AustralieFrV1, PascalFrancis, Corpus, bibRecord, 003702

A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma

Identifieur interne : 003702 ( PascalFrancis/Corpus ); précédent : 003701; suivant : 003703

A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma

Auteurs : F. Morschhauser ; J. F. Seymour ; H. C. Kluin-Nelemans ; A. Grigg ; M. Wolf ; M. Pfreundschuh ; H. Tilly ; J. Raemaekers ; M. B. Van T Veer ; N. Milpied ; G. Cartron ; A. Pezzutto ; A. Spencer ; F. Reyes ; M. Dreyling

Source :

Annals of oncology [ 0923-7534 ] ; 2008.

RBID : Pascal:08-0139123

Descripteurs français

Pascal (Inist)
- Homme, Essai clinique phase II, Traitement, Enzastaurine, Protein kinase C, Inhibiteur, Récidive, Résistance traitement, Lymphome centrocytique, Lymphocyte B, Protein kinase Cβ, Hémopathie lymphoïde B.

English descriptors

KwdEn :
- B cell neoplasm, B-Lymphocyte, Enzastaurin, Human, Inhibitor, Mantle cell lymphoma, Phase II trial, Protein kinase C, Protein kinase Cβ, Relapse, Treatment, Treatment resistance.

Abstract

Background: Protein kinase C beta (PKCβ), a pivotal enzyme in B-cell signaling and survival, is overexpressed in most cases of mantle cell lymphoma (MCL). Activation of P13K/AKT pathway is involved in pathogenesis of MCL. Enzastaurin, an oral serine/threonine kinase inhibitor, suppresses signaling through PKCβ/P13K/AKT pathways, induces apoptosis, reduces proliferation, and suppresses tumor-induced angiogenesis. Patients and methods: Patients with relapsed/refractory MCL, and no more than four regimens of prior therapy, received 500 mg enzastaurin, orally, once daily. Results: Sixty patients, median age 66 years (range 45-85), Eastern Cooperative Oncology Group performance status of zero to two (48% had baseline International Prognostic Index of 3-5), were enrolled. Most patients had prior CHOP-like chemotherapy and/or rituximab (median = 2 regimens). No drug-related deaths occurred. There was one case each of grade 3 anemia, diarrhea, dyspnea, vomiting, hypotension, and syncope. Fatigue was the most common toxicity. Although no objective tumor responses occurred, 22 patients (37%, 95% Cl 25% to 49%) were free from progression (FFP) for ≥3 cycles (one cycle = 28 days); 6 of 22 were FFP for >6 months. Two patients remain on treatment and FFP at >23 months. Conclusion: Freedom from progression for >6 months in six patients and a favorable toxicity profile with minimal hematological toxicity indicate that enzastaurin warrants evaluation as maintenance therapy and combination chemotherapy in MCL.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

