Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas : Results of a phase II trial
Single-agent gemcitabine and vinorelbine have activity in treatment of patients with soft-tissue sarcomas. The combination of gemcitabine plus vinorelbine has activity against several forms of metastatic carcinoma with acceptable toxicity. This study evaluated the efficacy and tolerability of gemcit...
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| Veröffentlicht in: | Cancer 2007-05, Vol.109 (9), p.1863-1869 |
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| container_title | Cancer |
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| creator | DILEO, Palma MORGAN, Jeffrey A ZAHRIEH, David DESAI, Jayesh SALESI, Jeanine M HARMON, David C QUIGLEY, M. Travis POISON, Kathleen DEMETRI, George D GEORGE, Suzanne |
| description | Single-agent gemcitabine and vinorelbine have activity in treatment of patients with soft-tissue sarcomas. The combination of gemcitabine plus vinorelbine has activity against several forms of metastatic carcinoma with acceptable toxicity. This study evaluated the efficacy and tolerability of gemcitabine plus vinorelbine in advanced soft-tissue sarcoma.
A single academic center performed this phase II trial. Eligible patients had unresectable or metastatic soft-tissue sarcomas, Eastern Cooperative Group performance status of 0-2, adequate organ function, and 4 months. There has been 1 CR lasting >1 year in a patient with high-grade pleomorphic spindle-cell sarcoma.
Gemcitabine given by a fixed-dose rate of infusion combined with vinorelbine was associated with clinically meaningful rates of disease control in patients with advanced soft-tissue sarcoma. Toxicity was acceptable. This study contributed to data that have supported the administration of fixed-dose rate gemcitabine-based drug regimens in soft-tissue sarcomas. |
| doi_str_mv | 10.1002/cncr.22609 |
| format | Article |
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A single academic center performed this phase II trial. Eligible patients had unresectable or metastatic soft-tissue sarcomas, Eastern Cooperative Group performance status of 0-2, adequate organ function, and <or=1 prior regimen. Gemcitabine 800 mg/m2 was given over 90 minutes on Days 1 and 8 of a 21-day cycle after administration of vinorelbine 25 mg/m2. Dosing schedule was modified for toxicity (doses constant but administered on Days 1 and 15 of a 28-day cycle). Dose reductions were allowed if unacceptable toxicities recurred.
The study accrued 40 patients, and 248 dosing cycles were administered (range, 1-32). No treatment-related deaths occurred. Of 9 episodes of grade 4 toxicities, 8 were hematologic. Of 38 episodes of grade 3 toxicity, 24 were hematologic. Clinical benefit was seen in 25% of patients and was defined as complete response (CR), partial response (PR), or stable disease (SD) at >4 months. There has been 1 CR lasting >1 year in a patient with high-grade pleomorphic spindle-cell sarcoma.
Gemcitabine given by a fixed-dose rate of infusion combined with vinorelbine was associated with clinically meaningful rates of disease control in patients with advanced soft-tissue sarcoma. Toxicity was acceptable. This study contributed to data that have supported the administration of fixed-dose rate gemcitabine-based drug regimens in soft-tissue sarcomas.</description><identifier>ISSN: 0008-543X</identifier><identifier>EISSN: 1097-0142</identifier><identifier>DOI: 10.1002/cncr.22609</identifier><identifier>PMID: 17385194</identifier><identifier>CODEN: CANCAR</identifier><language>eng</language><publisher>New York, NY: Wiley-Liss</publisher><subject>Aged ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Dermatology ; Disease-Free Survival ; Dose-Response Relationship, Drug ; Female ; History, 16th Century ; History, 17th Century ; Humans ; Male ; Medical sciences ; Sarcoma - drug therapy ; Sarcoma - mortality ; Soft Tissue Neoplasms - drug therapy ; Soft Tissue Neoplasms - mortality ; Treatment Outcome ; Tumors ; Tumors of the skin and soft tissue. Premalignant lesions ; Vinblastine - administration & dosage ; Vinblastine - adverse effects ; Vinblastine - analogs & derivatives</subject><ispartof>Cancer, 2007-05, Vol.109 (9), p.1863-1869</ispartof><rights>2007 INIST-CNRS</rights><rights>Copyright (c) 2007 American Cancer Society</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c274t-f78a3545c9552f383ae371b83ceb904c80328b3e2854d78f369a609b1e0ee0653</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18691215$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17385194$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>DILEO, Palma</creatorcontrib><creatorcontrib>MORGAN, Jeffrey A</creatorcontrib><creatorcontrib>ZAHRIEH, David</creatorcontrib><creatorcontrib>DESAI, Jayesh</creatorcontrib><creatorcontrib>SALESI, Jeanine M</creatorcontrib><creatorcontrib>HARMON, David C</creatorcontrib><creatorcontrib>QUIGLEY, M. Travis</creatorcontrib><creatorcontrib>POISON, Kathleen</creatorcontrib><creatorcontrib>DEMETRI, George D</creatorcontrib><creatorcontrib>GEORGE, Suzanne</creatorcontrib><title>Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas : Results of a phase II trial</title><title>Cancer</title><addtitle>Cancer</addtitle><description>Single-agent gemcitabine and vinorelbine have activity in treatment of patients with soft-tissue sarcomas. The combination of gemcitabine plus vinorelbine has activity against several forms of metastatic carcinoma with acceptable toxicity. This study evaluated the efficacy and tolerability of gemcitabine plus vinorelbine in advanced soft-tissue sarcoma.
