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      Delayed Sentinel Lymph Node Dissection in Patients with a Preoperative Diagnosis of Ductal Cancer In Situ by Preoperative Injection with Superparamagnetic Iron Oxide (SPIO) Nanoparticles: The SentiNot Study

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          Abstract

          Background

          Difficulty in preoperatively assessing the risk for occult invasion or surgery that precludes future accurate axillary mapping in patients with ductal cancer in situ (DCIS) account for overutilization of SLND.

          Methods

          Prospective, multicenter, cohort study, including women with any DCIS planned for mastectomy or DCIS grade 2 and > 20 mm, any DCIS grade 3, any mass-forming DCIS and any planned surgery. Patients received an interstitial SPIO injection during breast surgery, but no upfront SLND was performed. If invasion was identified on final pathology, delayed SLND (d-SLND) was performed separately with the coadministration of isotope ± blue dye (BD). Study outcomes were proportion of upfront SLNDs that were avoided, detection rates during d-SLND, and impact on healthcare costs.

          Results

          In total, 78.7% of study participants ( N = 254, mean age 60 years, mean DCIS size 37.8 mm) avoided upfront SLND. On d-SLND (median 28 days, range 9–46), SPIO outperformed Tc 99 with (98.2% vs. 63.6%, p < 0.001) or without BD (92.7% vs. 50.9%, p < 0.001) and had higher nodal detection rate (86.9% vs. 32.3%, p < 0.001) and with BD (93.9% vs. 41.4%, p < 0.001). Only 27.9% of all SLNs retrieved were concordant for Tc 99 and SPIO. Type of breast procedure (WLE vs. oncoplastic BCT vs. mastectomy) affected these outcomes and accounted for the low performance of Tc 99 ( p < 0.001). d-SLND resulted in a 28.1% total cost containment for women with pure DCIS on final pathology (4190 vs. 5828 USD, p < 0.001).

          Conclusions

          Marking the SLN with SPIO may avoid overtreatment and allow for accurate d-SLND in patients with DCIS.

          Supplementary Information

          The online version contains supplementary material available at 10.1245/s10434-022-13064-0.

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          Most cited references47

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

          Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles.18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies.A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies
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            Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement

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              Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update.

              To provide evidence-based recommendations to practicing oncologists, surgeons, and radiation therapy clinicians to update the 2005 clinical practice guideline on the use of sentinel node biopsy (SNB) for patients with early-stage breast cancer.

                Author and article information

                Contributors
                andreas.karakatsanis@surgsci.uu.se
                Journal
                Ann Surg Oncol
                Ann Surg Oncol
                Annals of Surgical Oncology
                Springer International Publishing (Cham )
                1068-9265
                1534-4681
                31 January 2023
                31 January 2023
                2023
                : 30
                : 7
                : 4064-4072
                Affiliations
                [1 ]GRID grid.8993.b, ISNI 0000 0004 1936 9457, Department of Surgical Sciences, , Uppsala University, ; Uppsala, Sweden
                [2 ]GRID grid.412354.5, ISNI 0000 0001 2351 3333, Department of Surgery, , Uppsala University Hospital, ; Uppsala, Sweden
                [3 ]GRID grid.8993.b, ISNI 0000 0004 1936 9457, Centre for Clinical Research, , Uppsala University, ; Västerås, Sweden
                [4 ]Department of Surgery, Västmanland County Hospital, Västerås, Sweden
                [5 ]GRID grid.8761.8, ISNI 0000 0000 9919 9582, Department of Surgery, Sahlgrenska Center for Cancer Research, Institute of Clinical Sciences, , University of Gothenburg, Sahlgrenska Academy, ; Gothenburg, Sweden
                [6 ]GRID grid.1649.a, ISNI 000000009445082X, Department of Surgery, , Sahlgrenska University Hospital, ; Gothenburg, Sweden
                [7 ]GRID grid.8761.8, ISNI 0000 0000 9919 9582, Wallenberg Centre for Molecular and Translational Medicine, , University of Gothenburg, ; Gothenburg, Sweden
                [8 ]GRID grid.411384.b, ISNI 0000 0000 9309 6304, Breast Unit, Department of Surgery, , Linköping University Hospital, ; Linköping, Sweden
                [9 ]GRID grid.194645.b, ISNI 0000000121742757, Department of Surgery, , University of Hong Kong, ; Hong Kong, Hong Kong SAR China
                [10 ]GRID grid.194645.b, ISNI 0000000121742757, Department of Surgery, , The University of Hong, Kong-Shen Zhen Hospital, ; Shenzhen, China
                [11 ]GRID grid.414329.9, ISNI 0000 0004 1764 7097, Department of Surgery, , Hong Kong Sanatorium and Hospital, ; Hong Kong, Hong Kong SAR China
                Article
                13064
                10.1245/s10434-022-13064-0
                10250503
                36719570
                255d07c9-aeb6-49e8-836d-7f7e575585ef
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 1 November 2021
                : 22 December 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100009230, Landstinget i Uppsala län;
                Funded by: Bröstcancerförbundet
                Funded by: Uppsala University
                Categories
                Breast Oncology
                Custom metadata
                © Society of Surgical Oncology 2023

                Oncology & Radiotherapy
                Oncology & Radiotherapy

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