Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorSALAR, Antonio
dc.contributor.authorAVIVI, Irit
dc.contributor.authorBITTNER, Beate
dc.contributor.authorBOUABDALLAH, Reda
dc.contributor.authorBREWSTER, Mike
dc.contributor.authorCATALANI, Olivier
dc.contributor.authorFOLLOWS, George
dc.contributor.authorHAYNES, Andrew
dc.contributor.authorHOURCADE-POTELLERET, Florence
dc.contributor.authorJANIKOVA, Andrea
dc.contributor.authorLAROUCHE, Jean-Francois
dc.contributor.authorMCINTYRE, Christine
dc.contributor.authorPEDERSEN, Michael
dc.contributor.authorPEREIRA, Juliana
dc.contributor.authorSAYYED, Pakeeza
dc.contributor.authorSHPILBERG, Ofer
dc.contributor.authorTUMYAN, Gayane
dc.date.accessioned2014-09-30T14:38:06Z
dc.date.available2014-09-30T14:38:06Z
dc.date.issued2014
dc.description.abstractPurpose This two-stage phase IB study investigated the pharmacokinetics and safety of subcutaneous (SC) versus intravenous (IV) administration of rituximab as maintenance therapy in follicular lymphoma. Patients and Methods In stage 1 (dose finding), 124 patients who responded to rituximab induction were randomly assigned to SC rituximab (375 mg/m(2), 625 mg/m(2), or an additional group at 800 mg/m(2)) or IV rituximab (375 mg/m(2)). The objective was to determine an SC dose that would yield a rituximab serum trough concentration (C-trough) in the same range as that of IV rituximab. In stage 2, 154 additional patients were randomly assigned (1: 1) to SC rituximab (1,400 mg) or IV rituximab (375 mg/m(2)) given at 2-or 3-month intervals. The objective was to demonstrate noninferior rituximab C-trough of SC rituximab relative to IV rituximab 375 mg/m(2). Results Stage 1 data predicted that a fixed dose of 1,400 mg SC rituximab would result in a serum C-trough in the range of that of IV rituximab. Noninferiority (ie, meeting the prespecified 90% CI lower limit of 0.8) was then confirmed in stage 2, with geometric mean C-trough (SC): C-trough (IV) ratios for the 2-and 3-month regimens of 1.24 (90% CI, 1.02 to 1.51) and 1.12 (90% CI, 0.86 to 1.45), respectively. Overall safety profiles were similar between formulations (in stage 2, 79% of patients experienced one or more adverse events in each group). Local administration-related reactions (mainly mild to moderate) occurred more frequently after SC administration. Conclusion The fixed dose of 1,400 mg SC rituximab predicted by using stage 1 results was confirmed to have noninferior C-trough levels relative to IV rituximab 375 mg/m(2) dosing during maintenance, with a comparable safety profile. Additional investigation will be required to determine whether the SC route of administration for rituximab provides equivalent efficacy compared with that of IV administration. (C) 2014 by American Society of Clinical Oncology
dc.description.indexMEDLINE
dc.description.sponsorshipF. Hoffmann-La Roche
dc.identifier.citationJOURNAL OF CLINICAL ONCOLOGY, v.32, n.17, p.1782-U62, 2014
dc.identifier.doi10.1200/JCO.2013.52.2631
dc.identifier.eissn1527-7755
dc.identifier.issn0732-183X
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/7335
dc.language.isoeng
dc.publisherAMER SOC CLINICAL ONCOLOGY
dc.relation.ispartofJournal of Clinical Oncology
dc.rightsopenAccess
dc.rights.holderCopyright AMER SOC CLINICAL ONCOLOGY
dc.subject.otherchronic lymphocytic-leukemia
dc.subject.otherb-cell lymphoma
dc.subject.othermonoclonal-antibody
dc.subject.otherresponse duration
dc.subject.otherchop chemotherapy
dc.subject.othermultiple-myeloma
dc.subject.otherfree survival
dc.subject.otheropen-label
dc.subject.othertrial
dc.subject.othercyclophosphamide
dc.subject.wosOncology
dc.titleComparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countrySuíça
hcfmusp.affiliation.countryRússia
hcfmusp.affiliation.countryEspanha
hcfmusp.affiliation.countryIsrael
hcfmusp.affiliation.countryFrança
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countryRepública Tcheca
hcfmusp.affiliation.countryCanadá
hcfmusp.affiliation.countryDinamarca
hcfmusp.affiliation.countryisoes
hcfmusp.affiliation.countryisoil
hcfmusp.affiliation.countryisofr
hcfmusp.affiliation.countryisogb
hcfmusp.affiliation.countryisocz
hcfmusp.affiliation.countryisoca
hcfmusp.affiliation.countryisodk
hcfmusp.affiliation.countryisoch
hcfmusp.affiliation.countryisoru
hcfmusp.author.externalSALAR, Antonio:Hosp del Mar, Barcelona 08003, Spain
hcfmusp.author.externalAVIVI, Irit:Rambam Med Ctr, Haifa, Israel
hcfmusp.author.externalBOUABDALLAH, Reda:Inst J Paoli I Calmettes, F-13009 Marseille, France
hcfmusp.author.externalBREWSTER, Mike:Roche Prod, Welwyn Garden City, Herts, England
hcfmusp.author.externalFOLLOWS, George:Univ Cambridge, Addenbrookes Hosp, Cambridge CB2 2QQ, England
hcfmusp.author.externalHAYNES, Andrew:City Hosp Nottingham, Nottingham, England
hcfmusp.author.externalJANIKOVA, Andrea:Univ Hosp Brno, Brno, Czech Republic
hcfmusp.author.externalLAROUCHE, Jean-Francois:Univ Quebec, Ctr Hosp, Hop Enfants Jesus, Quebec City, PQ, Canada
hcfmusp.author.externalMCINTYRE, Christine:Roche Prod, Welwyn Garden City, Herts, England
hcfmusp.author.externalPEDERSEN, Michael:Herlev Hosp, DK-2730 Herlev, Denmark
hcfmusp.author.externalSAYYED, Pakeeza:L Hoffmann La Roche, Basel, Switzerland
hcfmusp.author.externalSHPILBERG, Ofer:Tel Aviv Univ, IL-69978 Tel Aviv, Israel
hcfmusp.author.externalTUMYAN, Gayane:Russian Canc Res Ctr, Moscow, Russia
hcfmusp.citation.scopus76
hcfmusp.contributor.author-fmusphcJULIANA PEREIRA
hcfmusp.description.beginpage1782
hcfmusp.description.endpageU62
hcfmusp.description.issue17
hcfmusp.description.volume32
hcfmusp.origemWOS
hcfmusp.origem.pubmed24821885
hcfmusp.origem.scopus2-s2.0-84905836916
hcfmusp.origem.wosWOS:000337239600010
hcfmusp.publisher.cityALEXANDRIA
hcfmusp.publisher.countryUSA
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hcfmusp.remissive.sponsorshipRoche
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