R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes
Identifieur interne : 003587 ( Main/Exploration ); précédent : 003586; suivant : 003588R-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.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Anticorps monoclonaux d'origine murine (administration et posologie), Anticorps monoclonaux humanisés (administration et posologie), Bévacizumab, Cyclophosphamide (administration et posologie), Doxorubicine (administration et posologie), Femelle, Humains, Inhibiteurs de l'angiogenèse (administration et posologie), Jeune adulte, Lymphome B diffus à grandes cellules (diagnostic), Lymphome B diffus à grandes cellules (traitement médicamenteux), Mâle, Prednisone (administration et posologie), Protocoles de polychimiothérapie antinéoplasique (administration et posologie), Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Vincristine (administration et posologie).
- MESH :
- administration et posologie : Anticorps monoclonaux d'origine murine, Anticorps monoclonaux humanisés, Cyclophosphamide, Doxorubicine, Inhibiteurs de l'angiogenèse, Prednisone, Protocoles de polychimiothérapie antinéoplasique, Vincristine.
- diagnostic : Lymphome B diffus à grandes cellules.
- traitement médicamenteux : Lymphome B diffus à grandes cellules.
- Adolescent, Adulte, Adulte d'âge moyen, Bévacizumab, Femelle, Humains, Jeune adulte, Mâle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors (administration & dosage), Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Murine-Derived (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (administration & dosage), Bevacizumab, Cyclophosphamide (administration & dosage), Doxorubicin (administration & dosage), Female, Humans, Lymphoma, Large B-Cell, Diffuse (diagnosis), Lymphoma, Large B-Cell, Diffuse (drug therapy), Male, Middle Aged, Prednisone (administration & dosage), Treatment Outcome, Vincristine (administration & dosage), Young Adult.
- MESH :
- chemical , administration & dosage : Angiogenesis Inhibitors, Antibodies, Monoclonal, Humanized, Antibodies, Monoclonal, Murine-Derived, Cyclophosphamide, Doxorubicin, Prednisone, Vincristine.
- administration & dosage : Antineoplastic Combined Chemotherapy Protocols.
- diagnosis : Lymphoma, Large B-Cell, Diffuse.
- drug therapy : Lymphoma, Large B-Cell, Diffuse.
- Adolescent, Adult, Aged, Aged, 80 and over, Bevacizumab, Female, Humans, Male, Middle Aged, Treatment Outcome, Young Adult.
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
Affiliations:
- Allemagne, Australie, Canada, France, République tchèque, Suisse
- Auvergne-Rhône-Alpes, Bohême centrale, Rhône-Alpes, Victoria (État)
- Lyon, Melbourne, Prague
- Université de Melbourne
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Le document en format XML
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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><wicri:noRegion>British Columbia Cancer Agency</wicri:noRegion></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><wicri:noRegion>Frankston</wicri:noRegion></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><wicri:noRegion>Basel</wicri:noRegion></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><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation wicri:level="3"><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><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></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><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Angiogenesis Inhibitors (administration & dosage)</term><term>Antibodies, Monoclonal, Humanized (administration & dosage)</term><term>Antibodies, Monoclonal, Murine-Derived (administration & dosage)</term><term>Antineoplastic Combined Chemotherapy Protocols (administration & dosage)</term><term>Bevacizumab</term><term>Cyclophosphamide (administration & dosage)</term><term>Doxorubicin (administration & dosage)</term><term>Female</term><term>Humans</term><term>Lymphoma, Large B-Cell, Diffuse (diagnosis)</term><term>Lymphoma, Large B-Cell, Diffuse (drug therapy)</term><term>Male</term><term>Middle Aged</term><term>Prednisone (administration & dosage)</term><term>Treatment Outcome</term><term>Vincristine (administration & dosage)</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticorps monoclonaux d'origine murine (administration et posologie)</term><term>Anticorps monoclonaux humanisés (administration et posologie)</term><term>Bévacizumab</term><term>Cyclophosphamide (administration et posologie)</term><term>Doxorubicine (administration et posologie)</term><term>Femelle</term><term>Humains</term><term>Inhibiteurs de l'angiogenèse (administration et posologie)</term><term>Jeune adulte</term><term>Lymphome B diffus à grandes cellules (diagnostic)</term><term>Lymphome B diffus à grandes cellules (traitement médicamenteux)</term><term>Mâle</term><term>Prednisone (administration et posologie)</term><term>Protocoles de polychimiothérapie antinéoplasique (administration et posologie)</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Vincristine (administration et posologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Angiogenesis Inhibitors</term><term>Antibodies, Monoclonal, Humanized</term><term>Antibodies, Monoclonal, Murine-Derived</term><term>Cyclophosphamide</term><term>Doxorubicin</term><term>Prednisone</term><term>Vincristine</term></keywords><keywords scheme="MESH" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux d'origine murine</term><term>Anticorps monoclonaux humanisés</term><term>Cyclophosphamide</term><term>Doxorubicine</term><term>Inhibiteurs de l'angiogenèse</term><term>Prednisone</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Vincristine</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Lymphoma, Large B-Cell, Diffuse</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Lymphome B diffus à grandes cellules</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Lymphoma, Large B-Cell, Diffuse</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Lymphome B diffus à grandes cellules</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Bevacizumab</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Bévacizumab</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term></keywords></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><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>France</li><li>République tchèque</li><li>Suisse</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Bohême centrale</li><li>Rhône-Alpes</li><li>Victoria (État)</li></region><settlement><li>Lyon</li><li>Melbourne</li><li>Prague</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="Australie"><noRegion><name sortKey="Seymour, John F" sort="Seymour, John F" uniqKey="Seymour J" first="John F." last="Seymour">John F. Seymour</name></noRegion><name sortKey="Catalano, John" sort="Catalano, John" uniqKey="Catalano J" first="John" last="Catalano">John Catalano</name><name sortKey="Seymour, John F" sort="Seymour, John F" uniqKey="Seymour J" first="John F." last="Seymour">John F. 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