A single academic center performed this phase II trial. Eligible patients had unresectable or metastatic soft-tissue sarcomas, Eastern Cooperative Group performance status of 0-2, adequate organ function, and <or=1 prior regimen. Gemcitabine 800 mg/m2 was given over 90 minutes on Days 1 and 8 of a 21-day cycle after administration of vinorelbine 25 mg/m2. Dosing schedule was modified for toxicity (doses constant but administered on Days 1 and 15 of a 28-day cycle). Dose reductions were allowed if unacceptable toxicities recurred.
The study accrued 40 patients, and 248 dosing cycles were administered (range, 1-32). No treatment-related deaths occurred. Of 9 episodes of grade 4 toxicities, 8 were hematologic. Of 38 episodes of grade 3 toxicity, 24 were hematologic. Clinical benefit was seen in 25% of patients and was defined as complete response (CR), partial response (PR), or stable disease (SD) at >4 months. There has been 1 CR lasting >1 year in a patient with high-grade pleomorphic spindle-cell sarcoma.
Gemcitabine given by a fixed-dose rate of infusion combined with vinorelbine was associated with clinically meaningful rates of disease control in patients with advanced soft-tissue sarcoma. Toxicity was acceptable. This study contributed to data that have supported the administration of fixed-dose rate gemcitabine-based drug regimens in soft-tissue sarcomas.</description><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Dermatology</subject><subject>Disease-Free Survival</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>History, 16th Century</subject><subject>History, 17th Century</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Sarcoma - drug therapy</subject><subject>Sarcoma - mortality</subject><subject>Soft Tissue Neoplasms - drug therapy</subject><subject>Soft Tissue Neoplasms - mortality</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Tumors of the skin and soft tissue. Premalignant lesions</subject><subject>Vinblastine - administration & dosage</subject><subject>Vinblastine - adverse effects</subject><subject>Vinblastine - analogs & derivatives</subject><issn>0008-543X</issn><issn>1097-0142</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkEtLAzEUhYMoWqsbf4Bk40YYzWPSybgT8VEoCKLgbriTuaGReZGklW795cZa6OpwLh8H7kfIBWc3nDFxa3rjb4SYsfKATDgri4zxXBySCWNMZyqXnyfkNISvVAuh5DE54YXUipf5hPw8Y2dchNr1SKFv6Nr1g8d2283QpYTohp6aJXZDXKKHcUPt4OmY7tjHQL9dXFJo1tAbbGgYbKTRhbBCGsCnCQj0jr5hWLUJHiwFOi4hIJ3PafQO2jNyZKENeL7LKfl4enx_eMkWr8_zh_tFZkSRx8wWGqTKlSmVElZqCSgLXmtpsC5ZbjSTQtcShVZ5U2grZyUkJTVHhshmSk7J9f-u8UMIHm01eteB31ScVX8iqz-R1VZkgi__4XFVd9js0Z25BFztAAgGWuvT-y7sOT0rueBK_gIiB31O</recordid><startdate>20070501</startdate><enddate>20070501</enddate><creator>DILEO, Palma</creator><creator>MORGAN, Jeffrey A</creator><creator>ZAHRIEH, David</creator><creator>DESAI, Jayesh</creator><creator>SALESI, Jeanine M</creator><creator>HARMON, David C</creator><creator>QUIGLEY, M. Travis</creator><creator>POISON, Kathleen</creator><creator>DEMETRI, George D</creator><creator>GEORGE, Suzanne</creator><general>Wiley-Liss</general><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>20070501</creationdate><title>Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas : Results of a phase II trial</title><author>DILEO, Palma ; MORGAN, Jeffrey A ; ZAHRIEH, David ; DESAI, Jayesh ; SALESI, Jeanine M ; HARMON, David C ; QUIGLEY, M. Travis ; POISON, Kathleen ; DEMETRI, George D ; GEORGE, Suzanne</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c274t-f78a3545c9552f383ae371b83ceb904c80328b3e2854d78f369a609b1e0ee0653</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Dermatology</topic><topic>Disease-Free Survival</topic><topic>Dose-Response Relationship, Drug</topic><topic>Female</topic><topic>History, 16th Century</topic><topic>History, 17th Century</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Sarcoma - drug therapy</topic><topic>Sarcoma - mortality</topic><topic>Soft Tissue Neoplasms - drug therapy</topic><topic>Soft Tissue Neoplasms - mortality</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Tumors of the skin and soft tissue. Premalignant lesions</topic><topic>Vinblastine - administration & dosage</topic><topic>Vinblastine - adverse effects</topic><topic>Vinblastine - analogs & derivatives</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>DILEO, Palma</creatorcontrib><creatorcontrib>MORGAN, Jeffrey A</creatorcontrib><creatorcontrib>ZAHRIEH, David</creatorcontrib><creatorcontrib>DESAI, Jayesh</creatorcontrib><creatorcontrib>SALESI, Jeanine M</creatorcontrib><creatorcontrib>HARMON, David C</creatorcontrib><creatorcontrib>QUIGLEY, M. Travis</creatorcontrib><creatorcontrib>POISON, Kathleen</creatorcontrib><creatorcontrib>DEMETRI, George D</creatorcontrib><creatorcontrib>GEORGE, Suzanne</creatorcontrib><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>Cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>DILEO, Palma</au><au>MORGAN, Jeffrey A</au><au>ZAHRIEH, David</au><au>DESAI, Jayesh</au><au>SALESI, Jeanine M</au><au>HARMON, David C</au><au>QUIGLEY, M. Travis</au><au>POISON, Kathleen</au><au>DEMETRI, George D</au><au>GEORGE, Suzanne</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas : Results of a phase II trial</atitle><jtitle>Cancer</jtitle><addtitle>Cancer</addtitle><date>2007-05-01</date><risdate>2007</risdate><volume>109</volume><issue>9</issue><spage>1863</spage><epage>1869</epage><pages>1863-1869</pages><issn>0008-543X</issn><eissn>1097-0142</eissn><coden>CANCAR</coden><abstract>Single-agent gemcitabine and vinorelbine have activity in treatment of patients with soft-tissue sarcomas. The combination of gemcitabine plus vinorelbine has activity against several forms of metastatic carcinoma with acceptable toxicity. This study evaluated the efficacy and tolerability of gemcitabine plus vinorelbine in advanced soft-tissue sarcoma.
A single academic center performed this phase II trial. Eligible patients had unresectable or metastatic soft-tissue sarcomas, Eastern Cooperative Group performance status of 0-2, adequate organ function, and <or=1 prior regimen. Gemcitabine 800 mg/m2 was given over 90 minutes on Days 1 and 8 of a 21-day cycle after administration of vinorelbine 25 mg/m2. Dosing schedule was modified for toxicity (doses constant but administered on Days 1 and 15 of a 28-day cycle). Dose reductions were allowed if unacceptable toxicities recurred.
The study accrued 40 patients, and 248 dosing cycles were administered (range, 1-32). No treatment-related deaths occurred. Of 9 episodes of grade 4 toxicities, 8 were hematologic. Of 38 episodes of grade 3 toxicity, 24 were hematologic. Clinical benefit was seen in 25% of patients and was defined as complete response (CR), partial response (PR), or stable disease (SD) at >4 months. There has been 1 CR lasting >1 year in a patient with high-grade pleomorphic spindle-cell sarcoma.
Gemcitabine given by a fixed-dose rate of infusion combined with vinorelbine was associated with clinically meaningful rates of disease control in patients with advanced soft-tissue sarcoma. Toxicity was acceptable. This study contributed to data that have supported the administration of fixed-dose rate gemcitabine-based drug regimens in soft-tissue sarcomas.</abstract><cop>New York, NY</cop><pub>Wiley-Liss</pub><pmid>17385194</pmid><doi>10.1002/cncr.22609</doi><tpages>7</tpages></addata></record> |
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| language | eng |
| recordid | cdi_crossref_primary_10_1002_cncr_22609 |
| source | MEDLINE; Access via Wiley Online Library; EZB-FREE-00999 freely available EZB journals; Wiley Online Library (Open Access Collection); Alma/SFX Local Collection |
| subjects | Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Dermatology Disease-Free Survival Dose-Response Relationship, Drug Female History, 16th Century History, 17th Century Humans Male Medical sciences Sarcoma - drug therapy Sarcoma - mortality Soft Tissue Neoplasms - drug therapy Soft Tissue Neoplasms - mortality Treatment Outcome Tumors Tumors of the skin and soft tissue. Premalignant lesions Vinblastine - administration & dosage Vinblastine - adverse effects Vinblastine - analogs & derivatives |
| title | Gemcitabine and vinorelbine combination chemotherapy for patients with advanced soft tissue sarcomas : Results of a phase II trial |
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