AustralieFrV1, Main, Exploration, bibRecord, 004C88

Rituximab Purging and/or Maintenance in Patients Undergoing Autologous Transplantation for Relapsed Follicular Lymphoma: A Prospective Randomized Trial From the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

Identifieur interne : 004C88 ( Main/Exploration ); précédent : 004C87; suivant : 004C89

Rituximab Purging and/or Maintenance in Patients Undergoing Autologous Transplantation for Relapsed Follicular Lymphoma: A Prospective Randomized Trial From the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

Auteurs : Ruth Pettengell [Royaume-Uni] ; Norbert Schmitz [Allemagne] ; Christian Gisselbrecht [France] ; Graeme Smith [Royaume-Uni] ; William N. Patton [Nouvelle-Zélande] ; Bernd Metzner [Allemagne] ; Dolores Caballero [Espagne] ; Herve Tilly [France] ; Jan A. Walewski [Pologne] ; Isabelle Bence-Bruckler [Canada] ; Bik To [Australie] ; Christian H. Geisler [Danemark] ; Rik Schots [Belgique] ; Eva Kimby [Suède] ; Christian J. Taverna [Suisse] ; Tomáš Kozak [République tchèque] ; Peter Dreger [Allemagne] ; Ruzena Uddin [Royaume-Uni] ; Carmen Ruiz De Elvira [Royaume-Uni] ; Anthony H. Goldstone [Royaume-Uni]

Source :

Journal of clinical oncology [ 0732-183X ] ; 2013.

RBID : Pascal:13-0178444

Descripteurs français

Pascal (Inist)
- Rituximab, Anticorps monoclonal, Maintenance, Lymphome folliculaire, Homme, Malade, Immunothérapie, Cellule hématopoïétique, Cellule souche, Récidive, Essai clinique, Randomisation, Prospective, Cancérologie, Anticancéreux, Immunomodulateur, Immunodépresseur, Traitement, Antigène CD20, Autogreffe de cellules souches hématopoïétiques, Hémopathie maligne lymphoïde, Hémopathie lymphoïde B, Groupe de travail.
Wicri :
- topic : Homme, Cellule souche, Prospective.

English descriptors

KwdEn :
- Antineoplastic agent, Autologous hematopoietic stem cell transplantation, B cell neoplasm, Cancerology, Clinical trial, Follicular lymphoma, Hematopoietic cell, Human, Immunomodulator, Immunosuppressive agent, Immunotherapy, Lymphoid neoplasm, Maintenance, Monoclonal antibody, Patient, Prospective, Randomization, Relapse, Rituximab, Stem cell, Treatment, Working group.

Abstract

Purpose The objective of this randomized trial was to assess the efficacy and safety of rituximab as in vivo purging before transplantation and as maintenance treatment immediately after high-dose chemotherapy and autologous stem-cell transplantation (HDC-ASCT) in patients with relapsed follicular lymphoma (FL). Patients and Methods Patients with relapsed FL who achieved either complete or very good partial remission with salvage chemotherapy were randomly assigned using a factorial design to rituximab purging (P+; 375 mg/m² once per week for 4 weeks) or observation (NP) before HDC-ASCT and to maintenance rituximab (M+; 375 mg/m² once every 2 months for four infusions) or observation (NM). Results From October 1999 to April 2006, 280 patients were enrolled. The median age was 51 years (range, 26 to 70 years), and baseline characteristics were well balanced between groups. On average, patients were 44 months (range, 3 to 464 months) from diagnosis, with 79% having received two lines and 15% three lines of prior therapy. Median follow-up was 8.3 years. In contrast to purging, 10-year progression-free survival (PFS) was 48% for P+ and 42% for NP groups (hazard ratio [HR], 0.80; 95% CI, 0.58 to 1.11; P = .18); maintenance had a significant effect on PFS (10-year PFS, 54% for M+ and 37% for NM; HR, 0.66; 95% CI, 0.47 to 0.91; P = .012). Overall survival (OS) was not improved by either rituximab purging or maintenance. Conclusion Rituximab maintenance after HDC-ASCT is safe and significantly prolongs PFS but not OS in patients undergoing transplantation for relapsed FL. Pretransplantation rituximab in vivo purging, even in rituximab-naive patients, failed to improve PFS or OS.

