Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (PALOMA-1, TRIO-18)
Purpose Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer (HR+/HER2− ABC). In the phase 2, open-la...
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| Veröffentlicht in: | Breast cancer research and treatment 2020-09, Vol.183 (2), p.419-428 |
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| creator | Finn, Richard S. Boer, Katalin Bondarenko, Igor Patel, Ravindranath Pinter, Tamas Schmidt, Marcus Shparyk, Yaroslav V. Thummala, Anu Voitko, Nataliia Bananis, Eustratios McRoy, Lynn Wilner, Keith Huang, Xin Kim, Sindy Slamon, Dennis J. Ettl, Johannes |
| description | Purpose
Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer (HR+/HER2− ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.319‒0.748;
P
= 0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor–positive (ER+)/HER2− ABC. Here, we present the final overall survival (OS) and updated safety results.
Methods
Postmenopausal women with ER+/HER2− ABC were randomized 1:1 to receive either palbociclib (125 mg/day, 3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was investigator-assessed PFS; secondary endpoints included OS and safety.
Results
A total of 165 patients were randomized. At the data cutoff date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratified hazard ratio for OS was 0.897 (95% CI 0.623–1.294;
P
= 0.281); median OS in the palbociclib plus letrozole and letrozole alone arms was 37.5 and 34.5 months, respectively. The median time from randomization to first subsequent chemotherapy use was longer with palbociclib plus letrozole than letrozole alone (26.7 and 17.7 months, respectively). The most frequently reported adverse event in the palbociclib plus letrozole arm was neutropenia (any grade, 75%; grade 3 or 4, 59%).
Conclusions
Palbociclib plus letrozole treatment led to a numerical but not statistically significant improvement in median OS.
Pfizer Inc (NCT00721409) |
| doi_str_mv | 10.1007/s10549-020-05755-7 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7383036</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A630709996</galeid><sourcerecordid>A630709996</sourcerecordid><originalsourceid>FETCH-LOGICAL-c572t-7fd22ef6f28dc2ed240d1db884dd86aa8e4f42d592c03912ee265255c26ab7a43</originalsourceid><addsrcrecordid>eNp9kt9qFDEUxgdRbF19AS8kIEhFp81k_iRzIyxltYWVlaVeh0xyppuSmaxJZqV9Aq99M1_BJzHj1nZXRHIRkvzOd07O-ZLkeYaPM4zpic9wWdQpJjjFJS3LlD5IDrOS5iklGX2YHOKsomnFcHWQPPH-CmNcU1w_Tg5yUrG8rMrD5MdiA04Yg_zgNnojDHLgBxM8ap3tUFgBcqJXttM3oNB6JTwggnwY1DWyLVoL01ippdEN0j2Stmt0L4K2PfqqwwoZCM7eWAMopvGD37kQxvaAWutQq50PqdHxGByI0EEfRvHZ8s3J2WxJfn77joTaiF7GEppI-IDkeHLo6NN0vvg4TbO36GJ5vkgz9vpp8qgVxsOz232SfH4_uzg9S-eLD-en03kqS0pCSltFCLRVS5iSBBQpsMpUw1ihFKuEYFC0BVFlTSTO64wAkKokZSlJJRoqinySvNvqroemAyVj0bGRfO10J9w1t0Lz_Zder_il3XCasxznVRQ4uhVw9ssAPvBOewnGiB7s4DkpYjpWs4JE9OVf6JUdXB-_N1I0YywWd09dCgNc962NeeUoyqdVjuPo63pMe_wPKi4FnZZxJq2O93sBr3YCViBMWHlrhnHKfh8kW1A6672D9q4ZGeajY_nWsTw6lv92bOzFJHmx28a7kD8WjUC-BXx86i_B3f_9P7K_ABRu-HI</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2427188265</pqid></control><display><type>article</type><title>Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (PALOMA-1, TRIO-18)</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Finn, Richard S. ; Boer, Katalin ; Bondarenko, Igor ; Patel, Ravindranath ; Pinter, Tamas ; Schmidt, Marcus ; Shparyk, Yaroslav V. ; Thummala, Anu ; Voitko, Nataliia ; Bananis, Eustratios ; McRoy, Lynn ; Wilner, Keith ; Huang, Xin ; Kim, Sindy ; Slamon, Dennis J. ; Ettl, Johannes</creator><creatorcontrib>Finn, Richard S. ; Boer, Katalin ; Bondarenko, Igor ; Patel, Ravindranath ; Pinter, Tamas ; Schmidt, Marcus ; Shparyk, Yaroslav V. ; Thummala, Anu ; Voitko, Nataliia ; Bananis, Eustratios ; McRoy, Lynn ; Wilner, Keith ; Huang, Xin ; Kim, Sindy ; Slamon, Dennis J. ; Ettl, Johannes</creatorcontrib><description>Purpose
Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer (HR+/HER2− ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.319‒0.748;
P
= 0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor–positive (ER+)/HER2− ABC. Here, we present the final overall survival (OS) and updated safety results.
