R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes
Identifieur interne : 001720 ( Pmc/Curation ); précédent : 001719; suivant : 001721R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes
Auteurs : John F. Seymour [Australie] ; Michael Pfreundschuh [Allemagne] ; Marek Trn N [République tchèque] ; Laurie H. Sehn [Canada] ; John Catalano [Australie] ; Eva Csinady [Suisse] ; Nicola Moore [Suisse] ; Bertrand Coiffier [France]Source :
- Haematologica [ 0390-6078 ] ; 2014.
Abstract
Vascular endothelial growth factor is involved in lymphoma growth, suggesting a potential role for anti-vascular endothelial growth factor therapies in hematologic malignancies. In this phase III study, patients with CD20-positive diffuse large B-cell lymphoma were randomized to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone plus either placebo (R-CHOP) or bevacizumab (RA-CHOP). Treatment was administered every 21 (8 cycles) or 14 days (6 cycles plus 2 rituximab cycles) as per institutional practice. An early analysis of risk/benefit by the Data and Safety Monitoring Board showed that RA-CHOP increased cardiotoxicity without prolonging progression-free survival compared with R-CHOP, and the trial was stopped early. The study protocol was amended to allow for 12 additional months of follow up to evaluate safety. With 787 patients enrolled, median follow up was 23.7 and 23.6 months for R-CHOP and RA-CHOP, respectively. Median progression-free survival for R-CHOP and RA CHOP was 42.9 and 40.2 months, respectively (hazard ratio=1.09;
Url:
DOI: 10.3324/haematol.2013.100818
PubMed: 24895339
PubMed Central: 4116833
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Seymour</name><affiliation wicri:level="1"><nlm:aff id="af1-0991343">Peter MacCallum Cancer Centre, East Melbourne, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Peter MacCallum Cancer Centre, East Melbourne</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af2-0991343">University of Melbourne, Parkville, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>University of Melbourne, Parkville</wicri:regionArea></affiliation></author><author><name sortKey="Pfreundschuh, Michael" sort="Pfreundschuh, Michael" uniqKey="Pfreundschuh M" first="Michael" last="Pfreundschuh">Michael Pfreundschuh</name><affiliation wicri:level="1"><nlm:aff id="af3-0991343">Saarland University Hospital, Homburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Saarland University Hospital, Homburg</wicri:regionArea></affiliation></author><author><name sortKey="Trn N, Marek" sort="Trn N, Marek" uniqKey="Trn N M" first="Marek" last="Trn N">Marek Trn N</name><affiliation wicri:level="1"><nlm:aff id="af4-0991343">General Hospital, Charles University First Faculty of Medicine, Prague, Czech Republic</nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea>General Hospital, Charles University First Faculty of Medicine, Prague</wicri:regionArea></affiliation></author><author><name sortKey="Sehn, Laurie H" sort="Sehn, Laurie H" uniqKey="Sehn L" first="Laurie H." last="Sehn">Laurie H. Sehn</name><affiliation wicri:level="1"><nlm:aff id="af5-0991343">Centre for Lymphoid Cancer, British Columbia Cancer Agency, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Centre for Lymphoid Cancer, British Columbia Cancer Agency</wicri:regionArea></affiliation></author><author><name sortKey="Catalano, John" sort="Catalano, John" uniqKey="Catalano J" first="John" last="Catalano">John Catalano</name><affiliation wicri:level="1"><nlm:aff id="af6-0991343">Frankston Hospital and Monash University, Frankston, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Frankston Hospital and Monash University, Frankston</wicri:regionArea></affiliation></author><author><name sortKey="Csinady, Eva" sort="Csinady, Eva" uniqKey="Csinady E" first="Eva" last="Csinady">Eva Csinady</name><affiliation wicri:level="1"><nlm:aff id="af7-0991343">F. Hoffmann-La Roche Ltd. Pharmaceuticals Division, PDCO, Basel, Switzerland</nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd. Pharmaceuticals Division, PDCO, Basel</wicri:regionArea></affiliation></author><author><name sortKey="Moore, Nicola" sort="Moore, Nicola" uniqKey="Moore N" first="Nicola" last="Moore">Nicola Moore</name><affiliation