Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411)

Maggie Banys-Paluchowski; Thorsten Kühn; Yazan Masannat; Isabel Rubio; Jana de Boniface; Nina Ditsch; Güldeniz Karadeniz Cakmak; Andreas Karakatsanis; Rajiv Dave; Markus Hahn; Shelley Potter; Ashutosh Kothari; Oreste Davide Gentilini; Bahadir M Gulluoglu; Michael Patrick Lux; Marjolein Smidt; Walter Paul Weber; Bilge Aktas Sezen; Natalia Krawczyk; Steffi Hartmann; Rosa Di Micco; Sarah Nietz; Francois Malherbe; Neslihan Cabioglu; Nuh Zafer Canturk; Maria Luisa Gasparri; Dawid Murawa; James Harvey

doi:10.3390/cancers15041173

Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411)

Maggie Banys-Paluchowski^*
, Thorsten Kühn
, Yazan Masannat
, Isabel Rubio
, Jana de Boniface
, Nina Ditsch
, Güldeniz Karadeniz Cakmak
, Andreas Karakatsanis
, Rajiv Dave
, Markus Hahn
, Shelley Potter
, Ashutosh Kothari
, Oreste Davide Gentilini
, Bahadir M Gulluoglu
, Michael Patrick Lux
, Marjolein Smidt
, Walter Paul Weber
, Bilge Aktas Sezen
, Natalia Krawczyk
, Steffi Hartmann

Rosa Di Micco, Sarah Nietz, Francois Malherbe, Neslihan Cabioglu, Nuh Zafer Canturk, Maria Luisa Gasparri, Dawid Murawa, James Harvey

^*Corresponding author for this work

Research output: Contribution to journal › Review article (Academic Journal) › peer-review

83 Citations (Scopus)

Abstract

BACKGROUND: Surgical excision of a non-palpable breast lesion requires a localization step. Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have been developed in the last two decades with the aim of improving outcomes and logistics.

METHODS: We performed a systematic review on localization techniques for non-palpable breast cancer.

RESULTS: For most techniques, oncological outcomes such as lesion identification and clear margin rate seem either comparable with or better than for WGL, but evidence is limited to small cohort studies for some of the devices. Intraoperative ultrasound is associated with significantly higher negative margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons' and radiologists' attitudes towards these techniques.

CONCLUSIONS: Large studies with an additional focus on patient, surgeon, and radiologist preference are necessary. This review aims to present the rationale for the MELODY (NCT05559411) study and to enable standardization of outcome measures for future studies.

Original language	English
Article number	1173
Journal	Cancers
Volume	15
Issue number	4
DOIs	https://doi.org/10.3390/cancers15041173
Publication status	Published - 12 Feb 2023

Bibliographical note

Funding Information:
Maggie Banys-Paluchowski has received honoraria for lectures and participation in advisory boards: Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, AstraZeneca, Amgen, Samsung, MSD, GSK, Daiichi Sankyo, Gilead, Canon, Sirius Pintuition, and Pierre Fabre; and study support from Endomag, Mammotome, MeritMedical, Gilead, ExactSciences. Ash Kothari has received a research grant from Endomag and acts as PI of the respective study. Andreas Karakatsanis has received a research grant from Endomag; acts as PI of the respective study; and recieved honoraria from Pfizer and Resitu AB. Michael P. Lux received honoraria for lectures and advisory participation from Lilly, AstraZeneca, MSD, Roche, Novartis, Pfizer, Eisai, Exact Sciences, Daiichi-Sankyo, Grünenthal, Gilead, Pierre Fabre, PharmaMar, pfm, Samantree, and Endomag; travel expenses from AstraZeneca, Roche, and Pfizer; editorial board membership for medac. Francois Malherbe received honoraria and travel support from Sysmex, the local distributor of Magseed. Dawid Murawa received honoraria for lectures from Roche, Medtronic, Stryker, Mammotome, MDT—diagnostic green, GEM-Italy, Combat-Medical. Other authors declared no conflicts of interest.

Funding Information:
MELODY is supported by the AGO-B study group, the Oncoplastic Breast Consortium (OPBC), SENATURK, AWOgyn (German Working Group for Reconstructive Surgery in Oncology-Gynecology), and German Breast Group (GBG).

Publisher Copyright:
© 2023 by the authors.

