Phase II Study of Weekly Gemcitabine and Vinorelbine for Children With Recurrent or Refractory Hodgkin's Disease: A Children's Oncology Group Report
The Children's Oncology Group conducted this phase II study to assess the efficacy and toxicity of gemcitabine and vinorelbine (GV) in pediatric patients with heavily pretreated relapsed/refractory Hodgkin's disease. Both agents have significant single-agent response rates in this setting....
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| Veröffentlicht in: | Journal of clinical oncology 2009-03, Vol.27 (9), p.1456-1461 |
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| creator | COLE, Peter D SCHWARTZ, Cindy L DRACHTMAN, Richard A DE ALARCON, Pedro A LU CHEN TRIPPETT, Tanya M |
| description | The Children's Oncology Group conducted this phase II study to assess the efficacy and toxicity of gemcitabine and vinorelbine (GV) in pediatric patients with heavily pretreated relapsed/refractory Hodgkin's disease. Both agents have significant single-agent response rates in this setting.
GV was given on days 1 and 8 of each 21-day treatment cycle: vinorelbine 25 mg/m(2)/dose administered via intravenous (IV) push before gemcitabine 1,000 mg/m(2)/dose IV over 100 minutes. Any patients who demonstrated a measurable response (complete response [CR], very good partial response [VGPR], or partial response [PR]) were considered to have experienced a response to GV. Response was evaluated after every two cycles. A two-stage minimax rule was used to test the null hypothesis that the response rate is |
| doi_str_mv | 10.1200/JCO.2008.20.3778 |
| format | Article |
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GV was given on days 1 and 8 of each 21-day treatment cycle: vinorelbine 25 mg/m(2)/dose administered via intravenous (IV) push before gemcitabine 1,000 mg/m(2)/dose IV over 100 minutes. Any patients who demonstrated a measurable response (complete response [CR], very good partial response [VGPR], or partial response [PR]) were considered to have experienced a response to GV. Response was evaluated after every two cycles. A two-stage minimax rule was used to test the null hypothesis that the response rate is <or= 40% against an alternative hypothesis of a response rate more than 65%.
Thirty eligible patients with a median age of 17.7 years (range, 10.7 to 29.4 years) were enrolled. All patients had received at least two prior chemotherapy regimens, and 17 patients had undergone prior autologous stem-cell transplantation. Hematologic toxicity was predominant in all treatment cycles. Nonhematologic grade 3 to 4 toxicity, including elevated hepatic enzymes and hyperbilirubinemia, was less common. Pericardial and pleural effusions developed in one patient after cycles 4 and 5 of GV, consistent with gemcitabine-induced radiation recall. There were no toxic deaths. Measurable responses were seen in 19 (76%) of 25 assessable patients (95% exact binomial CI, 55% to 91%), including six CRs, 11 VGPRs, and two PRs.
GV is an effective and well-tolerated reinduction regimen for children with relapsed or refractory Hodgkin's disease.</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.2008.20.3778</identifier><identifier>PMID: 19224841</identifier><language>eng</language><publisher>Alexandria, VA: American Society of Clinical Oncology</publisher><subject>Adolescent ; Adult ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Biological and medical sciences ; Child ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Disease-Free Survival ; Drug Administration Schedule ; Gemcitabine ; Hematologic and hematopoietic diseases ; Hodgkin Disease - drug therapy ; Humans ; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis ; Medical sciences ; Neoplasm Recurrence, Local - drug therapy ; Original Reports ; Treatment Outcome ; Tumors ; Vinblastine - administration & dosage ; Vinblastine - adverse effects ; Vinblastine - analogs & derivatives ; Vinorelbine ; Young Adult</subject><ispartof>Journal of clinical oncology, 2009-03, Vol.27 (9), p.1456-1461</ispartof><rights>2009 INIST-CNRS</rights><rights>2009 by American Society of Clinical Oncology 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c455t-e78f82ddc5f6dcd41a7624bfab43f6d4090a5dc3d0c0e742195f62078e636d623</citedby><cites>FETCH-LOGICAL-c455t-e78f82ddc5f6dcd41a7624bfab43f6d4090a5dc3d0c0e742195f62078e636d623</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,3716,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21273956$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19224841$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>COLE, Peter D</creatorcontrib><creatorcontrib>SCHWARTZ, Cindy L</creatorcontrib><creatorcontrib>DRACHTMAN, Richard A</creatorcontrib><creatorcontrib>DE ALARCON, Pedro A</creatorcontrib><creatorcontrib>LU CHEN</creatorcontrib><creatorcontrib>TRIPPETT, Tanya M</creatorcontrib><title>Phase II Study of Weekly Gemcitabine and Vinorelbine for Children With Recurrent or Refractory Hodgkin's Disease: A Children's Oncology Group Report</title><title>Journal of clinical oncology</title><addtitle>J Clin Oncol</addtitle><description>The Children's Oncology Group conducted this phase II study to assess the efficacy and toxicity of gemcitabine and vinorelbine (GV) in pediatric patients with heavily pretreated relapsed/refractory Hodgkin's disease. Both agents have significant single-agent response rates in this setting.
