Eribulin for the treatment of advanced breast cancer: A prospective observational registry study
Objective Eribulin treatment improved overall survival with predictable toxicities in phase 3 trials of patients with previously treated, locally advanced/metastatic breast cancer. This study (NCT02443428) prospectively observed eribulin‐treated patients in real‐world clinical practice. Methods This...
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| Veröffentlicht in: | European journal of cancer care 2022-11, Vol.31 (6), p.e13747-n/a |
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| container_title | European journal of cancer care |
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| creator | Kenny, Laura Beresford, Mark Brown, Ian Misra, Vivek Kristeleit, Hartmut |
| description | Objective
Eribulin treatment improved overall survival with predictable toxicities in phase 3 trials of patients with previously treated, locally advanced/metastatic breast cancer. This study (NCT02443428) prospectively observed eribulin‐treated patients in real‐world clinical practice.
Methods
This observational multicentre registry study enrolled 76 patients with locally advanced/metastatic breast cancer who had ≤2 prior chemotherapeutic regimens for advanced disease. Eribulin was administered at a 1.23 mg/m2 dose (days 1 and 8 of every 21‐day cycle). Adverse events (AEs) were monitored and effectiveness was assessed per local practice.
Results
AEs occurred in 98.7% of patients; 88.2% had eribulin‐related AEs. The most common AEs were fatigue (64.5%), alopecia (36.8%), nausea (35.5%) and constipation (30.3%). Serious AEs occurred in 42.1% of patients. The most common grade 3/4 AEs were neutropenia (9.2%), febrile neutropenia (9.2%), dyspnoea (5.3%) and pleural effusion (5.3%). No fatal AEs occurred. Dose reductions occurred in 31.6% of patients, 42.1% experienced dose delays and 9.2% discontinued due to worsening condition. There were complete responses in 2.6% and partial responses in 15.8% of patients. Median time to progression and overall survival were 4.0 and 8.3 months, respectively.
Conclusion
Eribulin was well tolerated in real‐world clinical practice, comparable to safety and effectiveness reported in other clinical trials. |
| doi_str_mv | 10.1111/ecc.13747 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9787722</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2739580525</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4437-81827efb1a89d5173b6cf8ec7a3e20a1b11f54787f630f392501487fe36b1fea3</originalsourceid><addsrcrecordid>eNp1kc1OGzEURq0KVAJl0ReoLLHqYoJ_xzNdVIqilCIhsaFr4_Fcg9FknNqeoLx9TZOissAb69pH5_rzRegzJXNa1iVYO6dcCfUBzSivZcW4FEdoRtqaVlIwfoJOU3oihHLaio_ohNec16JuZuh-FX03DX7ELkScHwHnCCavYcw4OGz6rRkt9Lgrpylj-1LFb3iBNzGkDdjst4BDlyBuTfZhNAOO8OBTjjuc8tTvPqFjZ4YE54f9DP36sbpb_qxubq-ul4ubygrBVdXQhilwHTVN20uqeFdb14BVhgMjhnaUOilUo1zNieMtk4SKUgGvO-rA8DP0fe_dTN0aelsCRDPoTfRrE3c6GK_f3oz-UT-ErW6LVDFWBBcHQQy_J0hZP4UplkBJM8Vb2RDJZKG-7ilb8qcI7rUDJfplGLoMQ_8dRmG__P-kV_Lf7xfgcg88-wF275v0arncK_8AgPSVSQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2739580525</pqid></control><display><type>article</type><title>Eribulin for the treatment of advanced breast cancer: A prospective observational registry study</title><source>MEDLINE</source><source>Wiley Journals</source><creator>Kenny, Laura ; Beresford, Mark ; Brown, Ian ; Misra, Vivek ; Kristeleit, Hartmut</creator><creatorcontrib>Kenny, Laura ; Beresford, Mark ; Brown, Ian ; Misra, Vivek ; Kristeleit, Hartmut</creatorcontrib><description>Objective
Eribulin treatment improved overall survival with predictable toxicities in phase 3 trials of patients with previously treated, locally advanced/metastatic breast cancer. This study (NCT02443428) prospectively observed eribulin‐treated patients in real‐world clinical practice.
Methods
This observational multicentre registry study enrolled 76 patients with locally advanced/metastatic breast cancer who had ≤2 prior chemotherapeutic regimens for advanced disease. Eribulin was administered at a 1.23 mg/m2 dose (days 1 and 8 of every 21‐day cycle). Adverse events (AEs) were monitored and effectiveness was assessed per local practice.
Results
AEs occurred in 98.7% of patients; 88.2% had eribulin‐related AEs. The most common AEs were fatigue (64.5%), alopecia (36.8%), nausea (35.5%) and constipation (30.3%). Serious AEs occurred in 42.1% of patients. The most common grade 3/4 AEs were neutropenia (9.2%), febrile neutropenia (9.2%), dyspnoea (5.3%) and pleural effusion (5.3%). No fatal AEs occurred. Dose reductions occurred in 31.6% of patients, 42.1% experienced dose delays and 9.2% discontinued due to worsening condition. There were complete responses in 2.6% and partial responses in 15.8% of patients. Median time to progression and overall survival were 4.0 and 8.3 months, respectively.
