Cargando…
False-negative rate in the extended prospective TATTOO trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy
PURPOSE: In clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy (NST), nodal metastases can be initially marked and then removed during surgical axillary staging. Marking methods vary significantly in terms of feasibility and cost. The purpose of the extended TATTO...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9114094/ https://www.ncbi.nlm.nih.gov/pubmed/35451733 http://dx.doi.org/10.1007/s10549-022-06588-2 |
_version_ | 1784709708719849472 |
---|---|
author | de Boniface, Jana Frisell, Jan Kühn, Thorsten Wiklander-Bråkenhielm, Ingrid Dembrower, Karin Nyman, Per Zouzos, Athanasios Gerber, Bernd Reimer, Toralf Hartmann, Steffi |
author_facet | de Boniface, Jana Frisell, Jan Kühn, Thorsten Wiklander-Bråkenhielm, Ingrid Dembrower, Karin Nyman, Per Zouzos, Athanasios Gerber, Bernd Reimer, Toralf Hartmann, Steffi |
author_sort | de Boniface, Jana |
collection | PubMed |
description | PURPOSE: In clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy (NST), nodal metastases can be initially marked and then removed during surgical axillary staging. Marking methods vary significantly in terms of feasibility and cost. The purpose of the extended TATTOO trial was to report on the false-negative rate (FNR) of the low-cost method carbon tattooing. METHODS: The international prospective single-arm TATTOO trial included clinically node-positive breast cancer patients planned for NST from November 2017 to January 2021. For the present analysis, patients who received both the targeted procedure with or without an additional sentinel lymph node (SLN) biopsy and a completion axillary lymph node dissection (ALND) were selected. Primary endpoint was the FNR. RESULTS: Out of 172 included patients, 149 had undergone a completion ALND. The detection rate for the tattooed node was 94.6% (141 out of 149). SLN biopsy was attempted in 132 out of 149 patients with a detection rate of 91.7% (121 out of 132). SLN and tattooed node were identical in 58 out of 121 individuals (47.9%). The combined procedure, i.e. targeted axillary dissection (TAD) was successful in 147 of 149 cases (98.7%). Four out of 65 patients with a clinically node-negative status after NST had a negative TAD but metastases on ALND, corresponding to a FNR of 6.2%. All false-negative TAD procedures were performed in the first 2 years of the trial (2018–2019, p = 0.022). CONCLUSION: Carbon tattooing is a feasible marking method for TAD with a high detection rate and an acceptably low FNR. The TATTOO trial was preregistered as prospective trial before initiation at the University of Rostock, Germany (DRKS00013169). |
format | Online Article Text |
id | pubmed-9114094 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-91140942022-05-19 False-negative rate in the extended prospective TATTOO trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy de Boniface, Jana Frisell, Jan Kühn, Thorsten Wiklander-Bråkenhielm, Ingrid Dembrower, Karin Nyman, Per Zouzos, Athanasios Gerber, Bernd Reimer, Toralf Hartmann, Steffi Breast Cancer Res Treat Clinical Trial PURPOSE: In clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy (NST), nodal metastases can be initially marked and then removed during surgical axillary staging. Marking methods vary significantly in terms of feasibility and cost. The purpose of the extended TATTOO trial was to report on the false-negative rate (FNR) of the low-cost method carbon tattooing. METHODS: The international prospective single-arm TATTOO trial included clinically node-positive breast cancer patients planned for NST from November 2017 to January 2021. For the present analysis, patients who received both the targeted procedure with or without an additional sentinel lymph node (SLN) biopsy and a completion axillary lymph node dissection (ALND) were selected. Primary endpoint was the FNR. RESULTS: Out of 172 included patients, 149 had undergone a completion ALND. The detection rate for the tattooed node was 94.6% (141 out of 149). SLN biopsy was attempted in 132 out of 149 patients with a detection rate of 91.7% (121 out of 132). SLN and tattooed node were identical in 58 out of 121 individuals (47.9%). The combined procedure, i.e. targeted axillary dissection (TAD) was successful in 147 of 149 cases (98.7%). Four out of 65 patients with a clinically node-negative status after NST had a negative TAD but metastases on ALND, corresponding to a FNR of 6.2%. All false-negative TAD procedures were performed in the first 2 years of the trial (2018–2019, p = 0.022). CONCLUSION: Carbon tattooing is a feasible marking method for TAD with a high detection rate and an acceptably low FNR. The TATTOO trial was preregistered as prospective trial before initiation at the University of Rostock, Germany (DRKS00013169). Springer US 2022-04-22 2022 /pmc/articles/PMC9114094/ /pubmed/35451733 http://dx.doi.org/10.1007/s10549-022-06588-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/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, visithttp://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) |
spellingShingle | Clinical Trial de Boniface, Jana Frisell, Jan Kühn, Thorsten Wiklander-Bråkenhielm, Ingrid Dembrower, Karin Nyman, Per Zouzos, Athanasios Gerber, Bernd Reimer, Toralf Hartmann, Steffi False-negative rate in the extended prospective TATTOO trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy |
title | False-negative rate in the extended prospective TATTOO trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy |
title_full | False-negative rate in the extended prospective TATTOO trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy |
title_fullStr | False-negative rate in the extended prospective TATTOO trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy |
title_full_unstemmed | False-negative rate in the extended prospective TATTOO trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy |
title_short | False-negative rate in the extended prospective TATTOO trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy |
title_sort | false-negative rate in the extended prospective tattoo trial evaluating targeted axillary dissection by carbon tattooing in clinically node-positive breast cancer patients receiving neoadjuvant systemic therapy |
topic | Clinical Trial |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9114094/ https://www.ncbi.nlm.nih.gov/pubmed/35451733 http://dx.doi.org/10.1007/s10549-022-06588-2 |
work_keys_str_mv | AT debonifacejana falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT friselljan falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT kuhnthorsten falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT wiklanderbrakenhielmingrid falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT dembrowerkarin falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT nymanper falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT zouzosathanasios falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT gerberbernd falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT reimertoralf falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy AT hartmannsteffi falsenegativerateintheextendedprospectivetattootrialevaluatingtargetedaxillarydissectionbycarbontattooinginclinicallynodepositivebreastcancerpatientsreceivingneoadjuvantsystemictherapy |