Links to Exploration step
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia</title><author><name sortKey="Assouline, Sarit" sort="Assouline, Sarit" uniqKey="Assouline S" first="Sarit" last="Assouline">Sarit Assouline</name><affiliation><nlm:aff id="au1"><institution>Jewish General Hospital</institution><addr-line>Montreal, Canada</addr-line></nlm:aff></affiliation></author><author><name sortKey="Buccheri, Valeria" sort="Buccheri, Valeria" uniqKey="Buccheri V" first="Valeria" last="Buccheri">Valeria Buccheri</name><affiliation><nlm:aff id="au2"><institution>Hematology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de Săo Paulo</institution><addr-line>Săo Paulo, Brazil</addr-line></nlm:aff></affiliation></author><author><name sortKey="Delmer, Alain" sort="Delmer, Alain" uniqKey="Delmer A" first="Alain" last="Delmer">Alain Delmer</name><affiliation><nlm:aff id="au3"><institution>Hematologie Clinique, Hôpital Robert Debré</institution><addr-line>Reims, France</addr-line></nlm:aff></affiliation></author><author><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name><affiliation><nlm:aff id="au4"><institution>Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont</institution><addr-line>Novara, Italy</addr-line></nlm:aff></affiliation></author><author><name sortKey="Mcintyre, Christine" sort="Mcintyre, Christine" uniqKey="Mcintyre C" first="Christine" last="Mcintyre">Christine Mcintyre</name><affiliation><nlm:aff id="au5"><institution>Roche Products Ltd</institution><addr-line>Welwyn Garden City, UK</addr-line></nlm:aff></affiliation></author><author><name sortKey="Brewster, Michael" sort="Brewster, Michael" uniqKey="Brewster M" first="Michael" last="Brewster">Michael Brewster</name><affiliation><nlm:aff id="au5"><institution>Roche Products Ltd</institution><addr-line>Welwyn Garden City, UK</addr-line></nlm:aff></affiliation></author><author><name sortKey="Catalani, Olivier" sort="Catalani, Olivier" uniqKey="Catalani O" first="Olivier" last="Catalani">Olivier Catalani</name><affiliation><nlm:aff id="au6"><institution>F. Hoffmann-La Roche Ltd</institution><addr-line>Basel, Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Hourcade Potelleret, Florence" sort="Hourcade Potelleret, Florence" uniqKey="Hourcade Potelleret F" first="Florence" last="Hourcade-Potelleret">Florence Hourcade-Potelleret</name><affiliation><nlm:aff id="au6"><institution>F. Hoffmann-La Roche Ltd</institution><addr-line>Basel, Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Sayyed, Pakeeza" sort="Sayyed, Pakeeza" uniqKey="Sayyed P" first="Pakeeza" last="Sayyed">Pakeeza Sayyed</name><affiliation><nlm:aff id="au6"><institution>F. Hoffmann-La Roche Ltd</institution><addr-line>Basel, Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Badoux, Xavier" sort="Badoux, Xavier" uniqKey="Badoux X" first="Xavier" last="Badoux">Xavier Badoux</name><affiliation><nlm:aff id="au7"><institution>Department of Haematology, St. George Hospital</institution><addr-line>Kogarah, Australia</addr-line></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25900065</idno><idno type="pmc">4631173</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631173</idno><idno type="RBID">PMC:4631173</idno><idno type="doi">10.1111/bcp.12662</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000176</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000176</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia</title><author><name sortKey="Assouline, Sarit" sort="Assouline, Sarit" uniqKey="Assouline S" first="Sarit" last="Assouline">Sarit Assouline</name><affiliation><nlm:aff id="au1"><institution>Jewish General Hospital</institution><addr-line>Montreal, Canada</addr-line></nlm:aff></affiliation></author><author><name sortKey="Buccheri, Valeria" sort="Buccheri, Valeria" uniqKey="Buccheri V" first="Valeria" last="Buccheri">Valeria