A01	`01`	`1`		`@0 0923-7534`
A03		`1`		`@0 Ann. oncol.`
A05				`@2 19`
A06				`@2 2`
A08	`01`	`1`	`ENG`	`@1 A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma`
A11	`01`	`1`		`@1 MORSCHHAUSER (F.)`
A11	`02`	`1`		`@1 SEYMOUR (J. F.)`
A11	`03`	`1`		`@1 KLUIN-NELEMANS (H. C.)`
A11	`04`	`1`		`@1 GRIGG (A.)`
A11	`05`	`1`		`@1 WOLF (M.)`
A11	`06`	`1`		`@1 PFREUNDSCHUH (M.)`
A11	`07`	`1`		`@1 TILLY (H.)`
A11	`08`	`1`		`@1 RAEMAEKERS (J.)`
A11	`09`	`1`		`@1 VAN 'T VEER (M. B.)`
A11	`10`	`1`		`@1 MILPIED (N.)`
A11	`11`	`1`		`@1 CARTRON (G.)`
A11	`12`	`1`		`@1 PEZZUTTO (A.)`
A11	`13`	`1`		`@1 SPENCER (A.)`
A11	`14`	`1`		`@1 REYES (F.)`
A11	`15`	`1`		`@1 DREYLING (M.)`
A14	`01`			`@1 Hematology, Hopital C. Huriez Centre Hospitalier Universitaire @2 Lille @3 FRA @Z 1 aut.`
A14	`02`			`@1 Hematology, Peter Maccallum Cancer Center, East Melbourne, and University of Melbourne @3 AUS @Z 2 aut.`
A14	`03`			`@1 Hematology, University Medical Center Groningen, University of Groningen @3 NLD @Z 3 aut.`
A14	`04`			`@1 Clinical Hematology and Medical Oncology, Royal Melbourne Hospital @2 Melbourne, Victoria @3 AUS @Z 4 aut.`
A14	`05`			`@1 Onkologie, Hamatologie, Immunologie, Klinikum Kassel gmbh @2 Kassel @3 DEU @Z 5 aut.`
A14	`06`			`@1 Onkologie, Hematology, Klin Immunologie & Rheumatologie, Universitatskliniken Des Saarlandes @2 Homburg/Saar @3 DEU @Z 6 aut.`
A14	`07`			`@1 Centre Henri Becquerel @2 Rouen @3 FRA @Z 7 aut.`
A14	`08`			`@1 Hematology, University Medical Centre Nijmegen @2 Nijmegen @3 NLD @Z 8 aut.`
A14	`09`			`@1 Hematology, Erasmus Medisch Centrum @2 Rotterdam @3 NLD @Z 9 aut.`
A14	`10`			`@1 Hematology, Chru De Nantes Hotel-Dieu @2 Nantes @3 FRA @Z 10 aut.`
A14	`11`			`@1 Hematology, and Cell Therapy, Chru De Tours Hopital Bretonneau @2 Tours @3 FRA @Z 11 aut.`
A14	`12`			`@1 Med Klinic M.S.Hematologie/Oncologie, Universitatsklinikum Charite Med @2 Berlin @3 DEU @Z 12 aut.`
A14	`13`			`@1 Hematology and BMT, The Alfred Hospital @2 Melbourne @3 AUS @Z 13 aut.`
A14	`14`			`@1 Clinical Hematology, Hopital Henri Mondor @2 Creteil @3 FRA @Z 14 aut.`
A14	`15`			`@1 Klinikum Grosshadern der Ludwig-Maximillans-Universitat @2 Munchen @3 DEU @Z 15 aut.`
A20				`@1 247-253`
A21				`@1 2008`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 22429 @5 354000161905310080`
A44				`@0 0000 @1 © 2008 INIST-CNRS. All rights reserved.`
A45				`@0 40 ref.`
A47	`01`	`1`		`@0 08-0139123`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Annals of oncology`
A66	`01`			`@0 GBR`
C01	`01`		`ENG`	@0 Background: Protein kinase C beta (PKCβ), a pivotal enzyme in B-cell signaling and survival, is overexpressed in most cases of mantle cell lymphoma (MCL). Activation of P13K/AKT pathway is involved in pathogenesis of MCL. Enzastaurin, an oral serine/threonine kinase inhibitor, suppresses signaling through PKCβ/P13K/AKT pathways, induces apoptosis, reduces proliferation, and suppresses tumor-induced angiogenesis. Patients and methods: Patients with relapsed/refractory MCL, and no more than four regimens of prior therapy, received 500 mg enzastaurin, orally, once daily. Results: Sixty patients, median age 66 years (range 45-85), Eastern Cooperative Oncology Group performance status of zero to two (48% had baseline International Prognostic Index of 3-5), were