Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials
Purpose Approximately 70% of patients with metastatic breast cancer (MBC) are hormone receptor (HR)-positive. Recent studies have shown that CDK4/6 inhibitors (CDKI) improve survival in combination with ET in HR-positive, HER2-negative MBC. The risk of venous thromboembolism (VTE) is 3–4 times highe...
Gespeichert in:
Veröffentlicht in: | Breast cancer research and treatment 2020-09, Vol.183 (2), p.479-487 |
---|---|
Hauptverfasser: | , , , , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | 487 |
---|---|
container_issue | 2 |
container_start_page | 479 |
container_title | Breast cancer research and treatment |
container_volume | 183 |
creator | Thein, Kyaw Zin Htut, Thura Win Ball, Somedeb Swarup, Sriman Sultan, Anita Oo, Thein Hlaing |
description | Purpose
Approximately 70% of patients with metastatic breast cancer (MBC) are hormone receptor (HR)-positive. Recent studies have shown that CDK4/6 inhibitors (CDKI) improve survival in combination with ET in HR-positive, HER2-negative MBC. The risk of venous thromboembolism (VTE) is 3–4 times higher in patients with breast cancer (BC) than in patients without cancer. The risk is even higher in BC patients receiving ET and chemotherapy. The aim of the study was to determine the VTE risk of CDKIs plus ET versus ET alone in patients with HR-positive, HER2-negative MBC.
Methods
We performed a systematic review and meta-analysis to demonstrate the risk of VTE in patients with HR-positive HER2-negative MBC treated with combined CDKIs and ET versus ET alone.
Results
Eight randomized controlled trials (RCT) with a total of 4,557 patients were eligible. The study arms comprised of palbociclib or ribociclib or abemaciclib plus ET while the control arms utilized placebo plus ET. The VTE events were 56 (2%) in the CDKIs plus ET group compared to 10 (0.5%) in the control group. Pooled relative risk (RR) for VTE was 2.62 (95% CI 1.21–5.65;
P
= 0.01) and the risk difference (RD) was 0.01 (95% CI 0.00–0.03;
P
= 0.02). Over a median follow-up of up to 36 months, RR was 3.18 (95% CI 1.22–8.24;
P
= 0.02) and RD was 0.03 (95% CI 0.01–0.06,
P
= 0.008).
Conclusions
Our meta-analyses demonstrated that the addition of CDKIs to ET in patients with HR-positive HER 2-negative MBC contribute to a higher incidence of VTE. Further trials are required to define the actual relation and definitive incidence of VTE with different CDKIs. |
doi_str_mv | 10.1007/s10549-020-05783-3 |
format | Article |
fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_journals_2427188313</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A630710002</galeid><sourcerecordid>A630710002</sourcerecordid><originalsourceid>FETCH-LOGICAL-c473t-ae708b8cfbd2bcd827aaf801f27d164fdfc63503b5b673099e4c47393b070f2f3</originalsourceid><addsrcrecordid>eNp9Uk1v1DAQDQhEl8KJGwdkCYlbWsfOxgm3aikUUQkJAdfIcca7LokdPN6tll_P7G6hVKqQZc3Xm5k30suylwU_KThXp1jwednkXPCcz1Utc_kwmxVzJXMlCvUom_GiUnlV8-ooe4p4xTlvFG-eZEdSVKVqZDN78OI7-LBGllYxjF0A-oPDkUWHP5jzbNLJgU_Irl1asVWIY_DAIhiYUoj5FNAltwF2cf5F5B6Weh-NkDQm8g3rIpDLjPYGIksUJegP0wxtdJ6ixbtPrDytaN_KdY7mIpsGIgW-DyYShOhB1NOWbSDivQU9EK-3TDPcYoJxvzrCxsE1077fE8q118MWHbJgWaRsGN0v2m6CTzEMA7kpOj3gs-yxJQPPb-xx9u39-dfFRX75-cPHxdllbkolU65B8bqrje160Zm-FkprW_PCCtUXVWl7ayo557Kbd5WSvGmg3DU2suOKW2Hlcfb6MHeK4ecaMLVXYR2JJLaiFKqoa1nIW9RSD9A6b0OK2owOTXtWSa5IClwQ6uQeFL0eRkcXgnWUv9Pw5p-GFeghrTAM6-SCx7tAcQCaGBAj2HaKbtRx2xa83emwPeiwJR22ex22O9Kvbk5bdyP0f1v-CI8A8gBAKvklxNvb_zP2Nw0k7eo</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2427188313</pqid></control><display><type>article</type><title>Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Thein, Kyaw Zin ; Htut, Thura Win ; Ball, Somedeb ; Swarup, Sriman ; Sultan, Anita ; Oo, Thein Hlaing</creator><creatorcontrib>Thein, Kyaw Zin ; Htut, Thura Win ; Ball, Somedeb ; Swarup, Sriman ; Sultan, Anita ; Oo, Thein Hlaing</creatorcontrib><description>Purpose
