Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial.
Identifieur interne : 001967 ( Main/Exploration ); précédent : 001966; suivant : 001968Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial.
Auteurs : Sarit Assouline [Canada] ; Valeria Buccheri [Brésil] ; Alain Delmer [France] ; Gianluca Gaidano [Italie] ; Marek Trneny [République tchèque] ; Natalia Berthillon [Suisse] ; Michael Brewster [Royaume-Uni] ; Olivier Catalani [Suisse] ; Sai Li [Suisse] ; Christine Mcintyre [Royaume-Uni] ; Pakeeza Sayyed [Suisse] ; Xavier Badoux [Australie]Source :
- The Lancet. Haematology [ 2352-3026 ] ; 2016.
Descripteurs français
- KwdFr :
- Administration par voie cutanée, Administration par voie intraveineuse, Adulte, Adulte d'âge moyen, Antinéoplasiques (administration et posologie), Antinéoplasiques (effets indésirables), Antinéoplasiques (pharmacocinétique), Antinéoplasiques alcoylants (administration et posologie), Antinéoplasiques alcoylants (effets indésirables), Antinéoplasiques alcoylants (pharmacocinétique), Cyclophosphamide (administration et posologie), Cyclophosphamide (effets indésirables), Cyclophosphamide (pharmacocinétique), Femelle, Humains, Leucémie chronique lymphocytaire à cellules B (traitement médicamenteux), Mâle, Protocoles de polychimiothérapie antinéoplasique, Rituximab (administration et posologie), Rituximab (effets indésirables), Rituximab (pharmacocinétique), Résultat thérapeutique, Sujet âgé, Vidarabine (administration et posologie), Vidarabine (analogues et dérivés), Vidarabine (effets indésirables), Vidarabine (pharmacocinétique).
- MESH :
- administration et posologie : Antinéoplasiques, Antinéoplasiques alcoylants, Cyclophosphamide, Rituximab, Vidarabine.
- analogues et dérivés : Vidarabine.
- effets indésirables : Antinéoplasiques, Antinéoplasiques alcoylants, Cyclophosphamide, Rituximab, Vidarabine.
- pharmacocinétique : Antinéoplasiques, Antinéoplasiques alcoylants, Cyclophosphamide, Rituximab, Vidarabine.
- traitement médicamenteux : Leucémie chronique lymphocytaire à cellules B.
- Administration par voie cutanée, Administration par voie intraveineuse, Adulte, Adulte d'âge moyen, Femelle, Humains, Mâle, Protocoles de polychimiothérapie antinéoplasique, Résultat thérapeutique, Sujet âgé.
English descriptors
- KwdEn :
- Administration, Cutaneous, Administration, Intravenous, Adult, Aged, Antineoplastic Agents (administration & dosage), Antineoplastic Agents (adverse effects), Antineoplastic Agents (pharmacokinetics), Antineoplastic Agents, Alkylating (administration & dosage), Antineoplastic Agents, Alkylating (adverse effects), Antineoplastic Agents, Alkylating (pharmacokinetics), Antineoplastic Combined Chemotherapy Protocols, Cyclophosphamide (administration & dosage), Cyclophosphamide (adverse effects), Cyclophosphamide (pharmacokinetics), Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy), Male, Middle Aged, Rituximab (administration & dosage), Rituximab (adverse effects), Rituximab (pharmacokinetics), Treatment Outcome, Vidarabine (administration & dosage), Vidarabine (adverse effects), Vidarabine (analogs & derivatives), Vidarabine (pharmacokinetics).
- MESH :
- chemical , administration & dosage : Antineoplastic Agents, Antineoplastic Agents, Alkylating, Cyclophosphamide, Rituximab, Vidarabine.
- chemical , adverse effects : Antineoplastic Agents, Antineoplastic Agents, Alkylating, Cyclophosphamide, Rituximab, Vidarabine.
- chemical , analogs & derivatives : Vidarabine.
- chemical , pharmacokinetics : Antineoplastic Agents, Antineoplastic Agents, Alkylating, Cyclophosphamide, Rituximab, Vidarabine.
- drug therapy : Leukemia, Lymphocytic, Chronic, B-Cell.