enrolled. Most patients had prior CHOP-like chemotherapy and/or rituximab (median = 2 regimens). No drug-related deaths occurred. There was one case each of grade 3 anemia, diarrhea, dyspnea, vomiting, hypotension, and syncope. Fatigue was the most common toxicity. Although no objective tumor responses occurred, 22 patients (37%, 95% Cl 25% to 49%) were free from progression (FFP) for ≥3 cycles (one cycle = 28 days); 6 of 22 were FFP for >6 months. Two patients remain on treatment and FFP at >23 months. Conclusion: Freedom from progression for >6 months in six patients and a favorable toxicity profile with minimal hematological toxicity indicate that enzastaurin warrants evaluation as maintenance therapy and combination chemotherapy in MCL.
C02	`01`	`X`		`@0 002B02R`
C02	`02`	`X`		`@0 002B19B`
C03	`01`	`X`	`FRE`	`@0 Homme @5 01`
C03	`01`	`X`	`ENG`	`@0 Human @5 01`
C03	`01`	`X`	`SPA`	`@0 Hombre @5 01`
C03	`02`	`X`	`FRE`	`@0 Essai clinique phase II @5 02`
C03	`02`	`X`	`ENG`	`@0 Phase II trial @5 02`
C03	`02`	`X`	`SPA`	`@0 Ensayo clínico fase II @5 02`
C03	`03`	`X`	`FRE`	`@0 Traitement @5 03`
C03	`03`	`X`	`ENG`	`@0 Treatment @5 03`
C03	`03`	`X`	`SPA`	`@0 Tratamiento @5 03`
C03	`04`	`X`	`FRE`	`@0 Enzastaurine @2 FR @5 04`
C03	`04`	`X`	`ENG`	`@0 Enzastaurin @2 FR @5 04`
C03	`04`	`X`	`SPA`	`@0 Enzastaurina @2 FR @5 04`
C03	`05`	`X`	`FRE`	`@0 Protein kinase C @2 FE @5 05`
C03	`05`	`X`	`ENG`	`@0 Protein kinase C @2 FE @5 05`
C03	`05`	`X`	`SPA`	`@0 Protein kinase C @2 FE @5 05`
C03	`06`	`X`	`FRE`	`@0 Inhibiteur @5 06`
C03	`06`	`X`	`ENG`	`@0 Inhibitor @5 06`
C03	`06`	`X`	`SPA`	`@0 Inhibidor @5 06`
C03	`07`	`X`	`FRE`	`@0 Récidive @5 07`
C03	`07`	`X`	`ENG`	`@0 Relapse @5 07`
C03	`07`	`X`	`SPA`	`@0 Recaida @5 07`
C03	`08`	`X`	`FRE`	`@0 Résistance traitement @5 08`
C03	`08`	`X`	`ENG`	`@0 Treatment resistance @5 08`
C03	`08`	`X`	`SPA`	`@0 Resistencia tratamiento @5 08`
C03	`09`	`X`	`FRE`	`@0 Lymphome centrocytique @2 NM @5 09`
C03	`09`	`X`	`ENG`	`@0 Mantle cell lymphoma @2 NM @5 09`
C03	`09`	`X`	`SPA`	`@0 Linfoma centrocítico @2 NM @5 09`
C03	`10`	`X`	`FRE`	`@0 Lymphocyte B @5 23`
C03	`10`	`X`	`ENG`	`@0 B-Lymphocyte @5 23`
C03	`10`	`X`	`SPA`	`@0 Linfocito B @5 23`
C03	`11`	`X`	`FRE`	`@0 Protein kinase Cβ @4 CD @5 97`
C03	`11`	`X`	`ENG`	`@0 Protein kinase Cβ @4 CD @5 97`
C03	`12`	`X`	`FRE`	`@0 Hémopathie lymphoïde B @4 CD @5 98`
C03	`12`	`X`	`ENG`	`@0 B cell neoplasm @4 CD @5 98`
C07	`01`	`X`	`FRE`	`@0 Transferases @2 FE`
C07	`01`	`X`	`ENG`	`@0 Transferases @2 FE`
C07	`01`	`X`	`SPA`	`@0 Transferases @2 FE`
C07	`02`	`X`	`FRE`	`@0 Enzyme @2 FE`
C07	`02`	`X`	`ENG`	`@0 Enzyme @2 FE`
C07	`02`	`X`	`SPA`	`@0 Enzima @2 FE`
C07	`03`	`X`	`FRE`	`@0 Hémopathie maligne @2 NM @5 37`
C07	`03`	`X`	`ENG`	`@0 Malignant hemopathy @2 NM @5 37`
C07	`03`	`X`	`SPA`	`@0 Hemopatía maligna @2 NM @5 37`
C07	`04`	`X`	`FRE`	`@0 Cancer @2 NM`
C07	`04`	`X`	`ENG`	`@0 Cancer @2 NM`
C07	`04`	`X`	`SPA`	`@0 Cáncer @2 NM`
C07	`05`	`X`	`FRE`	`@0 Lymphome non hodgkinien @5 38`
C07	`05`	`X`	`ENG`	`@0 Non Hodgkin lymphoma @5 38`
C07	`05`	`X`	`SPA`	`@0 Linfoma no Hodgkin @5 38`
C07	`06`	`X`	`FRE`	`@0 Syndrome lymphoprolifératif @2 NM @5 39`
C07	`06`	`X`	`ENG`	`@0 Lymphoproliferative syndrome @2 NM @5 39`
C07	`06`	`X`	`SPA`	`@0 Linfoproliferativo síndrome @2 NM @5 39`
N21				`@1 084`

