Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma
Identifieur interne : 007067 ( Main/Exploration ); précédent : 007066; suivant : 007068Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma
Auteurs : F. Morschhauser [France] ; P. Marlton [Australie] ; U. Vitolo [Italie] ; O. Lindén [Suède] ; J. F. Seymour [Australie] ; M. Crump [Canada] ; B. Coiffier [France] ; R. Foà [Italie] ; E. Wassner [Suisse] ; H.-U. Burger [Suisse] ; B. Brennan [Suisse] ; M. Mendila [Suisse]Source :
- Annals of Oncology [ 0923-7534 ] ; 2010-09.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
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Abstract
Background: Ocrelizumab is a humanized anti-CD20 antibody with increased antibody-dependent cellular cytotoxicity compared with rituximab. This phase I/II study evaluated its safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy. Design and methods: Forty-seven patients were treated in three dose cohorts and received eight infusions every 3 weeks: cohort A, 200 mg/m2 (n = 15); cohort B, 375 mg/m2 (n = 16); cohort C, first dose 375 mg/m2, seven subsequent doses of 750 mg/m2 (n = 16). Patients were assessed for safety, efficacy, pharmacodynamics and pharmacokinetics. Results: The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received a median of 2 (range 1–6) prior regimens. Ocrelizumab was well tolerated with grade 3/4 toxicity occurring in 9% of patients. The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event. The objective response rate was 38% and was similar in patients with low-affinity and high-affinity variants of the Fcγ receptor IIIa (FcγRIIIa). With follow-up of ∼28 months, the median progression-free survival was 11.4 months. Conclusion: Ocrelizumab demonstrated activity in patients with relapsed/refractory FL following prior rituximab treatment, with safety similar to rituximab although adverse events appeared milder.
Url:
DOI: 10.1093/annonc/mdq027
Affiliations:
- Australie, Canada, France, Italie, Suisse, Suède
- Hauts-de-France, Latium, Nord-Pas-de-Calais, Piémont, Victoria (État)
- Lille, Melbourne, Rome, Turin
- Université de Melbourne
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Morschhauser</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Department of Hematology, Claude Huriez Hospital, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation><affiliation wicri:level="1"><country wicri:rule="url">France</country></affiliation><affiliation><wicri:noCountry code="syntax">???</wicri:noCountry></affiliation><affiliation wicri:level="1"><country wicri:rule="url">France</country></affiliation></author><author><name sortKey="Marlton, P" sort="Marlton, P" uniqKey="Marlton P" first="P." last="Marlton">P. Marlton</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Clinical Hematology and Medical Oncology, Princess Alexandra Hospital, Brisbane</wicri:regionArea><wicri:noRegion>Brisbane</wicri:noRegion></affiliation></author><author><name sortKey="Vitolo, U" sort="Vitolo, U" uniqKey="Vitolo U" first="U." last="Vitolo">U. Vitolo</name><affiliation wicri:level="3"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Hematology, San Giovanni Battista Hospital, Turin</wicri:regionArea><placeName><settlement type="city">Turin</settlement><region type="région" nuts="2">Piémont</region></placeName></affiliation></author><author><name sortKey="Linden, O" sort="Linden, O" uniqKey="Linden O" first="O." last="Lindén">O. Lindén</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Oncology, Lund University Hospital, Lund</wicri:regionArea><wicri:noRegion>Lund</wicri:noRegion></affiliation></author><author><name sortKey="Seymour, J F" sort="Seymour, J F" uniqKey="Seymour J" first="J. F." last="Seymour">J. F. Seymour</name><affiliation wicri:level="4"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Hematology and Medical Oncology, Peter MacCallum Cancer Institute and University of Melbourne, Victoria</wicri:regionArea><orgName type="university">Université de Melbourne</orgName><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Crump, M" sort="Crump, M" uniqKey="Crump M" first="M." last="Crump">M. Crump</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medical Oncology, Princess Margaret Hospital, Toronto</wicri:regionArea><wicri:noRegion>Toronto</wicri:noRegion></affiliation></author><author><name sortKey="Coiffier, B" sort="Coiffier, B" uniqKey="Coiffier B" first="B." last="Coiffier">B. Coiffier</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre Bénite</wicri:regionArea><wicri:noRegion>Pierre Bénite</wicri:noRegion><wicri:noRegion>Pierre Bénite</wicri:noRegion></affiliation></author><author><name sortKey="Foa, R" sort="Foa, R" uniqKey="Foa R" first="R." last="Foà">R. Foà</name><affiliation wicri:level="3"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Cellular Biotechnologies and Hematology, ‘Sapienza University’, Rome</wicri:regionArea><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Wassner, E" sort="Wassner, E" uniqKey="Wassner E" first="E." last="Wassner">E. Wassner</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Burger, H U" sort="Burger, H U" uniqKey="Burger H" first="H.