Michael D Alvarado1, Elizabeth A Mittendorf2, Mediget Teshome2, Alastair M Thompson2, Richard J Bold3, Mark A Gittleman4, Peter D Beitsch5, Sarah L Blair6, Kaisa Kivilaid7, Quentin J Harmer8, Kelly K Hunt2. 1. Department of Surgery, University of California San Francisco, San Francisco, CA, USA. michael.alvarado@ucsf.edu. 2. Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. 3. Division of Surgical Oncology, Department of Surgery, UC Davis Medical Center, Sacramento, CA, USA. 4. Breastcare Specialists, Allentown, PA, USA. 5. Dallas Surgical Group, Dallas, TX, USA. 6. Department of Surgery, Moores Cancer Center, University of California San Diego, La Jolla, CA, USA. 7. Regulatory and Clinical Research Institute, Inc., Minneapolis, MN, USA. 8. Endomagnetics Limited, Cambridge, UK.
Abstract
BACKGROUND: Sentinel lymph node biopsy (SLNB) is a highly accurate method for staging the axilla in early breast cancer. Superparamagnetic iron oxide mapping agents have been explored to overcome the disadvantages of the standard SLNB technique, which uses a radioisotope tracer with or without blue dye. One such agent, Sienna+, was shown to be non-inferior to the standard technique for SLNB in a number of studies. The SentimagIC trial was designed to establish the non-inferiority of a new formulation of this magnetic tracer, Magtrace (formerly SiennaXP). METHODS: Patients with clinically node-negative early-stage breast cancer were recruited from six centers in the US. Patients received radioisotope and isosulfan blue dye injections, followed by an intraoperative injection of magnetic tracer, prior to SLNB. The sentinel node identification rate was compared between the magnetic and standard techniques to evaluate non-inferiority and concordance. RESULTS: Data were collected for 146 procedures in 146 patients. The per patient detection rate was 99.3% (145/146) when using the magnetic tracer and 98.6% (144/146) when using the standard technique, while the nodal detection rate was 94.3% (348/369 nodes) when using the magnetic tracer and 93.5% (345/369) when using the standard technique (difference 0.8%, 95% binomial confidence interval lower bound - 2.1%). Of the 22 patients with positive sentinel lymph nodes (SLNs), 21 (95.4%) were detected by both the magnetic tracer and the standard technique. All malignant nodes detected by standard technique were also identified by the magnetic technique. CONCLUSION: The magnetic technique is non-inferior to the standard technique of radioisotope and blue dye for axillary SLN detection in early-stage breast cancer. The magnetic technique is therefore a viable alternative.
BACKGROUND: Sentinel lymph node biopsy (SLNB) is a highly accurate method for staging the axilla in early breast cancer. Superparamagnetic iron oxide mapping agents have been explored to overcome the disadvantages of the standard SLNB technique, which uses a radioisotope tracer with or without blue dye. One such agent, Sienna+, was shown to be non-inferior to the standard technique for SLNB in a number of studies. The SentimagIC trial was designed to establish the non-inferiority of a new formulation of this magnetic tracer, Magtrace (formerly SiennaXP). METHODS:Patients with clinically node-negative early-stage breast cancer were recruited from six centers in the US. Patients received radioisotope and isosulfan blue dye injections, followed by an intraoperative injection of magnetic tracer, prior to SLNB. The sentinel node identification rate was compared between the magnetic and standard techniques to evaluate non-inferiority and concordance. RESULTS: Data were collected for 146 procedures in 146 patients. The per patient detection rate was 99.3% (145/146) when using the magnetic tracer and 98.6% (144/146) when using the standard technique, while the nodal detection rate was 94.3% (348/369 nodes) when using the magnetic tracer and 93.5% (345/369) when using the standard technique (difference 0.8%, 95% binomial confidence interval lower bound - 2.1%). Of the 22 patients with positive sentinel lymph nodes (SLNs), 21 (95.4%) were detected by both the magnetic tracer and the standard technique. All malignant nodes detected by standard technique were also identified by the magnetic technique. CONCLUSION: The magnetic technique is non-inferior to the standard technique of radioisotope and blue dye for axillary SLN detection in early-stage breast cancer. The magnetic technique is therefore a viable alternative.
Authors: Eliane R Nieuwenhuis; Barry Kolenaar; Jurrit J Hof; Joop van Baarlen; Alexander J M van Bemmel; Anke Christenhusz; Tom W J Scheenen; Bernard Ten Haken; Remco de Bree; Lejla Alic Journal: Cancers (Basel) Date: 2022-01-28 Impact factor: 6.639
Authors: Zuzanna Pelc; Magdalena Skórzewska; Maria Kurylcio; Tomasz Nowikiewicz; Radosław Mlak; Katarzyna Sędłak; Katarzyna Gęca; Karol Rawicz-Pruszyński; Wojciech Zegarski; Wojciech P Polkowski; Andrzej Kurylcio Journal: Cancers (Basel) Date: 2022-01-28 Impact factor: 6.639
Authors: Loeki Aldenhoven; Caroline Frotscher; Rachelle Körver-Steeman; Milou H Martens; Damir Kuburic; Alfred Janssen; Geerard L Beets; James van Bastelaar Journal: BMC Cancer Date: 2022-10-14 Impact factor: 4.638
Authors: Martha S Kedrzycki; Maria Leiloglou; Hutan Ashrafian; Natasha Jiwa; Paul T R Thiruchelvam; Daniel S Elson; Daniel R Leff Journal: Ann Surg Oncol Date: 2020-11-06 Impact factor: 5.344