Randomized Phase III Trial of Temsirolimus Versus Sorafenib As Second-Line Therapy After Sunitinib in Patients With Metastatic Renal Cell Carcinoma
Identifieur interne : 004520 ( Main/Exploration ); précédent : 004519; suivant : 004521Randomized 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 [ 0732-183X ] ; 2013.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Estimation de Kaplan-Meier, Facteurs temps, Femelle, Humains, Indoles (usage thérapeutique), Inhibiteurs de l'angiogenèse (effets indésirables), Inhibiteurs de l'angiogenèse (usage thérapeutique), Inhibiteurs de protéines kinases (effets indésirables), Inhibiteurs de protéines kinases (usage thérapeutique), Jeune adulte, Mâle, Nicotinamide (analogues et dérivés), Nicotinamide (effets indésirables), Nicotinamide (usage thérapeutique), Néphrocarcinome (enzymologie), Néphrocarcinome (mortalité), Néphrocarcinome (secondaire), Néphrocarcinome (traitement médicamenteux), Phénylurées (effets indésirables), Phénylurées (usage thérapeutique), Pyrroles (usage thérapeutique), Récepteurs aux facteurs de croissance endothéliale vasculaire (antagonistes et inhibiteurs), Récepteurs aux facteurs de croissance endothéliale vasculaire (métabolisme), Sirolimus (analogues et dérivés), Sirolimus (effets indésirables), Sirolimus (usage thérapeutique), Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Sérine-thréonine kinases TOR (antagonistes et inhibiteurs), Sérine-thréonine kinases TOR (métabolisme), Thérapie moléculaire ciblée, Tumeurs du rein (anatomopathologie), Tumeurs du rein (enzymologie), Tumeurs du rein (mortalité), Tumeurs du rein (traitement médicamenteux), Échec thérapeutique, Évolution de la maladie.
- MESH :
- analogues et dérivés : Nicotinamide, Sirolimus.
- anatomopathologie : Tumeurs du rein.
- antagonistes et inhibiteurs : Récepteurs aux facteurs de croissance endothéliale vasculaire, Sérine-thréonine kinases TOR.
- effets indésirables : Inhibiteurs de l'angiogenèse, Inhibiteurs de protéines kinases, Nicotinamide, Phénylurées, Sirolimus.
- enzymologie : Néphrocarcinome, Tumeurs du rein.
- mortalité : Néphrocarcinome, Tumeurs du rein.
- métabolisme : Récepteurs aux facteurs de croissance endothéliale vasculaire, Sérine-thréonine kinases TOR.
- secondaire : Néphrocarcinome.
- traitement médicamenteux : Néphrocarcinome, Tumeurs du rein.
- usage thérapeutique : Indoles, Inhibiteurs de l'angiogenèse, Inhibiteurs de protéines kinases, Nicotinamide, Phénylurées, Pyrroles, Sirolimus.
- Adulte, Adulte d'âge moyen, Estimation de Kaplan-Meier, Facteurs temps, Femelle, Humains, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Thérapie moléculaire ciblée, Échec thérapeutique, Évolution de la maladie.
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.
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.
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
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.
Url:
DOI: 10.1200/JCO.2013.50.3961
PubMed: 24297950
PubMed Central: 5569683
Affiliations:
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Le document en format XML
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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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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. 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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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><idno type="wicri:Area/Pmc/Curation">001815</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001815</idno><idno type="wicri:Area/Pmc/Checkpoint">001921</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001921</idno><idno type="wicri:source">PubMed</idno><idno type="wicri:Area/PubMed/Corpus">003896</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003896</idno><idno type="wicri:Area/PubMed/Curation">003781</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">003781</idno><idno type="wicri:Area/PubMed/Checkpoint">003781</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">003781</idno><idno type="wicri:Area/Ncbi/Merge">001619</idno><idno type="wicri:Area/Ncbi/Curation">001619</idno><idno type="wicri:Area/Ncbi/Checkpoint">001619</idno><idno type="wicri:doubleKey">0732-183X:2013:Hutson T:randomized:phase:iii</idno><idno type="wicri:Area/Main/Merge">004610</idno><idno type="wicri:Area/Main/Curation">004520</idno><idno type="wicri:Area/Main/Exploration">004520</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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><wicri:noCountry code="subfield">NY.