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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Veröffentlicht in:European journal of cancer (1990) 2022-06, Vol.168, p.12-24
Hauptverfasser: 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
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container_title European journal of cancer (1990)
container_volume 168
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
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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><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). 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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 ; 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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>
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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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