A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer
A multicenter NCI-sponsored phase II study was conducted to analyze the safety and efficacy of the combination of ixabepilone with trastuzumab in patients with metastatic HER2-positive breast cancer. Two cohorts were enrolled: cohort 1 had received no prior chemotherapy or trastuzumab for metastatic...
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| Veröffentlicht in: | Annals of oncology 2013-07, Vol.24 (7), p.1841-1847 |
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| container_title | Annals of oncology |
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| creator | Tolaney, S.M. Najita, J. Sperinde, J. Huang, W. Chen, W.Y. Savoie, J. Fornier, M. Winer, E.P. Bunnell, C. Krop, I.E. |
| description | A multicenter NCI-sponsored phase II study was conducted to analyze the safety and efficacy of the combination of ixabepilone with trastuzumab in patients with metastatic HER2-positive breast cancer.
Two cohorts were enrolled: cohort 1 had received no prior chemotherapy or trastuzumab for metastatic disease and cohort 2 had received 1–2 prior trastuzumab-containing regimens for metastatic disease. Patients in both cohorts received ixabepilone 40 mg/m2 as a 3-h infusion and trastuzumab on day 1 of a 21-day cycle. Tumor biomarkers that may predict response to trastuzumab were explored.
Thirty-nine women entered the study with 15 patients in cohort 1 and 24 patients in cohort 2. Across both cohorts, the overall RR was 44%, with a clinical benefit rate (CR + PR + SD for at least 24 weeks) of 56%. Treatment-related toxic effects included neuropathy (grade ≥2, 56%), leukopenia (grade ≥2, 26%), myalgias (grade ≥2, 21%), neutropenia (grade ≥2, 23%), and anemia (grade ≥2, 18%).
This represents the first study of the combination of ixabepilone with trastuzumab for the treatment of metastatic HER2-positive breast cancer. These results suggest that the combination has encouraging activity as first and subsequent line therapy for metastatic breast cancer. |
| doi_str_mv | 10.1093/annonc/mdt121 |
| format | Article |
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Two cohorts were enrolled: cohort 1 had received no prior chemotherapy or trastuzumab for metastatic disease and cohort 2 had received 1–2 prior trastuzumab-containing regimens for metastatic disease. Patients in both cohorts received ixabepilone 40 mg/m2 as a 3-h infusion and trastuzumab on day 1 of a 21-day cycle. Tumor biomarkers that may predict response to trastuzumab were explored.
Thirty-nine women entered the study with 15 patients in cohort 1 and 24 patients in cohort 2. Across both cohorts, the overall RR was 44%, with a clinical benefit rate (CR + PR + SD for at least 24 weeks) of 56%. Treatment-related toxic effects included neuropathy (grade ≥2, 56%), leukopenia (grade ≥2, 26%), myalgias (grade ≥2, 21%), neutropenia (grade ≥2, 23%), and anemia (grade ≥2, 18%).
This represents the first study of the combination of ixabepilone with trastuzumab for the treatment of metastatic HER2-positive breast cancer. These results suggest that the combination has encouraging activity as first and subsequent line therapy for metastatic breast cancer.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdt121</identifier><identifier>PMID: 23559151</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adult ; Aged ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; breast ; Breast Neoplasms - drug therapy ; Breast Neoplasms - metabolism ; Breast Neoplasms - mortality ; Breast Neoplasms - pathology ; cancer ; Disease-Free Survival ; Epothilones - administration & dosage ; Female ; Gynecology. Andrology. Obstetrics ; HER2 ; Humans ; ixabepilone ; Kaplan-Meier Estimate ; Mammary gland diseases ; Medical sciences ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Neoplasm Metastasis ; Original ; Pharmacology. Drug treatments ; Trastuzumab ; Treatment Outcome ; Tumors</subject><ispartof>Annals of oncology, 2013-07, Vol.24 (7), p.1841-1847</ispartof><rights>2013 European Society for Medical Oncology</rights><rights>2014 INIST-CNRS</rights><rights>The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c465t-62fb578c6744f9196b9176cead8842c1ed58975d9362611a303bd545b50eadd93</citedby><cites>FETCH-LOGICAL-c465t-62fb578c6744f9196b9176cead8842c1ed58975d9362611a303bd545b50eadd93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27480870$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23559151$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tolaney, S.M.</creatorcontrib><creatorcontrib>Najita, J.</creatorcontrib><creatorcontrib>Sperinde, J.</creatorcontrib><creatorcontrib>Huang, W.</creatorcontrib><creatorcontrib>Chen, W.Y.</creatorcontrib><creatorcontrib>Savoie, J.</creatorcontrib><creatorcontrib>Fornier, M.</creatorcontrib><creatorcontrib>Winer, E.P.</creatorcontrib><creatorcontrib>Bunnell, C.</creatorcontrib><creatorcontrib>Krop, I.E.</creatorcontrib><title>A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>A multicenter NCI-sponsored phase II study was conducted to analyze the safety and efficacy of the combination of ixabepilone with trastuzumab in patients with metastatic HER2-positive breast cancer.