Conclusion
Eribulin was well tolerated in real‐world clinical practice, comparable to safety and effectiveness reported in other clinical trials.</description><identifier>ISSN: 0961-5423</identifier><identifier>EISSN: 1365-2354</identifier><identifier>DOI: 10.1111/ecc.13747</identifier><identifier>PMID: 36336468</identifier><language>eng</language><publisher>England: Hindawi Limited</publisher><subject>adverse events ; Alopecia ; Breast cancer ; Breast Neoplasms - pathology ; Clinical medicine ; Clinical trials ; Constipation ; Dyspnea ; Effectiveness ; eribulin ; Female ; Furans - adverse effects ; Health services ; Humans ; Ketones - adverse effects ; Metastases ; Metastasis ; metastatic ; Neutropenia ; Original ; Patients ; Pleural effusion ; real‐world study ; Registries ; Respiration ; Survival ; Toxicity ; Treatment Outcome</subject><ispartof>European journal of cancer care, 2022-11, Vol.31 (6), p.e13747-n/a</ispartof><rights>2022 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2022 The Authors. European Journal of Cancer Care published by John Wiley & Sons Ltd.</rights><rights>2022. This article is published under http://creativecommons.org/licenses/by-nc/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-c4437-81827efb1a89d5173b6cf8ec7a3e20a1b11f54787f630f392501487fe36b1fea3</citedby><cites>FETCH-LOGICAL-c4437-81827efb1a89d5173b6cf8ec7a3e20a1b11f54787f630f392501487fe36b1fea3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fecc.13747$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fecc.13747$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36336468$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kenny, Laura</creatorcontrib><creatorcontrib>Beresford, Mark</creatorcontrib><creatorcontrib>Brown, Ian</creatorcontrib><creatorcontrib>Misra, Vivek</creatorcontrib><creatorcontrib>Kristeleit, Hartmut</creatorcontrib><title>Eribulin for the treatment of advanced breast cancer: A prospective observational registry study</title><title>European journal of cancer care</title><addtitle>Eur J Cancer Care (Engl)</addtitle><description>Objective
Eribulin treatment improved overall survival with predictable toxicities in phase 3 trials of patients with previously treated, locally advanced/metastatic breast cancer. This study (NCT02443428) prospectively observed eribulin‐treated patients in real‐world clinical practice.
Methods
This observational multicentre registry study enrolled 76 patients with locally advanced/metastatic breast cancer who had ≤2 prior chemotherapeutic regimens for advanced disease. Eribulin was administered at a 1.23 mg/m2 dose (days 1 and 8 of every 21‐day cycle). Adverse events (AEs) were monitored and effectiveness was assessed per local practice.
Results
AEs occurred in 98.7% of patients; 88.2% had eribulin‐related AEs. The most common AEs were fatigue (64.5%), alopecia (36.8%), nausea (35.5%) and constipation (30.3%). Serious AEs occurred in 42.1% of patients. The most common grade 3/4 AEs were neutropenia (9.2%), febrile neutropenia (9.2%), dyspnoea (5.3%) and pleural effusion (5.3%). No fatal AEs occurred. Dose reductions occurred in 31.6% of patients, 42.1% experienced dose delays and 9.2% discontinued due to worsening condition. There were complete responses in 2.6% and partial responses in 15.8% of patients. Median time to progression and overall survival were 4.0 and 8.3 months, respectively.
Conclusion
Eribulin was well tolerated in real‐world clinical practice, comparable to safety and effectiveness reported in other clinical trials.</description><subject>adverse events</subject><subject>Alopecia</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - pathology</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Constipation</subject><subject>Dyspnea</subject><subject>Effectiveness</subject><subject>eribulin</subject><subject>Female</subject><subject>Furans - adverse effects</subject><subject>Health services</subject><subject>Humans</subject><subject>Ketones - adverse effects</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>metastatic</subject><subject>Neutropenia</subject><subject>Original</subject><subject>Patients</subject><subject>Pleural effusion</subject><subject>real‐world study</subject><subject>Registries</subject><subject>Respiration</subject><subject>Survival</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><issn>0961-5423</issn><issn>1365-2354</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc1OGzEURq0KVAJl0ReoLLHqYoJ_xzNdVIqilCIhsaFr4_Fcg9FknNqeoLx9TZOissAb69pH5_rzRegzJXNa1iVYO6dcCfUBzSivZcW4FEdoRtqaVlIwfoJOU3oihHLaio_ohNec16JuZuh-FX03DX7ELkScHwHnCCavYcw4OGz6rRkt9Lgrpylj-1LFb3iBNzGkDdjst4BDlyBuTfZhNAOO8OBTjjuc8tTvPqFjZ4YE54f9DP36sbpb_qxubq-ul4ubygrBVdXQhilwHTVN20uqeFdb14BVhgMjhnaUOilUo1zNieMtk4SKUgGvO-rA8DP0fe_dTN0aelsCRDPoTfRrE3c6GK_f3oz-UT-ErW6LVDFWBBcHQQy_J0hZP4UplkBJM8Vb2RDJZKG-7ilb8qcI7rUDJfplGLoMQ_8dRmG__P-kV_Lf7xfgcg88-wF275v0arncK_8AgPSVSQ</recordid><startdate>202211</startdate><enddate>202211</enddate><creator>Kenny, Laura</creator><creator>Beresford, Mark</creator><creator>Brown, Ian</creator><creator>Misra, Vivek</creator><creator>Kristeleit, Hartmut</creator><general>Hindawi Limited</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</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>8FD</scope><scope>ASE</scope><scope>FPQ</scope><scope>FR3</scope><scope>K6X</scope><scope>K9.