Methods
Postmenopausal women with ER+/HER2− ABC were randomized 1:1 to receive either palbociclib (125 mg/day, 3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was investigator-assessed PFS; secondary endpoints included OS and safety.
Results
A total of 165 patients were randomized. At the data cutoff date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratified hazard ratio for OS was 0.897 (95% CI 0.623–1.294;
P
= 0.281); median OS in the palbociclib plus letrozole and letrozole alone arms was 37.5 and 34.5 months, respectively. The median time from randomization to first subsequent chemotherapy use was longer with palbociclib plus letrozole than letrozole alone (26.7 and 17.7 months, respectively). The most frequently reported adverse event in the palbociclib plus letrozole arm was neutropenia (any grade, 75%; grade 3 or 4, 59%).
Conclusions
Palbociclib plus letrozole treatment led to a numerical but not statistically significant improvement in median OS.
Pfizer Inc (NCT00721409)</description><identifier>ISSN: 0167-6806</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-020-05755-7</identifier><identifier>PMID: 32683565</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Breast cancer ; Breast Neoplasms - drug therapy ; Breast Neoplasms - metabolism ; Breast Neoplasms - mortality ; Breast Neoplasms - pathology ; Cancer research ; Cancer therapies ; Care and treatment ; Chemotherapy ; Clinical Trial ; Cyclin-dependent kinase 4 ; Cyclin-dependent kinases ; Development and progression ; Endocrine therapy ; Epidermal growth factor ; ErbB-2 protein ; Estrogen Receptor alpha - metabolism ; Estrogen receptors ; Female ; Fulvestrant ; Humans ; Kinases ; Letrozole - administration & dosage ; Medicine ; Medicine & Public Health ; Middle Aged ; Neutropenia ; Oncology ; Patient outcomes ; Piperazines - administration & dosage ; Post-menopause ; Postmenopausal women ; Postmenopause ; Product development ; Pyridines - administration & dosage ; Receptor, ErbB-2 - metabolism ; Statistical analysis ; Survival ; Survival Rate ; Treatment Outcome ; Women</subject><ispartof>Breast cancer research and treatment, 2020-09, Vol.183 (2), p.419-428</ispartof><rights>The Author(s) 2020</rights><rights>COPYRIGHT 2020 Springer</rights><rights>The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c572t-7fd22ef6f28dc2ed240d1db884dd86aa8e4f42d592c03912ee265255c26ab7a43</citedby><cites>FETCH-LOGICAL-c572t-7fd22ef6f28dc2ed240d1db884dd86aa8e4f42d592c03912ee265255c26ab7a43</cites><orcidid>0000-0003-2494-2126</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/s10549-020-05755-7$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10549-020-05755-7$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32683565$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Finn, Richard S.</creatorcontrib><creatorcontrib>Boer, Katalin</creatorcontrib><creatorcontrib>Bondarenko, Igor</creatorcontrib><creatorcontrib>Patel, Ravindranath</creatorcontrib><creatorcontrib>Pinter, Tamas</creatorcontrib><creatorcontrib>Schmidt, Marcus</creatorcontrib><creatorcontrib>Shparyk, Yaroslav V.</creatorcontrib><creatorcontrib>Thummala, Anu</creatorcontrib><creatorcontrib>Voitko, Nataliia</creatorcontrib><creatorcontrib>Bananis, Eustratios</creatorcontrib><creatorcontrib>McRoy, Lynn</creatorcontrib><creatorcontrib>Wilner, Keith</creatorcontrib><creatorcontrib>Huang, Xin</creatorcontrib><creatorcontrib>Kim, Sindy</creatorcontrib><creatorcontrib>Slamon, Dennis J.</creatorcontrib><creatorcontrib>Ettl, Johannes</creatorcontrib><title>Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (PALOMA-1, TRIO-18)</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><addtitle>Breast Cancer Res Treat</addtitle><description>Purpose
Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer (HR+/HER2− ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.319‒0.748;
P
= 0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor–positive (ER+)/HER2− ABC. Here, we present the final overall survival (OS) and updated safety results.