Affiliations:

Links toward previous steps (curation, corpus...)

to stream PascalFrancis, to step Corpus: 000A70
to stream PascalFrancis, to step Curation: 005401
to stream PascalFrancis, to step Checkpoint: 000659
to stream Main, to step Merge: 004E33
to stream Main, to step Curation: 004C88

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Rituximab Purging and/or Maintenance in Patients Undergoing Autologous Transplantation for Relapsed Follicular Lymphoma: A Prospective Randomized Trial From the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation</title>
<author><name sortKey="Pettengell, Ruth" sort="Pettengell, Ruth" uniqKey="Pettengell R" first="Ruth" last="Pettengell">Ruth Pettengell</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>St George's University of London</s1>
<s3>GBR</s3>
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</inist:fA14>
<country>Royaume-Uni</country>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
<orgName type="university">Université de Londres</orgName>
</affiliation>
</author>
<author><name sortKey="Schmitz, Norbert" sort="Schmitz, Norbert" uniqKey="Schmitz N" first="Norbert" last="Schmitz">Norbert Schmitz</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Asklepios Hospital St Georg</s1>
<s2>Hamburg</s2>
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<author><name sortKey="Tilly, Herve" sort="Tilly, Herve" uniqKey="Tilly H" first="Herve" last="Tilly">Herve Tilly</name>
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<author><name sortKey="Walewski, Jan A" sort="Walewski, Jan A" uniqKey="Walewski J" first="Jan A." last="Walewski">Jan A. Walewski</name>
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<country>Pologne</country>
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</affiliation>
</author>
<author><name sortKey="Bence Bruckler, Isabelle" sort="Bence Bruckler, Isabelle" uniqKey="Bence Bruckler I" first="Isabelle" last="Bence-Bruckler">Isabelle Bence-Bruckler</name>
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<s2>Ottawa, Ontario</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Ottawa, Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="To, Bik" sort="To, Bik" uniqKey="To B" first="Bik" last="To">Bik To</name>
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<s2>Adelaide</s2>
<s3>AUS</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Royal Adelaide Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Geisler, Christian H" sort="Geisler, Christian H" uniqKey="Geisler C" first="Christian H." last="Geisler">Christian H. Geisler</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Rigshospitalet</s1>
<s2>Copenhagen</s2>
<s3>DNK</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Danemark</country>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schots, Rik" sort="Schots, Rik" uniqKey="Schots R" first="Rik" last="Schots">Rik Schots</name>
<affiliation wicri:level="3"><inist:fA14 i1="16"><s1>University Hospital Vrije Universiteit Brussel</s1>
<s2>Brussels</s2>
<s3>BEL</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
<placeName><settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kimby, Eva" sort="Kimby, Eva" uniqKey="Kimby E" first="Eva" last="Kimby">Eva Kimby</name>
<affiliation wicri:level="3"><inist:fA14 i1="17"><s1>Karolinska Institutet, Karolinska University Hospital</s1>
<s2>Stockholm</s2>
<s3>SWE</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Suède</country>
<placeName><settlement type="city">Stockholm</settlement>
<region nuts="2">Svealand</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Taverna, Christian J" sort="Taverna, Christian J" uniqKey="Taverna C" first="Christian J." last="Taverna">Christian J. Taverna</name>
<affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Kantonsspital</s1>
<s2>Munsterlingen</s2>
<s3>CHE</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Kantonsspital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kozak, Tomas" sort="Kozak, Tomas" uniqKey="Kozak T" first="Tomáš" last="Kozak">Tomáš Kozak</name>
<affiliation wicri:level="3"><inist:fA14 i1="19"><s1>University Hospital Kralovske Vinohrady, Charles University</s1>
<s2>Prague</s2>
<s3>CZE</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>République tchèque</country>
<placeName><settlement type="city">Prague</settlement>
<region type="région" nuts="2">Bohême centrale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dreger, Peter" sort="Dreger, Peter" uniqKey="Dreger P" first="Peter" last="Dreger">Peter Dreger</name>
<affiliation wicri:level="3"><inist:fA14 i1="07"><s1>University of Heidelberg</s1>
<s2>Heidelberg</s2>
