Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma.
Identifieur interne : 003896 ( PubMed/Corpus ); précédent : 003895; suivant : 003897Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma.
Auteurs : Thomas E. Hutson ; Bernard Escudier ; Emilio Esteban ; Georg A. Bjarnason ; Ho Yeong Lim ; Kenneth B. Pittman ; Peggy Senico ; Andreas Niethammer ; Dongrui Ray Lu ; Subramanian Hariharan ; Robert J. MotzerSource :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology [ 1527-7755 ] ; 2014.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors (adverse effects), Angiogenesis Inhibitors (therapeutic use), Carcinoma, Renal Cell (drug therapy), Carcinoma, Renal Cell (enzymology), Carcinoma, Renal Cell (mortality), Carcinoma, Renal Cell (secondary), Disease Progression, Disease-Free Survival, Female, Humans, Indoles (therapeutic use), Kaplan-Meier Estimate, Kidney Neoplasms (drug therapy), Kidney Neoplasms (enzymology), Kidney Neoplasms (mortality), Kidney Neoplasms (pathology), Male, Middle Aged, Molecular Targeted Therapy, Niacinamide (adverse effects), Niacinamide (analogs & derivatives), Niacinamide (therapeutic use), Phenylurea Compounds (adverse effects), Phenylurea Compounds (therapeutic use), Protein Kinase Inhibitors (adverse effects), Protein Kinase Inhibitors (therapeutic use), Pyrroles (therapeutic use), Receptors, Vascular Endothelial Growth Factor (antagonists & inhibitors), Receptors, Vascular Endothelial Growth Factor (metabolism), Sirolimus (adverse effects), Sirolimus (analogs & derivatives), Sirolimus (therapeutic use), TOR Serine-Threonine Kinases (antagonists & inhibitors), TOR Serine-Threonine Kinases (metabolism), Time Factors, Treatment Failure, Young Adult.
- MESH :
- chemical , adverse effects : Angiogenesis Inhibitors, Niacinamide, Phenylurea Compounds, Protein Kinase Inhibitors, Sirolimus.
- chemical , analogs & derivatives : Niacinamide, Sirolimus.
- chemical , antagonists & inhibitors : Receptors, Vascular Endothelial Growth Factor, TOR Serine-Threonine Kinases.
- chemical , metabolism : Receptors, Vascular Endothelial Growth Factor, TOR Serine-Threonine Kinases.
- chemical , therapeutic use : Angiogenesis Inhibitors, Indoles, Niacinamide, Phenylurea Compounds, Protein Kinase Inhibitors, Pyrroles, Sirolimus.
- drug therapy : Carcinoma, Renal Cell, Kidney Neoplasms.
- enzymology : Carcinoma, Renal Cell, Kidney Neoplasms.
- mortality : Carcinoma, Renal Cell, Kidney Neoplasms.
- pathology : Kidney Neoplasms.
- secondary : Carcinoma, Renal Cell.
- Adult, Aged, Aged, 80 and over, Disease Progression, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Molecular Targeted Therapy, Time Factors, Treatment Failure, Young Adult.
Abstract
This international phase III trial (Investigating Torisel As Second-Line Therapy [INTORSECT]) compared the efficacy of temsirolimus (mammalian target of rapamycin inhibitor) and sorafenib (vascular endothelial growth factor receptor [VEGFR] tyrosine kinase inhibitor) as second-line therapy in patients with metastatic renal cell carcinoma (mRCC) after disease progression on sunitinib.
DOI: 10.1200/JCO.2013.50.3961
PubMed: 24297950
Links to Exploration step
pubmed:24297950Le document en format XML
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Sammons Cancer Center, Baylor University Medical Center, Dallas, TX; Bernard Escudier, Institut Gustave Roussy, Villejuif, France; Emilio Esteban, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Georg A. Bjarnason, Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada; Ho Yeong Lim, Samsung Medical Center, Seoul, Korea; Kenneth B. Pittman, The Queen Elizabeth Hospital, Woodville South, Adelaide, Australia; Peggy Senico, Pfizer, Collegeville, PA; Andreas Niethammer and Dongrui Ray Lu Pfizer, La Jolla, CA; Subramanian Hariharan, Pfizer; and Robert J. 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Pittman</name></author><author><name sortKey="Senico, Peggy" sort="Senico, Peggy" uniqKey="Senico P" first="Peggy" last="Senico">Peggy Senico</name></author><author><name sortKey="Niethammer, Andreas" sort="Niethammer, Andreas" uniqKey="Niethammer A" first="Andreas" last="Niethammer">Andreas Niethammer</name></author><author><name sortKey="Lu, Dongrui Ray" sort="Lu, Dongrui Ray" uniqKey="Lu D" first="Dongrui Ray" last="Lu">Dongrui Ray Lu</name></author><author><name sortKey="Hariharan, Subramanian" sort="Hariharan, Subramanian" uniqKey="Hariharan S" first="Subramanian" last="Hariharan">Subramanian Hariharan</name></author><author><name sortKey="Motzer, Robert J" sort="Motzer, Robert J" uniqKey="Motzer R" first="Robert J" last="Motzer">Robert J. Motzer</name></author></analytic><series><title level="j">Journal of clinical oncology : official journal of the American Society of Clinical Oncology</title><idno type="eISSN">1527-7755</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Angiogenesis Inhibitors (adverse effects)</term><term>Angiogenesis Inhibitors (therapeutic use)</term><term>Carcinoma, Renal Cell (drug therapy)</term><term>Carcinoma, Renal Cell (enzymology)</term><term>Carcinoma, Renal Cell (mortality)</term><term>Carcinoma, Renal Cell (secondary)</term><term>Disease Progression</term><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Indoles (therapeutic use)</term><term>Kaplan-Meier Estimate</term><term>Kidney Neoplasms (drug therapy)</term><term>Kidney Neoplasms (enzymology)</term><term>Kidney Neoplasms (mortality)</term><term>Kidney Neoplasms (pathology)</term><term>Male</term><term>Middle Aged</term><term>Molecular Targeted Therapy</term><term>Niacinamide (adverse effects)</term><term>Niacinamide (analogs & derivatives)</term><term>Niacinamide (therapeutic use)</term><term>Phenylurea Compounds (adverse effects)</term><term>Phenylurea Compounds (therapeutic use)</term><term>Protein Kinase Inhibitors (adverse effects)</term><term>Protein Kinase Inhibitors (therapeutic use)</term><term>Pyrroles (therapeutic use)</term><term>Receptors, Vascular Endothelial Growth Factor (antagonists & inhibitors)</term><term>Receptors, Vascular Endothelial Growth Factor (metabolism)</term><term>Sirolimus (adverse effects)</term><term>Sirolimus (analogs & derivatives)</term><term>Sirolimus (therapeutic use)</term><term>TOR Serine-Threonine Kinases (antagonists & inhibitors)</term><term>TOR Serine-Threonine Kinases (metabolism)</term><term>Time Factors</term><term>Treatment Failure</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Angiogenesis Inhibitors</term><term>Niacinamide</term><term>Phenylurea Compounds</term><term>Protein Kinase Inhibitors</term><term>Sirolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Niacinamide</term><term>Sirolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Receptors, Vascular Endothelial Growth Factor</term><term>TOR Serine-Threonine Kinases</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Receptors, Vascular Endothelial Growth Factor</term><term>TOR Serine-Threonine Kinases</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Angiogenesis Inhibitors</term><term>Indoles</term><term>Niacinamide</term><term>Phenylurea Compounds</term><term>Protein Kinase Inhibitors</term><term>Pyrroles</term><term>Sirolimus</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Carcinoma, Renal Cell</term><term>Kidney Neoplasms</term></keywords><keywords scheme="MESH" qualifier="enzymology" xml:lang="en"><term>Carcinoma, Renal Cell</term><term>Kidney Neoplasms</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Carcinoma, Renal Cell</term><term>Kidney Neoplasms</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Kidney Neoplasms</term></keywords><keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Carcinoma, Renal Cell</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Disease Progression</term><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Molecular Targeted Therapy</term><term>Time Factors</term><term>Treatment Failure</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This international phase III trial (Investigating Torisel As Second-Line Therapy [INTORSECT]) compared the efficacy of temsirolimus (mammalian target of rapamycin inhibitor) and sorafenib (vascular endothelial growth factor receptor [VEGFR] tyrosine kinase inhibitor) as second-line therapy in patients with metastatic renal cell carcinoma (mRCC) after disease progression on sunitinib.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24297950</PMID><DateCreated><Year>2014</Year><Month>03</Month><Day>10</Day></DateCreated><DateCompleted><Year>2014</Year><Month>05</Month><Day>02</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>17</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1527-7755</ISSN><JournalIssue CitedMedium="Internet"><Volume>32</Volume><Issue>8</Issue><PubDate><Year>2014</Year><Month>Mar</Month><Day>10</Day></PubDate></JournalIssue><Title>Journal of clinical oncology : official journal of the American Society of Clinical Oncology</Title><ISOAbbreviation>J. Clin. Oncol.</ISOAbbreviation></Journal><ArticleTitle>Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma.</ArticleTitle><Pagination><MedlinePgn>760-7</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1200/JCO.2013.50.3961</ELocationID><Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">This international phase III trial (Investigating Torisel As Second-Line Therapy [INTORSECT]) compared the efficacy of temsirolimus (mammalian target of rapamycin inhibitor) and sorafenib (vascular endothelial growth factor receptor [VEGFR] tyrosine kinase inhibitor) as second-line therapy in patients with metastatic renal cell carcinoma (mRCC) after disease progression on sunitinib.</AbstractText><AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">In total, 512 patients were randomly assigned 1:1 to receive intravenous temsirolimus 25 mg once weekly (n = 259) or oral sorafenib 400 mg twice per day (n = 253), with stratification according to duration of prior sunitinib therapy (≤ or > 180 days), prognostic risk, histology (clear cell or non-clear cell), and nephrectomy status. The primary end point was progression-free survival (PFS) by independent review committee assessment. Safety, objective response rate (ORR), and overall survival (OS) were secondary end points.