Phase 2 study of single-agent IV vinflunine as third-line treatment of metastatic breast cancer after failure of anthracycline-/taxane-based chemotherapy
A multicenter, open-label, phase 2 study evaluated the efficacy and safety of intravenous vinflunine as third-line treatment in patients with progressing metastatic breast cancer (MBC) after failure of anthracycline- and taxane-based chemotherapy. Fifty-six patients with MBC, relapsing after receivi...
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Veröffentlicht in: | American journal of clinical oncology 2009-08, Vol.32 (4), p.375-380 |
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creator | Fumoleau, Pierre Cortés-Funes, Hernan Taleb, Amina B Chan, Stephen Campone, Mario Pouget, Jean-Christophe Tubiana-Hulin, Michèle Slabber, Conrad F Caroff-Paraïso, Isabelle Alberts, Albert S Ben Ayed, Farhat |
description | A multicenter, open-label, phase 2 study evaluated the efficacy and safety of intravenous vinflunine as third-line treatment in patients with progressing metastatic breast cancer (MBC) after failure of anthracycline- and taxane-based chemotherapy.
Fifty-six patients with MBC, relapsing after receiving 2 previous treatments for advanced disease, including both anthracyclines and taxanes, received 320 mg/m(2) of vinflunine once every 3 weeks (median number of 2.5 cycles, range: 1-13).
According to an independent radiologist, the response rate was 12.5% (95% CI: 5.2-24.1) and 14% (95% CI: 5.3-27.9) (6 partial responses) in the treated and evaluable populations, respectively. Disease control was achieved in 42.9% and 51.2% of the patients, respectively. Median progression-free survival was 2.6 months (95% CI: 1.6-4.0 months) with a median overall survival of 11.4 months (95% CI: 7.4-14.2 months). Duration of response was 6.8 months (95% CI: 5.6 months, upper limit not reached). Leukopenia was the most frequent hematologic toxicity, with grade 3/4 severity in 49.1% of the patients. Grade 3 neutropenia in 30.9%, grade 4 in 40.0% of patients, febrile neutropenia (5.4%), and 1 case of neutropenia infection (1.8%) were reported. Other grade 3 toxicities included anemia (5.5%), fatigue (14.3%), and constipation (7.1%), which were noncumulative. The adverse events associated with vinflunine were predictable and manageable.
Vinflunine is an active and well-tolerated agent as third-line treatment of patients with MBC after failure of anthracycline- and taxane-based therapy. These results warrant further investigation of vinflunine monotherapy or in combination for the treatment of MBC. |
doi_str_mv | 10.1097/COC.0b013e31818f2d2f |
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Fifty-six patients with MBC, relapsing after receiving 2 previous treatments for advanced disease, including both anthracyclines and taxanes, received 320 mg/m(2) of vinflunine once every 3 weeks (median number of 2.5 cycles, range: 1-13).
According to an independent radiologist, the response rate was 12.5% (95% CI: 5.2-24.1) and 14% (95% CI: 5.3-27.9) (6 partial responses) in the treated and evaluable populations, respectively. Disease control was achieved in 42.9% and 51.2% of the patients, respectively. Median progression-free survival was 2.6 months (95% CI: 1.6-4.0 months) with a median overall survival of 11.4 months (95% CI: 7.4-14.2 months). Duration of response was 6.8 months (95% CI: 5.6 months, upper limit not reached). Leukopenia was the most frequent hematologic toxicity, with grade 3/4 severity in 49.1% of the patients. Grade 3 neutropenia in 30.9%, grade 4 in 40.0% of patients, febrile neutropenia (5.4%), and 1 case of neutropenia infection (1.8%) were reported. Other grade 3 toxicities included anemia (5.5%), fatigue (14.3%), and constipation (7.1%), which were noncumulative. The adverse events associated with vinflunine were predictable and manageable.