Format Inist (serveur)

NO :	PASCAL 08-0139123 INIST
ET :	A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma
AU :	MORSCHHAUSER (F.); SEYMOUR (J. F.); KLUIN-NELEMANS (H. C.); GRIGG (A.); WOLF (M.); PFREUNDSCHUH (M.); TILLY (H.); RAEMAEKERS (J.); VAN 'T VEER (M. B.); MILPIED (N.); CARTRON (G.); PEZZUTTO (A.); SPENCER (A.); REYES (F.); DREYLING (M.)
AF :	Hematology, Hopital C. Huriez Centre Hospitalier Universitaire/Lille/France (1 aut.); Hematology, Peter Maccallum Cancer Center, East Melbourne, and University of Melbourne/Australie (2 aut.); Hematology, University Medical Center Groningen, University of Groningen/Pays-Bas (3 aut.); Clinical Hematology and Medical Oncology, Royal Melbourne Hospital/Melbourne, Victoria/Australie (4 aut.); Onkologie, Hamatologie, Immunologie, Klinikum Kassel gmbh/Kassel/Allemagne (5 aut.); Onkologie, Hematology, Klin Immunologie & Rheumatologie, Universitatskliniken Des Saarlandes/Homburg/Saar/Allemagne (6 aut.); Centre Henri Becquerel/Rouen/France (7 aut.); Hematology, University Medical Centre Nijmegen/Nijmegen/Pays-Bas (8 aut.); Hematology, Erasmus Medisch Centrum/Rotterdam/Pays-Bas (9 aut.); Hematology, Chru De Nantes Hotel-Dieu/Nantes/France (10 aut.); Hematology, and Cell Therapy, Chru De Tours Hopital Bretonneau/Tours/France (11 aut.); Med Klinic M.S.Hematologie/Oncologie, Universitatsklinikum Charite Med/Berlin/Allemagne (12 aut.); Hematology and BMT, The Alfred Hospital/Melbourne/Australie (13 aut.); Clinical Hematology, Hopital Henri Mondor/Creteil/France (14 aut.); Klinikum Grosshadern der Ludwig-Maximillans-Universitat/Munchen/Allemagne (15 aut.)
DT :	Publication en série; Niveau analytique
SO :	Annals of oncology; ISSN 0923-7534; Royaume-Uni; Da. 2008; Vol. 19; No. 2; Pp. 247-253; Bibl. 40 ref.
LA :	Anglais
EA :	Background: Protein kinase C beta (PKCβ), a pivotal enzyme in B-cell signaling and survival, is overexpressed in most cases of mantle cell lymphoma (MCL). Activation of P13K/AKT pathway is involved in pathogenesis of MCL. Enzastaurin, an oral serine/threonine kinase inhibitor, suppresses signaling through PKCβ/P13K/AKT pathways, induces apoptosis, reduces proliferation, and suppresses tumor-induced angiogenesis. Patients and methods: Patients with relapsed/refractory MCL, and no more than four regimens of prior therapy, received 500 mg enzastaurin, orally, once daily. Results: Sixty patients, median age 66 years (range 45-85), Eastern Cooperative Oncology Group performance status of zero to two (48% had baseline International Prognostic Index of 3-5), were enrolled. Most patients had prior CHOP-like chemotherapy and/or rituximab (median = 2 regimens). No drug-related deaths occurred. There was one case each of grade 3 anemia, diarrhea, dyspnea, vomiting, hypotension, and syncope. Fatigue was the most common toxicity. Although no objective tumor responses occurred, 22 patients (37%, 95% Cl 25% to 49%) were free from progression (FFP) for ≥3 cycles (one cycle = 28 days); 6 of 22 were FFP for >6 months. Two patients remain on treatment and FFP at >23 months. Conclusion: Freedom from progression for >6 months in six patients and a favorable toxicity profile with minimal hematological toxicity indicate that enzastaurin warrants evaluation as maintenance therapy and combination chemotherapy in MCL.
CC :	002B02R; 002B19B
FD :	Homme; Essai clinique phase II; Traitement; Enzastaurine; Protein kinase C; Inhibiteur; Récidive; Résistance traitement; Lymphome centrocytique; Lymphocyte B; Protein kinase Cβ; Hémopathie lymphoïde B
FG :	Transferases; Enzyme; Hémopathie maligne; Cancer; Lymphome non hodgkinien; Syndrome lymphoprolifératif
ED :	Human; Phase II trial; Treatment; Enzastaurin; Protein kinase C; Inhibitor; Relapse; Treatment resistance; Mantle cell lymphoma; B-Lymphocyte; Protein kinase Cβ; B cell neoplasm
EG :	Transferases; Enzyme; Malignant hemopathy; Cancer; Non Hodgkin lymphoma; Lymphoproliferative syndrome
SD :	Hombre; Ensayo clínico fase II; Tratamiento; Enzastaurina; Protein kinase C; Inhibidor; Recaida; Resistencia tratamiento; Linfoma centrocítico; Linfocito B
LO :	INIST-22429.354000161905310080
ID :	08-0139123

