Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.

Martín M; Zielinski C; Ruiz-Borrego M; Carrasco E; Ciruelos EM; Muñoz M; Bermejo B; Margelí M; Csöszi T; Antón A; Turner N; Casas MI; Morales S; Alba E; Calvo L; de la Haba-Rodríguez J; Ramos M; Murillo L; Santaballa A; Alonso-Romero JL; Sánchez-Rovira P; Corsaro M; Huang X; Thallinger C; Kahan Z; Gil-Gil M

Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.

BACKGROUND: An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic...

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Autores:	Martín M, Zielinski C, Ruiz-Borrego M, Carrasco E, Ciruelos EM, Muñoz M, Bermejo B, Margelí M, Csöszi T, Antón A, Turner N, Casas MI, Morales S, Alba E, Calvo L, de la Haba-Rodríguez J, Ramos M, Murillo L, Santaballa A, Alonso-Romero JL, Sánchez-Rovira P, Corsaro M, Huang X, Thallinger C, Kahan Z, Gil-Gil M
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2022
País:	España
Institución:	INCLIVA
Repositorio:	r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:	oai:incliva.fundanetsuite.com:p16586
Acceso en línea:	https://incliva.portalinvestigacion.com/publicaciones/16586
Access Level:	acceso abierto
Palabra clave:	CDK4/6 inhibitor Capecitabine Endocrine therapy HER2–negative Hormone receptor-positive metastatic breast cancer Overall survival Palbociclib

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spelling	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.Martín MZielinski CRuiz-Borrego MCarrasco ECiruelos EMMuñoz MBermejo BMargelí MCsöszi TAntón ATurner NCasas MIMorales SAlba ECalvo Lde la Haba-Rodríguez JRamos MMurillo LSantaballa AAlonso-Romero JLSánchez-Rovira PCorsaro MHuang XThallinger CKahan ZGil-Gil MCDK4/6 inhibitorCapecitabineEndocrine therapyHER2–negativeHormone receptor-positive metastatic breast cancerOverall survivalPalbociclibBACKGROUND: An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis. METHODS: Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death). RESULTS: OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81-1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed. CONCLUSIONS: Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors. TRIAL REGISTRATION: NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).ELSEVIER SCI LTD2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/16586EUROPEAN JOURNAL OF CANCERISSN: 09598049ISSNe: 18790852reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p165862026-06-07T16:35:31Z
dc.title.none.fl_str_mv	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
title	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
spellingShingle	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study. Martín M CDK4/6 inhibitor Capecitabine Endocrine therapy HER2–negative Hormone receptor-positive metastatic breast cancer Overall survival Palbociclib
title_short	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
title_full	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
title_fullStr	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
title_full_unstemmed	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
title_sort	Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
dc.creator.none.fl_str_mv	Martín M Zielinski C Ruiz-Borrego M Carrasco E Ciruelos EM Muñoz M Bermejo B Margelí M Csöszi T Antón A Turner N Casas MI Morales S Alba E Calvo L de la Haba-Rodríguez J Ramos M Murillo L Santaballa A Alonso-Romero JL Sánchez-Rovira P Corsaro M Huang X Thallinger C Kahan Z Gil-Gil M
author	Martín M
author_facet	Martín M Zielinski C Ruiz-Borrego M Carrasco E Ciruelos EM Muñoz M Bermejo B Margelí M Csöszi T Antón A Turner N Casas MI Morales S Alba E Calvo L de la Haba-Rodríguez J Ramos M Murillo L Santaballa A Alonso-Romero JL Sánchez-Rovira P Corsaro M Huang X Thallinger C Kahan Z Gil-Gil M
author_role	author
author2	Zielinski C Ruiz-Borrego M Carrasco E Ciruelos EM Muñoz M Bermejo B Margelí M Csöszi T Antón A Turner N Casas MI Morales S Alba E Calvo L de la Haba-Rodríguez J Ramos M Murillo L Santaballa A Alonso-Romero JL Sánchez-Rovira P Corsaro M Huang X Thallinger C Kahan Z Gil-Gil M
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	CDK4/6 inhibitor Capecitabine Endocrine therapy HER2–negative Hormone receptor-positive metastatic breast cancer Overall survival Palbociclib
topic	CDK4/6 inhibitor Capecitabine Endocrine therapy HER2–negative Hormone receptor-positive metastatic breast cancer Overall survival Palbociclib
description	BACKGROUND: An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis. METHODS: Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death). RESULTS: OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81-1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed. CONCLUSIONS: Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors. TRIAL REGISTRATION: NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
publishDate	2022
dc.date.none.fl_str_mv	2022
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	https://incliva.portalinvestigacion.com/publicaciones/16586
url	https://incliva.portalinvestigacion.com/publicaciones/16586
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	ELSEVIER SCI LTD
publisher.none.fl_str_mv	ELSEVIER SCI LTD
dc.source.none.fl_str_mv	EUROPEAN JOURNAL OF CANCER ISSN: 09598049 ISSNe: 18790852 reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA instname:INCLIVA
instname_str	INCLIVA
reponame_str	r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
collection	r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score	15,811543

Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.

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