Phase III Study of R-CVP Compared With Cyclophosphamide, Vincristine, and Prednisone Alone in Patients With Previously Untreated Advanced Follicular Lymphoma
Identifieur interne : 008B37 ( Main/Exploration ); précédent : 008B36; suivant : 008B38Phase III Study of R-CVP Compared With Cyclophosphamide, Vincristine, and Prednisone Alone in Patients With Previously Untreated Advanced Follicular Lymphoma
Auteurs : Robert Marcus [Royaume-Uni, Canada, France, Australie, Pologne, Portugal, Belgique, Espagne, Suisse] ; Kevin Imrie ; Philippe Solal-Celigny ; John V. Catalano ; Anna Dmoszynska ; Joao C. Raposo ; Fritz C. Offner ; José Gomez-Codina ; Andrew Belch ; David Cunningham ; Elisabeth Wassner-Fritsch ; George SteinSource :
- Journal of clinical oncology [ 0732-183X ] ; 2008.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Purpose To compare the long-term outcome of patients with previously untreated follicular lymphoma (FL) needing therapy, after treatment with cyclophosphamide, vincristine and prednisone (CVP) versus CVP plus rituximab (R-CVP) and to evaluate the predictive value of known prognostic factors after treatment with R-CVP. Patients and Methods Patients with previously untreated CD20-positive stage III/IV FL were randomly assigned to eight cycles of R-CVP (n = 159) or CVP alone (n = 162). The median follow-up period was 53 months. Results The primary end point-time to treatment failure (TTF), which included patients without a response after four cycles as an event-was significantly prolonged in patients receiving R-CVP versus CVP (P <.0001). Improvements in all other end points, including overall and complete response rates (P <.0001), time to progression (TTP; P <.0001), response duration (P <.0001), time to next antilymphoma treatment (P<.0001), and overall survival (OS; P =.029; 4-year OS: 83% v77%;) were achieved with R-CVP versus CVP alone. Univariate analyses demonstrated an improvement in TTP with R-CVP versus CVP irrespective of the Follicular Lymphoma International Prognostic Index (FLIPI) subgroup, the International Prognostic Index (IPI) subgroup, baseline histology, and the presence or absence of B symptoms or bulky disease. By multivariate analysis, FLIPI retains a strong predictive power for TTP in the presence of the trial treatment effect. Conclusion Analysis of all outcome measures, including OS, confirm the benefit of adding R to CVP in the front-line treatment of FL.
Affiliations:
- Australie, Belgique, Canada, Espagne, France, Pologne, Portugal, Royaume-Uni, Suisse
- Pays de la Loire
- Le Mans
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Surrey</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Sutton. Surrey</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Medicine Toronto-Sunnybrook Regional Cancer Centre</s1><s2>Toronto, Ontario</s2><s3>CAN</s3></inist:fA14><country>Canada</country><wicri:noRegion>Department of Medicine Toronto-Sunnybrook Regional Cancer Centre</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Cross Cancer Institute</s1><s2>Edmonton, Alberta</s2><s3>CAN</s3></inist:fA14><country>Canada</country><wicri:noRegion>Cross Cancer Institute</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Hematology and Medical Oncology, Clinique Victor Hugo</s1><s2>Le Mans</s2><s3>FRA</s3></inist:fA14><country>France</country><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Le Mans</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Hematology. Monash Medical Centre</s1><s2>Clayton, Victoria</s2><s3>AUS</s3></inist:fA14><country>Australie</country><wicri:noRegion>Department of Hematology. Monash Medical Centre</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Hematology, Medical University of Lublin</s1><s2>Lublin</s2><s3>POL</s3></inist:fA14><country>Pologne</country><wicri:noRegion>Lublin</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Servicio de Hematologia, Hospital Santa Maria</s1><s2>Lisbon</s2><s3>PRT</s3></inist:fA14><country>Portugal</country><wicri:noRegion>Lisbon</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Dienst Hematologie, Universitair Ziekenhuis</s1><s2>Gent</s2><s3>BEL</s3></inist:fA14><country>Belgique</country><wicri:noRegion>Gent</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Servicio de Oncologa Medica, Hospital La Fe de Valencia</s1><s2>Valencia</s2><s3>ESP</s3></inist:fA14><country>Espagne</country><wicri:noRegion>Valencia</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>F. Hoffmann-La Roche</s1><s3>CHE</s3></inist:fA14><country>Suisse</country><wicri:noRegion>F. Hoffmann-La Roche</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Statistics for Research</s1><s2>Basel</s2><s3>CHE</s3></inist:fA14><country>Suisse</country><wicri:noRegion>Statistics for Research</wicri:noRegion></affiliation></author><author><name sortKey="Imrie, Kevin" sort="Imrie, Kevin" uniqKey="Imrie K" first="Kevin" last="Imrie">Kevin Imrie</name></author><author><name sortKey="Solal Celigny, Philippe" sort="Solal Celigny, Philippe" uniqKey="Solal Celigny P" first="Philippe" last="Solal-Celigny">Philippe Solal-Celigny</name></author><author><name sortKey="Catalano, John V" sort="Catalano, John V" uniqKey="Catalano J" first="John V." last="Catalano">John V. Catalano</name></author><author><name sortKey="Dmoszynska, Anna" sort="Dmoszynska, Anna" uniqKey="Dmoszynska A" first="Anna" last="Dmoszynska">Anna Dmoszynska</name></author><author><name sortKey="Raposo, Joao C" sort="Raposo, Joao C" uniqKey="Raposo J" first="Joao C." last="Raposo">Joao C. Raposo</name></author><author><name sortKey="Offner, Fritz C" sort="Offner, Fritz