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This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.3390/cancers15041173Licence: CC BY

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Persistent link

The BRAVER Study - Methods to develop less and better research in reconstructive breast surgery
Potter, S. (Principal Investigator)
1/03/17 → 31/08/23
Project: Research

Cite this

Banys-Paluchowski, M., Kühn, T., Masannat, Y., Rubio, I., de Boniface, J., Ditsch, N., Karadeniz Cakmak, G., Karakatsanis, A., Dave, R., Hahn, M., Potter, S., Kothari, A., Gentilini, O. D., Gulluoglu, B. M., Lux, M. P., Smidt, M., Weber, W. P., Aktas Sezen, B., Krawczyk, N., ... Harvey, J. (2023). Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411). Cancers, 15(4), Article 1173. https://doi.org/10.3390/cancers15041173

@article{cd30b5a5030e42719900f30cd3128a7a,

title = "Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411)",

abstract = "BACKGROUND: Surgical excision of a non-palpable breast lesion requires a localization step. Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have been developed in the last two decades with the aim of improving outcomes and logistics.METHODS: We performed a systematic review on localization techniques for non-palpable breast cancer.RESULTS: For most techniques, oncological outcomes such as lesion identification and clear margin rate seem either comparable with or better than for WGL, but evidence is limited to small cohort studies for some of the devices. Intraoperative ultrasound is associated with significantly higher negative margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons' and radiologists' attitudes towards these techniques.CONCLUSIONS: Large studies with an additional focus on patient, surgeon, and radiologist preference are necessary. This review aims to present the rationale for the MELODY (NCT05559411) study and to enable standardization of outcome measures for future studies.",

author = "Maggie Banys-Paluchowski and Thorsten K{\"u}hn and Yazan Masannat and Isabel Rubio and \{de Boniface\}, Jana and Nina Ditsch and \{Karadeniz Cakmak\}, G{\"u}ldeniz and Andreas Karakatsanis and Rajiv Dave and Markus Hahn and Shelley Potter and Ashutosh Kothari and Gentilini, \{Oreste Davide\} and Gulluoglu, \{Bahadir M\} and Lux, \{Michael Patrick\} and Marjolein Smidt and Weber, \{Walter Paul\} and \{Aktas Sezen\}, Bilge and Natalia Krawczyk and Steffi Hartmann and \{Di Micco\}, Rosa and Sarah Nietz and Francois Malherbe and Neslihan Cabioglu and Canturk, \{Nuh Zafer\} and Gasparri, \{Maria Luisa\} and Dawid Murawa and James Harvey",

note = "Funding Information: Maggie Banys-Paluchowski has received honoraria for lectures and participation in advisory boards: Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, AstraZeneca, Amgen, Samsung, MSD, GSK, Daiichi Sankyo, Gilead, Canon, Sirius Pintuition, and Pierre Fabre; and study support from Endomag, Mammotome, MeritMedical, Gilead, ExactSciences. Ash Kothari has received a research grant from Endomag and acts as PI of the respective study. Andreas Karakatsanis has received a research grant from Endomag; acts as PI of the respective study; and recieved honoraria from Pfizer and Resitu AB. Michael P. Lux received honoraria for lectures and advisory participation from Lilly, AstraZeneca, MSD, Roche, Novartis, Pfizer, Eisai, Exact Sciences, Daiichi-Sankyo, Gr{\"u}nenthal, Gilead, Pierre Fabre, PharmaMar, pfm, Samantree, and Endomag; travel expenses from AstraZeneca, Roche, and Pfizer; editorial board membership for medac. Francois Malherbe received honoraria and travel support from Sysmex, the local distributor of Magseed. Dawid Murawa received honoraria for lectures from Roche, Medtronic, Stryker, Mammotome, MDT—diagnostic green, GEM-Italy, Combat-Medical. Other authors declared no conflicts of interest. Funding Information: MELODY is supported by the AGO-B study group, the Oncoplastic Breast Consortium (OPBC), SENATURK, AWOgyn (German Working Group for Reconstructive Surgery in Oncology-Gynecology), and German Breast Group (GBG). Publisher Copyright: {\textcopyright} 2023 by the authors.",

year = "2023",

month = feb,

day = "12",

doi = "10.3390/cancers15041173",

language = "English",

volume = "15",

journal = "Cancers",

issn = "2072-6694",

publisher = "MDPI AG",

number = "4",

}

Banys-Paluchowski, M, Kühn, T, Masannat, Y, Rubio, I, de Boniface, J, Ditsch, N, Karadeniz Cakmak, G, Karakatsanis, A, Dave, R, Hahn, M, Potter, S, Kothari, A, Gentilini, OD, Gulluoglu, BM, Lux, MP, Smidt, M, Weber, WP, Aktas Sezen, B, Krawczyk, N, Hartmann, S, Di Micco, R, Nietz, S, Malherbe, F, Cabioglu, N, Canturk, NZ, Gasparri, ML, Murawa, D & Harvey, J 2023, 'Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411)', Cancers, vol. 15, no. 4, 1173. https://doi.org/10.3390/cancers15041173

Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411). / Banys-Paluchowski, Maggie; Kühn, Thorsten; Masannat, Yazan et al.
In: Cancers, Vol. 15, No. 4, 1173, 12.02.2023.

