Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy
We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS). An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Pati...
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| Veröffentlicht in: | Annals of oncology 2013-04, Vol.24 (4), p.1093-1098 |
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| creator | Santoro, A. Comandone, A. Basso, U. Soto Parra, H. De Sanctis, R. Stroppa, E. Marcon, I. Giordano, L. Lutman, F.R. Boglione, A. Bertuzzi, A. |
| description | We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS).
An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A).
Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5%) achieved partial response and 25 (32.9%) stable disease; 6-month PFS rates were all histologies, 34.5%; L, 38.4%; and A, 56.3%. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5% in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P = 0.033). Treatment was well tolerated.
Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials. |
| doi_str_mv | 10.1093/annonc/mds607 |
| format | Article |
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An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A).
Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5%) achieved partial response and 25 (32.9%) stable disease; 6-month PFS rates were all histologies, 34.5%; L, 38.4%; and A, 56.3%. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5% in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P = 0.033). Treatment was well tolerated.
Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mds607</identifier><identifier>PMID: 23230134</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; angiosarcoma ; Anthracyclines - administration & dosage ; Anthracyclines - adverse effects ; Antineoplastic agents ; Biological and medical sciences ; Dermatology ; Disease-Free Survival ; Female ; Humans ; leiomyosarcoma ; Leiomyosarcoma - drug therapy ; Leiomyosarcoma - pathology ; Male ; Medical sciences ; Middle Aged ; Neoplasm Staging ; Niacinamide - administration & dosage ; Niacinamide - adverse effects ; Niacinamide - analogs & derivatives ; Pharmacology. Drug treatments ; Phenylurea Compounds - administration & dosage ; Phenylurea Compounds - adverse effects ; Prospective Studies ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - adverse effects ; Sarcoma - drug therapy ; Sarcoma - pathology ; soft tissue sarcoma ; Sorafenib ; Tumors of the skin and soft tissue. Premalignant lesions ; vascular sarcoma</subject><ispartof>Annals of oncology, 2013-04, Vol.24 (4), p.1093-1098</ispartof><rights>2012 European Society for Medical Oncology</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-83b1638d2d39c8366d9859d01707ac35810e5c109032a4acb66d39b1b289c3403</citedby><cites>FETCH-LOGICAL-c410t-83b1638d2d39c8366d9859d01707ac35810e5c109032a4acb66d39b1b289c3403</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27179685$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23230134$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Santoro, A.</creatorcontrib><creatorcontrib>Comandone, A.</creatorcontrib><creatorcontrib>Basso, U.</creatorcontrib><creatorcontrib>Soto Parra, H.</creatorcontrib><creatorcontrib>De Sanctis, R.</creatorcontrib><creatorcontrib>Stroppa, E.</creatorcontrib><creatorcontrib>Marcon, I.</creatorcontrib><creatorcontrib>Giordano, L.</creatorcontrib><creatorcontrib>Lutman, F.R.</creatorcontrib><creatorcontrib>Boglione, A.</creatorcontrib><creatorcontrib>Bertuzzi, A.</creatorcontrib><title>Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS).
An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A).
Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5%) achieved partial response and 25 (32.9%) stable disease; 6-month PFS rates were all histologies, 34.5%; L, 38.4%; and A, 56.3%. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5% in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P = 0.033). Treatment was well tolerated.
Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>angiosarcoma</subject><subject>Anthracyclines - administration & dosage</subject><subject>Anthracyclines - adverse effects</subject><subject>Antineoplastic agents</subject><subject>Biological and medical sciences</subject><subject>Dermatology</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Humans</subject><subject>leiomyosarcoma</subject><subject>Leiomyosarcoma - drug therapy</subject><subject>Leiomyosarcoma - pathology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Niacinamide - administration & dosage</subject><subject>Niacinamide - adverse effects</subject><subject>Niacinamide - analogs & derivatives</subject><subject>Pharmacology. Drug treatments</subject><subject>Phenylurea Compounds - administration & dosage</subject><subject>Phenylurea Compounds - adverse effects</subject><subject>Prospective Studies</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Sarcoma - drug therapy</subject><subject>Sarcoma - pathology</subject><subject>soft tissue sarcoma</subject><subject>Sorafenib</subject><subject>Tumors of the skin and soft tissue. Premalignant lesions</subject><subject>vascular sarcoma</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>eNp10M9LwzAUwPEgipvTo1fJxWNd0vRHchTxx2CgBz2X1ySlkTYtSTbpf29Gp548BcKHx3tfhK4puaNEsDVYO1i57pUvSHmCljQvRMJJRk_RkoiUJWXOsgW68P6TEFKIVJyjRcpSRijLlqh7a8FrvNng0Q1-1DKYvcY-7NSEv0xosR8cNNqaGhuLQe3BSq3ibxNwMN7vIgYnhx48hiZoh8GG1oGcZGesTuo4XeHQagfjdInOGui8vjq-K_Tx9Pj-8JJsX583D_fbRGaUhISzmhaMq1QxITkrCiV4LhShJSlBspxTonMZrycshQxkHQUTNa1TLiTLCFuhZJ4r403e6aYanenBTRUl1aFaNVer5mrR38x-3NW9Vr_6J1MEt0cAXkLXuFjB-D9X0lIUPI-unJ2O1-2NdpWXRh-KGRfTVmow_6zwDbmEjEk</recordid><startdate>20130401</startdate><enddate>20130401</enddate><creator>Santoro, A.