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Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Clinical and experimental pathology.
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2017 (English)In: British Journal of Surgery, ISSN 0007-1323, E-ISSN 1365-2168, Vol. 104, no 12, p. 1675-1685Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Sentinel node biopsy (SNB) using superparamagnetic iron oxide (SPIO) nanoparticles is a novel method in breast cancer. Several studies have verified the non-inferiority of SPIO compared with the standard use of radioisotope (99m) Tc with or without blue dye. The aim of the MONOS study presented here was to evaluate the use of SPIO as a sole tracer and the efficacy of tracer injection in the preoperative setting.

METHODS: This prospective cohort study was carried out in two hospitals, one using (99m) Tc and the other SPIO. (99m) Tc was injected in the morning of the day of surgery or the day before. SPIO was either injected before surgery in the outpatient clinic or 1 h before the operation.

RESULTS: A total of 338 consecutive patients with breast cancer underwent 343 procedures; SPIO nanoparticles were used in 184 procedures and (99m) Tc-labelled tracer in 159. Detection rates for SPIO and (99m) Tc were 95·6 and 96·9 per cent respectively (P = 0·537). All nodes with SPIO uptake were coloured brown. Fewer nodes were retrieved with SPIO (mean 1·35 versus 1·89), regardless of whether blue dye was used (P < 0·001). Preoperative SPIO injection (58·7 per cent of procedures), a median of 16 (range 2-27) days before the procedure, was associated with a better tracer-specific detection rate (95·3 versus 86 per cent; P = 0·031) and retrieval of more nodes (mean 1·43 versus 1·03; P < 0·001) than perioperative administration. Skin staining was present in 39·9 per cent of patients, and was related to breast-conserving surgery and periareolar injection.

CONCLUSION: The use of SPIO alone is a safe alternative, with results comparable to those of the standard dual technique using (99m) Tc and blue dye. The efficacy of injection in the preoperative setting simplifies logistics and improves performance. Skin staining can be prevented by a deeper peritumoral injection.

Place, publisher, year, edition, pages
2017. Vol. 104, no 12, p. 1675-1685
National Category
Surgery
Identifiers
URN: urn:nbn:se:uu:diva-333258DOI: 10.1002/bjs.10606ISI: 000413157100012PubMedID: 28877348OAI: oai:DiVA.org:uu-333258DiVA, id: diva2:1155783
Available from: 2017-11-09 Created: 2017-11-09 Last updated: 2018-08-26Bibliographically approved
In thesis
1. Sentinel Node Biopsy for Breast Cancer: Aspects and evolution
Open this publication in new window or tab >>Sentinel Node Biopsy for Breast Cancer: Aspects and evolution
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Sentinel Node Biopsy (SNB) in clinical practice was pivotal to the shaping of modern diagnosis, staging and treatment of patients with breast cancer. The use of radioisotope (RI) and blue dye (BD) has led to high detection rates with low false negatives, but delivery-of-care limitations connected to these tracers as well as the need for methods addressing new clinical conundrums delineates the urge for new tracers with comparable performance, easier logistics and, ideally expanded implementations. Aim of the present thesis is to examine the outcomes of Superparamagnetic Iron Oxide (SPIO) nanoparticles, a new tracer based on magnetism for the detection of the sentinel nodes.

Paper I is a prospective multicentre trial comparing SPIO to RI+BD, with all tracers injected at the same patient. In 206 patients, SPIO had a similar detection rate (97.6 vs 97.1%, p=0.76) whereas concordance between methods was 98%. The study was completed by a meta-analysis of similar trials published until that point. The detection rates were comparable (fixed OR:1.10; 0.67,1.79, p=0.71), and so was concordance between tracers (fixed RD: 0.00; -0.01, 0.01, p=0.82). Discoloration was present after periareolar SPIO injection in 39% of patients, almost exclusively treated with breast conservation, which reduced to 8.6% after 15 months of follow-up.

Paper II was a pilot study of twelve patients with breast cancer and SNB performed where SPIO and the combination of RI+BD were injected, but SPIO was injected up to 15 days preoperatively, with total success in detection and complete concordance.

Paper III tested the performance of SPIO as a sole tracer in a pragmatic double-arm non-randomised trial comparing it to the combination of RI+BD. Detection was 95.7% for SPIO and 96.8% for RI (p = 0.59). The preoperative injection of SPIO (1-27 d) enhanced SPIO specific detection (95.7 vs 86%, p=0.002).

Paper IV is an interim analysis of a multicentre cohort study including patients with high-risk DCIS planned for breast conservation or any DCIS planned for mastectomy. SPIO was injected to “mark” the sentinel node but SNB was performed in a second operation only if invasive cancer was found at the first operation. In 151 included patients, this technique led to avoidance of 81.5% SNB, with a cost reduction of 14.1% for the entire cohort and 25.8% for the patients that did not have invasive cancer. The detection rate at reoperation was superior for SPIO and comparable with SNB detection at primary operation.

In conclusion, SPIO is a novel tracer for SNB in breast cancer with comparable performance, fit for performance in a global setting and with wider clinical implementations compared to RI+BD.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2018. p. 78
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1491
Keywords
Breast Cancer, Sentinel Node Biopsy, Superparamagnetic Iron Oxide
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-358236 (URN)978-91-513-0423-6 (ISBN)
Public defence
2018-10-12, Rosénsalen, Akademiska sjukhuset, ing 95-96, Uppsala, 09:00 (English)
Opponent
Supervisors
Available from: 2018-09-21 Created: 2018-08-26 Last updated: 2018-10-02

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Karakatsanis, AndreasDaskalakis, KosmasStålberg, PeterBergkvist, LeifWärnberg, Fredrik

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Endocrine SurgeryClinical and experimental pathologyCentre for Clinical Research, County of Västmanland
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