Cabozantinib versus everolimus in advanced renal cell carcinoma
Identifieur interne : 003090 ( Main/Exploration ); précédent : 003089; suivant : 003091Cabozantinib versus everolimus in advanced renal cell carcinoma
Auteurs : Toni K. Choueiri ; Bernard Escudier ; Thomas Powles ; Paul Mainwaring ; Brian I. Rini ; Frede Donskov ; Hans Hammers ; Thomas E. Hutson ; Jae-Lyun Lee ; Katriina Peltola ; Bruce J. Roth ; Georg A. Bjarnason ; Lajos Géczi ; Bhumsuk Keam ; Pablo Moroto ; Daniel Y. C. Heng ; Manuela Schmidinger ; Philip W. Kantoff ; Anne Borgman ; Colin Hessel ; Christian Scheffold ; Gisela M. Schwab ; Nizar M. Tannir ; Robert J. MotzerSource :
- The New England journal of medicine [ 0028-4793 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Analyse de survie, Anilides (effets indésirables), Anilides (usage thérapeutique), Antinéoplasiques (effets indésirables), Antinéoplasiques (usage thérapeutique), Femelle, Humains, Mâle, Néphrocarcinome (mortalité), Néphrocarcinome (traitement médicamenteux), Pyridines (effets indésirables), Pyridines (usage thérapeutique), Qualité de vie, Sirolimus (analogues et dérivés), Sirolimus (effets indésirables), Sirolimus (usage thérapeutique), Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tumeurs du rein (mortalité), Tumeurs du rein (traitement médicamenteux), Évérolimus.
- MESH :
- analogues et dérivés : Sirolimus.
- effets indésirables : Anilides, Antinéoplasiques, Pyridines, Sirolimus.
- mortalité : Néphrocarcinome, Tumeurs du rein.
- traitement médicamenteux : Néphrocarcinome, Tumeurs du rein.
- usage thérapeutique : Anilides, Antinéoplasiques, Pyridines, Sirolimus.
- Adulte, Adulte d'âge moyen, Analyse de survie, Femelle, Humains, Mâle, Qualité de vie, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Évérolimus.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Anilides (adverse effects), Anilides (therapeutic use), Antineoplastic Agents (adverse effects), Antineoplastic Agents (therapeutic use), Carcinoma, Renal Cell (drug therapy), Carcinoma, Renal Cell (mortality), Disease-Free Survival, Everolimus, Female, Humans, Kidney Neoplasms (drug therapy), Kidney Neoplasms (mortality), Male, Middle Aged, Pyridines (adverse effects), Pyridines (therapeutic use), Quality of Life, Sirolimus (adverse effects), Sirolimus (analogs & derivatives), Sirolimus (therapeutic use), Survival Analysis.
- MESH :
- chemical , adverse effects : Anilides, Antineoplastic Agents, Pyridines, Sirolimus.
- chemical , analogs & derivatives : Sirolimus.
- chemical , therapeutic use : Anilides, Antineoplastic Agents, Pyridines, Sirolimus.
- drug therapy : Carcinoma, Renal Cell, Kidney Neoplasms.
- mortality : Carcinoma, Renal Cell, Kidney Neoplasms.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Everolimus, Female, Humans, Male, Middle Aged, Quality of Life, Survival Analysis.
Abstract
Cabozantinib is an oral small molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR) as well as MET and AXL; each has been implicated in metastatic renal cell carcinoma (RCC) pathobiology or development of resistance to antiangiogenic drugs. This randomized open-label phase 3 trial evaluated the efficacy of cabozantinib compared to everolimus in RCC patients who progressed after VEGFR-targeted therapy.
The trial randomized 658 patients to receive cabozantinib at a dose of 60 mg daily, or everolimus at a dose of 10 mg daily. The primary endpoint was progression-free survival. Secondary efficacy endpoints were overall survival and objective response rate.