</wicri:noCountry></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><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="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Estimation de Kaplan-Meier</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Indoles (usage thérapeutique)</term><term>Inhibiteurs de l'angiogenèse (effets indésirables)</term><term>Inhibiteurs de l'angiogenèse (usage thérapeutique)</term><term>Inhibiteurs de protéines kinases (effets indésirables)</term><term>Inhibiteurs de protéines kinases (usage thérapeutique)</term><term>Jeune adulte</term><term>Mâle</term><term>Nicotinamide (analogues et dérivés)</term><term>Nicotinamide (effets indésirables)</term><term>Nicotinamide (usage thérapeutique)</term><term>Néphrocarcinome (enzymologie)</term><term>Néphrocarcinome (mortalité)</term><term>Néphrocarcinome (secondaire)</term><term>Néphrocarcinome (traitement médicamenteux)</term><term>Phénylurées (effets indésirables)</term><term>Phénylurées (usage thérapeutique)</term><term>Pyrroles (usage thérapeutique)</term><term>Récepteurs aux facteurs de croissance endothéliale vasculaire (antagonistes et inhibiteurs)</term><term>Récepteurs aux facteurs de croissance endothéliale vasculaire (métabolisme)</term><term>Sirolimus (analogues et dérivés)</term><term>Sirolimus (effets indésirables)</term><term>Sirolimus (usage thérapeutique)</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie sans rechute</term><term>Sérine-thréonine kinases TOR (antagonistes et inhibiteurs)</term><term>Sérine-thréonine kinases TOR (métabolisme)</term><term>Thérapie moléculaire ciblée</term><term>Tumeurs du rein (anatomopathologie)</term><term>Tumeurs du rein (enzymologie)</term><term>Tumeurs du rein (mortalité)</term><term>Tumeurs du rein (traitement médicamenteux)</term><term>Échec thérapeutique</term><term>Évolution de la maladie</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="analogues et dérivés" xml:lang="fr"><term>Nicotinamide</term><term>Sirolimus</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Tumeurs du rein</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Récepteurs aux facteurs de croissance endothéliale vasculaire</term><term>Sérine-thréonine kinases TOR</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="effets indésirables" xml:lang="fr"><term>Inhibiteurs de l'angiogenèse</term><term>Inhibiteurs de protéines kinases</term><term>Nicotinamide</term><term>Phénylurées</term><term>Sirolimus</term></keywords><keywords scheme="MESH" qualifier="enzymologie" xml:lang="fr"><term>Néphrocarcinome</term><term>Tumeurs du rein</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="mortalité" xml:lang="fr"><term>Néphrocarcinome</term><term>Tumeurs du rein</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Récepteurs aux facteurs de croissance endothéliale vasculaire</term><term>Sérine-thréonine kinases TOR</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Kidney Neoplasms</term></keywords><keywords scheme="MESH" qualifier="secondaire" xml:lang="fr"><term>Néphrocarcinome</term></keywords><keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Carcinoma, Renal Cell</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Néphrocarcinome</term><term>Tumeurs du rein</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Indoles</term><term>Inhibiteurs de l'angiogenèse</term><term>Inhibiteurs de protéines kinases</term><term>Nicotinamide</term><term>Phénylurées</term><term>Pyrroles</term><term>Sirolimus</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><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Estimation de Kaplan-Meier</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie sans rechute</term><term>Thérapie moléculaire ciblée</term><term>Échec thérapeutique</term><term>Évolution de la maladie</term></keywords></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><affiliations><list></list><tree><noCountry><name sortKey="Bjarnason, Georg A" sort="Bjarnason, Georg A" uniqKey="Bjarnason G" first="Georg A." last="Bjarnason">Georg A. Bjarnason</name><name sortKey="Escudier, Bernard" sort="Escudier, Bernard" uniqKey="Escudier B" first="Bernard" last="Escudier">Bernard Escudier</name><name sortKey="Esteban, Emilio" sort="Esteban, Emilio" uniqKey="Esteban E" first="Emilio" last="Esteban">Emilio Esteban</name><name sortKey="Hariharan, Subramanian" sort="Hariharan, Subramanian" uniqKey="Hariharan S" first="Subramanian" last="Hariharan">Subramanian Hariharan</name><name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name><name sortKey="Lim, Ho Yeong" sort="Lim, Ho Yeong" uniqKey="Lim H" first="Ho Yeong" last="Lim">Ho Yeong Lim</name><name sortKey="Lu, Dongrui Ray" sort="Lu, Dongrui Ray" uniqKey="Lu D" first="Dongrui Ray" last="Lu">Dongrui Ray Lu</name><name sortKey="Motzer, Robert J" sort="Motzer, Robert J" uniqKey="Motzer R" first="Robert J." last="Motzer">Robert J. Motzer</name><name sortKey="Niethammer, Andreas" sort="Niethammer, Andreas" uniqKey="Niethammer A" first="Andreas" last="Niethammer">Andreas Niethammer</name><name sortKey="Pittman, Kenneth B" sort="Pittman, Kenneth B" uniqKey="Pittman K" first="Kenneth B." last="Pittman">Kenneth B. Pittman</name><name sortKey="Senico, Peggy" sort="Senico, Peggy" uniqKey="Senico P" first="Peggy" last="Senico">Peggy Senico</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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