A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy
Recurrent platinum-resistant ovarian cancer usually has a poor outcome with conventional chemotherapeutic therapy and new treatment modalities are warranted. This phase II study was conducted to evaluate sunitinib, an oral antiangiogenic multitargeted tyrosin kinase inhibitor, in this setting. The p...
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| Veröffentlicht in: | Annals of oncology 2012-09, Vol.23 (9), p.2265-2271 |
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| creator | Baumann, K.H. du Bois, A. Meier, W. Rau, J. Wimberger, P. Sehouli, J. Kurzeder, C. Hilpert, F. Hasenburg, A. Canzler, U. Hanker, L.C. Hillemanns, P. Richter, B. Wollschlaeger, K. Dewitz, T. Bauerschlag, D. Wagner, U. |
| description | Recurrent platinum-resistant ovarian cancer usually has a poor outcome with conventional chemotherapeutic therapy and new treatment modalities are warranted. This phase II study was conducted to evaluate sunitinib, an oral antiangiogenic multitargeted tyrosin kinase inhibitor, in this setting.
The primary end point of this randomized phase II trial was the objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies. A selection design was employed to compare two schedules of sunitinib (arm 1: 50 mg sunitinib daily orally for 28 days followed by 14 days off drug; and arm 2: 37.5 mg sunitinib administered daily continuously).
Of 73 patients enrolled, 36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients were randomly allocated to the continuous treatment arm (arm 2). The mean age was 58.8 and 58.5 years, respectively. We observed six responders (complete response+partial response) in arm 1 (16.7%) and 2 responders in arm 2 (5.4%). The median progression-free survival (arm 1: 4.8 [2.9–8.1] months; arm 2: 2.9 [2.9–5.1] months) and the median overall survival (arm 1: 13.6 [7.0–23.2] months; arm 2: 13.7 [8.4–25.6] months) revealed no significant difference. Adverse events included fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities. Pattern and frequency of adverse events revealed no substantial differences between both treatment groups.
Sunitinib treatment is feasible and moderately active in relapsed platinum-resistant ovarian cancer. The noncontinuous treatment schedule should be chosen for further studies in ovarian cancer. |
| doi_str_mv | 10.1093/annonc/mds003 |
| format | Article |
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The primary end point of this randomized phase II trial was the objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies. A selection design was employed to compare two schedules of sunitinib (arm 1: 50 mg sunitinib daily orally for 28 days followed by 14 days off drug; and arm 2: 37.5 mg sunitinib administered daily continuously).
Of 73 patients enrolled, 36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients were randomly allocated to the continuous treatment arm (arm 2). The mean age was 58.8 and 58.5 years, respectively. We observed six responders (complete response+partial response) in arm 1 (16.7%) and 2 responders in arm 2 (5.4%). The median progression-free survival (arm 1: 4.8 [2.9–8.1] months; arm 2: 2.9 [2.9–5.1] months) and the median overall survival (arm 1: 13.6 [7.0–23.2] months; arm 2: 13.7 [8.4–25.6] months) revealed no significant difference. Adverse events included fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities. Pattern and frequency of adverse events revealed no substantial differences between both treatment groups.
Sunitinib treatment is feasible and moderately active in relapsed platinum-resistant ovarian cancer. The noncontinuous treatment schedule should be chosen for further studies in ovarian cancer.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mds003</identifier><identifier>PMID: 22377563</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>angiogenesis inhibitor ; Angiogenesis Inhibitors - administration & dosage ; Angiogenesis Inhibitors - adverse effects ; Antineoplastic agents ; Biological and medical sciences ; Disease-Free Survival ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drug Resistance, Neoplasm ; Female ; Female genital diseases ; Gynecology. Andrology. Obstetrics ; Humans ; Indoles - administration & dosage ; Indoles - adverse effects ; Kaplan-Meier Estimate ; Medical sciences ; Middle Aged ; Neoplasm Recurrence, Local - drug therapy ; Neoplasm Recurrence, Local - mortality ; Neoplasms, Cystic, Mucinous, and Serous - drug therapy ; Neoplasms, Cystic, Mucinous, and Serous - mortality ; ovarian cancer ; Ovarian Neoplasms - drug therapy ; Ovarian Neoplasms - mortality ; Pharmacology. Drug treatments ; Platinum Compounds - pharmacology ; platinum resistant ; Proportional Hazards Models ; Pyrroles - administration & dosage ; Pyrroles - adverse effects ; Receptor Protein-Tyrosine Kinases - antagonists & inhibitors ; Sunitinib ; Tumors</subject><ispartof>Annals of oncology, 2012-09, Vol.23 (9), p.2265-2271</ispartof><rights>2012 European Society for Medical Oncology</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c410t-ba2d506ba76f3a053a5db230585a3e62492b06766978cbe7c34f68b992273d0a3</citedby><cites>FETCH-LOGICAL-c410t-ba2d506ba76f3a053a5db230585a3e62492b06766978cbe7c34f68b992273d0a3</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=26294772$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22377563$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Baumann, K.H.