Two cohorts were enrolled: cohort 1 had received no prior chemotherapy or trastuzumab for metastatic disease and cohort 2 had received 1–2 prior trastuzumab-containing regimens for metastatic disease. Patients in both cohorts received ixabepilone 40 mg/m2 as a 3-h infusion and trastuzumab on day 1 of a 21-day cycle. Tumor biomarkers that may predict response to trastuzumab were explored.
Thirty-nine women entered the study with 15 patients in cohort 1 and 24 patients in cohort 2. Across both cohorts, the overall RR was 44%, with a clinical benefit rate (CR + PR + SD for at least 24 weeks) of 56%. Treatment-related toxic effects included neuropathy (grade ≥2, 56%), leukopenia (grade ≥2, 26%), myalgias (grade ≥2, 21%), neutropenia (grade ≥2, 23%), and anemia (grade ≥2, 18%).
This represents the first study of the combination of ixabepilone with trastuzumab for the treatment of metastatic HER2-positive breast cancer. These results suggest that the combination has encouraging activity as first and subsequent line therapy for metastatic breast cancer.</description><subject>Adult</subject><subject>Aged</subject><subject>Antibodies, Monoclonal, Humanized - administration & dosage</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>breast</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - metabolism</subject><subject>Breast Neoplasms - mortality</subject><subject>Breast Neoplasms - pathology</subject><subject>cancer</subject><subject>Disease-Free Survival</subject><subject>Epothilones - administration & dosage</subject><subject>Female</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>HER2</subject><subject>Humans</subject><subject>ixabepilone</subject><subject>Kaplan-Meier Estimate</subject><subject>Mammary gland diseases</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Neoplasm Metastasis</subject><subject>Original</subject><subject>Pharmacology. Drug treatments</subject><subject>Trastuzumab</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kEtLxDAURoMozvhYupVsXFaTtkmbjTDIqAOCILpxE9LkViPTpiSZwfHXG6nPhavA_U6-ezkIHVFySokozlTfu16fdSbSnG6hKWVcZDUp6TaaEpEXWcWKcoL2QnghhHCRi100yQvGBGV0ih5neHhWAfBigUNcmQ12LbavqoHBLl0PWPUGR69S9rbqVINb53EHMQ1UtBpfz-_ybHDBRrsG3HhIAdaq1-AP0E6rlgEOP9999HA5v7-4zm5urxYXs5tMl5zFjOdtw6pa86osW0EFbwStuAZl6rrMNQXDalExIwqec0pVQYrGsJI1jCQmjffR-dg7rJoOjIY-3buUg7ed8hvplJV_k94-yye3lgUXRFCSCrKxQHsXgof2-y8l8kOyHCXLUXLij38v_Ka_rCbg5BNQQatl65MPG364qqxJXX0srkYOkp61BS-DtpDcGetBR2mc_eeEdwjBnF4</recordid><startdate>20130701</startdate><enddate>20130701</enddate><creator>Tolaney, S.M.</creator><creator>Najita, J.</creator><creator>Sperinde, J.</creator><creator>Huang, W.</creator><creator>Chen, W.Y.</creator><creator>Savoie, J.</creator><creator>Fornier, M.</creator><creator>Winer, E.P.</creator><creator>Bunnell, C.</creator><creator>Krop, I.E.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</scope><scope>IQODW</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>5PM</scope></search><sort><creationdate>20130701</creationdate><title>A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer</title><author>Tolaney, S.M. ; Najita, J. ; Sperinde, J. ; Huang, W. ; Chen, W.Y. ; Savoie, J. ; Fornier, M. ; Winer, E.P. ; Bunnell, C. ; Krop, I.E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c465t-62fb578c6744f9196b9176cead8842c1ed58975d9362611a303bd545b50eadd93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antibodies, Monoclonal, Humanized - administration & dosage</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>breast</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - metabolism</topic><topic>Breast