Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL

Martin, M.; Zielinski, C.; Ruiz Borrego, Manuel; Carrasco, E.; Turner, N.; Ciruelos, Eva; Muñoz Mateu, Montserrat; Bermejo de las Heras, Begoña; Margelí Vila, Mireia; Anton, A.; Kahan, Z.; Csöszi, T.; Casas, M. I.; Murillo, L.; Morales, S.; Alba, Emilio; Gal Yam, E.; Guerrero Zotano, A.; Calvo, L.; Haba Rodríguez, J. de la; Ramos, M.; Álvarez López, Isabel; García Palomo, Andrés; Huang Bartlett, C.; Koehler, M.; Caballero, R.; Corsaro, M.; Huang, X.; García Sáenz, José Ángel; Chacón, José Ignacio; Swift, C.; Thallinger, C.; Gil Gil, Miguel

Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL

Background: Palbociclib plus endocrine therapy (ET) is the standard treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative, metastatic breast cancer (MBC). However, its efficacy has not been compared with that of chemotherapy in a phase III trial. Patients and m...

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Autores:	Martin, M., Zielinski, C., Ruiz Borrego, Manuel, Carrasco, E., Turner, N., Ciruelos, Eva, Muñoz Mateu, Montserrat, Bermejo de las Heras, Begoña, Margelí Vila, Mireia, Anton, A., Kahan, Z., Csöszi, T., Casas, M. I., Murillo, L., Morales, S., Alba, Emilio, Gal Yam, E., Guerrero Zotano, A., Calvo, L., Haba Rodríguez, J. de la, Ramos, M., Álvarez López, Isabel, García Palomo, Andrés, Huang Bartlett, C., Koehler, M., Caballero, R., Corsaro, M., Huang, X., García Sáenz, José Ángel, Chacón, José Ignacio, Swift, C., Thallinger, C., Gil Gil, Miguel
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2021
País:	España
Institución:	Universidad de Barcelona
Repositorio:	Dipòsit Digital de la UB
OAI Identifier:	oai:diposit.ub.edu:2445/176002
Acceso en línea:	https://hdl.handle.net/2445/176002
Access Level:	acceso abierto
Palabra clave:	Càncer de mama Hormonoteràpia Breast cancer Hormone therapy

