Trabectedin Plus Pegylated Liposomal Doxorubicin in Recurrent Ovarian Cancer
The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy. Women > or = 18 years, stratified by performance sta...
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| Veröffentlicht in: | Journal of clinical oncology 2010-07, Vol.28 (19), p.3107-3114 |
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| creator | Monk, Bradley J Herzog, Thomas J Kaye, Stanley B Krasner, Carolyn N Vermorken, Jan B Muggia, Franco M Pujade-Lauraine, Eric Lisyanskaya, Alla S Makhson, Anatoly N Rolski, Janusz Gorbounova, Vera A Ghatage, Prafull Bidzinski, Mariusz Shen, Keng Ngan, Hextan Yuen-Sheung Vergote, Ignace B Nam, Joo-Hyun Park, Youn Choi Lebedinsky, Claudia A Poveda, Andrés M |
| description | The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy.
Women > or = 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment.
Patients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone.
When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer. |
| doi_str_mv | 10.1200/JCO.2009.25.4037 |
| format | Article |
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Women > or = 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment.
Patients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone.
When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer.</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.2009.25.4037</identifier><identifier>PMID: 20516432</identifier><language>eng</language><publisher>United States: American Society of Clinical Oncology</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Dioxoles - administration & dosage ; Dioxoles - adverse effects ; Doxorubicin - administration & dosage ; Doxorubicin - adverse effects ; Doxorubicin - analogs & derivatives ; Drug Administration Schedule ; Female ; Humans ; Kaplan-Meier Estimate ; Leukopenia - chemically induced ; Middle Aged ; Multivariate Analysis ; Neoplasm Recurrence, Local ; Neutropenia - chemically induced ; Ovarian Neoplasms - drug therapy ; Ovarian Neoplasms - pathology ; Polyethylene Glycols - administration & dosage ; Polyethylene Glycols - adverse effects ; Stomatitis - chemically induced ; Tetrahydroisoquinolines - administration & dosage ; Tetrahydroisoquinolines - adverse effects ; Treatment Outcome</subject><ispartof>Journal of clinical oncology, 2010-07, Vol.28 (19), p.3107-3114</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c485t-ace1c5eee4864284e0e23948b3eb335d80007e3a8c8cfe4ba6c162754c6cf21b3</citedby><cites>FETCH-LOGICAL-c485t-ace1c5eee4864284e0e23948b3eb335d80007e3a8c8cfe4ba6c162754c6cf21b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3716,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20516432$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Monk, Bradley J</creatorcontrib><creatorcontrib>Herzog, Thomas J</creatorcontrib><creatorcontrib>Kaye, Stanley B</creatorcontrib><creatorcontrib>Krasner, Carolyn N</creatorcontrib><creatorcontrib>Vermorken, Jan B</creatorcontrib><creatorcontrib>Muggia, Franco M</creatorcontrib><creatorcontrib>Pujade-Lauraine, Eric</creatorcontrib><creatorcontrib>Lisyanskaya, Alla S</creatorcontrib><creatorcontrib>Makhson, Anatoly N</creatorcontrib><creatorcontrib>Rolski, Janusz</creatorcontrib><creatorcontrib>Gorbounova, Vera A</creatorcontrib><creatorcontrib>Ghatage, Prafull</creatorcontrib><creatorcontrib>Bidzinski, Mariusz</creatorcontrib><creatorcontrib>Shen, Keng</creatorcontrib><creatorcontrib>Ngan, Hextan Yuen-Sheung</creatorcontrib><creatorcontrib>Vergote, Ignace B</creatorcontrib><creatorcontrib>Nam, Joo-Hyun</creatorcontrib><creatorcontrib>Park, Youn Choi</creatorcontrib><creatorcontrib>Lebedinsky, Claudia A</creatorcontrib><creatorcontrib>Poveda, Andrés M</creatorcontrib><title>Trabectedin Plus Pegylated Liposomal Doxorubicin in Recurrent Ovarian Cancer</title><title>Journal of clinical oncology</title><addtitle>J Clin Oncol</addtitle><description>The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy.
Women > or = 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment.
Patients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone.