</creatorcontrib><creatorcontrib>du Bois, A.</creatorcontrib><creatorcontrib>Meier, W.</creatorcontrib><creatorcontrib>Rau, J.</creatorcontrib><creatorcontrib>Wimberger, P.</creatorcontrib><creatorcontrib>Sehouli, J.</creatorcontrib><creatorcontrib>Kurzeder, C.</creatorcontrib><creatorcontrib>Hilpert, F.</creatorcontrib><creatorcontrib>Hasenburg, A.</creatorcontrib><creatorcontrib>Canzler, U.</creatorcontrib><creatorcontrib>Hanker, L.C.</creatorcontrib><creatorcontrib>Hillemanns, P.</creatorcontrib><creatorcontrib>Richter, B.</creatorcontrib><creatorcontrib>Wollschlaeger, K.</creatorcontrib><creatorcontrib>Dewitz, T.</creatorcontrib><creatorcontrib>Bauerschlag, D.</creatorcontrib><creatorcontrib>Wagner, U.</creatorcontrib><title>A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Recurrent platinum-resistant ovarian cancer usually has a poor outcome with conventional chemotherapeutic therapy and new treatment modalities are warranted. This phase II study was conducted to evaluate sunitinib, an oral antiangiogenic multitargeted tyrosin kinase inhibitor, in this setting.
The primary end point of this randomized phase II trial was the objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies. A selection design was employed to compare two schedules of sunitinib (arm 1: 50 mg sunitinib daily orally for 28 days followed by 14 days off drug; and arm 2: 37.5 mg sunitinib administered daily continuously).
Of 73 patients enrolled, 36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients were randomly allocated to the continuous treatment arm (arm 2). The mean age was 58.8 and 58.5 years, respectively. We observed six responders (complete response+partial response) in arm 1 (16.7%) and 2 responders in arm 2 (5.4%). The median progression-free survival (arm 1: 4.8 [2.9–8.1] months; arm 2: 2.9 [2.9–5.1] months) and the median overall survival (arm 1: 13.6 [7.0–23.2] months; arm 2: 13.7 [8.4–25.6] months) revealed no significant difference. Adverse events included fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities. Pattern and frequency of adverse events revealed no substantial differences between both treatment groups.
Sunitinib treatment is feasible and moderately active in relapsed platinum-resistant ovarian cancer. The noncontinuous treatment schedule should be chosen for further studies in ovarian cancer.</description><subject>angiogenesis inhibitor</subject><subject>Angiogenesis Inhibitors - administration & dosage</subject><subject>Angiogenesis Inhibitors - adverse effects</subject><subject>Antineoplastic agents</subject><subject>Biological and medical sciences</subject><subject>Disease-Free Survival</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Drug Resistance, Neoplasm</subject><subject>Female</subject><subject>Female genital diseases</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Indoles - administration & dosage</subject><subject>Indoles - adverse effects</subject><subject>Kaplan-Meier Estimate</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Neoplasm Recurrence, Local - mortality</subject><subject>Neoplasms, Cystic, Mucinous, and Serous - drug therapy</subject><subject>Neoplasms, Cystic, Mucinous, and Serous - mortality</subject><subject>ovarian cancer</subject><subject>Ovarian Neoplasms - drug therapy</subject><subject>Ovarian Neoplasms - mortality</subject><subject>Pharmacology. Drug treatments</subject><subject>Platinum Compounds - pharmacology</subject><subject>platinum resistant</subject><subject>Proportional Hazards Models</subject><subject>Pyrroles - administration & dosage</subject><subject>Pyrroles - adverse effects</subject><subject>Receptor Protein-Tyrosine Kinases - antagonists & inhibitors</subject><subject>Sunitinib</subject><subject>Tumors</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUFv1DAQhUMFokvhyBX5gtRKpHXsxNlwW1VQVqrUA_QcTexJdyCxI9tZ2P76etkFTpw8lj-998Yvy94W_LLgjbwCa53VV6MJnMuTbFFUqsmXvCyeZwveCJnXlSxPs1chfOecq0Y0L7NTIWRdV0ounp2s2LSBgGy9ZtETDOx8dXPHxGVRXDCybBogkp3H3GOgEMFG5raQQMs0WI3-IwPmwRo30iMaNs5DJI02oj_q_aS4YWG2lHSoY-df74tClMsLFh3DLQwzRGTGBXjADyzoDZp5SFN0A3roaKC4299-kU4TS04M-x51pC1aDIG5PiX4bRvBP2BMITxqnKJLCXbeBbLIfpDdL0l2Qx3tX0ZnXdwkh2n3OnvRwxDwzfE8y-4_f_p2_SW_vbtZX69uc10WPOYdCFNx1UGtegm8klCZTkheLSuQqETZiI6rWqmmXuoOay3LXi27phGiloaDPMvyg65OoYLHvp08jeB3bcHbfZftocv20GXi3x34ae5GNH_pP-Ul4P0RgKBh6FMNmsI_TommrGuRuPrAYdpuS-jboAlTeYbST8XWOPpPhCf0H8Fv</recordid><startdate>20120901</startdate><enddate>20120901</enddate><creator>Baumann, K.H.