</creator><creator>Comandone, A.</creator><creator>Basso, U.</creator><creator>Soto Parra, H.</creator><creator>De Sanctis, R.</creator><creator>Stroppa, E.</creator><creator>Marcon, I.</creator><creator>Giordano, L.</creator><creator>Lutman, F.R.</creator><creator>Boglione, A.</creator><creator>Bertuzzi, A.</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></search><sort><creationdate>20130401</creationdate><title>Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy</title><author>Santoro, A. ; Comandone, A. ; Basso, U. ; Soto Parra, H. ; De Sanctis, R. ; Stroppa, E. ; Marcon, I. ; Giordano, L. ; Lutman, F.R. ; Boglione, A. ; Bertuzzi, A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-83b1638d2d39c8366d9859d01707ac35810e5c109032a4acb66d39b1b289c3403</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>angiosarcoma</topic><topic>Anthracyclines - administration & dosage</topic><topic>Anthracyclines - adverse effects</topic><topic>Antineoplastic agents</topic><topic>Biological and medical sciences</topic><topic>Dermatology</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Humans</topic><topic>leiomyosarcoma</topic><topic>Leiomyosarcoma - drug therapy</topic><topic>Leiomyosarcoma - pathology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Niacinamide - administration & dosage</topic><topic>Niacinamide - adverse effects</topic><topic>Niacinamide - analogs & derivatives</topic><topic>Pharmacology. Drug treatments</topic><topic>Phenylurea Compounds - administration & dosage</topic><topic>Phenylurea Compounds - adverse effects</topic><topic>Prospective Studies</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Sarcoma - drug therapy</topic><topic>Sarcoma - pathology</topic><topic>soft tissue sarcoma</topic><topic>Sorafenib</topic><topic>Tumors of the skin and soft tissue. Premalignant lesions</topic><topic>vascular sarcoma</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Santoro, A.</creatorcontrib><creatorcontrib>Comandone, A.</creatorcontrib><creatorcontrib>Basso, U.</creatorcontrib><creatorcontrib>Soto Parra, H.</creatorcontrib><creatorcontrib>De Sanctis, R.</creatorcontrib><creatorcontrib>Stroppa, E.</creatorcontrib><creatorcontrib>Marcon, I.</creatorcontrib><creatorcontrib>Giordano, L.</creatorcontrib><creatorcontrib>Lutman, F.R.</creatorcontrib><creatorcontrib>Boglione, A.</creatorcontrib><creatorcontrib>Bertuzzi, A.</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><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Santoro, A.</au><au>Comandone, A.</au><au>Basso, U.</au><au>Soto Parra, H.</au><au>De Sanctis, R.</au><au>Stroppa, E.</au><au>Marcon, I.</au><au>Giordano, L.</au><au>Lutman, F.R.</au><au>Boglione, A.</au><au>Bertuzzi, A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2013-04-01</date><risdate>2013</risdate><volume>24</volume><issue>4</issue><spage>1093</spage><epage>1098</epage><pages>1093-1098</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS).
An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A).
Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5%) achieved partial response and 25 (32.9%) stable disease; 6-month PFS rates were all histologies, 34.5%; L, 38.4%; and A, 56.3%. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5% in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P = 0.033). Treatment was well tolerated.
Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>23230134</pmid><doi>10.1093/annonc/mds607</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Annals of oncology, 2013-04, Vol.24 (4), p.1093-1098 |
| issn | 0923-7534 1569-8041 |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Aged Aged, 80 and over angiosarcoma Anthracyclines - administration & dosage Anthracyclines - adverse effects Antineoplastic agents Biological and medical sciences Dermatology Disease-Free Survival Female Humans leiomyosarcoma Leiomyosarcoma - drug therapy Leiomyosarcoma - pathology Male Medical sciences Middle Aged Neoplasm Staging Niacinamide - administration & dosage Niacinamide - adverse effects Niacinamide - analogs & derivatives Pharmacology. Drug treatments Phenylurea Compounds - administration & dosage Phenylurea Compounds - adverse effects Prospective Studies Protein Kinase Inhibitors - administration & dosage Protein Kinase Inhibitors - adverse effects Sarcoma - drug therapy Sarcoma - pathology soft tissue sarcoma Sorafenib Tumors of the skin and soft tissue. Premalignant lesions vascular sarcoma |
| title | Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy |
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