<s3>DEU</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Uddin, Ruzena" sort="Uddin, Ruzena" uniqKey="Uddin R" first="Ruzena" last="Uddin">Ruzena Uddin</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>European Group for Blood and Marrow Transplantation</s1>
<s3>GBR</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>European Group for Blood and Marrow Transplantation</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="De Elvira, Carmen Ruiz" sort="De Elvira, Carmen Ruiz" uniqKey="De Elvira C" first="Carmen Ruiz" last="De Elvira">Carmen Ruiz De Elvira</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>European Group for Blood and Marrow Transplantation</s1>
<s3>GBR</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>European Group for Blood and Marrow Transplantation</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Goldstone, Anthony H" sort="Goldstone, Anthony H" uniqKey="Goldstone A" first="Anthony H." last="Goldstone">Anthony H. Goldstone</name>
<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>University College London Hospital</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</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="2013">2013</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>Antineoplastic agent</term>
<term>Autologous hematopoietic stem cell transplantation</term>
<term>B cell neoplasm</term>
<term>Cancerology</term>
<term>Clinical trial</term>
<term>Follicular lymphoma</term>
<term>Hematopoietic cell</term>
<term>Human</term>
<term>Immunomodulator</term>
<term>Immunosuppressive agent</term>
<term>Immunotherapy</term>
<term>Lymphoid neoplasm</term>
<term>Maintenance</term>
<term>Monoclonal antibody</term>
<term>Patient</term>
<term>Prospective</term>
<term>Randomization</term>
<term>Relapse</term>
<term>Rituximab</term>
<term>Stem cell</term>
<term>Treatment</term>
<term>Working group</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Rituximab</term>
<term>Anticorps monoclonal</term>
<term>Maintenance</term>
<term>Lymphome folliculaire</term>
<term>Homme</term>
<term>Malade</term>
<term>Immunothérapie</term>
<term>Cellule hématopoïétique</term>
<term>Cellule souche</term>
<term>Récidive</term>
<term>Essai clinique</term>
<term>Randomisation</term>
<term>Prospective</term>
<term>Cancérologie</term>
<term>Anticancéreux</term>
<term>Immunomodulateur</term>
<term>Immunodépresseur</term>
<term>Traitement</term>
<term>Antigène CD20</term>
<term>Autogreffe de cellules souches hématopoïétiques</term>
<term>Hémopathie maligne lymphoïde</term>
<term>Hémopathie lymphoïde B</term>
<term>Groupe de travail</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
<term>Cellule souche</term>
<term>Prospective</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose The objective of this randomized trial was to assess the efficacy and safety of rituximab as in vivo purging before transplantation and as maintenance treatment immediately after high-dose chemotherapy and autologous stem-cell transplantation (HDC-ASCT) in patients with relapsed follicular lymphoma (FL). Patients and Methods Patients with relapsed FL who achieved either complete or very good partial remission with salvage chemotherapy were randomly assigned using a factorial design to rituximab purging (P+; 375 mg/m<sup>2</sup>
 once per week for 4 weeks) or observation (NP) before HDC-ASCT and to maintenance rituximab (M+; 375 mg/m<sup>2</sup>
 once every 2 months for four infusions) or observation (NM). Results From October 1999 to April 2006, 280 patients were enrolled. The median age was 51 years (range, 26 to 70 years), and baseline characteristics were well balanced between groups. On average, patients were 44 months (range, 3 to 464 months) from diagnosis, with 79% having received two lines and 15% three lines of prior therapy. Median follow-up was 8.3 years. In contrast to purging, 10-year progression-free survival (PFS) was 48% for P+ and 42% for NP groups (hazard ratio [HR], 0.80; 95% CI, 0.58 to 1.11; P = .18); maintenance had a significant effect on PFS (10-year PFS, 54% for M+ and 37% for NM; HR, 0.66; 95% CI, 0.47 to 0.91; P = .012). Overall survival (OS) was not improved by either rituximab purging or maintenance. Conclusion Rituximab maintenance after HDC-ASCT is safe and significantly prolongs PFS but not OS in patients undergoing transplantation for relapsed FL. Pretransplantation rituximab in vivo purging, even in rituximab-naive patients, failed to improve PFS or OS.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>Danemark</li>
<li>Espagne</li>
<li>France</li>
<li>Nouvelle-Zélande</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>République tchèque</li>
<li>Suisse</li>
<li>Suède</li>
</country>
<region><li>Angleterre</li>
<li>Bade-Wurtemberg</li>
