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. 2021 Oct 25;7(1):139.
doi: 10.1038/s41523-021-00348-z.

Decreased enrollment in breast cancer trials by histologic subtype: does invasive lobular carcinoma resist RECIST?

Mary Kathryn Abel  1   2 , Michelle E Melisko  3 , Hope S Rugo  3 , A Jo Chien  3 , Italia Diaz  4 , Julia K Levine  5 , Ann Griffin  6 , Joseph McGuire  6 , Laura J Esserman  2 , Hala T Borno  3 , Rita A Mukhtar  7
Affiliations

Decreased enrollment in breast cancer trials by histologic subtype: does invasive lobular carcinoma resist RECIST?

Mary Kathryn Abel et al. NPJ Breast Cancer. .

Abstract

Enrollment in metastatic breast cancer trials usually requires measurable lesions, but patients with invasive lobular carcinoma (ILC) tend to form diffuse disease. We found that the proportion of patients with metastatic ILC enrolled in clinical trials at our institution was significantly lower than that of patients with invasive ductal carcinoma (IDC). Possible links between requiring measurable disease and decreased enrollment of ILC patients require further study to ensure equitable trial access.

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Conflict of interest statement

Dr. Melisko receives research funding from Astra Zeneca, Novartis, KCRN Research, and Puma and consulting fees from Biotheranostics. Dr. Rugo receives research support for clinical trials through the University of California from Pfizer, Merck, Novartis, Lilly, Genentech, OBI, Odonate, Daiichi, Seattle Genetics, Eisai, Macrogenics, Sermonix, Immunomedics, and AstraZeneca. She has also received travel support from Daiichi, Mylan, Pfizer, Merck, AstraZeneca, Novartis, and Macrogenics and honoraria from Puma, Mylan, and Samsung. Dr. Chien receives research funding from Merck, Puma, Amgen, and Seattle Genetics. Dr. Esserman is an unpaid member of the board of directors of Quantum Leap Healthcare Collaborative and receives research funding from QLHC for the I-SPY TRIAL. She is a member of the Blue Cross/Blue Shield Medical Advisory Panel and receives honoraria and travel funding. She has a grant from Merck for an Investigator-initiated trial of DCIS. The remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Proportion of patients with invasive lobular carcinoma in the UCSF Cancer Registry versus the OnCore Clinical Trials Management System (CTMS), stratified by stage.
Patients with stage IV invasive lobular carcinoma (ILC) are significantly under-represented in the OnCore CTMS registry compared with the UCSF Cancer Registry. *Two-sample test of proportion: p = 0.005.
See this image and copyright information in PMC

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