- Administration, Cutaneous, Administration, Intravenous, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
Part one of the two-part SAWYER study predicted that subcutaneous rituximab 1600 mg would achieve trough serum concentrations that were non-inferior to those achieved with intravenous rituximab 500 mg/m(2) in patients with chronic lymphocytic leukaemia. In part two of the study, we aimed to confirm the pharmacokinetic non-inferiority of subcutaneous rituximab, and investigate its safety and efficacy.
DOI: 10.1016/S2352-3026(16)00004-1
PubMed: 26947201
Affiliations:
- Australie, Brésil, Canada, France, Italie, Royaume-Uni, République tchèque, Suisse
- Bohême centrale, Champagne-Ardenne, Grand Est, Québec, État de São Paulo
- Montréal, Prague, Reims, São Paulo
- Université McGill, Université de São Paulo
Links toward previous steps (curation, corpus...)
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Le document en format XML
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xml:lang="en">Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial.</title><author><name sortKey="Assouline, Sarit" sort="Assouline, Sarit" uniqKey="Assouline S" first="Sarit" last="Assouline">Sarit Assouline</name><affiliation wicri:level="4"><nlm:affiliation>Jewish General Hospital, McGill University, Montréal, QC, Canada. Electronic address: sarit.assouline@mcgill.ca.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Jewish General Hospital, McGill University, Montréal, QC</wicri:regionArea><orgName type="university">Université McGill</orgName><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Buccheri, Valeria" sort="Buccheri, Valeria" uniqKey="Buccheri V" first="Valeria" last="Buccheri">Valeria Buccheri</name><affiliation wicri:level="4"><nlm:affiliation>Hematology Division-Clinics Hospital, University of São Paulo, São Paulo, Brazil.</nlm:affiliation><country xml:lang="fr">Brésil</country><wicri:regionArea>Hematology Division-Clinics Hospital, University of São Paulo, São Paulo</wicri:regionArea><placeName><settlement type="city">São Paulo</settlement><region type="state">État de São Paulo</region><settlement type="city">São Paulo</settlement></placeName><orgName type="university">Université de São Paulo</orgName></affiliation></author><author><name sortKey="Delmer, Alain" sort="Delmer, Alain" uniqKey="Delmer A" first="Alain" last="Delmer">Alain Delmer</name><affiliation wicri:level="3"><nlm:affiliation>Department of Haematology, Hôpital Robert Debré, Reims, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Haematology, Hôpital Robert Debré, Reims</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Champagne-Ardenne</region><settlement type="city">Reims</settlement></placeName></affiliation></author><author><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name><affiliation wicri:level="1"><nlm:affiliation>Division of Haematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Division of Haematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara</wicri:regionArea><wicri:noRegion>Novara</wicri:noRegion></affiliation></author><author><name sortKey="Trneny, Marek" sort="Trneny, Marek" uniqKey="Trneny M" first="Marek" last="Trneny">Marek Trneny</name><affiliation wicri:level="3"><nlm:affiliation>Charles University, General Hospital Prague, Prague, Czech Republic.</nlm:affiliation><country xml:lang="fr">République tchèque</country><wicri:regionArea>Charles University, General Hospital Prague, Prague</wicri:regionArea><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Berthillon, Natalia" sort="Berthillon, Natalia" uniqKey="Berthillon N" first="Natalia" last="Berthillon">Natalia Berthillon</name><affiliation wicri:level="1"><nlm:affiliation>F Hoffmann-La Roche, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>F Hoffmann-La Roche, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Brewster, Michael" sort="Brewster, Michael" uniqKey="Brewster M" first="Michael" last="Brewster">Michael Brewster</name><affiliation wicri:level="1"><nlm:affiliation>Roche Pharmaceutical Research and Early Development, Roche Innovation Center, Welwyn, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Roche Pharmaceutical Research and Early Development, Roche Innovation Center, Welwyn</wicri:regionArea><wicri:noRegion>Welwyn</wicri:noRegion></affiliation></author><author><name sortKey="Catalani, Olivier" sort="Catalani, Olivier" uniqKey="Catalani O" first="Olivier" last="Catalani">Olivier Catalani</name><affiliation