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Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial

BACKGROUND: The phase IIIb CompLEEment-1 study evaluated ribociclib plus letrozole in patients with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC). Outcomes were investigated in the following subgroups: central nervous system (...

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Autores principales: Cottu, Paul, Ring, Alistair, Abdel-Razeq, Hikmat, Marchetti, Paolo, Cardoso, Fatima, Salvador Bofill, Javier, Martín, Miguel, Menon-Singh, Lakshmi, Wu, Jiwen, De Laurentiis, Michelino
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9073296/
https://www.ncbi.nlm.nih.gov/pubmed/35131646
http://dx.doi.org/10.1016/j.breast.2022.01.016
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author Cottu, Paul
Ring, Alistair
Abdel-Razeq, Hikmat
Marchetti, Paolo
Cardoso, Fatima
Salvador Bofill, Javier
Martín, Miguel
Menon-Singh, Lakshmi
Wu, Jiwen
De Laurentiis, Michelino
author_facet Cottu, Paul
Ring, Alistair
Abdel-Razeq, Hikmat
Marchetti, Paolo
Cardoso, Fatima
Salvador Bofill, Javier
Martín, Miguel
Menon-Singh, Lakshmi
Wu, Jiwen
De Laurentiis, Michelino
author_sort Cottu, Paul
collection PubMed
description BACKGROUND: The phase IIIb CompLEEment-1 study evaluated ribociclib plus letrozole in patients with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC). Outcomes were investigated in the following subgroups: central nervous system (CNS) metastases, prior chemotherapy for advanced disease, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, and visceral metastases plus prior chemotherapy for advanced disease or ECOG PS 2. PATIENTS AND METHODS: Patients with HR+, HER2– ABC without prior hormonal treatment for advanced disease received oral ribociclib (600 mg once daily, 3 weeks on/1 week off) plus letrozole (2.5 mg once daily, continuous). Primary endpoint was safety/tolerability, assessed via occurrence of adverse events (AEs); key secondary endpoints included time to progression (TTP), overall response rate, and clinical benefit rate. RESULTS: 51 patients had CNS metastases, 194 received prior chemotherapy for advanced disease, 112 had ECOG PS 2, 146 had visceral metastases plus prior chemotherapy, and 77 had visceral metastases plus ECOG PS 2. Safety results were consistent with those in the overall CompLEEment-1 population; no new safety concerns were identified. The AE profile was manageable with low rates of discontinuations due to AEs. TTP in patients with CNS metastases was consistent with the overall study population and shorter for other patient subgroups. Each patient subgroup achieved meaningful clinical benefit from treatment, consistent with the overall population. CONCLUSION: These findings confirm the clinical benefit of ribociclib plus endocrine therapy in high-risk patient subgroups of clinical interest commonly underrepresented in clinical trials.
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spelling pubmed-90732962022-05-07 Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial Cottu, Paul Ring, Alistair Abdel-Razeq, Hikmat Marchetti, Paolo Cardoso, Fatima Salvador Bofill, Javier Martín, Miguel Menon-Singh, Lakshmi Wu, Jiwen De Laurentiis, Michelino Breast Original Article BACKGROUND: The phase IIIb CompLEEment-1 study evaluated ribociclib plus letrozole in patients with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC). Outcomes were investigated in the following subgroups: central nervous system (CNS) metastases, prior chemotherapy for advanced disease, Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, and visceral metastases plus prior chemotherapy for advanced disease or ECOG PS 2. PATIENTS AND METHODS: Patients with HR+, HER2– ABC without prior hormonal treatment for advanced disease received oral ribociclib (600 mg once daily, 3 weeks on/1 week off) plus letrozole (2.5 mg once daily, continuous). Primary endpoint was safety/tolerability, assessed via occurrence of adverse events (AEs); key secondary endpoints included time to progression (TTP), overall response rate, and clinical benefit rate. RESULTS: 51 patients had CNS metastases, 194 received prior chemotherapy for advanced disease, 112 had ECOG PS 2, 146 had visceral metastases plus prior chemotherapy, and 77 had visceral metastases plus ECOG PS 2. Safety results were consistent with those in the overall CompLEEment-1 population; no new safety concerns were identified. The AE profile was manageable with low rates of discontinuations due to AEs. TTP in patients with CNS metastases was consistent with the overall study population and shorter for other patient subgroups. Each patient subgroup achieved meaningful clinical benefit from treatment, consistent with the overall population. CONCLUSION: These findings confirm the clinical benefit of ribociclib plus endocrine therapy in high-risk patient subgroups of clinical interest commonly underrepresented in clinical trials. Elsevier 2022-01-31 /pmc/articles/PMC9073296/ /pubmed/35131646 http://dx.doi.org/10.1016/j.breast.2022.01.016 Text en © 2022 The Authors https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Original Article
Cottu, Paul
Ring, Alistair
Abdel-Razeq, Hikmat
Marchetti, Paolo
Cardoso, Fatima
Salvador Bofill, Javier
Martín, Miguel
Menon-Singh, Lakshmi
Wu, Jiwen
De Laurentiis, Michelino
Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial
title Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial
title_full Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial
title_fullStr Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial
title_full_unstemmed Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial
title_short Ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial
title_sort ribociclib plus letrozole in subgroups of special clinical interest with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: subgroup analysis of the phase iiib compleement-1 trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9073296/
https://www.ncbi.nlm.nih.gov/pubmed/35131646
http://dx.doi.org/10.1016/j.breast.2022.01.016
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