Research output: Contribution to journal › Review article (Academic Journal) › peer-review

TY - JOUR

T1 - Localization Techniques for Non-Palpable Breast Lesions

T2 - Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411)

AU - Banys-Paluchowski, Maggie

AU - Kühn, Thorsten

AU - Masannat, Yazan

AU - Rubio, Isabel

AU - de Boniface, Jana

AU - Ditsch, Nina

AU - Karadeniz Cakmak, Güldeniz

AU - Karakatsanis, Andreas

AU - Dave, Rajiv

AU - Hahn, Markus

AU - Potter, Shelley

AU - Kothari, Ashutosh

AU - Gentilini, Oreste Davide

AU - Gulluoglu, Bahadir M

AU - Lux, Michael Patrick

AU - Smidt, Marjolein

AU - Weber, Walter Paul

AU - Aktas Sezen, Bilge

AU - Krawczyk, Natalia

AU - Hartmann, Steffi

AU - Di Micco, Rosa

AU - Nietz, Sarah

AU - Malherbe, Francois

AU - Cabioglu, Neslihan

AU - Canturk, Nuh Zafer

AU - Gasparri, Maria Luisa

AU - Murawa, Dawid

AU - Harvey, James

N1 - Funding Information: Maggie Banys-Paluchowski has received honoraria for lectures and participation in advisory boards: Roche, Novartis, Pfizer, pfm, Eli Lilly, Onkowissen, Seagen, AstraZeneca, Eisai, AstraZeneca, Amgen, Samsung, MSD, GSK, Daiichi Sankyo, Gilead, Canon, Sirius Pintuition, and Pierre Fabre; and study support from Endomag, Mammotome, MeritMedical, Gilead, ExactSciences. Ash Kothari has received a research grant from Endomag and acts as PI of the respective study. Andreas Karakatsanis has received a research grant from Endomag; acts as PI of the respective study; and recieved honoraria from Pfizer and Resitu AB. Michael P. Lux received honoraria for lectures and advisory participation from Lilly, AstraZeneca, MSD, Roche, Novartis, Pfizer, Eisai, Exact Sciences, Daiichi-Sankyo, Grünenthal, Gilead, Pierre Fabre, PharmaMar, pfm, Samantree, and Endomag; travel expenses from AstraZeneca, Roche, and Pfizer; editorial board membership for medac. Francois Malherbe received honoraria and travel support from Sysmex, the local distributor of Magseed. Dawid Murawa received honoraria for lectures from Roche, Medtronic, Stryker, Mammotome, MDT—diagnostic green, GEM-Italy, Combat-Medical. Other authors declared no conflicts of interest. Funding Information: MELODY is supported by the AGO-B study group, the Oncoplastic Breast Consortium (OPBC), SENATURK, AWOgyn (German Working Group for Reconstructive Surgery in Oncology-Gynecology), and German Breast Group (GBG). Publisher Copyright: © 2023 by the authors.

PY - 2023/2/12

Y1 - 2023/2/12

N2 - BACKGROUND: Surgical excision of a non-palpable breast lesion requires a localization step. Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have been developed in the last two decades with the aim of improving outcomes and logistics.METHODS: We performed a systematic review on localization techniques for non-palpable breast cancer.RESULTS: For most techniques, oncological outcomes such as lesion identification and clear margin rate seem either comparable with or better than for WGL, but evidence is limited to small cohort studies for some of the devices. Intraoperative ultrasound is associated with significantly higher negative margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons' and radiologists' attitudes towards these techniques.CONCLUSIONS: Large studies with an additional focus on patient, surgeon, and radiologist preference are necessary. This review aims to present the rationale for the MELODY (NCT05559411) study and to enable standardization of outcome measures for future studies.

AB - BACKGROUND: Surgical excision of a non-palpable breast lesion requires a localization step. Among available techniques, wire-guided localization (WGL) is most commonly used. Other techniques (radioactive, magnetic, radar or radiofrequency-based, and intraoperative ultrasound) have been developed in the last two decades with the aim of improving outcomes and logistics.METHODS: We performed a systematic review on localization techniques for non-palpable breast cancer.RESULTS: For most techniques, oncological outcomes such as lesion identification and clear margin rate seem either comparable with or better than for WGL, but evidence is limited to small cohort studies for some of the devices. Intraoperative ultrasound is associated with significantly higher negative margin rates in meta-analyses of randomized clinical trials (RCTs). Radioactive techniques were studied in several RCTs and are non-inferior to WGL. Smaller studies show higher patient preference towards wire-free localization, but little is known about surgeons' and radiologists' attitudes towards these techniques.CONCLUSIONS: Large studies with an additional focus on patient, surgeon, and radiologist preference are necessary. This review aims to present the rationale for the MELODY (NCT05559411) study and to enable standardization of outcome measures for future studies.

U2 - 10.3390/cancers15041173

DO - 10.3390/cancers15041173

M3 - Review article (Academic Journal)

C2 - 36831516

SN - 2072-6694

VL - 15

JO - Cancers

JF - Cancers

IS - 4

M1 - 1173

ER -

Localization Techniques for Non-Palpable Breast Lesions: Current Status, Knowledge Gaps, and Rationale for the MELODY Study (EUBREAST-4/iBRA-NET, NCT 05559411)

Abstract

Bibliographical note

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The BRAVER Study - Methods to develop less and better research in reconstructive breast surgery

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