Approximately 70% of patients with metastatic breast cancer (MBC) are hormone receptor (HR)-positive. Recent studies have shown that CDK4/6 inhibitors (CDKI) improve survival in combination with ET in HR-positive, HER2-negative MBC. The risk of venous thromboembolism (VTE) is 3–4 times higher in patients with breast cancer (BC) than in patients without cancer. The risk is even higher in BC patients receiving ET and chemotherapy. The aim of the study was to determine the VTE risk of CDKIs plus ET versus ET alone in patients with HR-positive, HER2-negative MBC.
Methods
We performed a systematic review and meta-analysis to demonstrate the risk of VTE in patients with HR-positive HER2-negative MBC treated with combined CDKIs and ET versus ET alone.
Results
Eight randomized controlled trials (RCT) with a total of 4,557 patients were eligible. The study arms comprised of palbociclib or ribociclib or abemaciclib plus ET while the control arms utilized placebo plus ET. The VTE events were 56 (2%) in the CDKIs plus ET group compared to 10 (0.5%) in the control group. Pooled relative risk (RR) for VTE was 2.62 (95% CI 1.21–5.65;
P
= 0.01) and the risk difference (RD) was 0.01 (95% CI 0.00–0.03;
P
= 0.02). Over a median follow-up of up to 36 months, RR was 3.18 (95% CI 1.22–8.24;
P
= 0.02) and RD was 0.03 (95% CI 0.01–0.06,
P
= 0.008).
Conclusions
Our meta-analyses demonstrated that the addition of CDKIs to ET in patients with HR-positive HER 2-negative MBC contribute to a higher incidence of VTE. Further trials are required to define the actual relation and definitive incidence of VTE with different CDKIs.</description><identifier>ISSN: 0167-6806</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-020-05783-3</identifier><identifier>PMID: 32647939</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Antineoplastic Agents, Hormonal - adverse effects ; Breast cancer ; Breast Neoplasms - drug therapy ; Breast Neoplasms - metabolism ; Breast Neoplasms - pathology ; Brief Report ; Cancer ; Cancer patients ; Cancer research ; Care and treatment ; Chemotherapy ; Clinical trials ; Cyclin-dependent kinase 4 ; Cyclin-Dependent Kinase 4 - antagonists & inhibitors ; Cyclin-Dependent Kinase 6 - antagonists & inhibitors ; Drug Therapy, Combination ; Endocrine therapy ; ErbB-2 protein ; Estrogen Receptor alpha - metabolism ; Female ; Health aspects ; Health risk assessment ; Hormones ; Humans ; Medicine ; Medicine & Public Health ; Meta-analysis ; Metastases ; Metastasis ; Neoplasm Metastasis ; Oncology ; Oncology, Experimental ; Protein Kinase Inhibitors - adverse effects ; Randomized Controlled Trials as Topic ; Receptor, ErbB-2 - metabolism ; Receptors, Progesterone - metabolism ; Risk Factors ; Systematic review ; Thromboembolism ; Venous Thromboembolism - chemically induced ; Venous Thromboembolism - pathology</subject><ispartof>Breast cancer research and treatment, 2020-09, Vol.183 (2), p.479-487</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020</rights><rights>COPYRIGHT 2020 Springer</rights><rights>Springer Science+Business Media, LLC, part of Springer Nature 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c473t-ae708b8cfbd2bcd827aaf801f27d164fdfc63503b5b673099e4c47393b070f2f3</citedby><cites>FETCH-LOGICAL-c473t-ae708b8cfbd2bcd827aaf801f27d164fdfc63503b5b673099e4c47393b070f2f3</cites><orcidid>0000-0002-5201-731X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10549-020-05783-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10549-020-05783-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32647939$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thein, Kyaw Zin</creatorcontrib><creatorcontrib>Htut, Thura Win</creatorcontrib><creatorcontrib>Ball, Somedeb</creatorcontrib><creatorcontrib>Swarup, Sriman</creatorcontrib><creatorcontrib>Sultan, Anita</creatorcontrib><creatorcontrib>Oo, Thein Hlaing</creatorcontrib><title>Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><addtitle>Breast Cancer Res Treat</addtitle><description>Purpose
