Superparamagnetic iron oxide nanoparticles (SPIO) are non-inferior to radioisotope and blue dye (RI + BD) for sentinel lymph node (SLN) detection. Previously, 2 mL SPIO (Sienna+®) in 3 mL NaCl was used. In this dose-optimizing study, lower doses of a new refined SPIO solution (Magtrace®) (1.5 vs. 1.0 mL) were tested in different timeframes (0–24 h perioperative vs. 1–7 days preoperative) and injections sites (subareolar vs. peritumoral). Two consecutive breast cancer cohorts (n = 328) scheduled for SLN-biopsy were included from 2017 to 2019. All patients received isotope ± blue dye as back-up. SLNs were identified primarily with the SentiMag® probe and thereafter a gamma-probe. The primary endpoint was SLN detection rate with SPIO. Analyses were performed as a one-step individual patient-level meta-analysis using patient-level data from the previously published Nordic Trial (n = 206) as a third, reference cohort. In 534 patients, the SPIO SLN detection rates were similar (97.5% vs. 100% vs. 97.6%, p = 0.11) and non-inferior to the dual technique. Significantly more SLNs were retrieved in the preoperative 1.0 mL cohort compared with 1.5 and the 2.0 mL cohorts (2.18 vs. 1.85 vs. 1.83, p = 0.003). Lower SPIO volumes injected up to 7 days before the operation have comparable efficacy to standard SPIO dose and RI + BD for SLN detection.
Background: Superparamagnetic iron oxide (SPIO) nanoparticles is a magnetic sentinel lymph node (SN) tracer. Since no radioisotope (technetium, Tc99) is used, there is no need for a nuclear medicine department. Compared to the use of Patent Blue V® (PB), no allergic reactions have been reported so far. However, a long lasting skin staining has been observed. We compared skin staining in women who were injected with both SPIO (MagTrace®) and PB. Methods: SPIO, Tc99 and PB were injected in all women in the SentiDose study (2017-2019), a SPIO dose optimizing trial, including six Swedish hospitals. For PB, a 1.0ml sub/intradermal, peri-areolar injection was administred. For SPIO either a 1.5ml retro-areolar (Cohort 1.5, n=163) or a 1.0ml peri-tumoral (Cohort 1.0, n=164) interstitial injection was administred. Staining was assessed by telephone interviews at 6, 12 and 24 months post surgery, and mean size calculations only included women with a stain. Mastectomy cases (n=63) were excluded from the analysis. SN detection rates will be reported elsewhere. Results: In Cohort 1.5, 27.7% (33/119) of the women had a SPIO stain and 25.2% (30/119) a PB stain at 6 months (p=0.66). The mean stain sizes were 13.4 and 9.1cm2 (p=0.16), respectively. At 12 months, 20.8% still had a SPIO stain and 17.6% a PB stain (p=0.91), with mean sizes of 4.1 and 3.7 cm2 (p=0.73), respectively. At 24 months, from the 11 women followed so far, all 3 with an earlier SPIO stain and 7 of 8 with an earlier PB stain are now stain free. In Cohort 1.0, 16.5% (25/145) had a SPIO stain and 16.9% (24/139) had a PB stain at 6 months (p=0.94). The mean stain sizes were 11.8 and 8.4 cm2 (p=0.42), respectively. Nine women were not injected with PB. After 12 months, 15.9% still had a SPIO stain and 12.4% a PB stain (p=0.42). The mean sizes were 5.1 and 2.6 cm2 (p=0.99), respectively. Comparing all women at 6 months, 22.0% had a SPIO stain and 20.5% a PB stain (p=0.12) with mean sizes 12.5 and 8.6 cm2 (p=0.83), respectively. At 12 months, 17.8% had a residual SPIO stain and 14.9% a PB stain (p=0.37) with mean sizes 4.6 and 3.3 cm2 (p=0.16), respectively. The difference in incidence of SPIO staining between Cohort 1.5 and Cohort 1.0 was statistically significant at 6 months, but not at 12 months, 27.7% vs. 16.5%, (p=0.04) and 20.8% vs 15.9% (p=0.28), respectively. The difference in SPIO stain sizes between the cohorts was neither significant at 6 months, 13.4 vs 11.8 cm2(p=0.61) nor at 12 months, 4.1 vs 5.1 cm2 (p=0.30). Conclusion: No statistically significant differences in incidence or stain size were observed between SPIO and PB. The 2-year follow up will be completed during 2021. The 1.0ml compared to 1.5ml SPIO dose, resulted in fewer but equally large stains at 6 months, but there was no difference at 1 year. Table 1. Skin staining after SPIO and Patent Blue (PB) for sentinel lymph node detectionTracerStaining/SizeStaining/Size6 months12 monthsSPIO 1.5ml, n=11927.7%/13.4cm220.8%/4.1cm2SPIO 1.0ml, n=14516.5%/11.8 cm215.9%/5.1 cm2PB, n=25820.5%/8.6 cm214.9%/3.3 cm2 Citation Format: Madeleine Warnberg, Andreas Karakatsanis, Fredrik Nilsson, Christine Obondo, Lida Pistiolis, Imad Mohammad, Carlos Dussan Luberth, Staffan Eriksson, Abdi-Fatah Hersi, Fredrik Wärnberg. A prospective comparison of skin staining after sentinel lymph node biopsy, using blue ink (PB) and superparamagnetic iron oxide nanoparticles (SPIO) tracers [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS1-52.
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