: Results of a large pilot studyEmad Khallaf MD FRCSEd*, Mohamed Abdoon MSc MRCS**, Abdelrahman Lotfi MSc MRCS**, Youmna Abdelaziz MSc MRCS**,Rasha Kamal MD***and Hanaa Attia MD*****Professor of Surgery, Breast Surgery Unit, Cairo University**Senior Registrar, Breast Surgery Unit, Cairo University***Professor of Radiology, Woman’s Imaging Unit, Cairo University****Professor of Clinical Oncology, Breast Cancer Unit, Cairo UniversityKhallaf613@Emadkhallaf@kasralainy.edu.egSentinel lymph node biopsy (SLNB) had become an accepted standard of care to stage the axilla for clinically node-negative early stage breast cancer. We adopted 1% MB as a single agent for SLNB because the addition of radiocolloids to blue dye in SLNB in early stage breast cancer does not increase identification rate to the degree that justify its costs and restrictions in its use (1,2). However, the performance of SLNB using only a blue dye is highly dependent on a surgeons’ experience requiring the underlying tissue to be exposed and relies, obviously, on visual detection of the dye lacking the guidance of devices such as a gamma probe used in radioisotope guided SLNB. Isosulphan blue is occasionally associated with severe allergic reaction, including anaphylaxis and death. The use of 1% methylene blue (MB) as a method of identifying the SLNs in breast cancer has been reported previously with fewer deleterious side effects ( 3). After obtaining Institutional Review Board approval, a total of 242 consecutive patients with (T1,2 N0 M0) were included in the study . The patients were seen by the breast cancer multidisciplinary team of Cairo University Hospital between May 2014 and May 2018. Negative axillary LNs (N0) were judged by the combination of clinical examination and US examination (typically showing LNs oval in shape with a smooth contour, a uniformly thin hypoechoic cortex, and an echogenic fatty hilum (4). The standard technique includes injection of 1% MB after intravenous sedation or general anesthesia is achieved. A volume of 5 cc is injected in retroalealar position, lymphadenectomy is performed after 10-15 minutes through a 2-3 cm incision placed in the axilla 1cm below the hair line. To simplify identification of the SLNs , after incision of the axillary fascia the axilla is divided into 4 areas starting from the intersection of the second intercostobrachial nerve and lateral thoracic vein . Most of the SLNs are located inferior to the second intercostobrachial nerve and at the medial area of the lateral thoracic vein (5). SLN was successfully identified if a blue lymph node or a lymph node with a blue afferent lymphatic was visualized; then any enlarged axillary LN even if not stained blue is also removed (6). All cases were followed up for an average of 18 months.We have an identification rate (IR) of 96.3 %, 233 out of 242 patients had a SLN identified, figure 1. The mean number of SLNs identified was 2.8 +_ 1.2 (range 1-5). Eighty % (187/233) of the SLNs were found in level one axillary LN, inferior to the second intercostobrachial nerve. Retroareolar injection of MB gives a slightly higher success rate than peritumoral injection besides; using 1% concentration of MB gives higher identification rates than the intermediate or the low MB concentrations (7). Our SLN identification rates are comparable to previous reports using blue dyes or radiocolloids ( 8). Most of the patients have a change in the color of urine to green- blue for about 24 hours. No cases of anaphylaxis or other allergic reactions were identified, temporary skin tattooing was observed in 11 cases, 2 cases (1%) showed partial skin necrosis at the edge of the areola which healed by repeated dressings, this was notice in 2 cases who had an oncoplastic surgery entailing mobilization of the nipple areola complex ,so, we advise when such procedure is anticipated to inject 1% MB peritumoral rather than reroareolar (9) . No cases reported arm swelling during the period of follow up. Fifty six of 233 SLNs identified (24.0%) harbored metastatic disease , applying ACOSOG Z0011 guidelines (10) only 12 out 56 cases required ALND (19.6%) and the rest were followed up. No evidence of locoregional recurrence in any of the patients in the study group.We found a high degree of success with 1% MB in SLNB in early stage breast cancer. It is an efficient and safe alternative to isosulphan blue and we feel that more widespread use should be considered. The most striking difference between the two dyes is the cost. MB is sold for $2.00 (5 cc vial) at our institute, while isosulphan blue for $96.00 (5 cc vial). Although this forms a small fraction of the entire cost of SLNB, it does have a signi?cant impact in the developing countries where there are budgetary funding constraints and patients are poor. Key Words: Breast cancer, methylene blue, sentinel lymph node biopsy Refences: Hung WK, Chan CM, Ying M, Chong SF, Mak KL, Yip AW. Randomized clinical trial comparing blue dye with combined dye and isotope for sentinel lymph node biopsy in breast cancer. British journal of surgery. 2005 Dec 1;92(12):1494-7.Ang CH, Tan MY, Teo C, Seah DW, Chen JC, Chan MY, Tan EY. Blue dye is sufficient for sentinel lymph node biopsy in breast cancer. British Journal of Surgery. 2014 Mar 1;101(4):383-9.Thevarajah S, Huston TL, Simmons RM. A comparison of the adverse reactions associated with isosulfan blue versus methylene blue dye in sentinel lymph node biopsy for breast cancer.?Am J Surg. 2005; 189(2):236-239..Bedi DG, Krishnamurthy R, Krishnamurthy S, Edeiken BS, Le-Petross H, Fornage BD, Bassett Jr RL, Hunt KK. Cortical morphologic features of axillary lymph nodes as a predictor of metastasis in breast cancer: in vitro sonographic study. American Journal of Roentgenology. 2008 Sep;191(3):646-52. Clough KB, Nasr R, Nos C, Vieira M, Inguenault C, Poulet B. New anatomical classification of the axilla with implications for sentinel node biopsy. British Journal of Surgery. 2010 Nov 1;97(11):1659-65. Yue Yu, Ning chui, Heng-Yu li et al, Sentinel lymph node biopsy after neoadjuvant chemotherapy for breast cancer: retrospective comparative evaluation of clinically axillary lymph node positive and negative patients, including those with axillary lymph node metastases confirmed by fine needle aspiration, BMC (2016) 16:808Zakaria S, Hoskin TL, Degnim AC. Safety and technical success of methylene blue dye for lymphatic mapping in breast cancer.?Am J Surg. 2008;196(2):228-233 Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Duez N, Cataliotti L, Klinkenbijl JH, Westenberg HA, van der Mijle H. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Annals of surgical oncology. 2010 Jul 1;17(7):1854-61Bauer TW, Spitz FR, Callans LS, et al. Subareolar and peritumoral injection identify similar sentinel nodes for breast cancer. Ann Surg Oncol 2002;9:169–76. injection for sentinel node biopsy in a patient with breast cancer. In International Seminars .Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance)ab c dFigure 1: Intraoperative view of methylene blue stained sentinel lymph nodes (a-c). Blue stained lymphatics (d) ................
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