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spelling	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARLMartin, M.Zielinski, C.Ruiz Borrego, ManuelCarrasco, E.Turner, N.Ciruelos, EvaMuñoz Mateu, MontserratBermejo de las Heras, BegoñaMargelí Vila, MireiaAnton, A.Kahan, Z.Csöszi, T.Casas, M. I.Murillo, L.Morales, S.Alba, EmilioGal Yam, E.Guerrero Zotano, A.Calvo, L.Haba Rodríguez, J. de laRamos, M.Álvarez López, IsabelGarcía Palomo, AndrésHuang Bartlett, C.Koehler, M.Caballero, R.Corsaro, M.Huang, X.García Sáenz, José ÁngelChacón, José IgnacioSwift, C.Thallinger, C.Gil Gil, MiguelCàncer de mamaHormonoteràpiaBreast cancerHormone therapyBackground: Palbociclib plus endocrine therapy (ET) is the standard treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative, metastatic breast cancer (MBC). However, its efficacy has not been compared with that of chemotherapy in a phase III trial. Patients and methods: PEARL is a multicentre, phase III randomised study in which patients with aromatase inhibitor (AI)-resistant MBC were included in two consecutive cohorts. In cohort 1, patients were randomised 1 : 1 to palbociclib plus exemestane or capecitabine. On discovering new evidence about estrogen receptor-1 (ESR1) mutations inducing resistance to AIs, the trial was amended to include cohort 2, in which patients were randomised 1 : 1 between palbociclib plus fulvestrant and capecitabine. The stratification criteria were disease site, prior sensitivity to ET, prior chemotherapy for MBC, and country of origin. Co-primary endpoints were progression-free survival (PFS) in cohort 2 and in wild-type ESR1 patients (cohort 1 + cohort 2). ESR1 hotspot mutations were analysed in baseline circulating tumour DNA. Results: From March 2014 to July 2018, 296 and 305 patients were included in cohort 1 and cohort 2, respectively. Palbociclib plus ET was not superior to capecitabine in both cohort 2 [median PFS: 7.5 versus 10.0 months; adjusted hazard ratio (aHR): 1.13; 95% confidence interval (CI): 0.85-1.50] and wild-type ESR1 patients (median PFS: 8.0 versus 10.6 months; aHR: 1.11; 95% CI: 0.87-1.41). The most frequent grade 3-4 toxicities with palbociclib plus exemestane, palbociclib plus fulvestrant and capecitabine, respectively, were neutropenia (57.4%, 55.7% and 5.5%), hand/foot syndrome (0%, 0% and 23.5%), and diarrhoea (1.3%, 1.3% and 7.6%). Palbociclib plus ET offered better quality of life (aHR for time to deterioration of global health status: 0.67; 95% CI: 0.53-0.85). Conclusions: There was no statistical superiority of palbociclib plus ET over capecitabine with respect to PFS in MBC patients resistant to AIs. Palbociclib plus ET showed a better safety profile and improved quality of life.Elsevier B. V.2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/176002Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1016/j.annonc.2020.12.013Annals of Oncology, 2021, vol. 32, num. 4, p. 488-499https://doi.org/10.1016/j.annonc.2020.12.013cc by-nc-nd (c) Martin et al., 2020http://creativecommons.org/licenses/by-nc-nd/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1760022026-05-27T06:46:51Z
dc.title.none.fl_str_mv	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL
title	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL
spellingShingle	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL Martin, M. Càncer de mama Hormonoteràpia Breast cancer Hormone therapy
title_short	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL
title_full	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL
title_fullStr	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL
title_full_unstemmed	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL
title_sort	Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL
dc.creator.none.fl_str_mv	Martin, M. Zielinski, C. Ruiz Borrego, Manuel Carrasco, E. Turner, N. Ciruelos, Eva Muñoz Mateu, Montserrat Bermejo de las Heras, Begoña Margelí Vila, Mireia Anton, A. Kahan, Z. Csöszi, T. Casas, M. I. Murillo, L. Morales, S. Alba, Emilio Gal Yam, E. Guerrero Zotano, A. Calvo, L. Haba Rodríguez, J. de la Ramos, M. Álvarez López, Isabel García Palomo, Andrés Huang Bartlett, C. Koehler, M. Caballero, R. Corsaro, M. Huang, X. García Sáenz, José Ángel Chacón, José Ignacio Swift, C. Thallinger, C. Gil Gil, Miguel
author	Martin, M.
