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
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 canc...
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creator | Martín, Miguel Zielinski, Christoph Ruiz-Borrego, Manuel Carrasco, Eva Ciruelos, Eva M. Muñoz, Montserrat Bermejo, Begoña Margelí, Mireia Csöszi, Tibor Antón, Antonio Turner, Nicholas Casas, María I. Morales, Serafín Alba, Emilio Calvo, Lourdes de la Haba-Rodríguez, Juan Ramos, Manuel Murillo, Laura Santaballa, Ana Alonso-Romero, José L. Sánchez-Rovira, Pedro Corsaro, Massimo Huang, Xin Thallinger, Christiane Kahan, Zsuzsanna Gil-Gil, Miguel |
description | 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.
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).
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.
Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.
NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
•Overall survival (OS) was assessed in patients with metastatic breast cancer (MBC).•OS was similar for palbociclib + fulvestrant and capecitabine in AI-resistant MBC.•The results were independent of the ESR1 mutational status.•In wild-type ESR1 tumours, palbociclib + ET and capecitabine also had similar OS.•Progression-free survival 2 was similar in both treatment arms. |
doi_str_mv | 10.1016/j.ejca.2022.03.006 |
format | Article |
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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).
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.
Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.
NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
•Overall survival (OS) was assessed in patients with metastatic breast cancer (MBC).•OS was similar for palbociclib + fulvestrant and capecitabine in AI-resistant MBC.•The results were independent of the ESR1 mutational status.•In wild-type ESR1 tumours, palbociclib + ET and capecitabine also had similar OS.•Progression-free survival 2 was similar in both treatment arms.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2022.03.006</identifier><identifier>PMID: 35429901</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Aromatase ; Breast cancer ; Capecitabine ; CDK4/6 inhibitor ; Confidence intervals ; Endocrine therapy ; Epidermal growth factor ; ErbB-2 protein ; ESR1 protein ; Fulvestrant ; Growth factors ; HER2–negative ; Hormone receptor-positive metastatic breast cancer ; Metastases ; Metastasis ; Overall survival ; Palbociclib ; Population ; Post-menopause ; Randomization ; Receptors ; Subgroups ; Survival ; Therapy</subject><ispartof>European journal of cancer (1990), 2022-06, Vol.168, p.12-24</ispartof><rights>2022 The Author(s)</rights><rights>Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.</rights><rights>Copyright Elsevier Science Ltd. Jun 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-a8f33e6c394deab3087217c27bd92c161531563673441b597a2ff89319a503ce3</citedby><cites>FETCH-LOGICAL-c428t-a8f33e6c394deab3087217c27bd92c161531563673441b597a2ff89319a503ce3</cites><orcidid>0000-0001-7773-5994 ; 0000-0001-8746-2096 ; 0000-0003-1380-2718 ; 0000-0001-7772-1437 ; 0000-0001-8314-0241 ; 0000-0001-9237-3231</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejca.2022.03.006$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>315,781,785,3551,27928,27929,45999</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35429901$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Martín, Miguel</creatorcontrib><creatorcontrib>Zielinski, Christoph</creatorcontrib><creatorcontrib>Ruiz-Borrego, Manuel</creatorcontrib><creatorcontrib>Carrasco, Eva</creatorcontrib><creatorcontrib>Ciruelos, Eva M.</creatorcontrib><creatorcontrib>Muñoz, Montserrat</creatorcontrib><creatorcontrib>Bermejo, Begoña</creatorcontrib><creatorcontrib>Margelí, Mireia</creatorcontrib><creatorcontrib>Csöszi, Tibor</creatorcontrib><creatorcontrib>Antón, Antonio</creatorcontrib><creatorcontrib>Turner, Nicholas</creatorcontrib><creatorcontrib>Casas, María I.</creatorcontrib><creatorcontrib>Morales, Serafín</creatorcontrib><creatorcontrib>Alba, Emilio</creatorcontrib><creatorcontrib>Calvo, Lourdes</creatorcontrib><creatorcontrib>de la Haba-Rodríguez, Juan</creatorcontrib><creatorcontrib>Ramos, Manuel</creatorcontrib><creatorcontrib>Murillo, Laura</creatorcontrib><creatorcontrib>Santaballa, Ana</creatorcontrib><creatorcontrib>Alonso-Romero, José L.</creatorcontrib><creatorcontrib>Sánchez-Rovira, Pedro</creatorcontrib><creatorcontrib>Corsaro, Massimo</creatorcontrib><creatorcontrib>Huang, Xin</creatorcontrib><creatorcontrib>Thallinger, Christiane</creatorcontrib><creatorcontrib>Kahan, Zsuzsanna</creatorcontrib><creatorcontrib>Gil-Gil, Miguel</creatorcontrib><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</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>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.
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).
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.
Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.
NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
•Overall survival (OS) was assessed in patients with metastatic breast cancer (MBC).•OS was similar for palbociclib + fulvestrant and capecitabine in AI-resistant MBC.•The results were independent of the ESR1 mutational status.•In wild-type ESR1 tumours, palbociclib + ET and capecitabine also had similar OS.•Progression-free survival 2 was similar in both treatment arms.</description><subject>Aromatase</subject><subject>Breast cancer</subject><subject>Capecitabine</subject><subject>CDK4/6 inhibitor</subject><subject>Confidence intervals</subject><subject>Endocrine therapy</subject><subject>Epidermal growth factor</subject><subject>ErbB-2 protein</subject><subject>ESR1 protein</subject><subject>Fulvestrant</subject><subject>Growth factors</subject><subject>HER2–negative</subject><subject>Hormone receptor-positive metastatic breast cancer</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Overall survival</subject><subject>Palbociclib</subject><subject>Population</subject><subject>Post-menopause</subject><subject>Randomization</subject><subject>Receptors</subject><subject>Subgroups</subject><subject>Survival</subject><subject>Therapy</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kc1u1TAQhSMEoreFF2CBLLFhQYJ_8meJTVVdWqQrFVWwthxnwnWUxMF2Ut3H482Y6BYWLFh5rPnOmdGcJHnDaMYoKz_2GfRGZ5xynlGRUVo-S3asrmRK64I_T3ZUFjKtaS4vkssQekppVef0ZXIhipxLSdku-XW_gtfDQMLiV7vqgTzaeCSzHhpnrBlsQ-ZhCQSm1hlvJyDxiIL5RFAXsGH0DMZG3Ww9O5HZhTjC5Ga9BHSbdbQwxXC2PTo_OuQ8GJij8ynSNtoVPpC7_QNPJ_ihty8ZIeoQsTak8YAlzpkM-G0CLkC-7q8fDiTEpT29Sl50egjw-um9Sr5_3n-7uUsP97dfbq4Pqcl5HVNdd0JAaYTMW9CNoHXFWWV41bSSG1ayQrCiFGUl8pw1haw077paCiZ1QYUBcZW8P_vO3v1cIEQ12mBgGPQEbgmKlwUrJYZQIfruH7R3i59wO6Sqguc15oAUP1PGuxA8dGr2dtT-pBhVW8CqV1vAagtYUaHQG0Vvn6yXZoT2r-RPogh8OgOAt1gteBUMJmCgtXj1qFpn_-f_G5p4un8</recordid><startdate>202206</startdate><enddate>202206</enddate><creator>Martín, Miguel</creator><creator>Zielinski, Christoph</creator><creator>Ruiz-Borrego, Manuel</creator><creator>Carrasco, Eva</creator><creator>Ciruelos, Eva M.</creator><creator>Muñoz, Montserrat</creator><creator>Bermejo, Begoña</creator><creator>Margelí, Mireia</creator><creator>Csöszi, Tibor</creator><creator>Antón, Antonio</creator><creator>Turner, Nicholas</creator><creator>Casas, María I.</creator><creator>Morales, Serafín</creator><creator>Alba, Emilio</creator><creator>Calvo, Lourdes</creator><creator>de la Haba-Rodríguez, Juan</creator><creator>Ramos, Manuel</creator><creator>Murillo, Laura</creator><creator>Santaballa, Ana</creator><creator>Alonso-Romero, José L.</creator><creator>Sánchez-Rovira, Pedro</creator><creator>Corsaro, Massimo</creator><creator>Huang, Xin</creator><creator>Thallinger, Christiane</creator><creator>Kahan, Zsuzsanna</creator><creator>Gil-Gil, Miguel</creator><general>Elsevier Ltd</general><general>Elsevier Science Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-7773-5994</orcidid><orcidid>https://orcid.org/0000-0001-8746-2096</orcidid><orcidid>https://orcid.org/0000-0003-1380-2718</orcidid><orcidid>https://orcid.org/0000-0001-7772-1437</orcidid><orcidid>https://orcid.org/0000-0001-8314-0241</orcidid><orcidid>https://orcid.org/0000-0001-9237-3231</orcidid></search><sort><creationdate>202206</creationdate><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</title><author>Martín, Miguel ; Zielinski, Christoph ; Ruiz-Borrego, Manuel ; Carrasco, Eva ; Ciruelos, Eva M. ; Muñoz, Montserrat ; Bermejo, Begoña ; Margelí, Mireia ; Csöszi, Tibor ; Antón, Antonio ; Turner, Nicholas ; Casas, María I. ; Morales, Serafín ; Alba, Emilio ; Calvo, Lourdes ; de la Haba-Rodríguez, Juan ; Ramos, Manuel ; Murillo, Laura ; Santaballa, Ana ; Alonso-Romero, José L. ; Sánchez-Rovira, Pedro ; Corsaro, Massimo ; Huang, Xin ; Thallinger, Christiane ; Kahan, Zsuzsanna ; Gil-Gil, Miguel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c428t-a8f33e6c394deab3087217c27bd92c161531563673441b597a2ff89319a503ce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Aromatase</topic><topic>Breast cancer</topic><topic>Capecitabine</topic><topic>CDK4/6 inhibitor</topic><topic>Confidence intervals</topic><topic>Endocrine