Buccheri</name><affiliation><nlm:aff id="au2"><institution>Hematology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de Săo Paulo</institution><addr-line>Săo Paulo, Brazil</addr-line></nlm:aff></affiliation></author><author><name sortKey="Delmer, Alain" sort="Delmer, Alain" uniqKey="Delmer A" first="Alain" last="Delmer">Alain Delmer</name><affiliation><nlm:aff id="au3"><institution>Hematologie Clinique, Hôpital Robert Debré</institution><addr-line>Reims, France</addr-line></nlm:aff></affiliation></author><author><name sortKey="Gaidano, Gianluca" sort="Gaidano, Gianluca" uniqKey="Gaidano G" first="Gianluca" last="Gaidano">Gianluca Gaidano</name><affiliation><nlm:aff id="au4"><institution>Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont</institution><addr-line>Novara, Italy</addr-line></nlm:aff></affiliation></author><author><name sortKey="Mcintyre, Christine" sort="Mcintyre, Christine" uniqKey="Mcintyre C" first="Christine" last="Mcintyre">Christine Mcintyre</name><affiliation><nlm:aff id="au5"><institution>Roche Products Ltd</institution><addr-line>Welwyn Garden City, UK</addr-line></nlm:aff></affiliation></author><author><name sortKey="Brewster, Michael" sort="Brewster, Michael" uniqKey="Brewster M" first="Michael" last="Brewster">Michael Brewster</name><affiliation><nlm:aff id="au5"><institution>Roche Products Ltd</institution><addr-line>Welwyn Garden City, UK</addr-line></nlm:aff></affiliation></author><author><name sortKey="Catalani, Olivier" sort="Catalani, Olivier" uniqKey="Catalani O" first="Olivier" last="Catalani">Olivier Catalani</name><affiliation><nlm:aff id="au6"><institution>F. Hoffmann-La Roche Ltd</institution><addr-line>Basel, Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Hourcade Potelleret, Florence" sort="Hourcade Potelleret, Florence" uniqKey="Hourcade Potelleret F" first="Florence" last="Hourcade-Potelleret">Florence Hourcade-Potelleret</name><affiliation><nlm:aff id="au6"><institution>F. Hoffmann-La Roche Ltd</institution><addr-line>Basel, Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Sayyed, Pakeeza" sort="Sayyed, Pakeeza" uniqKey="Sayyed P" first="Pakeeza" last="Sayyed">Pakeeza Sayyed</name><affiliation><nlm:aff id="au6"><institution>F. Hoffmann-La Roche Ltd</institution><addr-line>Basel, Switzerland</addr-line></nlm:aff></affiliation></author><author><name sortKey="Badoux, Xavier" sort="Badoux, Xavier" uniqKey="Badoux X" first="Xavier" last="Badoux">Xavier Badoux</name><affiliation><nlm:aff id="au7"><institution>Department of Haematology, St. George Hospital</institution><addr-line>Kogarah, Australia</addr-line></nlm:aff></affiliation></author></analytic><series><title level="j">British Journal of Clinical Pharmacology</title><idno type="ISSN">0306-5251</idno><idno type="eISSN">1365-2125</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Aims</title><p>The aim of the phase Ib, two part SAWYER study (BO25341; NCT01292603) was to investigate the pharmacokinetics and safety of subcutaneous (s.c.) rituximab compared with intravenous (i.v.) rituximab, both in combination with fludarabine and cyclophosphamide (FC), as first line treatment for patients with chronic lymphocytic leukaemia (CLL).</p></sec><sec><title>Methods</title><p>During part 1 (dose-finding), CLL patients received rituximab i.v. followed by a single dose of rituximab s.c. at one of three fixed doses (1400, 1600 or 1870 mg) in cycle 6. The primary objective was to identify a fixed s.c. dose that would achieve comparable rituximab serum trough concentrations (<italic>C</italic><sub>trough</sub>) to those achieved with the standard 4 weekly 500 mg m<sup>–2</sup> rituximab i.v. dose.