-U." last="Burger">H.-U. Burger</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Brennan, B" sort="Brennan, B" uniqKey="Brennan B" first="B." last="Brennan">B. Brennan</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Mendila, M" sort="Mendila, M" uniqKey="Mendila M" first="M." last="Mendila">M. Mendila</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2010-09">2010-09</date><biblScope unit="volume">21</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1870">1870</biblScope><biblScope unit="page" to="1876">1876</biblScope></imprint><idno type="ISSN">0923-7534</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Anti-CD20</term><term>Antibody-dependent cell cytotoxicity</term><term>B cell neoplasm</term><term>Follicular lymphoma</term><term>Human</term><term>Lymphoid neoplasm</term><term>Monoclonal antibody</term><term>Ocrelizumab</term><term>Patient</term><term>Phase I trial</term><term>Phase II trial</term><term>Relapse</term><term>Treatment</term><term>Treatment resistance</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Anti-CD20</term><term>Anticorps monoclonal</term><term>Essai clinique phase I</term><term>Essai clinique phase II</term><term>Homme</term><term>Hémopathie lymphoïde B</term><term>Hémopathie maligne lymphoïde</term><term>Lymphome folliculaire</term><term>Malade</term><term>Ocrélizumab</term><term>Réaction ADCC</term><term>Récidive</term><term>Résistance traitement</term><term>Traitement</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract">Background: Ocrelizumab is a humanized anti-CD20 antibody with increased antibody-dependent cellular cytotoxicity compared with rituximab. This phase I/II study evaluated its safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy. Design and methods: Forty-seven patients were treated in three dose cohorts and received eight infusions every 3 weeks: cohort A, 200 mg/m2 (n = 15); cohort B, 375 mg/m2 (n = 16); cohort C, first dose 375 mg/m2, seven subsequent doses of 750 mg/m2 (n = 16). Patients were assessed for safety, efficacy, pharmacodynamics and pharmacokinetics. Results: The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received a median of 2 (range 1–6) prior regimens. Ocrelizumab was well tolerated with grade 3/4 toxicity occurring in 9% of patients. The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event. The objective response rate was 38% and was similar in patients with low-affinity and high-affinity variants of the Fcγ receptor IIIa (FcγRIIIa). With follow-up of ∼28 months, the median progression-free survival was 11.4 months. Conclusion: Ocrelizumab demonstrated activity in patients with relapsed/refractory FL following prior rituximab treatment, with safety similar to rituximab although adverse events appeared milder.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li><li>Italie</li><li>Suisse</li><li>Suède</li></country><region><li>Hauts-de-France</li><li>Latium</li><li>Nord-Pas-de-Calais</li><li>Piémont</li><li>Victoria (État)</li></region><settlement><li>Lille</li><li>Melbourne</li><li>Rome</li><li>Turin</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="France"><region name="Hauts-de-France"><name sortKey="Morschhauser, F" sort="Morschhauser, F" uniqKey="Morschhauser F" first="F." last="Morschhauser">F. Morschhauser</name></region><name sortKey="Coiffier, B" sort="Coiffier, B" uniqKey="Coiffier B" first="B." last="Coiffier">B. Coiffier</name><name sortKey="Morschhauser, F" sort="Morschhauser, F" uniqKey="Morschhauser F" first="F." last="Morschhauser">F. Morschhauser</name><name sortKey="Morschhauser, F" sort="Morschhauser, F" uniqKey="Morschhauser F" first="F." last="Morschhauser">F. Morschhauser</name></country><country name="Australie"><noRegion><name sortKey="Marlton, P" sort="Marlton, P" uniqKey="Marlton P" first="P." last="Marlton">P. Marlton</name></noRegion><name sortKey="Seymour, J F" sort="Seymour, J F" uniqKey="Seymour J" first="J. F." last="Seymour">J. F. Seymour</name></country><country name="Italie"><region name="Piémont"><name sortKey="Vitolo, U" sort="Vitolo, U" uniqKey="Vitolo U" first="U." last="Vitolo">U. Vitolo</name></region><name sortKey="Foa, R" sort="Foa, R" uniqKey="Foa R" first="R." last="Foà">R. Foà</name></country><country name="Suède"><noRegion><name sortKey="Linden, O" sort="Linden, O" uniqKey="Linden O" first="O." last="Lindén">O. Lindén</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Crump, M" sort="Crump, M" uniqKey="Crump M" first="M." last="Crump">M. Crump</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Wassner, E" sort="Wassner, E" uniqKey="Wassner E" first="E." last="Wassner">E. Wassner</name></noRegion><name sortKey="Brennan, B" sort="Brennan, B" uniqKey="Brennan B" first="B." last="Brennan">B. Brennan</name><name sortKey="Burger, H U" sort="Burger, H U" uniqKey="Burger H" first="H.-U." last="Burger">H.-U. Burger</name><name sortKey="Mendila, M" sort="Mendila, M" uniqKey="Mendila M" first="M." last="Mendila">M. Mendila</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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