Vinflunine is an active and well-tolerated agent as third-line treatment of patients with MBC after failure of anthracycline- and taxane-based therapy. These results warrant further investigation of vinflunine monotherapy or in combination for the treatment of MBC.</description><identifier>ISSN: 0277-3732</identifier><identifier>EISSN: 1537-453X</identifier><identifier>DOI: 10.1097/COC.0b013e31818f2d2f</identifier><identifier>PMID: 19487917</identifier><language>eng</language><publisher>United States</publisher><subject><![CDATA[Adult ; Aged ; Anthracyclines - administration & dosage ; Antineoplastic Agents - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Brain Neoplasms - drug therapy ; Brain Neoplasms - pathology ; Brain Neoplasms - secondary ; Breast Neoplasms - drug therapy ; Breast Neoplasms - pathology ; Bridged-Ring Compounds - administration & dosage ; Female ; Humans ; Middle Aged ; Neoplasm Staging ; Taxoids - administration & dosage ; Treatment Failure ; Vinblastine - administration & dosage ; Vinblastine - analogs & derivatives]]></subject><ispartof>American journal of clinical oncology, 2009-08, Vol.32 (4), p.375-380</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c307t-697460d4adf93a998a49e542ece831032a01cad2954342bdc9e3dec745ea1fe03</citedby><cites>FETCH-LOGICAL-c307t-697460d4adf93a998a49e542ece831032a01cad2954342bdc9e3dec745ea1fe03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19487917$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fumoleau, Pierre</creatorcontrib><creatorcontrib>Cortés-Funes, Hernan</creatorcontrib><creatorcontrib>Taleb, Amina B</creatorcontrib><creatorcontrib>Chan, Stephen</creatorcontrib><creatorcontrib>Campone, Mario</creatorcontrib><creatorcontrib>Pouget, Jean-Christophe</creatorcontrib><creatorcontrib>Tubiana-Hulin, Michèle</creatorcontrib><creatorcontrib>Slabber, Conrad F</creatorcontrib><creatorcontrib>Caroff-Paraïso, Isabelle</creatorcontrib><creatorcontrib>Alberts, Albert S</creatorcontrib><creatorcontrib>Ben Ayed, Farhat</creatorcontrib><title>Phase 2 study of single-agent IV vinflunine as third-line treatment of metastatic breast cancer after failure of anthracycline-/taxane-based chemotherapy</title><title>American journal of clinical oncology</title><addtitle>Am J Clin Oncol</addtitle><description>A multicenter, open-label, phase 2 study evaluated the efficacy and safety of intravenous vinflunine as third-line treatment in patients with progressing metastatic breast cancer (MBC) after failure of anthracycline- and taxane-based chemotherapy.
Fifty-six patients with MBC, relapsing after receiving 2 previous treatments for advanced disease, including both anthracyclines and taxanes, received 320 mg/m(2) of vinflunine once every 3 weeks (median number of 2.5 cycles, range: 1-13).
According to an independent radiologist, the response rate was 12.5% (95% CI: 5.2-24.1) and 14% (95% CI: 5.3-27.9) (6 partial responses) in the treated and evaluable populations, respectively. Disease control was achieved in 42.9% and 51.2% of the patients, respectively. Median progression-free survival was 2.6 months (95% CI: 1.6-4.0 months) with a median overall survival of 11.4 months (95% CI: 7.4-14.2 months). Duration of response was 6.8 months (95% CI: 5.6 months, upper limit not reached). Leukopenia was the most frequent hematologic toxicity, with grade 3/4 severity in 49.1% of the patients. Grade 3 neutropenia in 30.9%, grade 4 in 40.0% of patients, febrile neutropenia (5.4%), and 1 case of neutropenia infection (1.8%) were reported. Other grade 3 toxicities included anemia (5.5%), fatigue (14.3%), and constipation (7.1%), which were noncumulative. The adverse events associated with vinflunine were predictable and manageable.
Vinflunine is an active and well-tolerated agent as third-line treatment of patients with MBC after failure of anthracycline- and taxane-based therapy. These results warrant further investigation of vinflunine monotherapy or in combination for the treatment of MBC.</description><subject>Adult</subject><subject>Aged</subject><subject>Anthracyclines - administration & dosage</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Brain Neoplasms - drug therapy</subject><subject>Brain Neoplasms - pathology</subject><subject>Brain Neoplasms - secondary</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - pathology</subject><subject>Bridged-Ring Compounds - administration & dosage</subject><subject>Female</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Taxoids - administration & dosage</subject><subject>Treatment Failure</subject><subject>Vinblastine - administration & dosage</subject><subject>Vinblastine - analogs & derivatives</subject><issn>0277-3732</issn><issn>1537-453X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkN1Kw0AQhRdRbK2-gci-QOr-pZu9lOIfCHqh4l2Y7M42kSQtu1uxj-LbmtCC4M0cZjjnMHyEXHI258zo6-Xzcs4qxiVKXvDCCyf8EZnyXOpM5fLjmEyZ0DqTWooJOYvxkzGWL5g-JRNuVKEN11Py81JDRCpoTFu3o2tPY9OvWsxghX2ij-_0q-l9u-2bHilEmuomuKwdtxQQUje6hlSHCWKC1FhaDfeYqIXeYqDg0zA9NO024OiEPtUB7M6OJdl1gm8YtBq-cNTW2K1TjQE2u3Ny4qGNeHHQGXm7u31dPmRPz_ePy5unzEqmU7YwWi2YU-C8kWBMAcpgrgRaLCRnUgDjFpwwuZJKVM4alA6tVjkC98jkjKh9rw3rGAP6chOaDsKu5KwcSZcD6fI_6SF2tY9ttlWH7i90QCt_ARBrft4</recordid><startdate>20090801</startdate><enddate>20090801</enddate><creator>Fumoleau, Pierre</creator><creator>Cortés-Funes, Hernan</creator><creator>Taleb, Amina B</creator><creator>Chan, Stephen</creator><creator>Campone, Mario</creator><creator>Pouget, Jean-Christophe</creator><creator>Tubiana-Hulin, Michèle</creator><creator>Slabber, Conrad