</p></sec><sec><title>Results</title><p>Fifty-five patients received a fixed dose of rituximab s.c., 16 received 1400 mg, 17 received 1600 mg and 22 received 1870 mg. The 1600 mg dose was predicted to achieve non-inferior <italic>C</italic><sub>trough</sub> to standard rituximab i.v. treatment. The rituximab s.c. safety profile was comparable with rituximab i.v., except that local administration-related reactions, mainly mild/moderate injection site reactions, occurred more frequently with rituximab s.c., which was not unexpected. Subcutaneous administration was preferred to i.v. administration by >90% of patients and nurses (<italic>n</italic> = 112).</p></sec><sec><title>Conclusions</title><p>SAWYER part 1 data predict that rituximab s.c. 1600 mg will achieve non-inferior <italic>C</italic><sub>trough</sub> concentrations to rituximab i.v. 500 mg m<sup>–2</sup>, administered 4 weekly. This fixed s.c. dose is currently undergoing formal non-inferiority assessment in SAWYER part 2. In future, CLL treatment regimens comprising rituximab s.c. and oral FC could substantially reduce i.v. chair time.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Br J Clin Pharmacol</journal-id><journal-id journal-id-type="iso-abbrev">Br J Clin Pharmacol</journal-id><journal-id journal-id-type="publisher-id">bcp</journal-id><journal-title-group><journal-title>British Journal of Clinical Pharmacology</journal-title></journal-title-group><issn pub-type="ppub">0306-5251</issn><issn pub-type="epub">1365-2125</issn><publisher><publisher-name>John Wiley & Sons, Ltd</publisher-name><publisher-loc>Chichester, UK</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25900065</article-id><article-id pub-id-type="pmc">4631173</article-id><article-id pub-id-type="doi">10.1111/bcp.12662</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical Trials</subject></subj-group></article-categories><title-group><article-title>Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Assouline</surname><given-names>Sarit</given-names></name><xref ref-type="aff" rid="au1">1</xref></contrib><contrib contrib-type="author"><name><surname>Buccheri</surname><given-names>Valeria</given-names></name><xref ref-type="aff" rid="au2">2</xref></contrib><contrib contrib-type="author"><name><surname>Delmer</surname><given-names>Alain</given-names></name><xref ref-type="aff" rid="au3">3</xref></contrib><contrib contrib-type="author"><name><surname>Gaidano</surname><given-names>Gianluca</given-names></name><xref ref-type="aff" rid="au4">4</xref></contrib><contrib contrib-type="author"><name><surname>McIntyre</surname><given-names>Christine</given-names></name><xref ref-type="aff" rid="au5">5</xref></contrib><contrib contrib-type="author"><name><surname>Brewster</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="au5">5</xref></contrib><contrib contrib-type="author"><name><surname>Catalani</surname><given-names>Olivier</given-names></name><xref ref-type="aff" rid="au6">6</xref></contrib><contrib contrib-type="author"><name><surname>Hourcade-Potelleret</surname><given-names>Florence</given-names></name><xref ref-type="aff" rid="au6">6</xref></contrib><contrib contrib-type="author"><name><surname>Sayyed</surname><given-names>Pakeeza</given-names></name><xref ref-type="aff" rid="au6">6</xref></contrib><contrib contrib-type="author"><name><surname>Badoux</surname><given-names>Xavier</given-names></name><xref ref-type="aff" rid="au7">7</xref></contrib><aff id="au1"><label>1</label><institution>Jewish General Hospital</institution><addr-line>Montreal, Canada</addr-line></aff><aff id="au2"><label>2</label><institution>Hematology Division, Hospital das Clinicas da Faculdade de Medicina da Universidade de Săo Paulo</institution><addr-line>Săo Paulo, Brazil</addr-line></aff><aff id="au3"><label>3</label><institution>Hematologie Clinique, Hôpital Robert Debré</institution><addr-line>Reims, France</addr-line></aff><aff id="au4"><label>4</label><institution>Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont</institution><addr-line>Novara, Italy</addr-line></aff><aff