A randomized study comparing different doses of superparamagnetic iron oxide tracer for sentinel lymph node biopsy in breast cancer: The SUNRISE study

• Published in: European journal of surgical oncology 2020-12, Vol.46 (12), p.2195-2201
• Main Authors: Rubio, Isabel T., Rodriguez-Revuelto, Roberto, Espinosa-Bravo, Martin, Siso, Christian, Rivero, Joaquin, Esgueva, Antonio
• Format: Article
• Language: English
• Subjects: Axilla; Breast cancer; Breast Neoplasms - pathology; Breast Neoplasms - surgery; Carcinoma, Ductal, Breast - pathology; Carcinoma, Ductal, Breast - surgery; Carcinoma, Intraductal, Noninfiltrating - pathology; Carcinoma, Intraductal, Noninfiltrating - surgery; Carcinoma, Lobular - pathology; Carcinoma, Lobular - surgery; Female; Humans; Magnetic Iron Oxide Nanoparticles - administration & dosage; Magnetic tracer; Middle Aged; Postoperative Complications; Radioisotope; Sentinel Lymph Node - pathology; Sentinel Lymph Node Biopsy - methods; Sentinel node; Skin Pigmentation; Technetium Tc 99m Aggregated Albumin
• ISSN: 0748-7983; 1532-2157
• DOI: 10.1016/j.ejso.2020.06.018

The non-radioactive method that uses the magnetic tracer (SPIO/Sienna) has shown to be a feasible technique for the SLN detection in breast cancer patients. The aim of this study is to assess the efficacy of different doses of a new magnetic tracer Sienna XP (Magtrace) compared to Tc-99 m and to evaluate its non-inferiority. Patients diagnosed with early-stage breast cancer cT1-3 N0, from October 2016 to August 2018 were eligible and consecutively randomized to three different doses of new SPIO used: group 1 (1 mL), group 2 (1.5 mL) and group 3 (2 mL). A total of 135 patients were included in the study, 45 in each group. Detection of SLNs with the three doses of Sienna XP (1 mL, 1.5 mL and 2 mL) showed non-inferior rates compared to the conventional technique with radiotracer (p = 0.654). Concordance by patients with SLN positive was 100% for all groups. 83 (70.3%) patients reported skin staining at one month postoperatively, significantly lower in group 1 (p = 0.042). At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01). In multivariate analysis, dose of 2 mL showed statistically significant for the skin staining. The majority of patients (70%) felt that skin discoloration does not represent a problem. The use of the Sienna XP magnetic tracer at 1 mL is not inferior to higher doses of magnetic tracer neither is inferior to radiotracer. 1 mL of magnetic tracer resulted in significantly less skin discoloration compared to higher doses.