Reporting on invasive lobular breast cancer in clinical trials: a systematic review

Karen Van Baelen; Josephine Van Cauwenberge; Marion Maetens; Gabriela Beck; Ann Camden; Megan Claire Chase; Valerie Fraser; Siobhan Freeney; Laurie Hutcheson; Julia K. Levine; Tone Lien; Rian Terveer; Claire Turner; Elzbieta Senkus; Rachel C. Jankowitz; Vincent Vandecaveye; Giuseppe Floris; Patrick Neven; Hans Wildiers; Elinor Sawyer; Anne Vincent-Salomon; Patrick W.B. Derksen; Christine Desmedt

doi:10.1038/s41523-024-00627-5

Reporting on invasive lobular breast cancer in clinical trials: a systematic review

Karen Van Baelen, Josephine Van Cauwenberge, Marion Maetens, Gabriela Beck, Ann Camden, Megan Claire Chase, Valerie Fraser, Siobhan Freeney, Laurie Hutcheson, Julia K. Levine, Tone Lien, Rian Terveer, Claire Turner, Elzbieta Senkus, Rachel C. Jankowitz, Vincent Vandecaveye, Giuseppe Floris, Patrick Neven, Hans Wildiers, Elinor SawyerAnne Vincent-Salomon, Patrick W.B. Derksen, Christine Desmedt^*

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

Abstract

Invasive lobular breast cancer (ILC) differs from invasive breast cancer of no special type in many ways. Evidence on treatment efficacy for ILC is, however, lacking. We studied the degree of documentation and representation of ILC in phase III/IV clinical trials for novel breast cancer treatments. Trials were identified on Pubmed and clinicaltrials.gov. Inclusion/exclusion criteria were reviewed for requirements on histological subtype and tumor measurability. Documentation of ILC was assessed and ILC inclusion rate, central pathology and subgroup analyses were evaluated. Inclusion restrictions concerning tumor measurability were found in 39/93 manuscripts. Inclusion rates for ILC were documented in 13/93 manuscripts and varied between 2.0 and 26.0%. No central pathology for ILC was reported and 3/13 manuscripts had ILC sub-analyses. ILC is largely disregarded in most trials with poor representation and documentation. The current inclusion criteria using RECIST v1.1, fall short in recognizing the unique non-measurable metastatic infiltration of ILC.

Original language	English
Article number	23
Number of pages	8
Journal	npj Breast Cancer
Volume	10
Issue number	1
DOIs	https://doi.org/10.1038/s41523-024-00627-5
Publication status	Published - 20 Mar 2024

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s41523-024-00627-5Final published version, 0.99 MBLicence: CC BY

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Van Baelen, K., Van Cauwenberge, J., Maetens, M., Beck, G., Camden, A., Chase, M. C., Fraser, V., Freeney, S., Hutcheson, L., Levine, J. K., Lien, T., Terveer, R., Turner, C., Senkus, E., Jankowitz, R. C., Vandecaveye, V., Floris, G., Neven, P., Wildiers, H., ... Desmedt, C. (2024). Reporting on invasive lobular breast cancer in clinical trials: a systematic review. npj Breast Cancer, 10(1), Article 23. https://doi.org/10.1038/s41523-024-00627-5

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title = "Reporting on invasive lobular breast cancer in clinical trials: a systematic review",

abstract = "Invasive lobular breast cancer (ILC) differs from invasive breast cancer of no special type in many ways. Evidence on treatment efficacy for ILC is, however, lacking. We studied the degree of documentation and representation of ILC in phase III/IV clinical trials for novel breast cancer treatments. Trials were identified on Pubmed and clinicaltrials.gov. Inclusion/exclusion criteria were reviewed for requirements on histological subtype and tumor measurability. Documentation of ILC was assessed and ILC inclusion rate, central pathology and subgroup analyses were evaluated. Inclusion restrictions concerning tumor measurability were found in 39/93 manuscripts. Inclusion rates for ILC were documented in 13/93 manuscripts and varied between 2.0 and 26.0%. No central pathology for ILC was reported and 3/13 manuscripts had ILC sub-analyses. ILC is largely disregarded in most trials with poor representation and documentation. The current inclusion criteria using RECIST v1.1, fall short in recognizing the unique non-measurable metastatic infiltration of ILC.",

author = "{Van Baelen}, Karen and {Van Cauwenberge}, Josephine and Marion Maetens and Gabriela Beck and Ann Camden and Chase, {Megan Claire} and Valerie Fraser and Siobhan Freeney and Laurie Hutcheson and Levine, {Julia K.} and Tone Lien and Rian Terveer and Claire Turner and Elzbieta Senkus and Jankowitz, {Rachel C.} and Vincent Vandecaveye and Giuseppe Floris and Patrick Neven and Hans Wildiers and Elinor Sawyer and Anne Vincent-Salomon and Derksen, {Patrick W.B.} and Christine Desmedt",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

