Patient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review

Background: Although brain metastases (BM) affect 5% of all breast cancer patients and 14% of those with metastatic disease, patients with BM are often excluded from participation in clinical trials. We conducted a structured assessment of the contemporary restrictions to enrolment of, and results f...

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Autores principales:	Renata Duchnowska, Everardo D. Saad, Małgorzata Banaszek, Ewa Pawłowska, Hanna Liberek, Natalia Cichowska-Cwalińska, Jacek Jassem
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	brain metastases advanced breast cancer randomized controlled trials Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/d7ca7631cca749a3884fc7de5c6ff4ce
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spelling	oai:doaj.org-article:d7ca7631cca749a3884fc7de5c6ff4ce2021-11-11T15:27:50ZPatient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review10.3390/cancers132153062072-6694https://doaj.org/article/d7ca7631cca749a3884fc7de5c6ff4ce2021-10-01T00:00:00Zhttps://www.mdpi.com/2072-6694/13/21/5306https://doaj.org/toc/2072-6694Background: Although brain metastases (BM) affect 5% of all breast cancer patients and 14% of those with metastatic disease, patients with BM are often excluded from participation in clinical trials. We conducted a structured assessment of the contemporary restrictions to enrolment of, and results for, patients with BM in phase 3 trials published over a period of 23 years in advanced breast cancer. Methods: We used PubMed to search for completed randomized trials published between 01/98 and 12/20. For all eligible trials, two authors independently abstracted data on general characteristics of the studies and detailed information on patient eligibility regarding the presence of BM. Results: We analyzed 210 trials, which enrolled 92,409 eligible patients. Of that total, 162 (77.1%) publications explicitly mentioned eligibility criteria related to the presence of BM and 75 (35.7%) trials reportedly allowed patients with BM, usually with restrictions related to prior brain treatment or stability of lesions. There was a significant increase over time in the percentages of trials allowing patients with BM (<i>p</i> < 0.001), and these trials were more frequently dedicated to HER2-positive or triple-negative disease (<i>p</i> = 0.001). Only 11 trials reported separate results for patients with BM at baseline. The direct treatment activity on BM was usually not reported, although in subgroup analyses the treatment effect in relative terms was usually better among patients with BM than in overall populations. Conclusion: Nearly 36% of phase 3 trials in advanced breast cancer over a 23-year period allowed patients with BM, and this practice is increasing over time. More research is needed to establish the activity of current and promising therapies in patients with BM.Renata DuchnowskaEverardo D. SaadMałgorzata BanaszekEwa PawłowskaHanna LiberekNatalia Cichowska-CwalińskaJacek JassemMDPI AGarticlebrain metastasesadvanced breast cancerrandomized controlled trialsNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancers, Vol 13, Iss 5306, p 5306 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	brain metastases advanced breast cancer randomized controlled trials Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	brain metastases advanced breast cancer randomized controlled trials Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Renata Duchnowska Everardo D. Saad Małgorzata Banaszek Ewa Pawłowska Hanna Liberek Natalia Cichowska-Cwalińska Jacek Jassem Patient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review
description	Background: Although brain metastases (BM) affect 5% of all breast cancer patients and 14% of those with metastatic disease, patients with BM are often excluded from participation in clinical trials. We conducted a structured assessment of the contemporary restrictions to enrolment of, and results for, patients with BM in phase 3 trials published over a period of 23 years in advanced breast cancer. Methods: We used PubMed to search for completed randomized trials published between 01/98 and 12/20. For all eligible trials, two authors independently abstracted data on general characteristics of the studies and detailed information on patient eligibility regarding the presence of BM. Results: We analyzed 210 trials, which enrolled 92,409 eligible patients. Of that total, 162 (77.1%) publications explicitly mentioned eligibility criteria related to the presence of BM and 75 (35.7%) trials reportedly allowed patients with BM, usually with restrictions related to prior brain treatment or stability of lesions. There was a significant increase over time in the percentages of trials allowing patients with BM (<i>p</i> < 0.001), and these trials were more frequently dedicated to HER2-positive or triple-negative disease (<i>p</i> = 0.001). Only 11 trials reported separate results for patients with BM at baseline. The direct treatment activity on BM was usually not reported, although in subgroup analyses the treatment effect in relative terms was usually better among patients with BM than in overall populations. Conclusion: Nearly 36% of phase 3 trials in advanced breast cancer over a 23-year period allowed patients with BM, and this practice is increasing over time. More research is needed to establish the activity of current and promising therapies in patients with BM.
format	article
author	Renata Duchnowska Everardo D. Saad Małgorzata Banaszek Ewa Pawłowska Hanna Liberek Natalia Cichowska-Cwalińska Jacek Jassem
author_facet	Renata Duchnowska Everardo D. Saad Małgorzata Banaszek Ewa Pawłowska Hanna Liberek Natalia Cichowska-Cwalińska Jacek Jassem
author_sort	Renata Duchnowska
title	Patient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review
title_short	Patient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review
title_full	Patient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review
title_fullStr	Patient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review
title_full_unstemmed	Patient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review
title_sort	patient eligibility and results for brain metastasis in phase 3 trials of advanced breast cancer: a scoping review
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/d7ca7631cca749a3884fc7de5c6ff4ce
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Patient Eligibility and Results for Brain Metastasis in Phase 3 Trials of Advanced Breast Cancer: A Scoping Review

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