Approximately 70% of patients with metastatic breast cancer (MBC) are hormone receptor (HR)-positive. Recent studies have shown that CDK4/6 inhibitors (CDKI) improve survival in combination with ET in HR-positive, HER2-negative MBC. The risk of venous thromboembolism (VTE) is 3–4 times higher in patients with breast cancer (BC) than in patients without cancer. The risk is even higher in BC patients receiving ET and chemotherapy. The aim of the study was to determine the VTE risk of CDKIs plus ET versus ET alone in patients with HR-positive, HER2-negative MBC.
Methods
We performed a systematic review and meta-analysis to demonstrate the risk of VTE in patients with HR-positive HER2-negative MBC treated with combined CDKIs and ET versus ET alone.
Results
Eight randomized controlled trials (RCT) with a total of 4,557 patients were eligible. The study arms comprised of palbociclib or ribociclib or abemaciclib plus ET while the control arms utilized placebo plus ET. The VTE events were 56 (2%) in the CDKIs plus ET group compared to 10 (0.5%) in the control group. Pooled relative risk (RR) for VTE was 2.62 (95% CI 1.21–5.65;
P
= 0.01) and the risk difference (RD) was 0.01 (95% CI 0.00–0.03;
P
= 0.02). Over a median follow-up of up to 36 months, RR was 3.18 (95% CI 1.22–8.24;
P
= 0.02) and RD was 0.03 (95% CI 0.01–0.06,
P
= 0.008).
Conclusions
Our meta-analyses demonstrated that the addition of CDKIs to ET in patients with HR-positive HER 2-negative MBC contribute to a higher incidence of VTE. Further trials are required to define the actual relation and definitive incidence of VTE with different CDKIs.</description><subject>Antineoplastic Agents, Hormonal - adverse effects</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - metabolism</subject><subject>Breast Neoplasms - pathology</subject><subject>Brief Report</subject><subject>Cancer</subject><subject>Cancer patients</subject><subject>Cancer research</subject><subject>Care and treatment</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Cyclin-dependent kinase 4</subject><subject>Cyclin-Dependent Kinase 4 - antagonists & inhibitors</subject><subject>Cyclin-Dependent Kinase 6 - antagonists & inhibitors</subject><subject>Drug Therapy, Combination</subject><subject>Endocrine therapy</subject><subject>ErbB-2 protein</subject><subject>Estrogen Receptor alpha - metabolism</subject><subject>Female</subject><subject>Health aspects</subject><subject>Health risk assessment</subject><subject>Hormones</subject><subject>Humans</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Meta-analysis</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Neoplasm Metastasis</subject><subject>Oncology</subject><subject>Oncology, Experimental</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Receptor, ErbB-2 - metabolism</subject><subject>Receptors, Progesterone - metabolism</subject><subject>Risk Factors</subject><subject>Systematic review</subject><subject>Thromboembolism</subject><subject>Venous Thromboembolism - chemically induced</subject><subject>Venous Thromboembolism - pathology</subject><issn>0167-6806</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9Uk1v1DAQDQhEl8KJGwdkCYlbWsfOxgm3aikUUQkJAdfIcca7LokdPN6tll_P7G6hVKqQZc3Xm5k30suylwU_KThXp1jwednkXPCcz1Utc_kwmxVzJXMlCvUom_GiUnlV8-ooe4p4xTlvFG-eZEdSVKVqZDN78OI7-LBGllYxjF0A-oPDkUWHP5jzbNLJgU_Irl1asVWIY_DAIhiYUoj5FNAltwF2cf5F5B6Weh-NkDQm8g3rIpDLjPYGIksUJegP0wxtdJ6ixbtPrDytaN_KdY7mIpsGIgW-DyYShOhB1NOWbSDivQU9EK-3TDPcYoJxvzrCxsE1077fE8q118MWHbJgWaRsGN0v2m6CTzEMA7kpOj3gs-yxJQPPb-xx9u39-dfFRX75-cPHxdllbkolU65B8bqrje160Zm-FkprW_PCCtUXVWl7ayo557Kbd5WSvGmg3DU2suOKW2Hlcfb6MHeK4ecaMLVXYR2JJLaiFKqoa1nIW9RSD9A6b0OK2owOTXtWSa5IClwQ6uQeFL0eRkcXgnWUv9Pw5p-GFeghrTAM6-SCx7tAcQCaGBAj2HaKbtRx2xa83emwPeiwJR22ex22O9Kvbk5bdyP0f1v-CI8A8gBAKvklxNvb_zP2Nw0k7eo</recordid><startdate>20200901</startdate><enddate>20200901</enddate><creator>Thein, Kyaw