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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Randomized Phase III Trial of Temsirolimus Versus Sorafenib As Second-Line Therapy After Sunitinib in Patients With Metastatic Renal Cell Carcinoma</title><author><name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Escudier, Bernard" sort="Escudier, Bernard" uniqKey="Escudier B" first="Bernard" last="Escudier">Bernard Escudier</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Esteban, Emilio" sort="Esteban, Emilio" uniqKey="Esteban E" first="Emilio" last="Esteban">Emilio Esteban</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Bjarnason, Georg A" sort="Bjarnason, Georg A" uniqKey="Bjarnason G" first="Georg A." last="Bjarnason">Georg A. Bjarnason</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Lim, Ho Yeong" sort="Lim, Ho Yeong" uniqKey="Lim H" first="Ho Yeong" last="Lim">Ho Yeong Lim</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Pittman, Kenneth B" sort="Pittman, Kenneth B" uniqKey="Pittman K" first="Kenneth B." last="Pittman">Kenneth B. Pittman</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Senico, Peggy" sort="Senico, Peggy" uniqKey="Senico P" first="Peggy" last="Senico">Peggy Senico</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Niethammer, Andreas" sort="Niethammer, Andreas" uniqKey="Niethammer A" first="Andreas" last="Niethammer">Andreas Niethammer</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Lu, Dongrui Ray" sort="Lu, Dongrui Ray" uniqKey="Lu D" first="Dongrui Ray" last="Lu">Dongrui Ray Lu</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Hariharan, Subramanian" sort="Hariharan, Subramanian" uniqKey="Hariharan S" first="Subramanian" last="Hariharan">Subramanian Hariharan</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Motzer, Robert J" sort="Motzer, Robert J" uniqKey="Motzer R" first="Robert J." last="Motzer">Robert J. Motzer</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24297950</idno><idno type="pmc">5569683</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569683</idno><idno type="RBID">PMC:5569683</idno><idno type="doi">10.1200/JCO.2013.50.3961</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">001956</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001956</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Randomized Phase III Trial of Temsirolimus Versus Sorafenib As Second-Line Therapy After Sunitinib in Patients With Metastatic Renal Cell Carcinoma</title><author><name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Escudier, Bernard" sort="Escudier, Bernard" uniqKey="Escudier B" first="Bernard" last="Escudier">Bernard Escudier</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Esteban, Emilio" sort="Esteban, Emilio" uniqKey="Esteban E" first="Emilio" last="Esteban">Emilio Esteban</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Bjarnason, Georg A" sort="Bjarnason, Georg A" uniqKey="Bjarnason G" first="Georg A." last="Bjarnason">Georg A. Bjarnason</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Lim, Ho Yeong" sort="Lim, Ho Yeong" uniqKey="Lim H" first="Ho Yeong" last="Lim">Ho Yeong Lim</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Pittman, Kenneth B" sort="Pittman, Kenneth B" uniqKey="Pittman K" first="Kenneth B." last="Pittman">Kenneth B. Pittman</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Senico, Peggy" sort="Senico, Peggy" uniqKey="Senico P" first="Peggy" last="Senico">Peggy Senico</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Niethammer, Andreas" sort="Niethammer, Andreas" uniqKey="Niethammer A" first="Andreas" last="Niethammer">Andreas Niethammer</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Lu, Dongrui Ray" sort="Lu, Dongrui Ray" uniqKey="Lu D" first="Dongrui Ray" last="Lu">Dongrui Ray Lu</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Hariharan, Subramanian" sort="Hariharan, Subramanian" uniqKey="Hariharan S" first="Subramanian" last="Hariharan">Subramanian Hariharan</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author><author><name sortKey="Motzer, Robert J" sort="Motzer, Robert J" uniqKey="Motzer R" first="Robert J." last="Motzer">Robert J. Motzer</name><affiliation><nlm:aff id="aff1">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.</nlm:aff></affiliation></author></analytic><series><title level="j">Journal of Clinical Oncology</title><idno type="ISSN">0732-183X</idno><idno type="eISSN">1527-7755</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>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.</p></sec><sec><title>Patients and Methods</title><p>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.</p></sec><sec><title>Results</title><p>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 <italic>P</italic> = .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 <italic>P</italic> = .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.</p></sec><sec><title>Conclusion</title><p>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.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Clin Oncol</journal-id><journal-id journal-id-type="iso-abbrev">J. Clin. Oncol</journal-id><journal-id journal-id-type="hwp">jco</journal-id><journal-id journal-id-type="pmc">jco</journal-id><journal-id journal-id-type="publisher-id">JCO</journal-id><journal-title-group><journal-title>Journal of Clinical Oncology</journal-title></journal-title-group><issn pub-type="ppub">0732-183X</issn><issn pub-type="epub">1527-7755</issn><publisher><publisher-name>American Society of Clinical Oncology</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24297950</article-id><article-id pub-id-type="pmc">5569683</article-id><article-id pub-id-type="publisher-id">03961</article-id><article-id pub-id-type="doi">10.1200/JCO.2013.50.3961</article-id><article-categories><subj-group subj-group-type="heading"><subject>ORIGINAL REPORTS</subject><subj-group><subject>Urologic Oncology</subject></subj-group></subj-group></article-categories><title-group><article-title>Randomized Phase III Trial of Temsirolimus Versus Sorafenib As Second-Line Therapy After Sunitinib in Patients With Metastatic Renal Cell Carcinoma</article-title><alt-title alt-title-type="short">Temsirolimus <italic>v</italic> Sorafenib in Second-Line RCC After Prior Sunitinib</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Hutson</surname><given-names>Thomas E.</given-names></name><xref ref-type="aff" rid="aff1"></xref><xref ref-type="corresp" rid="cor1"></xref></contrib><contrib contrib-type="author"><name><surname>Escudier</surname><given-names>Bernard</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Esteban</surname><given-names>Emilio</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Bjarnason</surname><given-names>Georg A.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Lim</surname><given-names>Ho Yeong</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Pittman</surname><given-names>Kenneth B.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Senico</surname><given-names>Peggy</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Niethammer</surname><given-names>Andreas</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Lu</surname><given-names>Dongrui Ray</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Hariharan</surname><given-names>Subramanian</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Motzer</surname><given-names>Robert J.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><aff id="aff1">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.</aff></contrib-group><author-notes><corresp id="cor1">Corresponding author: Thomas E. Hutson, DO, PharmD, GU Oncology Program, Baylor Sammons Cancer Center-Texas Oncology, PA, 3535 Worth St, Dallas, TX 75246; e-mail: <email>thomas.hutson@usoncology.com</email>.</corresp></author-notes><pub-date pub-type="ppub"><day>10</day><month>3</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>2</day><month>12</month><year>2013</year></pub-date><pub-date pub-type="pmc-release"><day>10</day><month>10</month><year>2014</year></pub-date><pmc-comment> PMC Release delay is 7 months and
0 days and was based on the
<volume>32</volume><issue>8</issue><fpage>760</fpage><lpage>767</lpage><permissions><copyright-statement>© 2013 by American Society of Clinical Oncology</copyright-statement><copyright-year>2013</copyright-year></permissions><self-uri xlink:title="pdf" xlink:type="simple" content-type="pdf" xlink:href="JCO.2013.50.3961.pdf"></self-uri><abstract><sec><title>Purpose</title><p>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.</p></sec><sec><title>Patients and Methods</title><p>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.</p></sec><sec><title>Results</title><p>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 <italic>P</italic> = .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 <italic>P</italic> = .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.</p></sec><sec><title>Conclusion</title><p>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.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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