author_facet	Martin, M. Zielinski, C. Ruiz Borrego, Manuel Carrasco, E. Turner, N. Ciruelos, Eva Muñoz Mateu, Montserrat Bermejo de las Heras, Begoña Margelí Vila, Mireia Anton, A. Kahan, Z. Csöszi, T. Casas, M. I. Murillo, L. Morales, S. Alba, Emilio Gal Yam, E. Guerrero Zotano, A. Calvo, L. Haba Rodríguez, J. de la Ramos, M. Álvarez López, Isabel García Palomo, Andrés Huang Bartlett, C. Koehler, M. Caballero, R. Corsaro, M. Huang, X. García Sáenz, José Ángel Chacón, José Ignacio Swift, C. Thallinger, C. Gil Gil, Miguel
author_role	author
author2	Zielinski, C. Ruiz Borrego, Manuel Carrasco, E. Turner, N. Ciruelos, Eva Muñoz Mateu, Montserrat Bermejo de las Heras, Begoña Margelí Vila, Mireia Anton, A. Kahan, Z. Csöszi, T. Casas, M. I. Murillo, L. Morales, S. Alba, Emilio Gal Yam, E. Guerrero Zotano, A. Calvo, L. Haba Rodríguez, J. de la Ramos, M. Álvarez López, Isabel García Palomo, Andrés Huang Bartlett, C. Koehler, M. Caballero, R. Corsaro, M. Huang, X. García Sáenz, José Ángel Chacón, José Ignacio Swift, C. Thallinger, C. Gil Gil, Miguel
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 author author author author author author author
dc.subject.none.fl_str_mv	Càncer de mama Hormonoteràpia Breast cancer Hormone therapy
topic	Càncer de mama Hormonoteràpia Breast cancer Hormone therapy
description	Background: Palbociclib plus endocrine therapy (ET) is the standard treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative, metastatic breast cancer (MBC). However, its efficacy has not been compared with that of chemotherapy in a phase III trial. Patients and methods: PEARL is a multicentre, phase III randomised study in which patients with aromatase inhibitor (AI)-resistant MBC were included in two consecutive cohorts. In cohort 1, patients were randomised 1 : 1 to palbociclib plus exemestane or capecitabine. On discovering new evidence about estrogen receptor-1 (ESR1) mutations inducing resistance to AIs, the trial was amended to include cohort 2, in which patients were randomised 1 : 1 between palbociclib plus fulvestrant and capecitabine. The stratification criteria were disease site, prior sensitivity to ET, prior chemotherapy for MBC, and country of origin. Co-primary endpoints were progression-free survival (PFS) in cohort 2 and in wild-type ESR1 patients (cohort 1 + cohort 2). ESR1 hotspot mutations were analysed in baseline circulating tumour DNA. Results: From March 2014 to July 2018, 296 and 305 patients were included in cohort 1 and cohort 2, respectively. Palbociclib plus ET was not superior to capecitabine in both cohort 2 [median PFS: 7.5 versus 10.0 months; adjusted hazard ratio (aHR): 1.13; 95% confidence interval (CI): 0.85-1.50] and wild-type ESR1 patients (median PFS: 8.0 versus 10.6 months; aHR: 1.11; 95% CI: 0.87-1.41). The most frequent grade 3-4 toxicities with palbociclib plus exemestane, palbociclib plus fulvestrant and capecitabine, respectively, were neutropenia (57.4%, 55.7% and 5.5%), hand/foot syndrome (0%, 0% and 23.5%), and diarrhoea (1.3%, 1.3% and 7.6%). Palbociclib plus ET offered better quality of life (aHR for time to deterioration of global health status: 0.67; 95% CI: 0.53-0.85). Conclusions: There was no statistical superiority of palbociclib plus ET over capecitabine with respect to PFS in MBC patients resistant to AIs. Palbociclib plus ET showed a better safety profile and improved quality of life.
publishDate	2021
dc.date.none.fl_str_mv	2021
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://hdl.handle.net/2445/176002
url	https://hdl.handle.net/2445/176002
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	Reproducció del document publicat a: https://doi.org/10.1016/j.annonc.2020.12.013 Annals of Oncology, 2021, vol. 32, num. 4, p. 488-499 https://doi.org/10.1016/j.annonc.2020.12.013
dc.rights.none.fl_str_mv	cc by-nc-nd (c) Martin et al., 2020 http://creativecommons.org/licenses/by-nc-nd/3.0/es/ info:eu-repo/semantics/openAccess
rights_invalid_str_mv	cc by-nc-nd (c) Martin et al., 2020 http://creativecommons.org/licenses/by-nc-nd/3.0/es/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.publisher.none.fl_str_mv	Elsevier B. V.
publisher.none.fl_str_mv	Elsevier B. V.
dc.source.none.fl_str_mv	Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) reponame:Dipòsit Digital de la UB instname:Universidad de Barcelona
instname_str	Universidad de Barcelona
reponame_str	Dipòsit Digital de la UB
collection	Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL

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