C" uniqKey="Offner F" first="Fritz C." last="Offner">Fritz C. Offner</name></author><author><name sortKey="Gomez Codina, Jose" sort="Gomez Codina, Jose" uniqKey="Gomez Codina J" first="José" last="Gomez-Codina">José Gomez-Codina</name></author><author><name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name></author><author><name sortKey="Cunningham, David" sort="Cunningham, David" uniqKey="Cunningham D" first="David" last="Cunningham">David Cunningham</name></author><author><name sortKey="Wassner Fritsch, Elisabeth" sort="Wassner Fritsch, Elisabeth" uniqKey="Wassner Fritsch E" first="Elisabeth" last="Wassner-Fritsch">Elisabeth Wassner-Fritsch</name></author><author><name sortKey="Stein, George" sort="Stein, George" uniqKey="Stein G" first="George" last="Stein">George Stein</name></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Antineoplastic agent</term><term>B cell neoplasm</term><term>Cancerology</term><term>Comparative study</term><term>Cyclophosphamide</term><term>Follicular lymphoma</term><term>Human</term><term>Lymphoid neoplasm</term><term>Phase III trial</term><term>Prednisone</term><term>Treatment</term><term>Vincristine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term><term>Traitement</term><term>Etude comparative</term><term>Cyclophosphamide</term><term>Anticancéreux</term><term>Homme</term><term>Vincristine</term><term>Stade avancé</term><term>Cancérologie</term><term>Prednisone</term><term>Lymphome folliculaire</term><term>Hémopathie maligne lymphoïde</term><term>Hémopathie lymphoïde B</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose To compare the long-term outcome of patients with previously untreated follicular lymphoma (FL) needing therapy, after treatment with cyclophosphamide, vincristine and prednisone (CVP) versus CVP plus rituximab (R-CVP) and to evaluate the predictive value of known prognostic factors after treatment with R-CVP. Patients and Methods Patients with previously untreated CD20-positive stage III/IV FL were randomly assigned to eight cycles of R-CVP (n = 159) or CVP alone (n = 162). The median follow-up period was 53 months. Results The primary end point-time to treatment failure (TTF), which included patients without a response after four cycles as an event-was significantly prolonged in patients receiving R-CVP versus CVP (P <.0001). Improvements in all other end points, including overall and complete response rates (P <.0001), time to progression (TTP; P <.0001), response duration (P <.0001), time to next antilymphoma treatment (P<.0001), and overall survival (OS; P =.029; 4-year OS: 83% v77%;) were achieved with R-CVP versus CVP alone. Univariate analyses demonstrated an improvement in TTP with R-CVP versus CVP irrespective of the Follicular Lymphoma International Prognostic Index (FLIPI) subgroup, the International Prognostic Index (IPI) subgroup, baseline histology, and the presence or absence of B symptoms or bulky disease. By multivariate analysis, FLIPI retains a strong predictive power for TTP in the presence of the trial treatment effect. Conclusion Analysis of all outcome measures, including OS, confirm the benefit of adding R to CVP in the front-line treatment of FL.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Canada</li><li>Espagne</li><li>France</li><li>Pologne</li><li>Portugal</li><li>Royaume-Uni</li><li>Suisse</li></country><region><li>Pays de la Loire</li></region><settlement><li>Le Mans</li></settlement></list><tree><noCountry><name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name><name sortKey="Catalano, John V" sort="Catalano, John V" uniqKey="Catalano J" first="John V." last="Catalano">John V. Catalano</name><name sortKey="Cunningham, David" sort="Cunningham, David" uniqKey="Cunningham D" first="David" last="Cunningham">David Cunningham</name><name sortKey="Dmoszynska, Anna" sort="Dmoszynska, Anna" uniqKey="Dmoszynska A" first="Anna" last="Dmoszynska">Anna Dmoszynska</name><name sortKey="Gomez Codina, Jose" sort="Gomez Codina, Jose" uniqKey="Gomez Codina J" first="José" last="Gomez-Codina">José Gomez-Codina</name><name sortKey="Imrie, Kevin" sort="Imrie, Kevin" uniqKey="Imrie K" first="Kevin" last="Imrie">Kevin Imrie</name><name sortKey="Offner, Fritz C" sort="Offner, Fritz C" uniqKey="Offner F" first="Fritz C." last="Offner">Fritz C. Offner</name><name sortKey="Raposo, Joao C" sort="Raposo, Joao C" uniqKey="Raposo J" first="Joao C." last="Raposo">Joao C. Raposo</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="Stein, George" sort="Stein, George" uniqKey="Stein G" first="George" last="Stein">George Stein</name><name sortKey="Wassner Fritsch, Elisabeth" sort="Wassner Fritsch, Elisabeth" uniqKey="Wassner Fritsch E" first="Elisabeth" last="Wassner-Fritsch">Elisabeth Wassner-Fritsch</name></noCountry><country name="Royaume-Uni"><noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></country><country name="Canada"><noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></country><country name="France"><region name="Pays de la Loire"><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></region></country><country name="Australie"><noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></noRegion></country><country name="Pologne"><noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></noRegion></country><country name="Portugal"><noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></noRegion><name sortKey="Marcus, Robert" sort="Marcus, Robert" uniqKey="Marcus R" first="Robert" last="Marcus">Robert Marcus</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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