wicri:level="1"><nlm:affiliation>F Hoffmann-La Roche, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>F Hoffmann-La Roche, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Li, Sai" sort="Li, Sai" uniqKey="Li S" first="Sai" last="Li">Sai Li</name><affiliation wicri:level="1"><nlm:affiliation>F Hoffmann-La Roche, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>F Hoffmann-La Roche, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Mcintyre, Christine" sort="Mcintyre, Christine" uniqKey="Mcintyre C" first="Christine" last="Mcintyre">Christine Mcintyre</name><affiliation wicri:level="1"><nlm:affiliation>Roche Pharmaceutical Research and Early Development, Roche Innovation Center, Welwyn, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Roche Pharmaceutical Research and Early Development, Roche Innovation Center, Welwyn</wicri:regionArea><wicri:noRegion>Welwyn</wicri:noRegion></affiliation></author><author><name sortKey="Sayyed, Pakeeza" sort="Sayyed, Pakeeza" uniqKey="Sayyed P" first="Pakeeza" last="Sayyed">Pakeeza Sayyed</name><affiliation wicri:level="1"><nlm:affiliation>F Hoffmann-La Roche, Basel, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>F Hoffmann-La Roche, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Badoux, Xavier" sort="Badoux, Xavier" uniqKey="Badoux X" first="Xavier" last="Badoux">Xavier Badoux</name><affiliation wicri:level="1"><nlm:affiliation>Department of Haematology, St George Hospital, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Haematology, St George Hospital, Sydney, NSW</wicri:regionArea><wicri:noRegion>NSW</wicri:noRegion></affiliation></author></analytic><series><title level="j">The Lancet. Haematology</title><idno type="eISSN">2352-3026</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Cutaneous</term><term>Administration, Intravenous</term><term>Adult</term><term>Aged</term><term>Antineoplastic Agents (administration & dosage)</term><term>Antineoplastic Agents (adverse effects)</term><term>Antineoplastic Agents (pharmacokinetics)</term><term>Antineoplastic Agents, Alkylating (administration & dosage)</term><term>Antineoplastic Agents, Alkylating (adverse effects)</term><term>Antineoplastic Agents, Alkylating (pharmacokinetics)</term><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Cyclophosphamide (administration & dosage)</term><term>Cyclophosphamide (adverse effects)</term><term>Cyclophosphamide (pharmacokinetics)</term><term>Female</term><term>Humans</term><term>Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy)</term><term>Male</term><term>Middle Aged</term><term>Rituximab (administration & dosage)</term><term>Rituximab (adverse effects)</term><term>Rituximab (pharmacokinetics)</term><term>Treatment Outcome</term><term>Vidarabine (administration & dosage)</term><term>Vidarabine (adverse effects)</term><term>Vidarabine (analogs & derivatives)</term><term>Vidarabine (pharmacokinetics)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Administration par voie cutanée</term><term>Administration par voie intraveineuse</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Antinéoplasiques (administration et posologie)</term><term>Antinéoplasiques (effets indésirables)</term><term>Antinéoplasiques (pharmacocinétique)</term><term>Antinéoplasiques alcoylants (administration et posologie)</term><term>Antinéoplasiques alcoylants (effets indésirables)</term><term>Antinéoplasiques alcoylants (pharmacocinétique)</term><term>Cyclophosphamide (administration et posologie)</term><term>Cyclophosphamide (effets indésirables)</term><term>Cyclophosphamide (pharmacocinétique)</term><term>Femelle</term><term>Humains</term><term>Leucémie chronique lymphocytaire à cellules B (traitement médicamenteux)</term><term>Mâle</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Rituximab (administration et posologie)</term><term>Rituximab (effets indésirables)</term><term>Rituximab (pharmacocinétique)</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Vidarabine (administration et posologie)</term><term>Vidarabine (analogues et dérivés)</term><term>Vidarabine (effets indésirables)</term><term>Vidarabine (pharmacocinétique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Agents</term><term>Antineoplastic Agents, Alkylating</term><term>Cyclophosphamide</term><term>Rituximab</term><term>Vidarabine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Agents</term><term>Antineoplastic