Median progression-free survival was 7.4 months with cabozantinib and 3.8 months with everolimus. The risk of progression or death was 42% lower with cabozantinib compared to everolimus (hazard ratio, 0.58; 95% confidence interval [CI] 0.45 to 0.75; P < 0.001). Objective response rates were 21% with cabozantinib and 5% with everolimus (P < 0.001). A planned interim analysis showed that overall survival was improved with cabozantinib (hazard ratio, 0.67; 95% CI, 0.51 to 0.89; P = 0.005) but did not cross the significance boundary. Adverse events (grade 3 or 4, regardless of causality) were reported in 74% of cabozantinib patients and 65% of everolimus patients. Discontinuation of study treatment for adverse events occurred in 9.1% of cabozantinib patients and 10% of everolimus patients.
Cabozantinib improved progression-free survival compared to everolimus in RCC patients who progressed after VEGFR-targeted therapy.
Url:
DOI: 10.1056/NEJMoa1510016
PubMed: 26406150
PubMed Central: 5024539
Affiliations:
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Choueiri</name></author><author><name sortKey="Escudier, Bernard" sort="Escudier, Bernard" uniqKey="Escudier B" first="Bernard" last="Escudier">Bernard Escudier</name></author><author><name sortKey="Powles, Thomas" sort="Powles, Thomas" uniqKey="Powles T" first="Thomas" last="Powles">Thomas Powles</name></author><author><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name></author><author><name sortKey="Rini, Brian I" sort="Rini, Brian I" uniqKey="Rini B" first="Brian I." last="Rini">Brian I. Rini</name></author><author><name sortKey="Donskov, Frede" sort="Donskov, Frede" uniqKey="Donskov F" first="Frede" last="Donskov">Frede Donskov</name></author><author><name sortKey="Hammers, Hans" sort="Hammers, Hans" uniqKey="Hammers H" first="Hans" last="Hammers">Hans Hammers</name></author><author><name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name></author><author><name sortKey="Lee, Jae Lyun" sort="Lee, Jae Lyun" uniqKey="Lee J" first="Jae-Lyun" last="Lee">Jae-Lyun Lee</name></author><author><name sortKey="Peltola, Katriina" sort="Peltola, Katriina" uniqKey="Peltola K" first="Katriina" last="Peltola">Katriina Peltola</name></author><author><name sortKey="Roth, Bruce J" sort="Roth, Bruce J" uniqKey="Roth B" first="Bruce J." last="Roth">Bruce J. Roth</name></author><author><name sortKey="Bjarnason, Georg A" sort="Bjarnason, Georg A" uniqKey="Bjarnason G" first="Georg A." last="Bjarnason">Georg A. Bjarnason</name></author><author><name sortKey="Geczi, Lajos" sort="Geczi, Lajos" uniqKey="Geczi L" first="Lajos" last="Géczi">Lajos Géczi</name></author><author><name sortKey="Keam, Bhumsuk" sort="Keam, Bhumsuk" uniqKey="Keam B" first="Bhumsuk" last="Keam">Bhumsuk Keam</name></author><author><name sortKey="Moroto, Pablo" sort="Moroto, Pablo" uniqKey="Moroto P" first="Pablo" last="Moroto">Pablo Moroto</name></author><author><name sortKey="Heng, Daniel Y C" sort="Heng, Daniel Y C" uniqKey="Heng D" first="Daniel Y. C." last="Heng">Daniel Y. C. Heng</name></author><author><name sortKey="Schmidinger, Manuela" sort="Schmidinger, Manuela" uniqKey="Schmidinger M" first="Manuela" last="Schmidinger">Manuela Schmidinger</name></author><author><name sortKey="Kantoff, Philip W" sort="Kantoff, Philip W" uniqKey="Kantoff P" first="Philip W." last="Kantoff">Philip W. Kantoff</name></author><author><name sortKey="Borgman, Anne" sort="Borgman, Anne" uniqKey="Borgman A" first="Anne" last="Borgman">Anne Borgman</name></author><author><name sortKey="Hessel, Colin" sort="Hessel, Colin" uniqKey="Hessel C" first="Colin" last="Hessel">Colin Hessel</name></author><author><name sortKey="Scheffold, Christian" sort="Scheffold, Christian" uniqKey="Scheffold C" first="Christian" last="Scheffold">Christian Scheffold</name></author><author><name sortKey="Schwab, Gisela M" sort="Schwab, Gisela M" uniqKey="Schwab G" first="Gisela M." last="Schwab">Gisela