Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study
This expanded access program (EAP) was designed to provide trabectedin access for patients with incurable soft tissue sarcoma (STS) following progression of disease with standard therapy. The outcomes of trial participants accrued over approximately 5 years are reported. Adult patients with advanced...
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| Veröffentlicht in: | Annals of oncology 2013-06, Vol.24 (6), p.1703-1709 |
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| creator | Samuels, B.L. Chawla, S. Patel, S. von Mehren, M. Hamm, J. Kaiser, P.E. Schuetze, S. Li, J. Aymes, A. Demetri, G.D. |
| description | This expanded access program (EAP) was designed to provide trabectedin access for patients with incurable soft tissue sarcoma (STS) following progression of disease with standard therapy. The outcomes of trial participants accrued over approximately 5 years are reported.
Adult patients with advanced STS of multiple histologies, including leiomyosarcoma and liposarcoma (L-sarcomas), following relapse or disease progression following standard-of-care chemotherapy, were enrolled. Trabectedin treatment cycles (1.5 mg/m2, intravenously over 24 h) were repeated q21 days. Objective response, overall survival (OS), and safety were evaluated.
Of 1895 patients enrolled, 807 (43%) had evaluable objective response data, with stable disease reported in 343 (43%) as best response. L-sarcoma patients exhibited longer, OS compared with other histologies [16.2 months (95% confidence interval (CI) 14.1–19.5) versus 8.4 months (95% CI 7.1–10.7)], and a slightly higher objective response rate [6.9% (95% CI 4.8–9.6) versus 4.0% (95% CI 2.1–6.8)]. The median treatment duration was 70 days representing a median of three treatment cycles; 30% of patients received ≥6 cycles. Safety and tolerability in this EAP were consistent with prior clinical trial data.
Results of this EAP are consistent with previous reports of trabectedin, demonstrating disease control despite a low incidence of objective responses in advanced STS patients after failure of standard chemotherapy.
NCT00210665. |
| doi_str_mv | 10.1093/annonc/mds659 |
| format | Article |
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Adult patients with advanced STS of multiple histologies, including leiomyosarcoma and liposarcoma (L-sarcomas), following relapse or disease progression following standard-of-care chemotherapy, were enrolled. Trabectedin treatment cycles (1.5 mg/m2, intravenously over 24 h) were repeated q21 days. Objective response, overall survival (OS), and safety were evaluated.
Of 1895 patients enrolled, 807 (43%) had evaluable objective response data, with stable disease reported in 343 (43%) as best response. L-sarcoma patients exhibited longer, OS compared with other histologies [16.2 months (95% confidence interval (CI) 14.1–19.5) versus 8.4 months (95% CI 7.1–10.7)], and a slightly higher objective response rate [6.9% (95% CI 4.8–9.6) versus 4.0% (95% CI 2.1–6.8)]. The median treatment duration was 70 days representing a median of three treatment cycles; 30% of patients received ≥6 cycles. Safety and tolerability in this EAP were consistent with prior clinical trial data.
Results of this EAP are consistent with previous reports of trabectedin, demonstrating disease control despite a low incidence of objective responses in advanced STS patients after failure of standard chemotherapy.
NCT00210665.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mds659</identifier><identifier>PMID: 23385197</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic agents ; Antineoplastic Agents, Alkylating - administration & dosage ; Antineoplastic Agents, Alkylating - adverse effects ; Biological and medical sciences ; Compassionate Use Trials - mortality ; Compassionate Use Trials - trends ; Dermatology ; Dioxoles - administration & dosage ; Dioxoles - adverse effects ; Disease Progression ; expanded access program ; Female ; Global Health - trends ; Health Services Accessibility - trends ; Humans ; Kaplan-Meier Estimate ; L-sarcoma ; Male ; Medical sciences ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; objective response rate ; overall survival ; Pharmacology. Drug treatments ; Sarcoma - drug therapy ; Sarcoma - mortality ; Sarcoma - pathology ; soft tissue sarcoma ; Tetrahydroisoquinolines - administration & dosage ; Tetrahydroisoquinolines - adverse effects ; Trabectedin ; Treatment Failure ; Treatment Outcome ; Tumors ; Tumors of the skin and soft tissue. Premalignant lesions ; Young Adult</subject><ispartof>Annals of oncology, 2013-06, Vol.24 (6), p.1703-1709</ispartof><rights>2013 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-25fb23d136fd902d23f2fc4577e0d40b11aceafa415798c353c82f2d2e25257c3</citedby><cites>FETCH-LOGICAL-c410t-25fb23d136fd902d23f2fc4577e0d40b11aceafa415798c353c82f2d2e25257c3</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=27427250$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23385197$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Samuels, B.L.</creatorcontrib><creatorcontrib>Chawla, S.</creatorcontrib><creatorcontrib>Patel, S.</creatorcontrib><creatorcontrib>von Mehren, M.</creatorcontrib><creatorcontrib>Hamm, J.</creatorcontrib><creatorcontrib>Kaiser, P.E.</creatorcontrib><creatorcontrib>Schuetze, S.</creatorcontrib><creatorcontrib>Li, J.</creatorcontrib><creatorcontrib>Aymes, A.</creatorcontrib><creatorcontrib>Demetri, G.D.</creatorcontrib><title>Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>This expanded access program (EAP) was designed to provide trabectedin access for patients with incurable soft tissue sarcoma (STS) following progression of disease with standard therapy. The outcomes of trial participants accrued over approximately 5 years are reported.
