Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.

Kahan, Zsuzsanna; Gil-Gil, Miguel; Ruiz-Borrego, Manuel; Carrasco, Eva; Ciruelos, Eva; Munoz, Montserrat; Bermejo, Begona; Margeli, Mireia; Anton, Antonio; Casas, Maribel; Csoszi, Tibor; Murillo, Laura; Morales, Serafin; Calvo, Lourdes; Lang, Istvan; Alba, Emilio; de la Haba-Rodriguez, Juan; Ramos, Manuel; Lopez, Isabel Alvarez; Gal-Yam, Einav; Garcia-Palomo, Andres; Alvarez, Elena; Gonzalez-Santiago, Santiago; Rodriguez, Cesar A; Servitja, Sonia; Corsaro, Massimo; Rodrigalvarez, Graciela; Zielinski, Christoph; Martin, Miguel

Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.

BACKGROUND: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis comp...

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Detalhes bibliográficos
Autores:	Kahan, Zsuzsanna, Gil-Gil, Miguel, Ruiz-Borrego, Manuel, Carrasco, Eva, Ciruelos, Eva, Munoz, Montserrat, Bermejo, Begona, Margeli, Mireia, Anton, Antonio, Casas, Maribel, Csoszi, Tibor, Murillo, Laura, Morales, Serafin, Calvo, Lourdes, Lang, Istvan, Alba, Emilio, de la Haba-Rodriguez, Juan, Ramos, Manuel, Lopez, Isabel Alvarez, Gal-Yam, Einav, Garcia-Palomo, Andres, Alvarez, Elena, Gonzalez-Santiago, Santiago, Rodriguez, Cesar A, Servitja, Sonia, Corsaro, Massimo, Rodrigalvarez, Graciela, Zielinski, Christoph, Martin, Miguel
Formato:	artículo
Estado:	Versión publicada
Fecha de publicación:	2021
País:	España
Recursos:	INCLIVA
Repositorio:	r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:	oai:incliva.fundanetsuite.com:p15912
Acesso em linha:	https://incliva.portalinvestigacion.com/publicaciones/15912
Access Level:	acceso abierto
Palavra-chave:	CDK4/6 inhibitor Endocrine therapy Health-related quality of life Hormone receptor–positive metastatic breast cancer Palbociclib