Zin</creator><creator>Htut, Thura Win</creator><creator>Ball, Somedeb</creator><creator>Swarup, Sriman</creator><creator>Sultan, Anita</creator><creator>Oo, Thein Hlaing</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><orcidid>https://orcid.org/0000-0002-5201-731X</orcidid></search><sort><creationdate>20200901</creationdate><title>Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials</title><author>Thein, Kyaw Zin ; Htut, Thura Win ; Ball, Somedeb ; Swarup, Sriman ; Sultan, Anita ; Oo, Thein Hlaing</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c473t-ae708b8cfbd2bcd827aaf801f27d164fdfc63503b5b673099e4c47393b070f2f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antineoplastic Agents, Hormonal - adverse effects</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - metabolism</topic><topic>Breast Neoplasms - pathology</topic><topic>Brief Report</topic><topic>Cancer</topic><topic>Cancer patients</topic><topic>Cancer research</topic><topic>Care and treatment</topic><topic>Chemotherapy</topic><topic>Clinical trials</topic><topic>Cyclin-dependent kinase 4</topic><topic>Cyclin-Dependent Kinase 4 - antagonists & inhibitors</topic><topic>Cyclin-Dependent Kinase 6 - antagonists & inhibitors</topic><topic>Drug Therapy, Combination</topic><topic>Endocrine therapy</topic><topic>ErbB-2 protein</topic><topic>Estrogen Receptor alpha - metabolism</topic><topic>Female</topic><topic>Health aspects</topic><topic>Health risk assessment</topic><topic>Hormones</topic><topic>Humans</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Meta-analysis</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Neoplasm Metastasis</topic><topic>Oncology</topic><topic>Oncology, Experimental</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Receptor, ErbB-2 - metabolism</topic><topic>Receptors, Progesterone - metabolism</topic><topic>Risk Factors</topic><topic>Systematic review</topic><topic>Thromboembolism</topic><topic>Venous Thromboembolism - chemically induced</topic><topic>Venous Thromboembolism - pathology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Thein, Kyaw Zin</creatorcontrib><creatorcontrib>Htut, Thura Win</creatorcontrib><creatorcontrib>Ball, Somedeb</creatorcontrib><creatorcontrib>Swarup, Sriman</creatorcontrib><creatorcontrib>Sultan, Anita</creatorcontrib><creatorcontrib>Oo, Thein Hlaing</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Thein, Kyaw Zin</au><au>Htut, Thura Win</au><au>Ball, Somedeb</au><au>Swarup, Sriman</au><au>Sultan, Anita</au><au>Oo, Thein Hlaing</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials</atitle><jtitle>Breast cancer research and treatment</jtitle><stitle>Breast Cancer Res Treat</stitle><addtitle>Breast Cancer Res Treat</addtitle><date>2020-09-01</date><risdate>2020</risdate><volume>183</volume><issue>2</issue><spage>479</spage><epage>487</epage><pages>479-487</pages><issn>0167-6806</issn><eissn>1573-7217</eissn><abstract>Purpose
Approximately 70% of patients with metastatic breast cancer (MBC) are hormone receptor (HR)-positive. Recent studies have shown that CDK4/6 inhibitors (CDKI) improve survival in combination with ET in HR-positive, HER2-negative MBC. The risk of venous thromboembolism (VTE) is 3–4 times higher in patients with breast cancer (BC) than in patients without cancer. The risk is even higher in BC patients receiving ET and chemotherapy. The aim of the study was to determine the VTE risk of CDKIs plus ET versus ET alone in patients with HR-positive, HER2-negative MBC.