Methods
Postmenopausal women with ER+/HER2− ABC were randomized 1:1 to receive either palbociclib (125 mg/day, 3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was investigator-assessed PFS; secondary endpoints included OS and safety.
Results
A total of 165 patients were randomized. At the data cutoff date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratified hazard ratio for OS was 0.897 (95% CI 0.623–1.294;
P
= 0.281); median OS in the palbociclib plus letrozole and letrozole alone arms was 37.5 and 34.5 months, respectively. The median time from randomization to first subsequent chemotherapy use was longer with palbociclib plus letrozole than letrozole alone (26.7 and 17.7 months, respectively). The most frequently reported adverse event in the palbociclib plus letrozole arm was neutropenia (any grade, 75%; grade 3 or 4, 59%).
Conclusions
Palbociclib plus letrozole treatment led to a numerical but not statistically significant improvement in median OS.
Pfizer Inc (NCT00721409)</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - metabolism</subject><subject>Breast Neoplasms - mortality</subject><subject>Breast Neoplasms - pathology</subject><subject>Cancer research</subject><subject>Cancer therapies</subject><subject>Care and treatment</subject><subject>Chemotherapy</subject><subject>Clinical Trial</subject><subject>Cyclin-dependent kinase 4</subject><subject>Cyclin-dependent kinases</subject><subject>Development and progression</subject><subject>Endocrine therapy</subject><subject>Epidermal growth factor</subject><subject>ErbB-2 protein</subject><subject>Estrogen Receptor alpha - metabolism</subject><subject>Estrogen receptors</subject><subject>Female</subject><subject>Fulvestrant</subject><subject>Humans</subject><subject>Kinases</subject><subject>Letrozole - administration & dosage</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neutropenia</subject><subject>Oncology</subject><subject>Patient outcomes</subject><subject>Piperazines - administration & dosage</subject><subject>Post-menopause</subject><subject>Postmenopausal women</subject><subject>Postmenopause</subject><subject>Product development</subject><subject>Pyridines - administration & dosage</subject><subject>Receptor, ErbB-2 - metabolism</subject><subject>Statistical analysis</subject><subject>Survival</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><subject>Women</subject><issn>0167-6806</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kt9qFDEUxgdRbF19AS8kIEhFp81k_iRzIyxltYWVlaVeh0xyppuSmaxJZqV9Aq99M1_BJzHj1nZXRHIRkvzOd07O-ZLkeYaPM4zpic9wWdQpJjjFJS3LlD5IDrOS5iklGX2YHOKsomnFcHWQPPH-CmNcU1w_Tg5yUrG8rMrD5MdiA04Yg_zgNnojDHLgBxM8ap3tUFgBcqJXttM3oNB6JTwggnwY1DWyLVoL01ippdEN0j2Stmt0L4K2PfqqwwoZCM7eWAMopvGD37kQxvaAWutQq50PqdHxGByI0EEfRvHZ8s3J2WxJfn77joTaiF7GEppI-IDkeHLo6NN0vvg4TbO36GJ5vkgz9vpp8qgVxsOz232SfH4_uzg9S-eLD-en03kqS0pCSltFCLRVS5iSBBQpsMpUw1ihFKuEYFC0BVFlTSTO64wAkKokZSlJJRoqinySvNvqroemAyVj0bGRfO10J9w1t0Lz_Zder_il3XCasxznVRQ4uhVw9ssAPvBOewnGiB7s4DkpYjpWs4JE9OVf6JUdXB-_N1I0YywWd09dCgNc962NeeUoyqdVjuPo63pMe_wPKi4FnZZxJq2O93sBr3YCViBMWHlrhnHKfh8kW1A6672D9q4ZGeajY_nWsTw6lv92bOzFJHmx28a7kD8WjUC-BXx86i_B3f_9P7K_ABRu-HI</recordid><startdate>20200901</startdate><enddate>20200901</enddate><creator>Finn, Richard S.</creator><creator>Boer, Katalin</creator><creator>Bondarenko, Igor</creator><creator>Patel, Ravindranath</creator><creator>Pinter, Tamas</creator><creator>Schmidt, Marcus</creator><creator>Shparyk, Yaroslav V.</creator><creator>Thummala, Anu</creator><creator>Voitko, Nataliia</creator><creator>Bananis, Eustratios</creator><creator>McRoy, Lynn</creator><creator>Wilner, Keith</creator><creator>Huang, Xin</creator><creator>Kim, Sindy</creator><creator>Slamon, Dennis J.