id="au5"><label>5</label><institution>Roche Products Ltd</institution><addr-line>Welwyn Garden City, UK</addr-line></aff><aff id="au6"><label>6</label><institution>F. Hoffmann-La Roche Ltd</institution><addr-line>Basel, Switzerland</addr-line></aff><aff id="au7"><label>7</label><institution>Department of Haematology, St. George Hospital</institution><addr-line>Kogarah, Australia</addr-line></aff></contrib-group><author-notes><corresp id="cor1">Correspondence, Dr Sarit Assouline, Division of Hematology, McGill University, Jewish General Hospital, Montreal, Canada., Tel.: +1 514 340 8707, Fax: +1 514 340 8733, E-mail: <email>sarit.assouline@mcgill.ca</email></corresp></author-notes><pub-date pub-type="ppub"><month>11</month><year>2015</year></pub-date><pub-date pub-type="epub"><day>29</day><month>7</month><year>2015</year></pub-date><volume>80</volume><issue>5</issue><fpage>1001</fpage><lpage>1009</lpage><history><date date-type="received"><day>09</day><month>5</month><year>2014</year></date><date date-type="accepted"><day>15</day><month>4</month><year>2015</year></date></history><permissions><copyright-statement>© 2015 The British Pharmacological Society</copyright-statement><copyright-year>2015</copyright-year></permissions><abstract><sec><title>Aims</title><p>The aim of the phase Ib, two part SAWYER study (BO25341; NCT01292603) was to investigate the pharmacokinetics and safety of subcutaneous (s.c.) rituximab compared with intravenous (i.v.) rituximab, both in combination with fludarabine and cyclophosphamide (FC), as first line treatment for patients with chronic lymphocytic leukaemia (CLL).</p></sec><sec><title>Methods</title><p>During part 1 (dose-finding), CLL patients received rituximab i.v. followed by a single dose of rituximab s.c. at one of three fixed doses (1400, 1600 or 1870 mg) in cycle 6. The primary objective was to identify a fixed s.c. dose that would achieve comparable rituximab serum trough concentrations (<italic>C</italic><sub>trough</sub>) to those achieved with the standard 4 weekly 500 mg m<sup>–2</sup> rituximab i.v. dose.</p></sec><sec><title>Results</title><p>Fifty-five patients received a fixed dose of rituximab s.c., 16 received 1400 mg, 17 received 1600 mg and 22 received 1870 mg. The 1600 mg dose was predicted to achieve non-inferior <italic>C</italic><sub>trough</sub> to standard rituximab i.v. treatment. The rituximab s.c. safety profile was comparable with rituximab i.v., except that local administration-related reactions, mainly mild/moderate injection site reactions, occurred more frequently with rituximab s.c., which was not unexpected. Subcutaneous administration was preferred to i.v. administration by >90% of patients and nurses (<italic>n</italic> = 112).</p></sec><sec><title>Conclusions</title><p>SAWYER part 1 data predict that rituximab s.c. 1600 mg will achieve non-inferior <italic>C</italic><sub>trough</sub> concentrations to rituximab i.v. 500 mg m<sup>–2</sup>, administered 4 weekly. This fixed s.c. dose is currently undergoing formal non-inferiority assessment in SAWYER part 2. In future, CLL treatment regimens comprising rituximab s.c. and oral FC could substantially reduce i.v. chair time.</p></sec></abstract><kwd-group><kwd>chronic lymphocytic leukaemia</kwd><kwd>cyclophosphamide</kwd><kwd>fludarabine</kwd><kwd>pharmacokinetics</kwd><kwd>rituximab</kwd><kwd>subcutaneous</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Pmc/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000176 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Corpus/biblio.hfd -nk 000176 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Asie
|area= AustralieFrV1
|flux= Pmc
|étape= Corpus
|type= RBID
|clé=
|texte=
}}
| This area was generated with Dilib version V0.6.33. |  |