Cargando…

Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer

BACKGROUND: Talazoparib is a poly (adenosine diphosphate-ribose) polymerase inhibitor approved for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative, locally advanced or metastatic breast cancer (LA/mBC), with approval based on th...

Descripción completa

Detalles Bibliográficos
Autores principales: Savill, Kristin M Zimmerman, Ivanova, Jasmina, Asgarisabet, Parisa, Falkenstein, Angelica, Balanean, Alexandrina, Niyazov, Alexander, Ryan, Joanne C, Kish, Jonathan, Gajra, Ajeet, Mahtani, Reshma L
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10166159/
https://www.ncbi.nlm.nih.gov/pubmed/36952230
http://dx.doi.org/10.1093/oncolo/oyad021
_version_ 1785038387310231552
author Savill, Kristin M Zimmerman
Ivanova, Jasmina
Asgarisabet, Parisa
Falkenstein, Angelica
Balanean, Alexandrina
Niyazov, Alexander
Ryan, Joanne C
Kish, Jonathan
Gajra, Ajeet
Mahtani, Reshma L
author_facet Savill, Kristin M Zimmerman
Ivanova, Jasmina
Asgarisabet, Parisa
Falkenstein, Angelica
Balanean, Alexandrina
Niyazov, Alexander
Ryan, Joanne C
Kish, Jonathan
Gajra, Ajeet
Mahtani, Reshma L
author_sort Savill, Kristin M Zimmerman
collection PubMed
description BACKGROUND: Talazoparib is a poly (adenosine diphosphate-ribose) polymerase inhibitor approved for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative, locally advanced or metastatic breast cancer (LA/mBC), with approval based on the EMBRACA trial. To date, there are no published data on talazoparib use in the real-world United States (USA) setting. PATIENTS AND METHODS: Characteristics, treatment patterns, and clinical outcomes of real-world US patients with gBRCAm HER2-negative LA/mBC treated with talazoparib monotherapy were collected via retrospective chart review and summarized using descriptive statistics. RESULTS: Among 84 eligible patients, 35.7% had hormone receptor-positive tumors and 64.3% had triple-negative LA/mBC (TNBC). At talazoparib initiation, 29.8% had ECOG PS of ≥2 and 19.0% had brain metastasis. Mutations in gBRCA1 or 2 were detected among 64.3% and 35.7% of patients, respectively. Talazoparib was given as 1st-line therapy in 14.3% of patients, 2nd-line in 40.5%, and 3rd- or 4th-line in 45.2%. Median time to talazoparib treatment failure was 8.5 months (95% CI, 8.0-9.7), median progression-free survival was 8.7 months (95% CI, 8.0-9.9), the median time from initiation to chemotherapy was 12.2 months (95% CI, 10.5-20.1), and the overall response rate was 63.1%. No differences in clinical outcomes were observed between patients with HR-positive/HER2-negative LA/mBC and patients with TNBC by using unadjusted statistical comparisons. Brain metastasis and ECOG PS ≥2 at talazoparib initiation were associated with treatment failure and progression or mortality. CONCLUSION: Overall, talazoparib clinical outcomes in this real-world population are consistent with findings from EMBRACA.
format Online
Article
Text
id pubmed-10166159
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-101661592023-05-09 Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer Savill, Kristin M Zimmerman Ivanova, Jasmina Asgarisabet, Parisa Falkenstein, Angelica Balanean, Alexandrina Niyazov, Alexander Ryan, Joanne C Kish, Jonathan Gajra, Ajeet Mahtani, Reshma L Oncologist Breast Cancer BACKGROUND: Talazoparib is a poly (adenosine diphosphate-ribose) polymerase inhibitor approved for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative, locally advanced or metastatic breast cancer (LA/mBC), with approval based on the EMBRACA trial. To date, there are no published data on talazoparib use in the real-world United States (USA) setting. PATIENTS AND METHODS: Characteristics, treatment patterns, and clinical outcomes of real-world US patients with gBRCAm HER2-negative LA/mBC treated with talazoparib monotherapy were collected via retrospective chart review and summarized using descriptive statistics. RESULTS: Among 84 eligible patients, 35.7% had hormone receptor-positive tumors and 64.3% had triple-negative LA/mBC (TNBC). At talazoparib initiation, 29.8% had ECOG PS of ≥2 and 19.0% had brain metastasis. Mutations in gBRCA1 or 2 were detected among 64.3% and 35.7% of patients, respectively. Talazoparib was given as 1st-line therapy in 14.3% of patients, 2nd-line in 40.5%, and 3rd- or 4th-line in 45.2%. Median time to talazoparib treatment failure was 8.5 months (95% CI, 8.0-9.7), median progression-free survival was 8.7 months (95% CI, 8.0-9.9), the median time from initiation to chemotherapy was 12.2 months (95% CI, 10.5-20.1), and the overall response rate was 63.1%. No differences in clinical outcomes were observed between patients with HR-positive/HER2-negative LA/mBC and patients with TNBC by using unadjusted statistical comparisons. Brain metastasis and ECOG PS ≥2 at talazoparib initiation were associated with treatment failure and progression or mortality. CONCLUSION: Overall, talazoparib clinical outcomes in this real-world population are consistent with findings from EMBRACA. Oxford University Press 2023-03-23 /pmc/articles/PMC10166159/ /pubmed/36952230 http://dx.doi.org/10.1093/oncolo/oyad021 Text en © The Author(s) 2023. Published by Oxford University Press. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Breast Cancer
Savill, Kristin M Zimmerman
Ivanova, Jasmina
Asgarisabet, Parisa
Falkenstein, Angelica
Balanean, Alexandrina
Niyazov, Alexander
Ryan, Joanne C
Kish, Jonathan
Gajra, Ajeet
Mahtani, Reshma L
Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer
title Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer
title_full Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer
title_fullStr Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer
title_full_unstemmed Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer
title_short Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer
title_sort characteristics, treatment, and outcomes of real-world talazoparib-treated patients with germline brca-mutated advanced her2-negative breast cancer
topic Breast Cancer
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10166159/
https://www.ncbi.nlm.nih.gov/pubmed/36952230
http://dx.doi.org/10.1093/oncolo/oyad021
work_keys_str_mv AT savillkristinmzimmerman characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT ivanovajasmina characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT asgarisabetparisa characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT falkensteinangelica characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT balaneanalexandrina characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT niyazovalexander characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT ryanjoannec characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT kishjonathan characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT gajraajeet characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer
AT mahtanireshmal characteristicstreatmentandoutcomesofrealworldtalazoparibtreatedpatientswithgermlinebrcamutatedadvancedher2negativebreastcancer