</creator><creator>Ettl, Johannes</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><scope>C6C</scope><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>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-2494-2126</orcidid></search><sort><creationdate>20200901</creationdate><title>Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (PALOMA-1, TRIO-18)</title><author>Finn, Richard S. ; Boer, Katalin ; Bondarenko, Igor ; Patel, Ravindranath ; Pinter, Tamas ; Schmidt, Marcus ; Shparyk, Yaroslav V. ; Thummala, Anu ; Voitko, Nataliia ; Bananis, Eustratios ; McRoy, Lynn ; Wilner, Keith ; Huang, Xin ; Kim, Sindy ; Slamon, Dennis J. ; Ettl, Johannes</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c572t-7fd22ef6f28dc2ed240d1db884dd86aa8e4f42d592c03912ee265255c26ab7a43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - metabolism</topic><topic>Breast Neoplasms - mortality</topic><topic>Breast Neoplasms - pathology</topic><topic>Cancer research</topic><topic>Cancer therapies</topic><topic>Care and treatment</topic><topic>Chemotherapy</topic><topic>Clinical Trial</topic><topic>Cyclin-dependent kinase 4</topic><topic>Cyclin-dependent kinases</topic><topic>Development and progression</topic><topic>Endocrine therapy</topic><topic>Epidermal growth factor</topic><topic>ErbB-2 protein</topic><topic>Estrogen Receptor alpha - metabolism</topic><topic>Estrogen receptors</topic><topic>Female</topic><topic>Fulvestrant</topic><topic>Humans</topic><topic>Kinases</topic><topic>Letrozole - administration & dosage</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Neutropenia</topic><topic>Oncology</topic><topic>Patient outcomes</topic><topic>Piperazines - administration & dosage</topic><topic>Post-menopause</topic><topic>Postmenopausal women</topic><topic>Postmenopause</topic><topic>Product development</topic><topic>Pyridines - administration & dosage</topic><topic>Receptor, ErbB-2 - metabolism</topic><topic>Statistical analysis</topic><topic>Survival</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><topic>Women</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Finn, Richard S.</creatorcontrib><creatorcontrib>Boer, Katalin</creatorcontrib><creatorcontrib>Bondarenko, Igor</creatorcontrib><creatorcontrib>Patel, Ravindranath</creatorcontrib><creatorcontrib>Pinter, Tamas</creatorcontrib><creatorcontrib>Schmidt, Marcus</creatorcontrib><creatorcontrib>Shparyk, Yaroslav V.</creatorcontrib><creatorcontrib>Thummala, Anu</creatorcontrib><creatorcontrib>Voitko, Nataliia</creatorcontrib><creatorcontrib>Bananis, Eustratios</creatorcontrib><creatorcontrib>McRoy, Lynn</creatorcontrib><creatorcontrib>Wilner, Keith</creatorcontrib><creatorcontrib>Huang, Xin</creatorcontrib><creatorcontrib>Kim, Sindy</creatorcontrib><creatorcontrib>Slamon, Dennis J.</creatorcontrib><creatorcontrib>Ettl, Johannes</creatorcontrib><collection>Springer Nature OA Free Journals</collection><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 Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</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><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Finn, Richard S.</au><au>Boer, Katalin</au><au>Bondarenko, Igor</au><au>Patel, Ravindranath</au><au>Pinter, Tamas</au><au>Schmidt, Marcus</au><au>Shparyk, Yaroslav V.</au><au>Thummala, Anu</au><au>Voitko, Nataliia</au><au>Bananis, Eustratios</au><au>McRoy, Lynn</au><au>Wilner, Keith</au><au>Huang, Xin</au><au>Kim, Sindy</au><au>Slamon, Dennis J.</au><au>Ettl, Johannes</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (PALOMA-1, TRIO-18)</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>419</spage><epage>428</epage><pages>419-428</pages><issn>0167-6806</issn><eissn>1573-7217</eissn><abstract>Purpose
Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer (HR+/HER2− ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.319‒0.748;
P
= 0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor–positive (ER+)/HER2− ABC. Here, we present the final overall survival (OS) and updated safety results.