therapy</topic><topic>Epidermal growth factor</topic><topic>ErbB-2 protein</topic><topic>ESR1 protein</topic><topic>Fulvestrant</topic><topic>Growth factors</topic><topic>HER2–negative</topic><topic>Hormone receptor-positive metastatic breast cancer</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Overall survival</topic><topic>Palbociclib</topic><topic>Population</topic><topic>Post-menopause</topic><topic>Randomization</topic><topic>Receptors</topic><topic>Subgroups</topic><topic>Survival</topic><topic>Therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Martín, Miguel</creatorcontrib><creatorcontrib>Zielinski, Christoph</creatorcontrib><creatorcontrib>Ruiz-Borrego, Manuel</creatorcontrib><creatorcontrib>Carrasco, Eva</creatorcontrib><creatorcontrib>Ciruelos, Eva M.</creatorcontrib><creatorcontrib>Muñoz, Montserrat</creatorcontrib><creatorcontrib>Bermejo, Begoña</creatorcontrib><creatorcontrib>Margelí, Mireia</creatorcontrib><creatorcontrib>Csöszi, Tibor</creatorcontrib><creatorcontrib>Antón, Antonio</creatorcontrib><creatorcontrib>Turner, Nicholas</creatorcontrib><creatorcontrib>Casas, María I.</creatorcontrib><creatorcontrib>Morales, Serafín</creatorcontrib><creatorcontrib>Alba, Emilio</creatorcontrib><creatorcontrib>Calvo, Lourdes</creatorcontrib><creatorcontrib>de la Haba-Rodríguez, Juan</creatorcontrib><creatorcontrib>Ramos, Manuel</creatorcontrib><creatorcontrib>Murillo, Laura</creatorcontrib><creatorcontrib>Santaballa, Ana</creatorcontrib><creatorcontrib>Alonso-Romero, José L.</creatorcontrib><creatorcontrib>Sánchez-Rovira, Pedro</creatorcontrib><creatorcontrib>Corsaro, Massimo</creatorcontrib><creatorcontrib>Huang, Xin</creatorcontrib><creatorcontrib>Thallinger, Christiane</creatorcontrib><creatorcontrib>Kahan, Zsuzsanna</creatorcontrib><creatorcontrib>Gil-Gil, Miguel</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology 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L.</au><au>Sánchez-Rovira, Pedro</au><au>Corsaro, Massimo</au><au>Huang, Xin</au><au>Thallinger, Christiane</au><au>Kahan, Zsuzsanna</au><au>Gil-Gil, Miguel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2022-06</date><risdate>2022</risdate><volume>168</volume><spage>12</spage><epage>24</epage><pages>12-24</pages><issn>0959-8049</issn><eissn>1879-0852</eissn><abstract>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.
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).
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.
Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.
NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
•Overall survival (OS) was assessed in patients with metastatic breast cancer (MBC).•OS was similar for palbociclib + fulvestrant and capecitabine in AI-resistant MBC.•The results were independent of the ESR1 mutational status.•In wild-type ESR1 tumours, palbociclib + ET and capecitabine also had similar OS.•Progression-free survival 2 was similar in both treatment arms.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>35429901</pmid><doi>10.1016/j.ejca.2022.03.006</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0001-7773-5994</orcidid><orcidid>https://orcid.org/0000-0001-8746-2096</orcidid><orcidid>https://orcid.org/0000-0003-1380-2718</orcidid><orcidid>https://orcid.org/0000-0001-7772-1437</orcidid><orcidid>https://orcid.org/0000-0001-8314-0241</orcidid><orcidid>https://orcid.org/0000-0001-9237-3231</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0959-8049 |
ispartof | European journal of cancer (1990), 2022-06, Vol.168, p.12-24 |
issn | 0959-8049 1879-0852 |
language | eng |
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source | Access via ScienceDirect (Elsevier) |
subjects | Aromatase Breast cancer Capecitabine CDK4/6 inhibitor Confidence intervals Endocrine therapy Epidermal growth factor ErbB-2 protein ESR1 protein Fulvestrant Growth factors HER2–negative Hormone receptor-positive metastatic breast cancer Metastases Metastasis Overall survival Palbociclib Population Post-menopause Randomization Receptors Subgroups Survival Therapy |
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 |
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