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Pascal:08-0139123

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma</title>
<author><name sortKey="Morschhauser, F" sort="Morschhauser, F" uniqKey="Morschhauser F" first="F." last="Morschhauser">F. Morschhauser</name>
<affiliation><inist:fA14 i1="01"><s1>Hematology, Hopital C. Huriez Centre Hospitalier Universitaire</s1>
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<author><name sortKey="Seymour, J F" sort="Seymour, J F" uniqKey="Seymour J" first="J. F." last="Seymour">J. F. Seymour</name>
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</affiliation>
</author>
<author><name sortKey="Kluin Nelemans, H C" sort="Kluin Nelemans, H C" uniqKey="Kluin Nelemans H" first="H. C." last="Kluin-Nelemans">H. C. Kluin-Nelemans</name>
<affiliation><inist:fA14 i1="03"><s1>Hematology, University Medical Center Groningen, University of Groningen</s1>
<s3>NLD</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Grigg, A" sort="Grigg, A" uniqKey="Grigg A" first="A." last="Grigg">A. Grigg</name>
<affiliation><inist:fA14 i1="04"><s1>Clinical Hematology and Medical Oncology, Royal Melbourne Hospital</s1>
<s2>Melbourne, Victoria</s2>
<s3>AUS</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Wolf, M" sort="Wolf, M" uniqKey="Wolf M" first="M." last="Wolf">M. Wolf</name>
<affiliation><inist:fA14 i1="05"><s1>Onkologie, Hamatologie, Immunologie, Klinikum Kassel gmbh</s1>
<s2>Kassel</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Pfreundschuh, M" sort="Pfreundschuh, M" uniqKey="Pfreundschuh M" first="M." last="Pfreundschuh">M. Pfreundschuh</name>
<affiliation><inist:fA14 i1="06"><s1>Onkologie, Hematology, Klin Immunologie & Rheumatologie, Universitatskliniken Des Saarlandes</s1>
<s2>Homburg/Saar</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Tilly, H" sort="Tilly, H" uniqKey="Tilly H" first="H." last="Tilly">H. Tilly</name>
<affiliation><inist:fA14 i1="07"><s1>Centre Henri Becquerel</s1>
<s2>Rouen</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Raemaekers, J" sort="Raemaekers, J" uniqKey="Raemaekers J" first="J." last="Raemaekers">J. Raemaekers</name>
<affiliation><inist:fA14 i1="08"><s1>Hematology, University Medical Centre Nijmegen</s1>
<s2>Nijmegen</s2>
<s3>NLD</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Van T Veer, M B" sort="Van T Veer, M B" uniqKey="Van T Veer M" first="M. B." last="Van T Veer">M. B. Van T Veer</name>
<affiliation><inist:fA14 i1="09"><s1>Hematology, Erasmus Medisch Centrum</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Milpied, N" sort="Milpied, N" uniqKey="Milpied N" first="N." last="Milpied">N. Milpied</name>
<affiliation><inist:fA14 i1="10"><s1>Hematology, Chru De Nantes Hotel-Dieu</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Cartron, G" sort="Cartron, G" uniqKey="Cartron G" first="G." last="Cartron">G. Cartron</name>
<affiliation><inist:fA14 i1="11"><s1>Hematology, and Cell Therapy, Chru De Tours Hopital Bretonneau</s1>
<s2>Tours</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Pezzutto, A" sort="Pezzutto, A" uniqKey="Pezzutto A" first="A." last="Pezzutto">A. Pezzutto</name>
<affiliation><inist:fA14 i1="12"><s1>Med Klinic M.S.Hematologie/Oncologie, Universitatsklinikum Charite Med</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Spencer, A" sort="Spencer, A" uniqKey="Spencer A" first="A." last="Spencer">A. Spencer</name>
<affiliation><inist:fA14 i1="13"><s1>Hematology and BMT, The Alfred Hospital</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Reyes, F" sort="Reyes, F" uniqKey="Reyes F" first="F." last="Reyes">F. Reyes</name>
<affiliation><inist:fA14 i1="14"><s1>Clinical Hematology, Hopital Henri Mondor</s1>
<s2>Creteil</s2>
<s3>FRA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Dreyling, M" sort="Dreyling, M" uniqKey="Dreyling M" first="M." last="Dreyling">M. Dreyling</name>
<affiliation><inist:fA14 i1="15"><s1>Klinikum Grosshadern der Ludwig-Maximillans-Universitat</s1>
<s2>Munchen</s2>
<s3>DEU</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>B cell neoplasm</term>
<term>B-Lymphocyte</term>
<term>Enzastaurin</term>
<term>Human</term>
<term>Inhibitor</term>
<term>Mantle cell lymphoma</term>
<term>Phase II trial</term>
<term>Protein kinase C</term>
<term>Protein kinase Cβ</term>
<term>Relapse</term>
<term>Treatment</term>
<term>Treatment resistance</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Homme</term>
<term>Essai clinique phase II</term>
<term>Traitement</term>
<term>Enzastaurine</term>
<term>Protein kinase C</term>
<term>Inhibiteur</term>
<term>Récidive</term>
<term>Résistance traitement</term>
<term>Lymphome centrocytique</term>
<term>Lymphocyte B</term>
<term>Protein kinase Cβ</term>