Methods
Postmenopausal women with ER+/HER2− ABC were randomized 1:1 to receive either palbociclib (125 mg/day, 3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was investigator-assessed PFS; secondary endpoints included OS and safety.
Results
A total of 165 patients were randomized. At the data cutoff date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratified hazard ratio for OS was 0.897 (95% CI 0.623–1.294;
P
= 0.281); median OS in the palbociclib plus letrozole and letrozole alone arms was 37.5 and 34.5 months, respectively. The median time from randomization to first subsequent chemotherapy use was longer with palbociclib plus letrozole than letrozole alone (26.7 and 17.7 months, respectively). The most frequently reported adverse event in the palbociclib plus letrozole arm was neutropenia (any grade, 75%; grade 3 or 4, 59%).
Conclusions
Palbociclib plus letrozole treatment led to a numerical but not statistically significant improvement in median OS.
Pfizer Inc (NCT00721409)</abstract><cop>New York</cop><pub>Springer US</pub><pmid>32683565</pmid><doi>10.1007/s10549-020-05755-7</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-2494-2126</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6806 |
| ispartof | Breast cancer research and treatment, 2020-09, Vol.183 (2), p.419-428 |
| issn | 0167-6806 1573-7217 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7383036 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - therapeutic use Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - mortality Breast Neoplasms - pathology Cancer research Cancer therapies Care and treatment Chemotherapy Clinical Trial Cyclin-dependent kinase 4 Cyclin-dependent kinases Development and progression Endocrine therapy Epidermal growth factor ErbB-2 protein Estrogen Receptor alpha - metabolism Estrogen receptors Female Fulvestrant Humans Kinases Letrozole - administration & dosage Medicine Medicine & Public Health Middle Aged Neutropenia Oncology Patient outcomes Piperazines - administration & dosage Post-menopause Postmenopausal women Postmenopause Product development Pyridines - administration & dosage Receptor, ErbB-2 - metabolism Statistical analysis Survival Survival Rate Treatment Outcome Women |
| title | Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (PALOMA-1, TRIO-18) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-20T21%3A33%3A00IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Overall%20survival%20results%20from%20the%20randomized%20phase%202%20study%20of%20palbociclib%20in%20combination%20with%20letrozole%20versus%20letrozole%20alone%20for%20first-line%20treatment%20of%20ER+/HER2%E2%88%92%20advanced%20breast%20cancer%20(PALOMA-1,%20TRIO-18)&rft.jtitle=Breast%20cancer%20research%20and%20treatment&rft.au=Finn,%20Richard%20S.&rft.date=2020-09-01&rft.volume=183&rft.issue=2&rft.spage=419&rft.epage=428&rft.pages=419-428&rft.issn=0167-6806&rft.eissn=1573-7217&rft_id=info:doi/10.1007/s10549-020-05755-7&rft_dat=%3Cgale_pubme%3EA630709996%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2427188265&rft_id=info:pmid/32683565&rft_galeid=A630709996&rfr_iscdi=true |