When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Dioxoles - administration & dosage</subject><subject>Dioxoles - adverse effects</subject><subject>Doxorubicin - administration & dosage</subject><subject>Doxorubicin - adverse effects</subject><subject>Doxorubicin - analogs & derivatives</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Leukopenia - chemically induced</subject><subject>Middle Aged</subject><subject>Multivariate Analysis</subject><subject>Neoplasm Recurrence, Local</subject><subject>Neutropenia - chemically induced</subject><subject>Ovarian Neoplasms - drug therapy</subject><subject>Ovarian Neoplasms - pathology</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Polyethylene Glycols - adverse effects</subject><subject>Stomatitis - chemically induced</subject><subject>Tetrahydroisoquinolines - administration & dosage</subject><subject>Tetrahydroisoquinolines - adverse effects</subject><subject>Treatment Outcome</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkEtLw0AURgdRbK3uXUl2rhLnmZkuJb4ptEgFd8NketOm5FFnErX_3imtChc-uJzvXjgIXRKcEIrxzUs2TUKOEyoSjpk8QkMiqIylFOIYDbFkNCaKvQ_QmfdrjAlXTJyiAcWCpJzRIZrMncnBdrAom2hW9T6awXJbmbCIJuWm9W1tquiu_W5dn5c2QGFewfbOQdNF00_jStNEmWksuHN0UpjKw8UhR-jt4X6ePcWT6eNzdjuJLVeii40FYgUAcJVyqjhgoGzMVc4gZ0wsFMZYAjPKKlsAz01qSUql4Da1BSU5G6Hr_d2Naz968J2uS2-hqkwDbe-1ZIxLiRUNJN6T1rXeOyj0xpW1cVtNsN4p1EGh3inUVOidwlC5Ohzv8xoWf4VfZ__fV-Vy9VU60D44qgJO9dq2VGky1owE-T9xA3nL</recordid><startdate>20100701</startdate><enddate>20100701</enddate><creator>Monk, Bradley J</creator><creator>Herzog, Thomas J</creator><creator>Kaye, Stanley B</creator><creator>Krasner, Carolyn N</creator><creator>Vermorken, Jan B</creator><creator>Muggia, Franco M</creator><creator>Pujade-Lauraine, Eric</creator><creator>Lisyanskaya, Alla S</creator><creator>Makhson, Anatoly N</creator><creator>Rolski, Janusz</creator><creator>Gorbounova, Vera A</creator><creator>Ghatage, Prafull</creator><creator>Bidzinski, Mariusz</creator><creator>Shen, Keng</creator><creator>Ngan, Hextan Yuen-Sheung</creator><creator>Vergote, Ignace B</creator><creator>Nam, Joo-Hyun</creator><creator>Park, Youn Choi</creator><creator>Lebedinsky, Claudia A</creator><creator>Poveda, Andrés M</creator><general>American Society of Clinical Oncology</general><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>20100701</creationdate><title>Trabectedin Plus Pegylated Liposomal Doxorubicin in Recurrent Ovarian Cancer</title><author>Monk, Bradley J ; Herzog, Thomas J ; Kaye, Stanley B ; Krasner, Carolyn N ; Vermorken, Jan B ; Muggia, Franco M ; Pujade-Lauraine, Eric ; Lisyanskaya, Alla S ; Makhson, Anatoly N ; Rolski, Janusz ; Gorbounova, Vera A ; Ghatage, Prafull ; Bidzinski, Mariusz ; Shen, Keng ; Ngan, Hextan Yuen-Sheung ; Vergote, Ignace B ; Nam, Joo-Hyun ; Park, Youn Choi ; Lebedinsky, Claudia A ; Poveda, Andrés M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c485t-ace1c5eee4864284e0e23948b3eb335d80007e3a8c8cfe4ba6c162754c6cf21b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Dioxoles - administration & dosage</topic><topic>Dioxoles - adverse effects</topic><topic>Doxorubicin - administration & dosage</topic><topic>Doxorubicin - adverse effects</topic><topic>Doxorubicin - analogs & derivatives</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Leukopenia - chemically induced</topic><topic>Middle Aged</topic><topic>Multivariate Analysis</topic><topic>Neoplasm Recurrence, Local</topic><topic>Neutropenia - chemically induced</topic><topic>Ovarian Neoplasms - drug therapy</topic><topic>Ovarian Neoplasms - pathology</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Polyethylene Glycols - adverse effects</topic><topic>Stomatitis - chemically induced</topic><topic>Tetrahydroisoquinolines - administration & dosage</topic><topic>Tetrahydroisoquinolines - adverse effects</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Monk, Bradley J</creatorcontrib><creatorcontrib>Herzog, Thomas J</creatorcontrib><creatorcontrib>Kaye, Stanley B</creatorcontrib><creatorcontrib>Krasner, Carolyn N</creatorcontrib><creatorcontrib>Vermorken, Jan B</creatorcontrib><creatorcontrib>Muggia, Franco M</creatorcontrib><creatorcontrib>Pujade-Lauraine, Eric</creatorcontrib><creatorcontrib>Lisyanskaya, Alla S</creatorcontrib><creatorcontrib>Makhson, Anatoly N</creatorcontrib><creatorcontrib>Rolski, Janusz</creatorcontrib><creatorcontrib>Gorbounova, Vera