<term>Hémopathie lymphoïde B</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background: Protein kinase C beta (PKCβ), a pivotal enzyme in B-cell signaling and survival, is overexpressed in most cases of mantle cell lymphoma (MCL). Activation of P13K/AKT pathway is involved in pathogenesis of MCL. Enzastaurin, an oral serine/threonine kinase inhibitor, suppresses signaling through PKCβ/P13K/AKT pathways, induces apoptosis, reduces proliferation, and suppresses tumor-induced angiogenesis. Patients and methods: Patients with relapsed/refractory MCL, and no more than four regimens of prior therapy, received 500 mg enzastaurin, orally, once daily. Results: Sixty patients, median age 66 years (range 45-85), Eastern Cooperative Oncology Group performance status of zero to two (48% had baseline International Prognostic Index of 3-5), were enrolled. Most patients had prior CHOP-like chemotherapy and/or rituximab (median = 2 regimens). No drug-related deaths occurred. There was one case each of grade 3 anemia, diarrhea, dyspnea, vomiting, hypotension, and syncope. Fatigue was the most common toxicity. Although no objective tumor responses occurred, 22 patients (37%, 95% Cl 25% to 49%) were free from progression (FFP) for ≥3 cycles (one cycle = 28 days); 6 of 22 were FFP for >6 months. Two patients remain on treatment and FFP at >23 months. Conclusion: Freedom from progression for >6 months in six patients and a favorable toxicity profile with minimal hematological toxicity indicate that enzastaurin warrants evaluation as maintenance therapy and combination chemotherapy in MCL.</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0923-7534</s0>
</fA01>
<fA03 i2="1"><s0>Ann. oncol.</s0>
</fA03>
<fA05><s2>19</s2>
</fA05>
<fA06><s2>2</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>MORSCHHAUSER (F.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>SEYMOUR (J. F.)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>KLUIN-NELEMANS (H. C.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>GRIGG (A.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>WOLF (M.)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>PFREUNDSCHUH (M.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>TILLY (H.)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>RAEMAEKERS (J.)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>VAN 'T VEER (M. B.)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>MILPIED (N.)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>CARTRON (G.)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>PEZZUTTO (A.)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>SPENCER (A.)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>REYES (F.)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>DREYLING (M.)</s1>
</fA11>
<fA14 i1="01"><s1>Hematology, Hopital C. Huriez Centre Hospitalier Universitaire</s1>
<s2>Lille</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Hematology, Peter Maccallum Cancer Center, East Melbourne, and University of Melbourne</s1>
<s3>AUS</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Hematology, University Medical Center Groningen, University of Groningen</s1>
<s3>NLD</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Clinical Hematology and Medical Oncology, Royal Melbourne Hospital</s1>
<s2>Melbourne, Victoria</s2>
<s3>AUS</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Onkologie, Hamatologie, Immunologie, Klinikum Kassel gmbh</s1>
<s2>Kassel</s2>
<s3>DEU</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Onkologie, Hematology, Klin Immunologie & Rheumatologie, Universitatskliniken Des Saarlandes</s1>
<s2>Homburg/Saar</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Centre Henri Becquerel</s1>
<s2>Rouen</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Hematology, University Medical Centre Nijmegen</s1>
<s2>Nijmegen</s2>
<s3>NLD</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Hematology, Erasmus Medisch Centrum</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Hematology, Chru De Nantes Hotel-Dieu</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Hematology, and Cell Therapy, Chru De Tours Hopital Bretonneau</s1>
<s2>Tours</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Med Klinic M.S.Hematologie/Oncologie, Universitatsklinikum Charite Med</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>Hematology and BMT, The Alfred Hospital</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>Clinical Hematology, Hopital Henri Mondor</s1>
<s2>Creteil</s2>
<s3>FRA</s3>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Klinikum Grosshadern der Ludwig-Maximillans-Universitat</s1>
<s2>Munchen</s2>
<s3>DEU</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA20><s1>247-253</s1>
</fA20>
<fA21><s1>2008</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>22429</s2>
