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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<term>Angiogenesis Inhibitors (therapeutic use)</term>
<term>Carcinoma, Renal Cell (drug therapy)</term>
<term>Carcinoma, Renal Cell (enzymology)</term>
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<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>
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<term>Niacinamide (therapeutic use)</term>
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<term>Kidney Neoplasms</term>
</keywords>
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<term>Kidney Neoplasms</term>
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<term>Kidney Neoplasms</term>
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<term>Kaplan-Meier Estimate</term>
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<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>
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<AccessionNumberList><AccessionNumber>NCT00474766</AccessionNumber>
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<GrantList CompleteYN="Y"><Grant><GrantID>P30 CA008748</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
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