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Rituximab Plus Fludarabine and Cyclophosphamide Prolongs Progression-Free Survival Compared With Fludarabine and Cyclophosphamide Alone in Previously Treated Chronic Lymphocytic Leukemia

Identifieur interne : 007575 ( Main/Exploration ); précédent : 007574; suivant : 007576

Rituximab Plus Fludarabine and Cyclophosphamide Prolongs Progression-Free Survival Compared With Fludarabine and Cyclophosphamide Alone in Previously Treated Chronic Lymphocytic Leukemia

Auteurs : Tadeusz Robak [Pologne, France, Espagne, Australie, Russie, Canada, Danemark, Italie, Nouvelle-Zélande, Hongrie, Suisse, États-Unis] ; Anna Dmoszynska ; Philippe Solal-Celigny ; Krzysztof Warzocha ; Javier Loscertales ; John Catalano ; Boris V. Afanasiev ; Loree Larratt ; Christian H. Geisler ; Marco Montillo ; Ilya Zyuzgin ; Peter S. Ganly ; Caroline Dartigeas ; András Rosta ; Jörg Maurer ; Myriam Mendila ; M. Wayne Saville ; Nancy Valente ; Michael K. Wenger ; Sergey I. Moiseev

Source :

RBID : Pascal:10-0212123

Descripteurs français

English descriptors

Abstract

Purpose Rituximab, a monoclonal antibody that targets the CD20 cell surface antigen, has clinical activity in patients with non-Hodgkin's lymphoma and other B-lymphocyte disorders when administered alone or in combination with chemotherapy. Promising results have previously been reported in nonrandomized studies in patients with chronic lymphocytic leukemia (CLL). This trial was designed to compare chemoimmunotherapy with chemotherapy alone in patients with previously treated CLL. Patients and Methods This international, multicenter, randomized trial compared six cycles of rituximab plus fludarabine and cyclophosphamide (R-FC) with six cycles of fludarabine and cyclophosphamide alone (FC) in patients with previously treated CLL. A total of 552 patients with Binet stage A (10%), B (59%), or C (31 %) disease entered the study and were randomly assigned to receive R-FC (n = 276) or FC (n = 276). Results After a median follow-up time of 25 months, rituximab significantly improved progression-free survival in patients with previously treated CLL (hazard ratio = 0.65; P < .001; median, 30.6 months for R-FC v 20.6 months for FC). Event-free survival, response rate, complete response rate, duration of response, and time to new CLL treatment or death were also significantly improved. Although the rates of adverse events, grade 3 or 4 events, and serious adverse events were slightly higher in the R-FC arm, R-FC was generally well tolerated, with no new safety findings and no detrimental effect on quality of life. Conclusion R-FC significantly improved the outcome of patients with previously treated CLL.