wicri:level="1"><nlm:aff id="af8-0991343">F. Hoffmann-La Roche Ltd. Pharmaceuticals, Biostatistics, Basel, Switzerland</nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>F. Hoffmann-La Roche Ltd. Pharmaceuticals, Biostatistics, Basel</wicri:regionArea></affiliation></author><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation wicri:level="1"><nlm:aff id="af9-0991343">Centre Hospitalier Lyon-Sud, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre Hospitalier Lyon-Sud, Lyon</wicri:regionArea></affiliation></author></analytic><series><title level="j">Haematologica</title><idno type="ISSN">0390-6078</idno><idno type="eISSN">1592-8721</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Vascular endothelial growth factor is involved in lymphoma growth, suggesting a potential role for anti-vascular endothelial growth factor therapies in hematologic malignancies. In this phase III study, patients with CD20-positive diffuse large B-cell lymphoma were randomized to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone plus either placebo (R-CHOP) or bevacizumab (RA-CHOP). Treatment was administered every 21 (8 cycles) or 14 days (6 cycles plus 2 rituximab cycles) as per institutional practice. An early analysis of risk/benefit by the Data and Safety Monitoring Board showed that RA-CHOP increased cardiotoxicity without prolonging progression-free survival compared with R-CHOP, and the trial was stopped early. The study protocol was amended to allow for 12 additional months of follow up to evaluate safety. With 787 patients enrolled, median follow up was 23.7 and 23.6 months for R-CHOP and RA-CHOP, respectively. Median progression-free survival for R-CHOP and RA CHOP was 42.9 and 40.2 months, respectively (hazard ratio=1.09; <italic>P</italic>=0.49). The proportion of deaths was identical for R-CHOP (83 of 387, 21%) and RA-CHOP (82 of 390, 21%). Relative to R-CHOP, RA-CHOP had a higher rate of left ventricular ejection fraction perturbation (18% <italic>vs.</italic> 8%; odds ratio=2.51; 95% confidence interval (CI): 1.60–3.93) and congestive heart failure (16% <italic>vs.</italic> 7%; odds ratio=2.79; 95%CI: 1.72–4.54). Bevacizumab added to R-CHOP increased cardiac events, without increasing efficacy, arguing against further evaluation of RA-CHOP in patients with diffuse large B-cell lymphoma. The MAIN study is registered at <italic><ext-link ext-link-type="uri" xlink:href="clinicaltrials.gov">clinicaltrials.gov</ext-link> identifier:00486759</italic>.</p></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">Haematologica</journal-id><journal-id journal-id-type="iso-abbrev">Haematologica</journal-id><journal-id journal-id-type="hwp">haematol</journal-id><journal-id journal-id-type="publisher-id">Haematologica</journal-id><journal-title-group><journal-title>Haematologica</journal-title></journal-title-group><issn pub-type="ppub">0390-6078</issn><issn pub-type="epub">1592-8721</issn><publisher><publisher-name>Ferrata Storti Foundation</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24895339</article-id><article-id pub-id-type="pmc">4116833</article-id><article-id pub-id-type="doi">10.3324/haematol.2013.100818</article-id><article-id pub-id-type="publisher-id">0991343</article-id><article-categories><subj-group subj-group-type="heading"><subject>Articles</subject><subj-group subj-group-type="heading"><subject>Non-Hodgkin Lymphoma</subject></subj-group></subj-group></article-categories><title-group><article-title>R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Seymour</surname><given-names>John F.</given-names></name><xref ref-type="aff" rid="af1-0991343">1</xref><xref ref-type="aff" rid="af2-0991343">2</xref><xref ref-type="corresp" rid="c1-0991343"></xref></contrib><contrib contrib-type="author"><name><surname>Pfreundschuh</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="af3-0991343">3</xref></contrib><contrib contrib-type="author"><name><surname>Trnĕný</surname><given-names>Marek</given-names></name><xref ref-type="aff" rid="af4-0991343">4</xref></contrib><contrib contrib-type="author"><name><surname>Sehn</surname><given-names>Laurie H.