Neoplasms - mortality</topic><topic>Breast Neoplasms - pathology</topic><topic>cancer</topic><topic>Disease-Free Survival</topic><topic>Epothilones - administration & dosage</topic><topic>Female</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>HER2</topic><topic>Humans</topic><topic>ixabepilone</topic><topic>Kaplan-Meier Estimate</topic><topic>Mammary gland diseases</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Neoplasm Metastasis</topic><topic>Original</topic><topic>Pharmacology. Drug treatments</topic><topic>Trastuzumab</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tolaney, S.M.</creatorcontrib><creatorcontrib>Najita, J.</creatorcontrib><creatorcontrib>Sperinde, J.</creatorcontrib><creatorcontrib>Huang, W.</creatorcontrib><creatorcontrib>Chen, W.Y.</creatorcontrib><creatorcontrib>Savoie, J.</creatorcontrib><creatorcontrib>Fornier, M.</creatorcontrib><creatorcontrib>Winer, E.P.</creatorcontrib><creatorcontrib>Bunnell, C.</creatorcontrib><creatorcontrib>Krop, I.E.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tolaney, S.M.</au><au>Najita, J.</au><au>Sperinde, J.</au><au>Huang, W.</au><au>Chen, W.Y.</au><au>Savoie, J.</au><au>Fornier, M.</au><au>Winer, E.P.</au><au>Bunnell, C.</au><au>Krop, I.E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2013-07-01</date><risdate>2013</risdate><volume>24</volume><issue>7</issue><spage>1841</spage><epage>1847</epage><pages>1841-1847</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>A multicenter NCI-sponsored phase II study was conducted to analyze the safety and efficacy of the combination of ixabepilone with trastuzumab in patients with metastatic HER2-positive breast cancer.
Two cohorts were enrolled: cohort 1 had received no prior chemotherapy or trastuzumab for metastatic disease and cohort 2 had received 1–2 prior trastuzumab-containing regimens for metastatic disease. Patients in both cohorts received ixabepilone 40 mg/m2 as a 3-h infusion and trastuzumab on day 1 of a 21-day cycle. Tumor biomarkers that may predict response to trastuzumab were explored.
Thirty-nine women entered the study with 15 patients in cohort 1 and 24 patients in cohort 2. Across both cohorts, the overall RR was 44%, with a clinical benefit rate (CR + PR + SD for at least 24 weeks) of 56%. Treatment-related toxic effects included neuropathy (grade ≥2, 56%), leukopenia (grade ≥2, 26%), myalgias (grade ≥2, 21%), neutropenia (grade ≥2, 23%), and anemia (grade ≥2, 18%).
This represents the first study of the combination of ixabepilone with trastuzumab for the treatment of metastatic HER2-positive breast cancer. These results suggest that the combination has encouraging activity as first and subsequent line therapy for metastatic breast cancer.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>23559151</pmid><doi>10.1093/annonc/mdt121</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Antibodies, Monoclonal, Humanized - administration & dosage Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences breast Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - mortality Breast Neoplasms - pathology cancer Disease-Free Survival Epothilones - administration & dosage Female Gynecology. Andrology. Obstetrics HER2 Humans ixabepilone Kaplan-Meier Estimate Mammary gland diseases Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Neoplasm Metastasis Original Pharmacology. Drug treatments Trastuzumab Treatment Outcome Tumors |
| title | A phase II study of ixabepilone and trastuzumab for metastatic HER2-positive breast cancer |
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