A</creatorcontrib><creatorcontrib>Ghatage, Prafull</creatorcontrib><creatorcontrib>Bidzinski, Mariusz</creatorcontrib><creatorcontrib>Shen, Keng</creatorcontrib><creatorcontrib>Ngan, Hextan Yuen-Sheung</creatorcontrib><creatorcontrib>Vergote, Ignace B</creatorcontrib><creatorcontrib>Nam, Joo-Hyun</creatorcontrib><creatorcontrib>Park, Youn Choi</creatorcontrib><creatorcontrib>Lebedinsky, Claudia A</creatorcontrib><creatorcontrib>Poveda, Andrés M</creatorcontrib><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>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Monk, Bradley J</au><au>Herzog, Thomas J</au><au>Kaye, Stanley B</au><au>Krasner, Carolyn N</au><au>Vermorken, Jan B</au><au>Muggia, Franco M</au><au>Pujade-Lauraine, Eric</au><au>Lisyanskaya, Alla S</au><au>Makhson, Anatoly N</au><au>Rolski, Janusz</au><au>Gorbounova, Vera A</au><au>Ghatage, Prafull</au><au>Bidzinski, Mariusz</au><au>Shen, Keng</au><au>Ngan, Hextan Yuen-Sheung</au><au>Vergote, Ignace B</au><au>Nam, Joo-Hyun</au><au>Park, Youn Choi</au><au>Lebedinsky, Claudia A</au><au>Poveda, Andrés M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Trabectedin Plus Pegylated Liposomal Doxorubicin in Recurrent Ovarian Cancer</atitle><jtitle>Journal of clinical oncology</jtitle><addtitle>J Clin Oncol</addtitle><date>2010-07-01</date><risdate>2010</risdate><volume>28</volume><issue>19</issue><spage>3107</spage><epage>3114</epage><pages>3107-3114</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>The objective of this study was to compare the efficacy and safety of trabectedin plus pegylated liposomal doxorubicin (PLD) with that of PLD alone in women with recurrent ovarian cancer after failure of first-line, platinum-based chemotherapy.
Women > or = 18 years, stratified by performance status (0 to 1 v 2) and platinum sensitivity, were randomly assigned to receive an intravenous infusion of PLD 30 mg/m(2) followed by a 3-hour infusion of trabectedin 1.1 mg/m(2) every 3 weeks or PLD 50 mg/m(2) every 4 weeks. The primary end point was progression-free survival (PFS) by independent radiology assessment.
Patients (N = 672) were randomly assigned to trabectedin/PLD (n = 337) or PLD (n = 335). Median PFS was 7.3 months with trabectedin/PLD v 5.8 months with PLD (hazard ratio, 0.79; 95% CI, 0.65 to 0.96; P = .0190). For platinum-sensitive patients, median PFS was 9.2 months v 7.5 months, respectively (hazard ratio, 0.73; 95% CI, 0.56 to 0.95; P = .0170). Overall response rate (ORR) was 27.6% for trabectedin/PLD v 18.8% for PLD (P = .0080); for platinum-sensitive patients, it was 35.3% v 22.6% (P = .0042), respectively. ORR, PFS, and overall survival among platinum-resistant patients were not statistically different. Neutropenia was more common with trabectedin/PLD. Grade 3 to 4 transaminase elevations were also more common with the combination but were transient and noncumulative. Hand-foot syndrome and mucositis were less frequent with trabectedin/PLD than with PLD alone.
When combined with PLD, trabectedin improves PFS and ORR over PLD alone with acceptable tolerance in the second-line treatment of recurrent ovarian cancer.</abstract><cop>United States</cop><pub>American Society of Clinical Oncology</pub><pmid>20516432</pmid><doi>10.1200/JCO.2009.25.4037</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of clinical oncology, 2010-07, Vol.28 (19), p.3107-3114 |
| issn | 0732-183X 1527-7755 |
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| source | MEDLINE; American Society of Clinical Oncology Online Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Dioxoles - administration & dosage Dioxoles - adverse effects Doxorubicin - administration & dosage Doxorubicin - adverse effects Doxorubicin - analogs & derivatives Drug Administration Schedule Female Humans Kaplan-Meier Estimate Leukopenia - chemically induced Middle Aged Multivariate Analysis Neoplasm Recurrence, Local Neutropenia - chemically induced Ovarian Neoplasms - drug therapy Ovarian Neoplasms - pathology Polyethylene Glycols - administration & dosage Polyethylene Glycols - adverse effects Stomatitis - chemically induced Tetrahydroisoquinolines - administration & dosage Tetrahydroisoquinolines - adverse effects Treatment Outcome |
| title | Trabectedin Plus Pegylated Liposomal Doxorubicin in Recurrent Ovarian Cancer |
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