</creator><creator>du Bois, A.</creator><creator>Meier, W.</creator><creator>Rau, J.</creator><creator>Wimberger, P.</creator><creator>Sehouli, J.</creator><creator>Kurzeder, C.</creator><creator>Hilpert, F.</creator><creator>Hasenburg, A.</creator><creator>Canzler, U.</creator><creator>Hanker, L.C.</creator><creator>Hillemanns, P.</creator><creator>Richter, B.</creator><creator>Wollschlaeger, K.</creator><creator>Dewitz, T.</creator><creator>Bauerschlag, D.</creator><creator>Wagner, U.</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>20120901</creationdate><title>A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy</title><author>Baumann, K.H. ; du Bois, A. ; Meier, W. ; Rau, J. ; Wimberger, P. ; Sehouli, J. ; Kurzeder, C. ; Hilpert, F. ; Hasenburg, A. ; Canzler, U. ; Hanker, L.C. ; Hillemanns, P. ; Richter, B. ; Wollschlaeger, K. ; Dewitz, T. ; Bauerschlag, D. ; Wagner, U.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c410t-ba2d506ba76f3a053a5db230585a3e62492b06766978cbe7c34f68b992273d0a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>angiogenesis inhibitor</topic><topic>Angiogenesis Inhibitors - administration & dosage</topic><topic>Angiogenesis Inhibitors - adverse effects</topic><topic>Antineoplastic agents</topic><topic>Biological and medical sciences</topic><topic>Disease-Free Survival</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Drug Resistance, Neoplasm</topic><topic>Female</topic><topic>Female genital diseases</topic><topic>Gynecology. 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This phase II study was conducted to evaluate sunitinib, an oral antiangiogenic multitargeted tyrosin kinase inhibitor, in this setting.
The primary end point of this randomized phase II trial was the objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies. A selection design was employed to compare two schedules of sunitinib (arm 1: 50 mg sunitinib daily orally for 28 days followed by 14 days off drug; and arm 2: 37.5 mg sunitinib administered daily continuously).
Of 73 patients enrolled, 36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients were randomly allocated to the continuous treatment arm (arm 2). The mean age was 58.8 and 58.5 years, respectively. We observed six responders (complete response+partial response) in arm 1 (16.7%) and 2 responders in arm 2 (5.4%). The median progression-free survival (arm 1: 4.8 [2.9–8.1] months; arm 2: 2.9 [2.9–5.1] months) and the median overall survival (arm 1: 13.6 [7.0–23.2] months; arm 2: 13.7 [8.4–25.6] months) revealed no significant difference. Adverse events included fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities. Pattern and frequency of adverse events revealed no substantial differences between both treatment groups.
Sunitinib treatment is feasible and moderately active in relapsed platinum-resistant ovarian cancer. The noncontinuous treatment schedule should be chosen for further studies in ovarian cancer.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>22377563</pmid><doi>10.1093/annonc/mds003</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Annals of oncology, 2012-09, Vol.23 (9), p.2265-2271 |
| issn | 0923-7534 1569-8041 |
| language | eng |
| recordid | cdi_crossref_primary_10_1093_annonc_mds003 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | angiogenesis inhibitor Angiogenesis Inhibitors - administration & dosage Angiogenesis Inhibitors - adverse effects Antineoplastic agents Biological and medical sciences Disease-Free Survival Dose-Response Relationship, Drug Drug Administration Schedule Drug Resistance, Neoplasm Female Female genital diseases Gynecology. Andrology. Obstetrics Humans Indoles - administration & dosage Indoles - adverse effects Kaplan-Meier Estimate Medical sciences Middle Aged Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - mortality Neoplasms, Cystic, Mucinous, and Serous - drug therapy Neoplasms, Cystic, Mucinous, and Serous - mortality ovarian cancer Ovarian Neoplasms - drug therapy Ovarian Neoplasms - mortality Pharmacology. Drug treatments Platinum Compounds - pharmacology platinum resistant Proportional Hazards Models Pyrroles - administration & dosage Pyrroles - adverse effects Receptor Protein-Tyrosine Kinases - antagonists & inhibitors Sunitinib Tumors |
| title | A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy |
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