F</creator><creator>Caroff-Paraïso, Isabelle</creator><creator>Alberts, Albert S</creator><creator>Ben Ayed, Farhat</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20090801</creationdate><title>Phase 2 study of single-agent IV vinflunine as third-line treatment of metastatic breast cancer after failure of anthracycline-/taxane-based chemotherapy</title><author>Fumoleau, Pierre ; Cortés-Funes, Hernan ; Taleb, Amina B ; Chan, Stephen ; Campone, Mario ; Pouget, Jean-Christophe ; Tubiana-Hulin, Michèle ; Slabber, Conrad F ; Caroff-Paraïso, Isabelle ; Alberts, Albert S ; Ben Ayed, Farhat</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c307t-697460d4adf93a998a49e542ece831032a01cad2954342bdc9e3dec745ea1fe03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anthracyclines - administration & dosage</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Brain Neoplasms - drug therapy</topic><topic>Brain Neoplasms - pathology</topic><topic>Brain Neoplasms - secondary</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - pathology</topic><topic>Bridged-Ring Compounds - administration & dosage</topic><topic>Female</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Taxoids - administration & dosage</topic><topic>Treatment Failure</topic><topic>Vinblastine - administration & dosage</topic><topic>Vinblastine - analogs & derivatives</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fumoleau, Pierre</creatorcontrib><creatorcontrib>Cortés-Funes, Hernan</creatorcontrib><creatorcontrib>Taleb, Amina B</creatorcontrib><creatorcontrib>Chan, Stephen</creatorcontrib><creatorcontrib>Campone, Mario</creatorcontrib><creatorcontrib>Pouget, Jean-Christophe</creatorcontrib><creatorcontrib>Tubiana-Hulin, Michèle</creatorcontrib><creatorcontrib>Slabber, Conrad F</creatorcontrib><creatorcontrib>Caroff-Paraïso, Isabelle</creatorcontrib><creatorcontrib>Alberts, Albert S</creatorcontrib><creatorcontrib>Ben Ayed, Farhat</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>American journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fumoleau, Pierre</au><au>Cortés-Funes, Hernan</au><au>Taleb, Amina B</au><au>Chan, Stephen</au><au>Campone, Mario</au><au>Pouget, Jean-Christophe</au><au>Tubiana-Hulin, Michèle</au><au>Slabber, Conrad F</au><au>Caroff-Paraïso, Isabelle</au><au>Alberts, Albert S</au><au>Ben Ayed, Farhat</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase 2 study of single-agent IV vinflunine as third-line treatment of metastatic breast cancer after failure of anthracycline-/taxane-based chemotherapy</atitle><jtitle>American journal of clinical oncology</jtitle><addtitle>Am J Clin Oncol</addtitle><date>2009-08-01</date><risdate>2009</risdate><volume>32</volume><issue>4</issue><spage>375</spage><epage>380</epage><pages>375-380</pages><issn>0277-3732</issn><eissn>1537-453X</eissn><abstract>A multicenter, open-label, phase 2 study evaluated the efficacy and safety of intravenous vinflunine as third-line treatment in patients with progressing metastatic breast cancer (MBC) after failure of anthracycline- and taxane-based chemotherapy.
Fifty-six patients with MBC, relapsing after receiving 2 previous treatments for advanced disease, including both anthracyclines and taxanes, received 320 mg/m(2) of vinflunine once every 3 weeks (median number of 2.5 cycles, range: 1-13).
According to an independent radiologist, the response rate was 12.5% (95% CI: 5.2-24.1) and 14% (95% CI: 5.3-27.9) (6 partial responses) in the treated and evaluable populations, respectively. Disease control was achieved in 42.9% and 51.2% of the patients, respectively. Median progression-free survival was 2.6 months (95% CI: 1.6-4.0 months) with a median overall survival of 11.4 months (95% CI: 7.4-14.2 months). Duration of response was 6.8 months (95% CI: 5.6 months, upper limit not reached). Leukopenia was the most frequent hematologic toxicity, with grade 3/4 severity in 49.1% of the patients. Grade 3 neutropenia in 30.9%, grade 4 in 40.0% of patients, febrile neutropenia (5.4%), and 1 case of neutropenia infection (1.8%) were reported. Other grade 3 toxicities included anemia (5.5%), fatigue (14.3%), and constipation (7.1%), which were noncumulative. The adverse events associated with vinflunine were predictable and manageable.
Vinflunine is an active and well-tolerated agent as third-line treatment of patients with MBC after failure of anthracycline- and taxane-based therapy. These results warrant further investigation of vinflunine monotherapy or in combination for the treatment of MBC.</abstract><cop>United States</cop><pmid>19487917</pmid><doi>10.1097/COC.0b013e31818f2d2f</doi><tpages>6</tpages></addata></record> |
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subjects | Adult Aged Anthracyclines - administration & dosage Antineoplastic Agents - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Brain Neoplasms - drug therapy Brain Neoplasms - pathology Brain Neoplasms - secondary Breast Neoplasms - drug therapy Breast Neoplasms - pathology Bridged-Ring Compounds - administration & dosage Female Humans Middle Aged Neoplasm Staging Taxoids - administration & dosage Treatment Failure Vinblastine - administration & dosage Vinblastine - analogs & derivatives |
title | Phase 2 study of single-agent IV vinflunine as third-line treatment of metastatic breast cancer after failure of anthracycline-/taxane-based chemotherapy |
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