<s5>354000161905310080</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2008 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>40 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>08-0139123</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Annals of oncology</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Background: Protein kinase C beta (PKCβ), a pivotal enzyme in B-cell signaling and survival, is overexpressed in most cases of mantle cell lymphoma (MCL). Activation of P13K/AKT pathway is involved in pathogenesis of MCL. Enzastaurin, an oral serine/threonine kinase inhibitor, suppresses signaling through PKCβ/P13K/AKT pathways, induces apoptosis, reduces proliferation, and suppresses tumor-induced angiogenesis. Patients and methods: Patients with relapsed/refractory MCL, and no more than four regimens of prior therapy, received 500 mg enzastaurin, orally, once daily. Results: Sixty patients, median age 66 years (range 45-85), Eastern Cooperative Oncology Group performance status of zero to two (48% had baseline International Prognostic Index of 3-5), were enrolled. Most patients had prior CHOP-like chemotherapy and/or rituximab (median = 2 regimens). No drug-related deaths occurred. There was one case each of grade 3 anemia, diarrhea, dyspnea, vomiting, hypotension, and syncope. Fatigue was the most common toxicity. Although no objective tumor responses occurred, 22 patients (37%, 95% Cl 25% to 49%) were free from progression (FFP) for ≥3 cycles (one cycle = 28 days); 6 of 22 were FFP for >6 months. Two patients remain on treatment and FFP at >23 months. Conclusion: Freedom from progression for >6 months in six patients and a favorable toxicity profile with minimal hematological toxicity indicate that enzastaurin warrants evaluation as maintenance therapy and combination chemotherapy in MCL.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02R</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B19B</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Homme</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Human</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Hombre</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Essai clinique phase II</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Phase II trial</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Ensayo clínico fase II</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Traitement</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Treatment</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Enzastaurine</s0>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Enzastaurin</s0>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Enzastaurina</s0>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Protein kinase C</s0>
<s2>FE</s2>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Protein kinase C</s0>
<s2>FE</s2>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Protein kinase C</s0>
<s2>FE</s2>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Inhibiteur</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Inhibitor</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Inhibidor</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Récidive</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Relapse</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Recaida</s0>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Résistance traitement</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Treatment resistance</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Resistencia tratamiento</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Lymphome centrocytique</s0>
<s2>NM</s2>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Mantle cell lymphoma</s0>
<s2>NM</s2>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Linfoma centrocítico</s0>
<s2>NM</s2>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Lymphocyte B</s0>
<s5>23</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>B-Lymphocyte</s0>
<s5>23</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Linfocito B</s0>
<s5>23</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Protein kinase Cβ</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Protein kinase Cβ</s0>
<s4>CD</s4>
<s5>97</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE"><s0>Hémopathie lymphoïde B</s0>
<s4>CD</s4>
<s5>98</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG"><s0>B cell neoplasm</s0>
<s4>CD</s4>
<s5>98</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Transferases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Hémopathie maligne</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Malignant hemopathy</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Hemopatía maligna</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
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<fC07 i1="05" i2="X" l="FRE"><s0>Lymphome non hodgkinien</s0>
<s5>38</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Non Hodgkin lymphoma</s0>