<li>Bohême centrale</li>
<li>District de Karlsruhe</li>
<li>Grand Londres</li>
<li>Hambourg</li>
<li>Haute-Normandie</li>
<li>Hovedstaden</li>
<li>Région Normandie</li>
<li>Région de Bruxelles-Capitale</li>
<li>Svealand</li>
<li>Île-de-France</li>
</region>
<settlement><li>Bruxelles</li>
<li>Copenhague</li>
<li>Hambourg</li>
<li>Heidelberg</li>
<li>Londres</li>
<li>Paris</li>
<li>Prague</li>
<li>Rouen</li>
<li>Stockholm</li>
</settlement>
<orgName><li>Université de Londres</li>
</orgName>
</list>
<tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Pettengell, Ruth" sort="Pettengell, Ruth" uniqKey="Pettengell R" first="Ruth" last="Pettengell">Ruth Pettengell</name>
</region>
<name sortKey="De Elvira, Carmen Ruiz" sort="De Elvira, Carmen Ruiz" uniqKey="De Elvira C" first="Carmen Ruiz" last="De Elvira">Carmen Ruiz De Elvira</name>
<name sortKey="Goldstone, Anthony H" sort="Goldstone, Anthony H" uniqKey="Goldstone A" first="Anthony H." last="Goldstone">Anthony H. Goldstone</name>
<name sortKey="Smith, Graeme" sort="Smith, Graeme" uniqKey="Smith G" first="Graeme" last="Smith">Graeme Smith</name>
<name sortKey="Uddin, Ruzena" sort="Uddin, Ruzena" uniqKey="Uddin R" first="Ruzena" last="Uddin">Ruzena Uddin</name>
</country>
<country name="Allemagne"><region name="Hambourg"><name sortKey="Schmitz, Norbert" sort="Schmitz, Norbert" uniqKey="Schmitz N" first="Norbert" last="Schmitz">Norbert Schmitz</name>
</region>
<name sortKey="Dreger, Peter" sort="Dreger, Peter" uniqKey="Dreger P" first="Peter" last="Dreger">Peter Dreger</name>
<name sortKey="Metzner, Bernd" sort="Metzner, Bernd" uniqKey="Metzner B" first="Bernd" last="Metzner">Bernd Metzner</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Gisselbrecht, Christian" sort="Gisselbrecht, Christian" uniqKey="Gisselbrecht C" first="Christian" last="Gisselbrecht">Christian Gisselbrecht</name>
</region>
<name sortKey="Tilly, Herve" sort="Tilly, Herve" uniqKey="Tilly H" first="Herve" last="Tilly">Herve Tilly</name>
</country>
<country name="Nouvelle-Zélande"><noRegion><name sortKey="Patton, William N" sort="Patton, William N" uniqKey="Patton W" first="William N." last="Patton">William N. Patton</name>
</noRegion>
</country>
<country name="Espagne"><noRegion><name sortKey="Caballero, Dolores" sort="Caballero, Dolores" uniqKey="Caballero D" first="Dolores" last="Caballero">Dolores Caballero</name>
</noRegion>
</country>
<country name="Pologne"><noRegion><name sortKey="Walewski, Jan A" sort="Walewski, Jan A" uniqKey="Walewski J" first="Jan A." last="Walewski">Jan A. Walewski</name>
</noRegion>
</country>
<country name="Canada"><noRegion><name sortKey="Bence Bruckler, Isabelle" sort="Bence Bruckler, Isabelle" uniqKey="Bence Bruckler I" first="Isabelle" last="Bence-Bruckler">Isabelle Bence-Bruckler</name>
</noRegion>
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<country name="Australie"><noRegion><name sortKey="To, Bik" sort="To, Bik" uniqKey="To B" first="Bik" last="To">Bik To</name>
</noRegion>
</country>
<country name="Danemark"><region name="Hovedstaden"><name sortKey="Geisler, Christian H" sort="Geisler, Christian H" uniqKey="Geisler C" first="Christian H." last="Geisler">Christian H. Geisler</name>
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<country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Schots, Rik" sort="Schots, Rik" uniqKey="Schots R" first="Rik" last="Schots">Rik Schots</name>
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<country name="Suède"><region name="Svealand"><name sortKey="Kimby, Eva" sort="Kimby, Eva" uniqKey="Kimby E" first="Eva" last="Kimby">Eva Kimby</name>
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<country name="Suisse"><noRegion><name sortKey="Taverna, Christian J" sort="Taverna, Christian J" uniqKey="Taverna C" first="Christian J." last="Taverna">Christian J. Taverna</name>
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<country name="République tchèque"><region name="Bohême centrale"><name sortKey="Kozak, Tomas" sort="Kozak, Tomas" uniqKey="Kozak T" first="Tomáš" last="Kozak">Tomáš Kozak</name>
</region>
</country>
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</affiliations>
</record>

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Rituximab Purging and/or Maintenance in Patients Undergoing Autologous Transplantation for Relapsed Follicular Lymphoma: A Prospective Randomized Trial From the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

Rituximab Purging and/or Maintenance in Patients Undergoing Autologous Transplantation for Relapsed Follicular Lymphoma: A Prospective Randomized Trial From the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

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