Abstract P2-01-22: The long term outcomes of Metasin RTqPCR intra-operative sentinel node analysis in early breast cancer

Background: Axillary lymph node involvement is a prognostic factor in breast cancer and it is used to guide adjuvant therapy. Axillary clearance remains the standard of care in lymph node positive disease in most parts of the world. Usually this is performed as second procedure but immediate intra-operative node analysis allows clearance to be performed as part of the initial procedure where necessary. The Metasin assay targets the breast epithelial cell markers CK19 and mammaglobin mRNA and detects the presence of breast tissue (metastatic disease) in the sentinel nodes. Evidence shows the Metasin assay to be fast (average assay time 41.2min) and accurate with a discordance rate below 4% compared with histology. The cost effectiveness of the assay has been reported in our previous studies. Aim: The aim of this study is to assess the risk of axillary recurrence following the use of the Metasin assay to guide axillary management. Method: This is a single centre retrospective study which included all patients presenting to a district general hospital with early clinically node negative breast cancer undergoing sentinel node biopsy between Oct 2011 and Dec 2014. Alternate 2 mm slices of the node were examined intraoperatively using the Metasin assay and the remainder sent for histological examination. The results of the Metasin assay and histology were compared. The risk of axillary recurrence using the Metasin test to select patients for immediate axillary clearance was assessed. Results: 1073 sentinel nodes from 545 patients were analysed during this three-year period. 2 patients were lost to follow up. 94 patients were node positive and underwent axillary clearance as part of their primary surgery. 449 patients had sentinel node biopsy with no further axillary procedure. There were 36 nodes (3.34%) with discordant results. Median follow up was 32 months (range 18 to 55 months). Fourteen patients presented with recurrences (2.56%). The mean event free interval was 15 months. Of the 14 patients, 5 patients tested with Metasin had macrometastases and underwent immediate axillary clearance during the primary surgery. 7 patients were node negative and 2 patients were shown to have micrometastases. 11 patients recurred with distant metastases, 3 patients with local recurrence and 2 patients (0.36%) with axillary recurrences. The two axillary recurrences occurred at 3 and 5 months after primary surgery. Both patients underwent Metasin intraoperative analyses of sentinel nodes which were negative. Subsequent histological examination confirmed no metastatic node involvement in one patient but micro-metastases in the other. Both of these patients had aggressive disease with local, axillary and distant metastasis and subsequently died of their disease. Conclusions: The Metasin assay is a reliable intraoperative test for sentinel node involvement and when used to guide surgical axillary management is associated with very low axillary recurrences (0.36% with a median follow up of 32 months). Citation Format: Udayasankar S, Ashley E, Jenkins KS, Huws A, Sharaiha Y, Sai-Giridhar P, Thomas D, Munir A, Holt S, Khawaja S. The long term outcomes of Metasin RTqPCR intra-operative sentinel node analysis in early breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-01-22.