M. Schwab</name></author><author><name sortKey="Tannir, Nizar M" sort="Tannir, Nizar M" uniqKey="Tannir N" first="Nizar M." last="Tannir">Nizar M. Tannir</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">The New England journal of medicine</title><idno type="ISSN">0028-4793</idno><idno type="eISSN">1533-4406</idno><imprint><date when="2015">2015</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>Anilides (adverse effects)</term><term>Anilides (therapeutic use)</term><term>Antineoplastic Agents (adverse effects)</term><term>Antineoplastic Agents (therapeutic use)</term><term>Carcinoma, Renal Cell (drug therapy)</term><term>Carcinoma, Renal Cell (mortality)</term><term>Disease-Free Survival</term><term>Everolimus</term><term>Female</term><term>Humans</term><term>Kidney Neoplasms (drug therapy)</term><term>Kidney Neoplasms (mortality)</term><term>Male</term><term>Middle Aged</term><term>Pyridines (adverse effects)</term><term>Pyridines (therapeutic use)</term><term>Quality of Life</term><term>Sirolimus (adverse effects)</term><term>Sirolimus (analogs & derivatives)</term><term>Sirolimus (therapeutic use)</term><term>Survival Analysis</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Anilides (effets indésirables)</term><term>Anilides (usage thérapeutique)</term><term>Antinéoplasiques (effets indésirables)</term><term>Antinéoplasiques (usage thérapeutique)</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Néphrocarcinome (mortalité)</term><term>Néphrocarcinome (traitement médicamenteux)</term><term>Pyridines (effets indésirables)</term><term>Pyridines (usage thérapeutique)</term><term>Qualité de vie</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>Tumeurs du rein (mortalité)</term><term>Tumeurs du rein (traitement médicamenteux)</term><term>Évérolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anilides</term><term>Antineoplastic Agents</term><term>Pyridines</term><term>Sirolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Sirolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anilides</term><term>Antineoplastic Agents</term><term>Pyridines</term><term>Sirolimus</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><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="effets indésirables" xml:lang="fr"><term>Anilides</term><term>Antinéoplasiques</term><term>Pyridines</term><term>Sirolimus</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="traitement médicamenteux" xml:lang="fr"><term>Néphrocarcinome</term><term>Tumeurs du rein</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anilides</term><term>Antinéoplasiques</term><term>Pyridines</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-Free Survival</term><term>Everolimus</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Quality of Life</term><term>Survival Analysis</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Analyse de survie</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Qualité de vie</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Survie sans rechute</term><term>Évérolimus</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">Cabozantinib is an oral small molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR) as well as MET and AXL; each has been implicated in metastatic renal cell carcinoma (RCC) pathobiology or development of resistance to antiangiogenic drugs. This randomized open-label phase 3 trial evaluated the efficacy of cabozantinib compared to everolimus in RCC patients who progressed after VEGFR-targeted therapy.</p></sec><sec id="S2"><title>Methods</title><p id="P2">The trial randomized 658 patients to receive cabozantinib at a dose of 60 mg daily, or everolimus at a dose of 10 mg daily. The primary endpoint was progression-free survival. Secondary efficacy endpoints were overall survival and objective response rate.