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A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer

Background: Neither paclitaxel plus trastuzumab (P-H) nor docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared in HER2-positive early-stage breast cancer (EBC). A randomized trial was performed to assess the feasibility of a larger study. Methods: Lower-risk HER2-posit...

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Autores principales: Fernandes, Ricardo, Ng, Terry L., Alzahrani, Mashari Jemaan, Raphael, Jacques, Blanchette, Phillip, Black, Morgan, Stober, Carol, Pond, Gregory R., Cella, David, Vandermeer, Lisa, Ibrahim, Mohammed, Clemons, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10453132/
https://www.ncbi.nlm.nih.gov/pubmed/37623016
http://dx.doi.org/10.3390/curroncol30080535
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author Fernandes, Ricardo
Ng, Terry L.
Alzahrani, Mashari Jemaan
Raphael, Jacques
Blanchette, Phillip
Black, Morgan
Stober, Carol
Pond, Gregory R.
Cella, David
Vandermeer, Lisa
Ibrahim, Mohammed
Clemons, Mark
author_facet Fernandes, Ricardo
Ng, Terry L.
Alzahrani, Mashari Jemaan
Raphael, Jacques
Blanchette, Phillip
Black, Morgan
Stober, Carol
Pond, Gregory R.
Cella, David
Vandermeer, Lisa
Ibrahim, Mohammed
Clemons, Mark
author_sort Fernandes, Ricardo
collection PubMed
description Background: Neither paclitaxel plus trastuzumab (P-H) nor docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared in HER2-positive early-stage breast cancer (EBC). A randomized trial was performed to assess the feasibility of a larger study. Methods: Lower-risk HER2-positive EBC patients were randomized to either P-H or TC-H treatment arms. The co-primary feasibility outcomes were: ≥75% patient acceptability rate, active trial participation of ≥50% of medical oncologists, ≥75% and ≥90% treatment completion, and receipt rate of planned cycles of chemotherapy, respectively. Secondary outcomes: Febrile neutropenia (FN) rate, treatment-related hospitalizations, health-related quality of life (HR-QoL) questionnaires. Analyses were performed by per protocol and intention-to-treat. Results: Between May 2019 and March 2021, 49 of 52 patients agreed to study participation (94% acceptability rate). Fifteen (65%) of 23 medical oncologists approached patients. Rates of FN were higher (8.3% vs. 0%) in the TC-H vs. P-H arm. Median (IQR) changes in scores from baseline in FACT-Taxane Trial Outcome Index at 24 weeks were −4 (−10, −1) vs. −6.5 (−15, −2) for TC-H and P-H arms, respectively. Conclusions: A randomized trial comparing P-H and TC-H was feasible. Expansion to a larger trial would be feasible to explore patient-reported outcomes of these adjuvant HER2 chemotherapy regimens.
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spelling pubmed-104531322023-08-26 A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer Fernandes, Ricardo Ng, Terry L. Alzahrani, Mashari Jemaan Raphael, Jacques Blanchette, Phillip Black, Morgan Stober, Carol Pond, Gregory R. Cella, David Vandermeer, Lisa Ibrahim, Mohammed Clemons, Mark Curr Oncol Article Background: Neither paclitaxel plus trastuzumab (P-H) nor docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared in HER2-positive early-stage breast cancer (EBC). A randomized trial was performed to assess the feasibility of a larger study. Methods: Lower-risk HER2-positive EBC patients were randomized to either P-H or TC-H treatment arms. The co-primary feasibility outcomes were: ≥75% patient acceptability rate, active trial participation of ≥50% of medical oncologists, ≥75% and ≥90% treatment completion, and receipt rate of planned cycles of chemotherapy, respectively. Secondary outcomes: Febrile neutropenia (FN) rate, treatment-related hospitalizations, health-related quality of life (HR-QoL) questionnaires. Analyses were performed by per protocol and intention-to-treat. Results: Between May 2019 and March 2021, 49 of 52 patients agreed to study participation (94% acceptability rate). Fifteen (65%) of 23 medical oncologists approached patients. Rates of FN were higher (8.3% vs. 0%) in the TC-H vs. P-H arm. Median (IQR) changes in scores from baseline in FACT-Taxane Trial Outcome Index at 24 weeks were −4 (−10, −1) vs. −6.5 (−15, −2) for TC-H and P-H arms, respectively. Conclusions: A randomized trial comparing P-H and TC-H was feasible. Expansion to a larger trial would be feasible to explore patient-reported outcomes of these adjuvant HER2 chemotherapy regimens. MDPI 2023-08-04 /pmc/articles/PMC10453132/ /pubmed/37623016 http://dx.doi.org/10.3390/curroncol30080535 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Fernandes, Ricardo
Ng, Terry L.
Alzahrani, Mashari Jemaan
Raphael, Jacques
Blanchette, Phillip
Black, Morgan
Stober, Carol
Pond, Gregory R.
Cella, David
Vandermeer, Lisa
Ibrahim, Mohammed
Clemons, Mark
A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer
title A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer
title_full A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer
title_fullStr A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer
title_full_unstemmed A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer
title_short A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer
title_sort multi-centre randomized study comparing two standard of care chemotherapy regimens for lower-risk her2-positive breast cancer
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10453132/
https://www.ncbi.nlm.nih.gov/pubmed/37623016
http://dx.doi.org/10.3390/curroncol30080535
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