<s5>38</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Linfoma no Hodgkin</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Syndrome lymphoprolifératif</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Lymphoproliferative syndrome</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Linfoproliferativo síndrome</s0>
<s2>NM</s2>
<s5>39</s5>
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<server><NO>PASCAL 08-0139123 INIST</NO>
<ET>A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma</ET>
<AU>MORSCHHAUSER (F.); SEYMOUR (J. F.); KLUIN-NELEMANS (H. C.); GRIGG (A.); WOLF (M.); PFREUNDSCHUH (M.); TILLY (H.); RAEMAEKERS (J.); VAN 'T VEER (M. B.); MILPIED (N.); CARTRON (G.); PEZZUTTO (A.); SPENCER (A.); REYES (F.); DREYLING (M.)</AU>
<AF>Hematology, Hopital C. Huriez Centre Hospitalier Universitaire/Lille/France (1 aut.); Hematology, Peter Maccallum Cancer Center, East Melbourne, and University of Melbourne/Australie (2 aut.); Hematology, University Medical Center Groningen, University of Groningen/Pays-Bas (3 aut.); Clinical Hematology and Medical Oncology, Royal Melbourne Hospital/Melbourne, Victoria/Australie (4 aut.); Onkologie, Hamatologie, Immunologie, Klinikum Kassel gmbh/Kassel/Allemagne (5 aut.); Onkologie, Hematology, Klin Immunologie & Rheumatologie, Universitatskliniken Des Saarlandes/Homburg/Saar/Allemagne (6 aut.); Centre Henri Becquerel/Rouen/France (7 aut.); Hematology, University Medical Centre Nijmegen/Nijmegen/Pays-Bas (8 aut.); Hematology, Erasmus Medisch Centrum/Rotterdam/Pays-Bas (9 aut.); Hematology, Chru De Nantes Hotel-Dieu/Nantes/France (10 aut.); Hematology, and Cell Therapy, Chru De Tours Hopital Bretonneau/Tours/France (11 aut.); Med Klinic M.S.Hematologie/Oncologie, Universitatsklinikum Charite Med/Berlin/Allemagne (12 aut.); Hematology and BMT, The Alfred Hospital/Melbourne/Australie (13 aut.); Clinical Hematology, Hopital Henri Mondor/Creteil/France (14 aut.); Klinikum Grosshadern der Ludwig-Maximillans-Universitat/Munchen/Allemagne (15 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Annals of oncology; ISSN 0923-7534; Royaume-Uni; Da. 2008; Vol. 19; No. 2; Pp. 247-253; Bibl. 40 ref.</SO>
<LA>Anglais</LA>
<EA>Background: Protein kinase C beta (PKCβ), a pivotal enzyme in B-cell signaling and survival, is overexpressed in most cases of mantle cell lymphoma (MCL). Activation of P13K/AKT pathway is involved in pathogenesis of MCL. Enzastaurin, an oral serine/threonine kinase inhibitor, suppresses signaling through PKCβ/P13K/AKT pathways, induces apoptosis, reduces proliferation, and suppresses tumor-induced angiogenesis. Patients and methods: Patients with relapsed/refractory MCL, and no more than four regimens of prior therapy, received 500 mg enzastaurin, orally, once daily. Results: Sixty patients, median age 66 years (range 45-85), Eastern Cooperative Oncology Group performance status of zero to two (48% had baseline International Prognostic Index of 3-5), were enrolled. Most patients had prior CHOP-like chemotherapy and/or rituximab (median = 2 regimens). No drug-related deaths occurred. There was one case each of grade 3 anemia, diarrhea, dyspnea, vomiting, hypotension, and syncope. Fatigue was the most common toxicity. Although no objective tumor responses occurred, 22 patients (37%, 95% Cl 25% to 49%) were free from progression (FFP) for ≥3 cycles (one cycle = 28 days); 6 of 22 were FFP for >6 months. Two patients remain on treatment and FFP at >23 months. Conclusion: Freedom from progression for >6 months in six patients and a favorable toxicity profile with minimal hematological toxicity indicate that enzastaurin warrants evaluation as maintenance therapy and combination chemotherapy in MCL.</EA>
<CC>002B02R; 002B19B</CC>
<FD>Homme; Essai clinique phase II; Traitement; Enzastaurine; Protein kinase C; Inhibiteur; Récidive; Résistance traitement; Lymphome centrocytique; Lymphocyte B; Protein kinase Cβ; Hémopathie lymphoïde B</FD>
<FG>Transferases; Enzyme; Hémopathie maligne; Cancer; Lymphome non hodgkinien; Syndrome lymphoprolifératif</FG>
<ED>Human; Phase II trial; Treatment; Enzastaurin; Protein kinase C; Inhibitor; Relapse; Treatment resistance; Mantle cell lymphoma; B-Lymphocyte; Protein kinase Cβ; B cell neoplasm</ED>
<EG>Transferases; Enzyme; Malignant hemopathy; Cancer; Non Hodgkin lymphoma; Lymphoproliferative syndrome</EG>
<SD>Hombre; Ensayo clínico fase II; Tratamiento; Enzastaurina; Protein kinase C; Inhibidor; Recaida; Resistencia tratamiento; Linfoma centrocítico; Linfocito B</SD>
<LO>INIST-22429.354000161905310080</LO>
<ID>08-0139123</ID>
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A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma

A phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory mantle cell lymphoma

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