Methods
We performed a systematic review and meta-analysis to demonstrate the risk of VTE in patients with HR-positive HER2-negative MBC treated with combined CDKIs and ET versus ET alone.
Results
Eight randomized controlled trials (RCT) with a total of 4,557 patients were eligible. The study arms comprised of palbociclib or ribociclib or abemaciclib plus ET while the control arms utilized placebo plus ET. The VTE events were 56 (2%) in the CDKIs plus ET group compared to 10 (0.5%) in the control group. Pooled relative risk (RR) for VTE was 2.62 (95% CI 1.21–5.65;
P
= 0.01) and the risk difference (RD) was 0.01 (95% CI 0.00–0.03;
P
= 0.02). Over a median follow-up of up to 36 months, RR was 3.18 (95% CI 1.22–8.24;
P
= 0.02) and RD was 0.03 (95% CI 0.01–0.06,
P
= 0.008).
Conclusions
Our meta-analyses demonstrated that the addition of CDKIs to ET in patients with HR-positive HER 2-negative MBC contribute to a higher incidence of VTE. Further trials are required to define the actual relation and definitive incidence of VTE with different CDKIs.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>32647939</pmid><doi>10.1007/s10549-020-05783-3</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-5201-731X</orcidid></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0167-6806 |
ispartof | Breast cancer research and treatment, 2020-09, Vol.183 (2), p.479-487 |
issn | 0167-6806 1573-7217 |
language | eng |
recordid | cdi_proquest_journals_2427188313 |
source | MEDLINE; SpringerLink Journals - AutoHoldings |
subjects | Antineoplastic Agents, Hormonal - adverse effects Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - pathology Brief Report Cancer Cancer patients Cancer research Care and treatment Chemotherapy Clinical trials Cyclin-dependent kinase 4 Cyclin-Dependent Kinase 4 - antagonists & inhibitors Cyclin-Dependent Kinase 6 - antagonists & inhibitors Drug Therapy, Combination Endocrine therapy ErbB-2 protein Estrogen Receptor alpha - metabolism Female Health aspects Health risk assessment Hormones Humans Medicine Medicine & Public Health Meta-analysis Metastases Metastasis Neoplasm Metastasis Oncology Oncology, Experimental Protein Kinase Inhibitors - adverse effects Randomized Controlled Trials as Topic Receptor, ErbB-2 - metabolism Receptors, Progesterone - metabolism Risk Factors Systematic review Thromboembolism Venous Thromboembolism - chemically induced Venous Thromboembolism - pathology |
title | Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-28T05%3A37%3A36IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Venous%20thromboembolism%20risk%20in%20patients%20with%20hormone%20receptor-positive%20HER2-negative%20metastatic%20breast%20cancer%20treated%20with%20combined%20CDK%204/6%20inhibitors%20plus%20endocrine%20therapy%20versus%20endocrine%20therapy%20alone:%20a%20systematic%20review%20and%20meta-analysis%20of%20randomized%20controlled%20trials&rft.jtitle=Breast%20cancer%20research%20and%20treatment&rft.au=Thein,%20Kyaw%20Zin&rft.date=2020-09-01&rft.volume=183&rft.issue=2&rft.spage=479&rft.epage=487&rft.pages=479-487&rft.issn=0167-6806&rft.eissn=1573-7217&rft_id=info:doi/10.1007/s10549-020-05783-3&rft_dat=%3Cgale_proqu%3EA630710002%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2427188313&rft_id=info:pmid/32647939&rft_galeid=A630710002&rfr_iscdi=true |