</given-names></name><xref ref-type="aff" rid="af5-0991343">5</xref></contrib><contrib contrib-type="author"><name><surname>Catalano</surname><given-names>John</given-names></name><xref ref-type="aff" rid="af6-0991343">6</xref></contrib><contrib contrib-type="author"><name><surname>Csinady</surname><given-names>Eva</given-names></name><xref ref-type="aff" rid="af7-0991343">7</xref></contrib><contrib contrib-type="author"><name><surname>Moore</surname><given-names>Nicola</given-names></name><xref ref-type="aff" rid="af8-0991343">8</xref></contrib><contrib contrib-type="author"><name><surname>Coiffier</surname><given-names>Bertrand</given-names></name><xref ref-type="aff" rid="af9-0991343">9</xref></contrib><on-behalf-of>on behalf of the MAIN Study Investigators</on-behalf-of></contrib-group><aff id="af1-0991343"><label>1</label>Peter MacCallum Cancer Centre, East Melbourne, Australia</aff><aff id="af2-0991343"><label>2</label>University of Melbourne, Parkville, Australia</aff><aff id="af3-0991343"><label>3</label>Saarland University Hospital, Homburg, Germany</aff><aff id="af4-0991343"><label>4</label>General Hospital, Charles University First Faculty of Medicine, Prague, Czech Republic</aff><aff id="af5-0991343"><label>5</label>Centre for Lymphoid Cancer, British Columbia Cancer Agency, Canada</aff><aff id="af6-0991343"><label>6</label>Frankston Hospital and Monash University, Frankston, Australia</aff><aff id="af7-0991343"><label>7</label>F. Hoffmann-La Roche Ltd. Pharmaceuticals Division, PDCO, Basel, Switzerland</aff><aff id="af8-0991343"><label>8</label>F. Hoffmann-La Roche Ltd. Pharmaceuticals, Biostatistics, Basel, Switzerland</aff><aff id="af9-0991343"><label>9</label>Centre Hospitalier Lyon-Sud, Lyon, France</aff><author-notes><corresp id="c1-0991343">Correspondence: <email>John.Seymour@petermac.org</email></corresp></author-notes><pub-date pub-type="ppub"><month>8</month><year>2014</year></pub-date><volume>99</volume><issue>8</issue><fpage>1343</fpage><lpage>1349</lpage><history><date date-type="received"><day>12</day><month>11</month><year>2013</year></date><date date-type="accepted"><day>21</day><month>5</month><year>2014</year></date></history><permissions><copyright-statement>Copyright© Ferrata Storti Foundation</copyright-statement><copyright-year>2014</copyright-year></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="991343.pdf"></self-uri><abstract><p>Vascular endothelial growth factor is involved in lymphoma growth, suggesting a potential role for anti-vascular endothelial growth factor therapies in hematologic malignancies. In this phase III study, patients with CD20-positive diffuse large B-cell lymphoma were randomized to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone plus either placebo (R-CHOP) or bevacizumab (RA-CHOP). Treatment was administered every 21 (8 cycles) or 14 days (6 cycles plus 2 rituximab cycles) as per institutional practice. An early analysis of risk/benefit by the Data and Safety Monitoring Board showed that RA-CHOP increased cardiotoxicity without prolonging progression-free survival compared with R-CHOP, and the trial was stopped early. The study protocol was amended to allow for 12 additional months of follow up to evaluate safety. With 787 patients enrolled, median follow up was 23.7 and 23.6 months for R-CHOP and RA-CHOP, respectively. Median progression-free survival for R-CHOP and RA CHOP was 42.9 and 40.2 months, respectively (hazard ratio=1.09; <italic>P</italic>=0.49). The proportion of deaths was identical for R-CHOP (83 of 387, 21%) and RA-CHOP (82 of 390, 21%). Relative to R-CHOP, RA-CHOP had a higher rate of left ventricular ejection fraction perturbation (18% <italic>vs.</italic> 8%; odds ratio=2.51; 95% confidence interval (CI): 1.60–3.93) and congestive heart failure (16% <italic>vs.</italic> 7%; odds ratio=2.79; 95%CI: 1.72–4.54). Bevacizumab added to R-CHOP increased cardiac events, without increasing efficacy, arguing against further evaluation of RA-CHOP in patients with diffuse large B-cell lymphoma. The MAIN study is registered at <italic><ext-link ext-link-type="uri" xlink:href="clinicaltrials.gov">clinicaltrials.gov</ext-link> identifier:00486759</italic>.</p></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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