Adult patients with advanced STS of multiple histologies, including leiomyosarcoma and liposarcoma (L-sarcomas), following relapse or disease progression following standard-of-care chemotherapy, were enrolled. Trabectedin treatment cycles (1.5 mg/m2, intravenously over 24 h) were repeated q21 days. Objective response, overall survival (OS), and safety were evaluated.
Of 1895 patients enrolled, 807 (43%) had evaluable objective response data, with stable disease reported in 343 (43%) as best response. L-sarcoma patients exhibited longer, OS compared with other histologies [16.2 months (95% confidence interval (CI) 14.1–19.5) versus 8.4 months (95% CI 7.1–10.7)], and a slightly higher objective response rate [6.9% (95% CI 4.8–9.6) versus 4.0% (95% CI 2.1–6.8)]. The median treatment duration was 70 days representing a median of three treatment cycles; 30% of patients received ≥6 cycles. Safety and tolerability in this EAP were consistent with prior clinical trial data.
Results of this EAP are consistent with previous reports of trabectedin, demonstrating disease control despite a low incidence of objective responses in advanced STS patients after failure of standard chemotherapy.
NCT00210665.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents, Alkylating - administration & dosage</subject><subject>Antineoplastic Agents, Alkylating - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Compassionate Use Trials - mortality</subject><subject>Compassionate Use Trials - trends</subject><subject>Dermatology</subject><subject>Dioxoles - administration & dosage</subject><subject>Dioxoles - adverse effects</subject><subject>Disease Progression</subject><subject>expanded access program</subject><subject>Female</subject><subject>Global Health - trends</subject><subject>Health Services Accessibility - trends</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>L-sarcoma</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>objective response rate</subject><subject>overall survival</subject><subject>Pharmacology. Drug treatments</subject><subject>Sarcoma - drug therapy</subject><subject>Sarcoma - mortality</subject><subject>Sarcoma - pathology</subject><subject>soft tissue sarcoma</subject><subject>Tetrahydroisoquinolines - administration & dosage</subject><subject>Tetrahydroisoquinolines - adverse effects</subject><subject>Trabectedin</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Tumors of the skin and soft tissue. Premalignant lesions</subject><subject>Young Adult</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>eNp1kT2P1DAQhiME4paDkha5QaIJ54842dChFV_SSTRQR7P2-NYoiRePc8v-PX4Zg7JARWVLfub1zDxV9VzJ10r25gbmOc3uZvLU2v5BtVG27eutbNTDaiN7berOmuaqekL0TUrZ9rp_XF1pY7ZW9d2m-rkb4xwdjCItxaUJScDsBUHAchanWA6iZNijK-jjLMoBMxzPgq9HKBHnQisE_h5mh1yZQhElEi3IKZkjgURI45hOcb4TAeK4ZBQpiGOOKQt3wCldYt-IjLSMnMnPIE4pj_4UPQr8ceSuOB2cQyIuTXcZJkFl8een1aMAI-Gzy3ldfX3_7svuY337-cOn3dvb2jVKllrbsNfGK9MG30vttQk6uMZ2HUrfyL1S4BACNMp2_dYZa9xWB-ZQW207Z66rV2su__59QSrDFMnhOMKMaaFBGdt0vbS6ZbReUZcTUcYw8LAT5POg5PBb27BqG1ZtzL-4RC_7Cf1f-o8nBl5eACCWFTIvO9I_rmt0p61krls55EXcR8wDObbEYmJmh4NP8T8t_AKFcrxn</recordid><startdate>20130601</startdate><enddate>20130601</enddate><creator>Samuels, B.L.</creator><creator>Chawla, S.</creator><creator>Patel, S.</creator><creator>von Mehren, M.</creator><creator>Hamm, J.</creator><creator>Kaiser, P.E.</creator><creator>Schuetze, S.</creator><creator>Li, J.</creator><creator>Aymes, A.</creator><creator>Demetri, G.D.</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>7X8</scope></search><sort><creationdate>20130601</creationdate><title>Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study</title><author>Samuels, B.L. ; Chawla, S. ; Patel, S. ; von Mehren, M. ; Hamm, J. ; Kaiser, P.E. ; Schuetze, S. ; Li, J. ; Aymes, A. ; Demetri, G.D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-25fb23d136fd902d23f2fc4577e0d40b11aceafa415798c353c82f2d2e25257c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents, Alkylating - administration & dosage</topic><topic>Antineoplastic Agents, Alkylating - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Compassionate Use Trials - mortality</topic><topic>Compassionate Use Trials - trends</topic><topic>Dermatology</topic><topic>Dioxoles - administration & dosage</topic><topic>Dioxoles - adverse effects</topic><topic>Disease Progression</topic><topic>expanded access program</topic><topic>Female</topic><topic>Global Health - trends</topic><topic>Health Services Accessibility - trends</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>L-sarcoma</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>objective response rate</topic><topic>overall survival</topic><topic>Pharmacology. Drug treatments</topic><topic>Sarcoma - drug therapy</topic><topic>Sarcoma - mortality</topic><topic>Sarcoma - pathology</topic><topic>soft tissue sarcoma</topic><topic>Tetrahydroisoquinolines - administration & dosage</topic><topic>Tetrahydroisoquinolines - adverse effects</topic><topic>Trabectedin</topic><topic>Treatment Failure</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Tumors of the skin and soft tissue. Premalignant lesions</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Samuels, B.L.</creatorcontrib><creatorcontrib>Chawla, S.</creatorcontrib><creatorcontrib>Patel, S.</creatorcontrib><creatorcontrib>von Mehren, M.</creatorcontrib><creatorcontrib>Hamm, J.</creatorcontrib><creatorcontrib>Kaiser, P.E.</creatorcontrib><creatorcontrib>Schuetze, S.</creatorcontrib><creatorcontrib>Li, J.</creatorcontrib><creatorcontrib>Aymes, A.</creatorcontrib><creatorcontrib>Demetri, G.D.</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>MEDLINE - Academic</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Samuels, B.L.</au><au>Chawla, S.</au><au>Patel, S.</au><au>von Mehren, M.</au><au>Hamm, J.</au><au>Kaiser, P.E.</au><au>Schuetze, S.</au><au>Li, J.</au><au>Aymes, A.</au><au>Demetri, G.D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>24</volume><issue>6</issue><spage>1703</spage><epage>1709</epage><pages>1703-1709</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>This expanded access program (EAP) was designed to provide trabectedin access for patients with incurable soft tissue sarcoma (STS) following progression of disease with standard therapy. The outcomes of trial participants accrued over approximately 5 years are reported.
Adult patients with advanced STS of multiple histologies, including leiomyosarcoma and liposarcoma (L-sarcomas), following relapse or disease progression following standard-of-care chemotherapy, were enrolled. Trabectedin treatment cycles (1.5 mg/m2, intravenously over 24 h) were repeated q21 days. Objective response, overall survival (OS), and safety were evaluated.
Of 1895 patients enrolled, 807 (43%) had evaluable objective response data, with stable disease reported in 343 (43%) as best response. L-sarcoma patients exhibited longer, OS compared with other histologies [16.2 months (95% confidence interval (CI) 14.1–19.5) versus 8.4 months (95% CI 7.1–10.7)], and a slightly higher objective response rate [6.9% (95% CI 4.8–9.6) versus 4.0% (95% CI 2.1–6.8)]. The median treatment duration was 70 days representing a median of three treatment cycles; 30% of patients received ≥6 cycles. Safety and tolerability in this EAP were consistent with prior clinical trial data.
Results of this EAP are consistent with previous reports of trabectedin, demonstrating disease control despite a low incidence of objective responses in advanced STS patients after failure of standard chemotherapy.
NCT00210665.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>23385197</pmid><doi>10.1093/annonc/mds659</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | Annals of oncology, 2013-06, Vol.24 (6), p.1703-1709 |
| issn | 0923-7534 1569-8041 |
| language | eng |
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| subjects | Adolescent Adult Aged Aged, 80 and over Antineoplastic agents Antineoplastic Agents, Alkylating - administration & dosage Antineoplastic Agents, Alkylating - adverse effects Biological and medical sciences Compassionate Use Trials - mortality Compassionate Use Trials - trends Dermatology Dioxoles - administration & dosage Dioxoles - adverse effects Disease Progression expanded access program Female Global Health - trends Health Services Accessibility - trends Humans Kaplan-Meier Estimate L-sarcoma Male Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) objective response rate overall survival Pharmacology. Drug treatments Sarcoma - drug therapy Sarcoma - mortality Sarcoma - pathology soft tissue sarcoma Tetrahydroisoquinolines - administration & dosage Tetrahydroisoquinolines - adverse effects Trabectedin Treatment Failure Treatment Outcome Tumors Tumors of the skin and soft tissue. Premalignant lesions Young Adult |
| title | Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study |
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