</p></sec><sec id="S3"><title>Results</title><p id="P3">Median progression-free survival was 7.4 months with cabozantinib and 3.8 months with everolimus. The risk of progression or death was 42% lower with cabozantinib compared to everolimus (hazard ratio, 0.58; 95% confidence interval [CI] 0.45 to 0.75; P < 0.001). Objective response rates were 21% with cabozantinib and 5% with everolimus (P < 0.001). A planned interim analysis showed that overall survival was improved with cabozantinib (hazard ratio, 0.67; 95% CI, 0.51 to 0.89; P = 0.005) but did not cross the significance boundary. Adverse events (grade 3 or 4, regardless of causality) were reported in 74% of cabozantinib patients and 65% of everolimus patients. Discontinuation of study treatment for adverse events occurred in 9.1% of cabozantinib patients and 10% of everolimus patients.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">Cabozantinib improved progression-free survival compared to everolimus in RCC patients who progressed after VEGFR-targeted therapy.</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="Borgman, Anne" sort="Borgman, Anne" uniqKey="Borgman A" first="Anne" last="Borgman">Anne Borgman</name><name sortKey="Choueiri, Toni K" sort="Choueiri, Toni K" uniqKey="Choueiri T" first="Toni K." last="Choueiri">Toni K. Choueiri</name><name sortKey="Donskov, Frede" sort="Donskov, Frede" uniqKey="Donskov F" first="Frede" last="Donskov">Frede Donskov</name><name sortKey="Escudier, Bernard" sort="Escudier, Bernard" uniqKey="Escudier B" first="Bernard" last="Escudier">Bernard Escudier</name><name sortKey="Geczi, Lajos" sort="Geczi, Lajos" uniqKey="Geczi L" first="Lajos" last="Géczi">Lajos Géczi</name><name sortKey="Hammers, Hans" sort="Hammers, Hans" uniqKey="Hammers H" first="Hans" last="Hammers">Hans Hammers</name><name sortKey="Heng, Daniel Y C" sort="Heng, Daniel Y C" uniqKey="Heng D" first="Daniel Y. C." last="Heng">Daniel Y. C. Heng</name><name sortKey="Hessel, Colin" sort="Hessel, Colin" uniqKey="Hessel C" first="Colin" last="Hessel">Colin Hessel</name><name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name><name sortKey="Kantoff, Philip W" sort="Kantoff, Philip W" uniqKey="Kantoff P" first="Philip W." last="Kantoff">Philip W. Kantoff</name><name sortKey="Keam, Bhumsuk" sort="Keam, Bhumsuk" uniqKey="Keam B" first="Bhumsuk" last="Keam">Bhumsuk Keam</name><name sortKey="Lee, Jae Lyun" sort="Lee, Jae Lyun" uniqKey="Lee J" first="Jae-Lyun" last="Lee">Jae-Lyun Lee</name><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name><name sortKey="Moroto, Pablo" sort="Moroto, Pablo" uniqKey="Moroto P" first="Pablo" last="Moroto">Pablo Moroto</name><name sortKey="Motzer, Robert J" sort="Motzer, Robert J" uniqKey="Motzer R" first="Robert J." last="Motzer">Robert J. Motzer</name><name sortKey="Peltola, Katriina" sort="Peltola, Katriina" uniqKey="Peltola K" first="Katriina" last="Peltola">Katriina Peltola</name><name sortKey="Powles, Thomas" sort="Powles, Thomas" uniqKey="Powles T" first="Thomas" last="Powles">Thomas Powles</name><name sortKey="Rini, Brian I" sort="Rini, Brian I" uniqKey="Rini B" first="Brian I." last="Rini">Brian I. Rini</name><name sortKey="Roth, Bruce J" sort="Roth, Bruce J" uniqKey="Roth B" first="Bruce J." last="Roth">Bruce J. Roth</name><name sortKey="Scheffold, Christian" sort="Scheffold, Christian" uniqKey="Scheffold C" first="Christian" last="Scheffold">Christian Scheffold</name><name sortKey="Schmidinger, Manuela" sort="Schmidinger, Manuela" uniqKey="Schmidinger M" first="Manuela" last="Schmidinger">Manuela Schmidinger</name><name sortKey="Schwab, Gisela M" sort="Schwab, Gisela M" uniqKey="Schwab G" first="Gisela M." last="Schwab">Gisela M. Schwab</name><name sortKey="Tannir, Nizar M" sort="Tannir, Nizar M" uniqKey="Tannir N" first="Nizar M." last="Tannir">Nizar M. Tannir</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:26406150" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a AustralieFrV1
| This area was generated with Dilib version V0.6.33. |  |