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<name sortKey="Warzocha, Krzysztof" sort="Warzocha, Krzysztof" uniqKey="Warzocha K" first="Krzysztof" last="Warzocha">Krzysztof Warzocha</name>
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<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Antineoplastic agent</term>
<term>Cancerology</term>
<term>Chronic lymphocytic leukemia</term>
<term>Comparative study</term>
<term>Cyclophosphamide</term>
<term>Fludarabine</term>
<term>Immunotherapy</term>
<term>Progression free survival</term>
<term>Prolonged</term>
<term>Rituximab</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Rituximab</term>
<term>Prolongé</term>
<term>Etude comparative</term>
<term>Fludarabine</term>
<term>Traitement</term>
<term>Cancérologie</term>
<term>Immunothérapie</term>
<term>Cyclophosphamide</term>
<term>Leucémie lymphoïde chronique</term>
<term>Anticancéreux</term>
<term>Antigène CD20</term>
<term>Survie sans progression</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Purpose Rituximab, a monoclonal antibody that targets the CD20 cell surface antigen, has clinical activity in patients with non-Hodgkin's lymphoma and other B-lymphocyte disorders when administered alone or in combination with chemotherapy. Promising results have previously been reported in nonrandomized studies in patients with chronic lymphocytic leukemia (CLL). This trial was designed to compare chemoimmunotherapy with chemotherapy alone in patients with previously treated CLL. Patients and Methods This international, multicenter, randomized trial compared six cycles of rituximab plus fludarabine and cyclophosphamide (R-FC) with six cycles of fludarabine and cyclophosphamide alone (FC) in patients with previously treated CLL. A total of 552 patients with Binet stage A (10%), B (59%), or C (31 %) disease entered the study and were randomly assigned to receive R-FC (n = 276) or FC (n = 276). Results After a median follow-up time of 25 months, rituximab significantly improved progression-free survival in patients with previously treated CLL (hazard ratio = 0.65; P < .001; median, 30.6 months for R-FC v 20.6 months for FC). Event-free survival, response rate, complete response rate, duration of response, and time to new CLL treatment or death were also significantly improved. Although the rates of adverse events, grade 3 or 4 events, and serious adverse events were slightly higher in the R-FC arm, R-FC was generally well tolerated, with no new safety findings and no detrimental effect on quality of life. Conclusion R-FC significantly improved the outcome of patients with previously treated CLL.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>Canada</li>
<li>Danemark</li>
<li>Espagne</li>
<li>France</li>
<li>Hongrie</li>
<li>Italie</li>
<li>Nouvelle-Zélande</li>
<li>Pologne</li>
<li>Russie</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region>
<li>Centre-Val de Loire</li>
<li>Communauté de Madrid</li>
<li>Hongrie centrale</li>
<li>Hovedstaden</li>
<li>Pays de la Loire</li>
<li>Région Centre</li>
</region>
<settlement>
<li>Budapest</li>
<li>Copenhague</li>
<li>Le Mans</li>
<li>Madrid</li>
<li>Tours</li>
</settlement>
</list>
<tree>
<noCountry>
<name sortKey="Afanasiev, Boris V" sort="Afanasiev, Boris V" uniqKey="Afanasiev B" first="Boris V." last="Afanasiev">Boris V. Afanasiev</name>
<name sortKey="Catalano, John" sort="Catalano, John" uniqKey="Catalano J" first="John" last="Catalano">John Catalano</name>
<name sortKey="Dartigeas, Caroline" sort="Dartigeas, Caroline" uniqKey="Dartigeas C" first="Caroline" last="Dartigeas">Caroline Dartigeas</name>
<name sortKey="Dmoszynska, Anna" sort="Dmoszynska, Anna" uniqKey="Dmoszynska A" first="Anna" last="Dmoszynska">Anna Dmoszynska</name>
<name sortKey="Ganly, Peter S" sort="Ganly, Peter S" uniqKey="Ganly P" first="Peter S." last="Ganly">Peter S. Ganly</name>
<name sortKey="Geisler, Christian H" sort="Geisler, Christian H" uniqKey="Geisler C" first="Christian H." last="Geisler">Christian H. Geisler</name>
<name sortKey="Larratt, Loree" sort="Larratt, Loree" uniqKey="Larratt L" first="Loree" last="Larratt">Loree Larratt</name>
<name sortKey="Loscertales, Javier" sort="Loscertales, Javier" uniqKey="Loscertales J" first="Javier" last="Loscertales">Javier Loscertales</name>
<name sortKey="Maurer, Jorg" sort="Maurer, Jorg" uniqKey="Maurer J" first="Jörg" last="Maurer">Jörg Maurer</name>
<name sortKey="Mendila, Myriam" sort="Mendila, Myriam" uniqKey="Mendila M" first="Myriam" last="Mendila">Myriam Mendila</name>
<name sortKey="Moiseev, Sergey I" sort="Moiseev, Sergey I" uniqKey="Moiseev S" first="Sergey I." last="Moiseev">Sergey I. Moiseev</name>
<name sortKey="Montillo, Marco" sort="Montillo, Marco" uniqKey="Montillo M" first="Marco" last="Montillo">Marco Montillo</name>
<name sortKey="Rosta, Andras" sort="Rosta, Andras" uniqKey="Rosta A" first="András" last="Rosta">András Rosta</name>
<name sortKey="Saville, M Wayne" sort="Saville, M Wayne" uniqKey="Saville M" first="M. Wayne" last="Saville">M. Wayne Saville</name>
<name sortKey="Solal Celigny, Philippe" sort="Solal Celigny, Philippe" uniqKey="Solal Celigny P" first="Philippe" last="Solal-Celigny">Philippe Solal-Celigny</name>
<name sortKey="Valente, Nancy" sort="Valente, Nancy" uniqKey="Valente N" first="Nancy" last="Valente">Nancy Valente</name>
<name sortKey="Warzocha, Krzysztof" sort="Warzocha, Krzysztof" uniqKey="Warzocha K" first="Krzysztof" last="Warzocha">Krzysztof Warzocha</name>
<name sortKey="Wenger, Michael K" sort="Wenger, Michael K" uniqKey="Wenger M" first="Michael K." last="Wenger">Michael K. Wenger</name>
<name sortKey="Zyuzgin, Ilya" sort="Zyuzgin, Ilya" uniqKey="Zyuzgin I" first="Ilya" last="Zyuzgin">Ilya Zyuzgin</name>
</noCountry>
<country name="Pologne">
<noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</country>
<country name="France">
<region name="Pays de la Loire">
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</region>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</country>
<country name="Espagne">
<region name="Communauté de Madrid">
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</region>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</noRegion>
</country>
<country name="Russie">
<noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</noRegion>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</noRegion>
</country>
<country name="Danemark">
<region name="Hovedstaden">
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</region>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</noRegion>
</country>
<country name="Nouvelle-Zélande">
<noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</noRegion>
</country>
<country name="Hongrie">
<region name="Hongrie centrale">
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</region>
</country>
<country name="Suisse">
<noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</noRegion>
</country>
<country name="États-Unis">
<noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</noRegion>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
</country>
</tree>
</affiliations>
</record>

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