</scope><scope>M7Z</scope><scope>NAPCQ</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>202211</creationdate><title>Eribulin for the treatment of advanced breast cancer: A prospective observational registry study</title><author>Kenny, Laura ; Beresford, Mark ; Brown, Ian ; Misra, Vivek ; Kristeleit, Hartmut</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4437-81827efb1a89d5173b6cf8ec7a3e20a1b11f54787f630f392501487fe36b1fea3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>adverse events</topic><topic>Alopecia</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - pathology</topic><topic>Clinical medicine</topic><topic>Clinical trials</topic><topic>Constipation</topic><topic>Dyspnea</topic><topic>Effectiveness</topic><topic>eribulin</topic><topic>Female</topic><topic>Furans - adverse effects</topic><topic>Health services</topic><topic>Humans</topic><topic>Ketones - adverse effects</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>metastatic</topic><topic>Neutropenia</topic><topic>Original</topic><topic>Patients</topic><topic>Pleural effusion</topic><topic>real‐world study</topic><topic>Registries</topic><topic>Respiration</topic><topic>Survival</topic><topic>Toxicity</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kenny, Laura</creatorcontrib><creatorcontrib>Beresford, Mark</creatorcontrib><creatorcontrib>Brown, Ian</creatorcontrib><creatorcontrib>Misra, Vivek</creatorcontrib><creatorcontrib>Kristeleit, Hartmut</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Technology Research Database</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>Engineering Research Database</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biochemistry Abstracts 1</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of cancer care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kenny, Laura</au><au>Beresford, Mark</au><au>Brown, Ian</au><au>Misra, Vivek</au><au>Kristeleit, Hartmut</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Eribulin for the treatment of advanced breast cancer: A prospective observational registry study</atitle><jtitle>European journal of cancer care</jtitle><addtitle>Eur J Cancer Care (Engl)</addtitle><date>2022-11</date><risdate>2022</risdate><volume>31</volume><issue>6</issue><spage>e13747</spage><epage>n/a</epage><pages>e13747-n/a</pages><issn>0961-5423</issn><eissn>1365-2354</eissn><abstract>Objective
Eribulin treatment improved overall survival with predictable toxicities in phase 3 trials of patients with previously treated, locally advanced/metastatic breast cancer. This study (NCT02443428) prospectively observed eribulin‐treated patients in real‐world clinical practice.
Methods
This observational multicentre registry study enrolled 76 patients with locally advanced/metastatic breast cancer who had ≤2 prior chemotherapeutic regimens for advanced disease. Eribulin was administered at a 1.23 mg/m2 dose (days 1 and 8 of every 21‐day cycle). Adverse events (AEs) were monitored and effectiveness was assessed per local practice.
Results
AEs occurred in 98.7% of patients; 88.2% had eribulin‐related AEs. The most common AEs were fatigue (64.5%), alopecia (36.8%), nausea (35.5%) and constipation (30.3%). Serious AEs occurred in 42.1% of patients. The most common grade 3/4 AEs were neutropenia (9.2%), febrile neutropenia (9.2%), dyspnoea (5.3%) and pleural effusion (5.3%). No fatal AEs occurred. Dose reductions occurred in 31.6% of patients, 42.1% experienced dose delays and 9.2% discontinued due to worsening condition. There were complete responses in 2.6% and partial responses in 15.8% of patients. Median time to progression and overall survival were 4.0 and 8.3 months, respectively.
Conclusion
Eribulin was well tolerated in real‐world clinical practice, comparable to safety and effectiveness reported in other clinical trials.</abstract><cop>England</cop><pub>Hindawi Limited</pub><pmid>36336468</pmid><doi>10.1111/ecc.13747</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0961-5423 |
| ispartof | European journal of cancer care, 2022-11, Vol.31 (6), p.e13747-n/a |
| issn | 0961-5423 1365-2354 |
| language | eng |
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| source | MEDLINE; Wiley Journals |
| subjects | adverse events Alopecia Breast cancer Breast Neoplasms - pathology Clinical medicine Clinical trials Constipation Dyspnea Effectiveness eribulin Female Furans - adverse effects Health services Humans Ketones - adverse effects Metastases Metastasis metastatic Neutropenia Original Patients Pleural effusion real‐world study Registries Respiration Survival Toxicity Treatment Outcome |
| title | Eribulin for the treatment of advanced breast cancer: A prospective observational registry study |
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