Agents, Alkylating</term><term>Cyclophosphamide</term><term>Rituximab</term><term>Vidarabine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Vidarabine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Antineoplastic Agents</term><term>Antineoplastic Agents, Alkylating</term><term>Cyclophosphamide</term><term>Rituximab</term><term>Vidarabine</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Antinéoplasiques</term><term>Antinéoplasiques alcoylants</term><term>Cyclophosphamide</term><term>Rituximab</term><term>Vidarabine</term></keywords><keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Vidarabine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Lymphocytic, Chronic, B-Cell</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antinéoplasiques</term><term>Antinéoplasiques alcoylants</term><term>Cyclophosphamide</term><term>Rituximab</term><term>Vidarabine</term></keywords><keywords scheme="MESH" qualifier="pharmacocinétique" xml:lang="fr"><term>Antinéoplasiques</term><term>Antinéoplasiques alcoylants</term><term>Cyclophosphamide</term><term>Rituximab</term><term>Vidarabine</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Leucémie chronique lymphocytaire à cellules B</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Cutaneous</term><term>Administration, Intravenous</term><term>Adult</term><term>Aged</term><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Administration par voie cutanée</term><term>Administration par voie intraveineuse</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Résultat thérapeutique</term><term>Sujet âgé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Part one of the two-part SAWYER study predicted that subcutaneous rituximab 1600 mg would achieve trough serum concentrations that were non-inferior to those achieved with intravenous rituximab 500 mg/m(2) in patients with chronic lymphocytic leukaemia. In part two of the study, we aimed to confirm the pharmacokinetic non-inferiority of subcutaneous rituximab, and investigate its safety and efficacy.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Brésil</li><li>Canada</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>République tchèque</li><li>Suisse</li></country><region><li>Bohême centrale</li><li>Champagne-Ardenne</li><li>Grand Est</li><li>Québec</li><li>État de São Paulo</li></region><settlement><li>Montréal</li><li>Prague</li><li>Reims</li><li>São Paulo</li></settlement><orgName><li>Université McGill</li><li>Université de São Paulo</li></orgName></list><tree><country name="Canada"><region name="Québec"><name sortKey="Assouline, Sarit" sort="Assouline, Sarit" uniqKey="Assouline S" first="Sarit" last="Assouline">Sarit Assouline</name></region></country><country name="Brésil"><region name="État de São Paulo"><name sortKey="Buccheri, Valeria" sort="Buccheri, Valeria" uniqKey="Buccheri V" first="Valeria" last="Buccheri">Valeria Buccheri</name></region></country><country name="France"><region name="Grand Est"><name sortKey="Delmer, Alain" sort="Delmer, Alain" uniqKey="Delmer A" first="Alain" last="Delmer">Alain Delmer</name></region></country><country name="Italie"><noRegion><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name></noRegion></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Trneny, Marek" sort="Trneny, Marek" uniqKey="Trneny M" first="Marek" last="Trneny">Marek Trneny</name></region></country><country name="Suisse"><noRegion><name sortKey="Berthillon, Natalia" sort="Berthillon, Natalia" uniqKey="Berthillon N" first="Natalia" last="Berthillon">Natalia Berthillon</name></noRegion><name sortKey="Catalani, Olivier" sort="Catalani, Olivier" uniqKey="Catalani O" first="Olivier" last="Catalani">Olivier Catalani</name><name sortKey="Li, Sai" sort="Li, Sai" uniqKey="Li S" first="Sai" last="Li">Sai Li</name><name sortKey="Sayyed, Pakeeza" sort="Sayyed, Pakeeza" uniqKey="Sayyed P" first="Pakeeza" last="Sayyed">Pakeeza Sayyed</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Brewster, Michael" sort="Brewster, Michael" uniqKey="Brewster M" first="Michael" last="Brewster">Michael Brewster</name></noRegion><name sortKey="Mcintyre, Christine" sort="Mcintyre, Christine" uniqKey="Mcintyre C" first="Christine" last="Mcintyre">Christine Mcintyre</name></country><country name="Australie"><noRegion><name sortKey="Badoux, Xavier" sort="Badoux, Xavier" uniqKey="Badoux X" first="Xavier" last="Badoux">Xavier Badoux</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial.
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