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spelling	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.Kahan, ZsuzsannaGil-Gil, MiguelRuiz-Borrego, ManuelCarrasco, EvaCiruelos, EvaMunoz, MontserratBermejo, BegonaMargeli, MireiaAnton, AntonioCasas, MaribelCsoszi, TiborMurillo, LauraMorales, SerafinCalvo, LourdesLang, IstvanAlba, Emiliode la Haba-Rodriguez, JuanRamos, ManuelLopez, Isabel AlvarezGal-Yam, EinavGarcia-Palomo, AndresAlvarez, ElenaGonzalez-Santiago, SantiagoRodriguez, Cesar AServitja, SoniaCorsaro, MassimoRodrigalvarez, GracielaZielinski, ChristophMartin, MiguelCDK4/6 inhibitorEndocrine therapyHealth-related quality of lifeHormone receptor–positive metastatic breast cancerPalbociclibBACKGROUND: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis compared patient-reported outcomes. PATIENTS AND METHODS: The PEARL quality of life (QoL) population comprised 537 patients, 268 randomised to palbociclib/ET (exemestane or fulvestrant) and 269 to capecitabine. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23 and EQ-5D-3L questionnaires. Changes from the baseline and time to deterioration (TTD) were analysed using linear mixed-effect and stratified Cox regression models, respectively. RESULTS: Questionnaire completion rate was high and similar between treatment arms. Significant differences were observed in the mean change in global health status (GHS)/QoL scores from the baseline to cycle 3 (2.9 for palbociclib/ET vs. -2.1 for capecitabine (95% confidence interval [CI], 1.4-8.6; P = 0.007). The median TTD in GHS/QoL was 8.3 months for palbociclib/ET versus 5.3 months for capecitabine (adjusted hazard ratio, 0.70; 95% CI, 0.55-0.89; P = 0.003). Similar improvements for palbociclib/ET were also seen for other scales as physical, role, cognitive, social functioning, fatigue, nausea/vomiting and appetite loss. No differences were observed between the treatment arms in change from the baseline in any item of the EQ-5D-L3 questionnaire as per the overall index score and visual analogue scale. CONCLUSION: Patients receiving palbociclib/ET experienced a significant delay in deterioration of GHS/QoL and several functional and symptom scales compared with capecitabine, providing additional evidence that palbociclib/ET is better tolerated. TRIAL REGISTRATION NUMBER: NCT02028507 (ClinTrials.gov). EUDRACT STUDY NUMBER: 2013-003170-27.ELSEVIER SCI LTD2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/15912EUROPEAN JOURNAL OF CANCERISSN: 09598049ISSNe: 18790852reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p159122026-06-07T16:35:31Z
dc.title.none.fl_str_mv	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.
title	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.
spellingShingle	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study. Kahan, Zsuzsanna CDK4/6 inhibitor Endocrine therapy Health-related quality of life Hormone receptor–positive metastatic breast cancer Palbociclib
title_short	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.
title_full	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.
title_fullStr	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.
title_full_unstemmed	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.
title_sort	Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.
dc.creator.none.fl_str_mv	Kahan, Zsuzsanna Gil-Gil, Miguel Ruiz-Borrego, Manuel Carrasco, Eva Ciruelos, Eva Munoz, Montserrat Bermejo, Begona Margeli, Mireia Anton, Antonio Casas, Maribel Csoszi, Tibor Murillo, Laura Morales, Serafin Calvo, Lourdes Lang, Istvan Alba, Emilio de la Haba-Rodriguez, Juan Ramos, Manuel Lopez, Isabel Alvarez Gal-Yam, Einav Garcia-Palomo, Andres Alvarez, Elena Gonzalez-Santiago, Santiago Rodriguez, Cesar A Servitja, Sonia Corsaro, Massimo Rodrigalvarez, Graciela Zielinski, Christoph Martin, Miguel
author	Kahan, Zsuzsanna
author_facet	Kahan, Zsuzsanna Gil-Gil, Miguel Ruiz-Borrego, Manuel Carrasco, Eva Ciruelos, Eva Munoz, Montserrat Bermejo, Begona Margeli, Mireia Anton, Antonio Casas, Maribel Csoszi, Tibor Murillo, Laura Morales, Serafin Calvo, Lourdes Lang, Istvan Alba, Emilio de la Haba-Rodriguez, Juan Ramos, Manuel Lopez, Isabel Alvarez Gal-Yam, Einav Garcia-Palomo, Andres Alvarez, Elena Gonzalez-Santiago, Santiago Rodriguez, Cesar A Servitja, Sonia Corsaro, Massimo Rodrigalvarez, Graciela Zielinski, Christoph Martin, Miguel
author_role	author
author2	Gil-Gil, Miguel Ruiz-Borrego, Manuel Carrasco, Eva Ciruelos, Eva Munoz, Montserrat Bermejo, Begona Margeli, Mireia Anton, Antonio Casas, Maribel Csoszi, Tibor Murillo, Laura Morales, Serafin Calvo, Lourdes Lang, Istvan Alba, Emilio de la Haba-Rodriguez, Juan Ramos, Manuel Lopez, Isabel Alvarez Gal-Yam, Einav Garcia-Palomo, Andres Alvarez, Elena Gonzalez-Santiago, Santiago Rodriguez, Cesar A Servitja, Sonia Corsaro, Massimo Rodrigalvarez, Graciela Zielinski, Christoph Martin, 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
dc.subject.none.fl_str_mv	CDK4/6 inhibitor Endocrine therapy Health-related quality of life Hormone receptor–positive metastatic breast cancer Palbociclib
topic	CDK4/6 inhibitor Endocrine therapy Health-related quality of life Hormone receptor–positive metastatic breast cancer Palbociclib
description	BACKGROUND: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis compared patient-reported outcomes. PATIENTS AND METHODS: The PEARL quality of life (QoL) population comprised 537 patients, 268 randomised to palbociclib/ET (exemestane or fulvestrant) and 269 to capecitabine. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23 and EQ-5D-3L questionnaires. Changes from the baseline and time to deterioration (TTD) were analysed using linear mixed-effect and stratified Cox regression models, respectively. RESULTS: Questionnaire completion rate was high and similar between treatment arms. Significant differences were observed in the mean change in global health status (GHS)/QoL scores from the baseline to cycle 3 (2.9 for palbociclib/ET vs. -2.1 for capecitabine (95% confidence interval [CI], 1.4-8.6; P = 0.007). The median TTD in GHS/QoL was 8.3 months for palbociclib/ET versus 5.3 months for capecitabine (adjusted hazard ratio, 0.70; 95% CI, 0.55-0.89; P = 0.003). Similar improvements for palbociclib/ET were also seen for other scales as physical, role, cognitive, social functioning, fatigue, nausea/vomiting and appetite loss. No differences were observed between the treatment arms in change from the baseline in any item of the EQ-5D-L3 questionnaire as per the overall index score and visual analogue scale. CONCLUSION: Patients receiving palbociclib/ET experienced a significant delay in deterioration of GHS/QoL and several functional and symptom scales compared with capecitabine, providing additional evidence that palbociclib/ET is better tolerated. TRIAL REGISTRATION NUMBER: NCT02028507 (ClinTrials.gov). EUDRACT STUDY NUMBER: 2013-003170-27.
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://incliva.portalinvestigacion.com/publicaciones/15912
url	https://incliva.portalinvestigacion.com/publicaciones/15912
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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Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.

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