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doi = "10.1038/s41523-024-00627-5",

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Van Baelen, K, Van Cauwenberge, J, Maetens, M, Beck, G, Camden, A, Chase, MC, Fraser, V, Freeney, S, Hutcheson, L, Levine, JK, Lien, T, Terveer, R, Turner, C, Senkus, E, Jankowitz, RC, Vandecaveye, V, Floris, G, Neven, P, Wildiers, H, Sawyer, E, Vincent-Salomon, A, Derksen, PWB & Desmedt, C 2024, 'Reporting on invasive lobular breast cancer in clinical trials: a systematic review', npj Breast Cancer, vol. 10, no. 1, 23. https://doi.org/10.1038/s41523-024-00627-5

TY - JOUR

T1 - Reporting on invasive lobular breast cancer in clinical trials

T2 - a systematic review

AU - Van Baelen, Karen

AU - Van Cauwenberge, Josephine

AU - Maetens, Marion

AU - Beck, Gabriela

AU - Camden, Ann

AU - Chase, Megan Claire

AU - Fraser, Valerie

AU - Freeney, Siobhan

AU - Hutcheson, Laurie

AU - Levine, Julia K.

AU - Lien, Tone

AU - Terveer, Rian

AU - Turner, Claire

AU - Senkus, Elzbieta

AU - Jankowitz, Rachel C.

AU - Vandecaveye, Vincent

AU - Floris, Giuseppe

AU - Neven, Patrick

AU - Wildiers, Hans

AU - Sawyer, Elinor

AU - Vincent-Salomon, Anne

AU - Derksen, Patrick W.B.

AU - Desmedt, Christine

PY - 2024/3/20

Y1 - 2024/3/20

N2 - Invasive lobular breast cancer (ILC) differs from invasive breast cancer of no special type in many ways. Evidence on treatment efficacy for ILC is, however, lacking. We studied the degree of documentation and representation of ILC in phase III/IV clinical trials for novel breast cancer treatments. Trials were identified on Pubmed and clinicaltrials.gov. Inclusion/exclusion criteria were reviewed for requirements on histological subtype and tumor measurability. Documentation of ILC was assessed and ILC inclusion rate, central pathology and subgroup analyses were evaluated. Inclusion restrictions concerning tumor measurability were found in 39/93 manuscripts. Inclusion rates for ILC were documented in 13/93 manuscripts and varied between 2.0 and 26.0%. No central pathology for ILC was reported and 3/13 manuscripts had ILC sub-analyses. ILC is largely disregarded in most trials with poor representation and documentation. The current inclusion criteria using RECIST v1.1, fall short in recognizing the unique non-measurable metastatic infiltration of ILC.

AB - Invasive lobular breast cancer (ILC) differs from invasive breast cancer of no special type in many ways. Evidence on treatment efficacy for ILC is, however, lacking. We studied the degree of documentation and representation of ILC in phase III/IV clinical trials for novel breast cancer treatments. Trials were identified on Pubmed and clinicaltrials.gov. Inclusion/exclusion criteria were reviewed for requirements on histological subtype and tumor measurability. Documentation of ILC was assessed and ILC inclusion rate, central pathology and subgroup analyses were evaluated. Inclusion restrictions concerning tumor measurability were found in 39/93 manuscripts. Inclusion rates for ILC were documented in 13/93 manuscripts and varied between 2.0 and 26.0%. No central pathology for ILC was reported and 3/13 manuscripts had ILC sub-analyses. ILC is largely disregarded in most trials with poor representation and documentation. The current inclusion criteria using RECIST v1.1, fall short in recognizing the unique non-measurable metastatic infiltration of ILC.

UR - http://www.scopus.com/inward/record.url?scp=85188250451&partnerID=8YFLogxK

U2 - 10.1038/s41523-024-00627-5

DO - 10.1038/s41523-024-00627-5

M3 - Review article

C2 - 38509112

SN - 2374-4677

VL - 10

JO - npj Breast Cancer

JF - npj Breast Cancer

IS - 1

M1 - 23

ER -

Reporting on invasive lobular breast cancer in clinical trials: a systematic review

Abstract

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