GV was given on days 1 and 8 of each 21-day treatment cycle: vinorelbine 25 mg/m(2)/dose administered via intravenous (IV) push before gemcitabine 1,000 mg/m(2)/dose IV over 100 minutes. Any patients who demonstrated a measurable response (complete response [CR], very good partial response [VGPR], or partial response [PR]) were considered to have experienced a response to GV. Response was evaluated after every two cycles. A two-stage minimax rule was used to test the null hypothesis that the response rate is <or= 40% against an alternative hypothesis of a response rate more than 65%.
Thirty eligible patients with a median age of 17.7 years (range, 10.7 to 29.4 years) were enrolled. All patients had received at least two prior chemotherapy regimens, and 17 patients had undergone prior autologous stem-cell transplantation. Hematologic toxicity was predominant in all treatment cycles. Nonhematologic grade 3 to 4 toxicity, including elevated hepatic enzymes and hyperbilirubinemia, was less common. Pericardial and pleural effusions developed in one patient after cycles 4 and 5 of GV, consistent with gemcitabine-induced radiation recall. There were no toxic deaths. Measurable responses were seen in 19 (76%) of 25 assessable patients (95% exact binomial CI, 55% to 91%), including six CRs, 11 VGPRs, and two PRs.
GV is an effective and well-tolerated reinduction regimen for children with relapsed or refractory Hodgkin's disease.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Disease-Free Survival</subject><subject>Drug Administration Schedule</subject><subject>Gemcitabine</subject><subject>Hematologic and hematopoietic diseases</subject><subject>Hodgkin Disease - drug therapy</subject><subject>Humans</subject><subject>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</subject><subject>Medical sciences</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Original Reports</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Vinblastine - administration & dosage</subject><subject>Vinblastine - adverse effects</subject><subject>Vinblastine - analogs & derivatives</subject><subject>Vinorelbine</subject><subject>Young Adult</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUUtvEzEQthCIhpY7J-QLcNrUz_Uuh0pVKG2qSqnKo9wsx_Zm3W7Wkb0pyv_gBzMhUYDLjGbme1j-EHpDyZgyQk6vJ7Mx9ArKmCtVPUMjKpkqlJLyORoRxVlBK_7jCL3K-YEQKiouX6IjWjMmKkFH6Ndta7LH0yn-MqzdBscG33v_2G3wpV_aMJh56D02vcPfQx-T7_7MTUx40obOJd_j-zC0-M7bdYJpwHC6800ydohpg6-iWzyG_kPGn0L2YPURnx-osJ31NnZxAXYprlfAXMU0nKAXjemyf73vx-jb54uvk6viZnY5nZzfFFZIORReVU3FnLOyKZ11ghpVMjFvzFxw2AhSEyOd5Y5Y4pVgtAYgI6ryJS9dyfgxOtvprtbzpXcWnp9Mp1cpLE3a6GiC_v_Sh1Yv4pNmZVlJyUGA7ARsijkn3xy4lOhtQhoS0tuEoOhtQkB5-6_nX8I-EgC82wNMtqaDn-xtyAcco0zxWpaAe7_DtWHR_gzJ67w0XQeyTD_YyJSuNRUA_A1ibqku</recordid><startdate>20090320</startdate><enddate>20090320</enddate><creator>COLE, Peter D</creator><creator>SCHWARTZ, Cindy L</creator><creator>DRACHTMAN, Richard A</creator><creator>DE ALARCON, Pedro A</creator><creator>LU CHEN</creator><creator>TRIPPETT, Tanya M</creator><general>American Society of Clinical Oncology</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><scope>5PM</scope></search><sort><creationdate>20090320</creationdate><title>Phase II Study of Weekly Gemcitabine and Vinorelbine for Children With Recurrent or Refractory Hodgkin's Disease: A Children's Oncology Group Report</title><author>COLE, Peter D ; SCHWARTZ, Cindy L ; DRACHTMAN, Richard A ; DE ALARCON, Pedro A ; LU CHEN ; TRIPPETT, Tanya M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c455t-e78f82ddc5f6dcd41a7624bfab43f6d4090a5dc3d0c0e742195f62078e636d623</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Disease-Free Survival</topic><topic>Drug Administration Schedule</topic><topic>Gemcitabine</topic><topic>Hematologic and hematopoietic diseases</topic><topic>Hodgkin Disease - drug therapy</topic><topic>Humans</topic><topic>Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis</topic><topic>Medical sciences</topic><topic>Neoplasm Recurrence, Local - drug therapy</topic><topic>Original Reports</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Vinblastine - administration & dosage</topic><topic>Vinblastine - adverse effects</topic><topic>Vinblastine - analogs & derivatives</topic><topic>Vinorelbine</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>COLE, Peter D</creatorcontrib><creatorcontrib>SCHWARTZ, Cindy L</creatorcontrib><creatorcontrib>DRACHTMAN, Richard A</creatorcontrib><creatorcontrib>DE ALARCON, Pedro A</creatorcontrib><creatorcontrib>LU CHEN</creatorcontrib><creatorcontrib>TRIPPETT, Tanya M</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><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>COLE, Peter D</au><au>SCHWARTZ, Cindy L</au><au>DRACHTMAN, Richard A</au><au>DE ALARCON, Pedro A</au><au>LU CHEN</au><au>TRIPPETT, Tanya M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II Study of Weekly Gemcitabine and Vinorelbine for Children With Recurrent or Refractory Hodgkin's Disease: A Children's Oncology Group Report</atitle><jtitle>Journal of clinical oncology</jtitle><addtitle>J Clin Oncol</addtitle><date>2009-03-20</date><risdate>2009</risdate><volume>27</volume><issue>9</issue><spage>1456</spage><epage>1461</epage><pages>1456-1461</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>The Children's Oncology Group conducted this phase II study to assess the efficacy and toxicity of gemcitabine and vinorelbine (GV) in pediatric patients with heavily pretreated relapsed/refractory Hodgkin's disease. Both agents have significant single-agent response rates in this setting.
GV was given on days 1 and 8 of each 21-day treatment cycle: vinorelbine 25 mg/m(2)/dose administered via intravenous (IV) push before gemcitabine 1,000 mg/m(2)/dose IV over 100 minutes. Any patients who demonstrated a measurable response (complete response [CR], very good partial response [VGPR], or partial response [PR]) were considered to have experienced a response to GV. Response was evaluated after every two cycles. A two-stage minimax rule was used to test the null hypothesis that the response rate is <or= 40% against an alternative hypothesis of a response rate more than 65%.
Thirty eligible patients with a median age of 17.7 years (range, 10.7 to 29.4 years) were enrolled. All patients had received at least two prior chemotherapy regimens, and 17 patients had undergone prior autologous stem-cell transplantation. Hematologic toxicity was predominant in all treatment cycles. Nonhematologic grade 3 to 4 toxicity, including elevated hepatic enzymes and hyperbilirubinemia, was less common. Pericardial and pleural effusions developed in one patient after cycles 4 and 5 of GV, consistent with gemcitabine-induced radiation recall. There were no toxic deaths. Measurable responses were seen in 19 (76%) of 25 assessable patients (95% exact binomial CI, 55% to 91%), including six CRs, 11 VGPRs, and two PRs.
GV is an effective and well-tolerated reinduction regimen for children with relapsed or refractory Hodgkin's disease.</abstract><cop>Alexandria, VA</cop><pub>American Society of Clinical Oncology</pub><pmid>19224841</pmid><doi>10.1200/JCO.2008.20.3778</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0732-183X |
| ispartof | Journal of clinical oncology, 2009-03, Vol.27 (9), p.1456-1461 |
| issn | 0732-183X 1527-7755 |
| language | eng |
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| source | MEDLINE; American Society of Clinical Oncology Online Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adolescent Adult Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Biological and medical sciences Child Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Disease-Free Survival Drug Administration Schedule Gemcitabine Hematologic and hematopoietic diseases Hodgkin Disease - drug therapy Humans Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis Medical sciences Neoplasm Recurrence, Local - drug therapy Original Reports Treatment Outcome Tumors Vinblastine - administration & dosage Vinblastine - adverse effects Vinblastine - analogs & derivatives Vinorelbine Young Adult |
| title | Phase II Study of Weekly Gemcitabine and Vinorelbine for Children With Recurrent or Refractory Hodgkin's Disease: A Children's Oncology Group Report |
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