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Primary analysis revealed no significant difference between treatment arms for PFS (stratified hazard ratio [HR], 0.87; 95% CI, 0.71 to 1.07; two-sided P = .19) or ORR. Median PFS in the temsirolimus and sorafenib arms were 4.3 and 3.9 months, respectively. There was a significant OS difference in favor of sorafenib (stratified HR, 1.31; 95% CI, 1.05 to 1.63; two-sided P = .01). Median OS in the temsirolimus and sorafenib arms was 12.3 and 16.6 months, respectively. Safety profiles of both agents were consistent with previous studies.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">In patients with mRCC and progression on sunitinib, second-line temsirolimus did not demonstrate a PFS advantage compared with sorafenib. The longer OS observed with sorafenib suggests sequenced VEGFR inhibition may benefit patients with mRCC.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Hutson</LastName><ForeName>Thomas E</ForeName><Initials>TE</Initials><AffiliationInfo><Affiliation>Thomas E. Hutson, Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, TX; Bernard Escudier, Institut Gustave Roussy, Villejuif, France; Emilio Esteban, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Georg A. Bjarnason, Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada; Ho Yeong Lim, Samsung Medical Center, Seoul, Korea; Kenneth B. Pittman, The Queen Elizabeth Hospital, Woodville South, Adelaide, Australia; Peggy Senico, Pfizer, Collegeville, PA; Andreas Niethammer and Dongrui Ray Lu Pfizer, La Jolla, CA; Subramanian Hariharan, Pfizer; and Robert J. Motzer, Memorial Sloan-Kettering Cancer Center, New York, NY.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Escudier</LastName><ForeName>Bernard</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Esteban</LastName><ForeName>Emilio</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Bjarnason</LastName><ForeName>Georg A</ForeName><Initials>GA</Initials></Author><Author ValidYN="Y"><LastName>Lim</LastName><ForeName>Ho Yeong</ForeName><Initials>HY</Initials></Author><Author ValidYN="Y"><LastName>Pittman</LastName><ForeName>Kenneth B</ForeName><Initials>KB</Initials></Author><Author ValidYN="Y"><LastName>Senico</LastName><ForeName>Peggy</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Niethammer</LastName><ForeName>Andreas</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Lu</LastName><ForeName>Dongrui Ray</ForeName><Initials>DR</Initials></Author><Author ValidYN="Y"><LastName>Hariharan</LastName><ForeName>Subramanian</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Motzer</LastName><ForeName>Robert J</ForeName><Initials>RJ</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00474766</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>P30 CA008748</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>12</Month><Day>02</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Clin Oncol</MedlineTA><NlmUniqueID>8309333</NlmUniqueID><ISSNLinking>0732-183X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D020533">Angiogenesis Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007211">Indoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010671">Phenylurea Compounds</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D047428">Protein Kinase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011758">Pyrroles</NameOfSubstance></Chemical><Chemical><RegistryNumber>25X51I8RD4</RegistryNumber><NameOfSubstance UI="D009536">Niacinamide</NameOfSubstance></Chemical><Chemical><RegistryNumber>624KN6GM2T</RegistryNumber><NameOfSubstance UI="C401859">temsirolimus</NameOfSubstance></Chemical><Chemical><RegistryNumber>9ZOQ3TZI87</RegistryNumber><NameOfSubstance UI="C471405">sorafenib</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.1.1</RegistryNumber><NameOfSubstance UI="C546842">MTOR protein, human</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.1.1</RegistryNumber><NameOfSubstance UI="D058570">TOR Serine-Threonine Kinases</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber><NameOfSubstance UI="D040262">Receptors, Vascular Endothelial Growth Factor</NameOfSubstance></Chemical><Chemical><RegistryNumber>V99T50803M</RegistryNumber><NameOfSubstance UI="C473478">sunitinib</NameOfSubstance></Chemical><Chemical><RegistryNumber>W36ZG6FT64</RegistryNumber><NameOfSubstance UI="D020123">Sirolimus</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Nat Rev Clin Oncol. 2014 Feb;11(2):64</RefSource><PMID Version="1">24343669</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Nat Rev Urol. 2014 Jan;11(1):2</RefSource><PMID Version="1">24346004</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>J Clin Oncol. 2014 Mar 10;32(8):722-4</RefSource><PMID Version="1">24516015</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Natl Cancer Inst. 2000 Feb 2;92 (3):205-16</RefSource><PMID Version="1">10655437</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2007 Jan 11;356(2):115-24</RefSource><PMID 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RefType="Cites"><RefSource>Ann Oncol. 2011 Jan;22(1):145-8</RefSource><PMID Version="1">20595449</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020533" MajorTopicYN="N">Angiogenesis Inhibitors</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002292" MajorTopicYN="N">Carcinoma, Renal Cell</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000201" MajorTopicYN="N">enzymology</QualifierName><QualifierName UI="Q000401" 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