A Randomized Study of Interferon α-2b Versus No Treatment as Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Patients With Relapsed Lymphoma
Identifieur interne : 004869 ( Main/Exploration ); précédent : 004868; suivant : 004870A Randomized Study of Interferon α-2b Versus No Treatment as Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Patients With Relapsed Lymphoma
Auteurs : André Bosly [Belgique] ; Andrew Grigg [Australie] ; Harald Holte [Norvège] ; Christian Gisselbrecht [France] ; John Radford [Royaume-Uni] ; Andrea Rossi [Italie] ; Armando Lopez-Guillermo [Espagne] ; Marek Trneny [République tchèque] ; Catherine Sebban [France] ; Hans Hagberg [Norvège] ; Fernando Leal Da Costa [Portugal] ; Philippe Colombat [France] ; Dominique Bron [Belgique] ; Bertrand Coiffier [France]Source :
- The Oncologist [ 1083-7159 ] ; 2013.
Abstract
Patients with lymphoma who have experienced a first relapse or progression and have disease deemed sensitive to salvage chemotherapy nevertheless have a high likelihood of having a second relapse. To decrease the likelihood of a second relapse after high-dose therapy (HDT) and autologous stem cell transplantation (ASCT), interferon (IFN) α-2b was given in a prospective randomized international trial.
In this trial, 221 patients with varying histologic diagnoses (8 small lymphocytic, 37 follicular, 9 mantle, 90 diffuse large B-cell, 20 peripheral T-cell, 3 high-grade B-cell non-Hodgkin lymphoma, and 54 Hodgkin lymphoma) were randomly assigned to receive no further treatment (arm A: 117 patients) or IFNα-2b, 3 MU three times weekly, for 18 months (arm B: 104 patients).
In arm B, 21 patients (20%) did not receive IFNα-2b because of early progression or absence of hematologic recovery, 29 patients (28%) completed the 18 months of treatment, and 54 patients (52%) interrupted treatment because of progression (23%) or toxicity (29%). Event-free survival and overall survival were not different between the two arms on an intent-to-treat analysis and also if analysis was restricted to patients who were alive and had not experienced disease progression three months after transplantation. The study was not sufficiently powered to evaluate effects in histologic subtypes.
In this trial, post-autograft IFNα-2b did not improve outcomes in a heterogeneous group of patients with lymphoma.
Url:
DOI: 10.1634/theoncologist.2013-0223
PubMed: 24105750
PubMed Central: 3825302
Affiliations:
- Australie, Belgique, Espagne, France, Italie, Norvège, Portugal, Royaume-Uni, République tchèque
- Angleterre, Auvergne-Rhône-Alpes, Bohême centrale, Catalogne, Centre-Val de Loire, Grand Manchester, Rhône-Alpes, Région Centre, Région de Bruxelles-Capitale, Victoria (État), Île-de-France, Østlandet
- Barcelone, Bruxelles, Lyon, Manchester, Melbourne, Oslo, Paris, Prague, Tours
- Université de Manchester
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Occupational Diseases, National Institute of Public Health, Prague</wicri:regionArea><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Sebban, Catherine" sort="Sebban, Catherine" uniqKey="Sebban C" first="Catherine" last="Sebban">Catherine Sebban</name><affiliation wicri:level="3"><nlm:aff id="aff9">Centre Léon Bérard, Lyon, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre Léon Bérard, 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><author><name sortKey="Hagberg, Hans" sort="Hagberg, Hans" uniqKey="Hagberg H" first="Hans" last="Hagberg">Hans Hagberg</name><affiliation wicri:level="1"><nlm:aff id="aff10">Onkologiska Kliniken Akademiska Sjukhuset, Uppsala, Norway;</nlm:aff><country 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type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Tours</settlement></placeName></affiliation></author><author><name sortKey="Bron, Dominique" sort="Bron, Dominique" uniqKey="Bron D" first="Dominique" last="Bron">Dominique Bron</name><affiliation wicri:level="3"><nlm:aff id="aff13">Institut Jules Bordet, Bruxelles, Belgium;</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Institut Jules Bordet, Bruxelles</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></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="aff14">Centre Hospitalier Lyon Sud, Pierre Bénite, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre Hospitalier Lyon 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Yvoir</wicri:regionArea><wicri:noRegion>Yvoir</wicri:noRegion></affiliation></author><author><name sortKey="Grigg, Andrew" sort="Grigg, Andrew" uniqKey="Grigg A" first="Andrew" last="Grigg">Andrew Grigg</name><affiliation wicri:level="3"><nlm:aff id="aff2">Austin Hospital, Melbourne, Australia;</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Austin Hospital, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Holte, Harald" sort="Holte, Harald" uniqKey="Holte H" first="Harald" last="Holte">Harald Holte</name><affiliation wicri:level="3"><nlm:aff id="aff3">Oslo University Hospital, Oslo, Norway;</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Oslo University Hospital, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Gisselbrecht, Christian" sort="Gisselbrecht, Christian" uniqKey="Gisselbrecht C" first="Christian" last="Gisselbrecht">Christian Gisselbrecht</name><affiliation wicri:level="3"><nlm:aff id="aff4">Hôpital Saint Louis, Paris, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Saint Louis, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Radford, John" sort="Radford, John" uniqKey="Radford J" first="John" last="Radford">John Radford</name><affiliation wicri:level="4"><nlm:aff id="aff5">University of Manchester, The Christie National Health Service Foundation Trust, Manchester, UnitedKingdom;</nlm:aff><orgName type="university">Université de Manchester</orgName><country>Royaume-Uni</country><placeName><settlement type="city">Manchester</settlement><region type="nation">Angleterre</region><region nuts="2" type="region">Grand Manchester</region></placeName></affiliation></author><author><name sortKey="Rossi, Andrea" sort="Rossi, Andrea" uniqKey="Rossi A" first="Andrea" last="Rossi">Andrea Rossi</name><affiliation wicri:level="1"><nlm:aff id="aff6">Azienda Ospedaliera Papa Giovanni XXIII, Bergoma, Italy;</nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Azienda Ospedaliera Papa Giovanni XXIII, Bergoma</wicri:regionArea><wicri:noRegion>Bergoma</wicri:noRegion></affiliation></author><author><name sortKey="Lopez Guillermo, Armando" sort="Lopez Guillermo, Armando" uniqKey="Lopez Guillermo A" first="Armando" last="Lopez-Guillermo">Armando Lopez-Guillermo</name><affiliation wicri:level="3"><nlm:aff id="aff7">Hospital Clinic, Barcelona, Spain;</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Hospital Clinic, Barcelona</wicri:regionArea><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Trneny, Marek" sort="Trneny, Marek" uniqKey="Trneny M" first="Marek" last="Trneny">Marek Trneny</name><affiliation wicri:level="3"><nlm:aff id="aff8">Center of Occupational Diseases, National Institute of Public Health, Prague, Czech Republic;</nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea>Center of Occupational Diseases, National Institute of Public Health, Prague</wicri:regionArea><placeName><settlement type="city">Prague</settlement><region type="région" nuts="2">Bohême centrale</region></placeName></affiliation></author><author><name sortKey="Sebban, Catherine" sort="Sebban, Catherine" uniqKey="Sebban C" first="Catherine" last="Sebban">Catherine Sebban</name><affiliation wicri:level="3"><nlm:aff id="aff9">Centre Léon Bérard, Lyon, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre Léon Bérard, 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><author><name sortKey="Hagberg, Hans" sort="Hagberg, Hans" uniqKey="Hagberg H" first="Hans" last="Hagberg">Hans Hagberg</name><affiliation wicri:level="1"><nlm:aff id="aff10">Onkologiska Kliniken Akademiska Sjukhuset, Uppsala, Norway;</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Onkologiska Kliniken Akademiska Sjukhuset, Uppsala</wicri:regionArea><wicri:noRegion>Uppsala</wicri:noRegion></affiliation></author><author><name sortKey="Leal Da Costa, Fernando" sort="Leal Da Costa, Fernando" uniqKey="Leal Da Costa F" first="Fernando" last="Leal Da Costa">Fernando Leal Da Costa</name><affiliation wicri:level="1"><nlm:aff id="aff11">Institute of Saude, Lisboa, Portugal;</nlm:aff><country xml:lang="fr">Portugal</country><wicri:regionArea>Institute of Saude, Lisboa</wicri:regionArea><wicri:noRegion>Lisboa</wicri:noRegion></affiliation></author><author><name sortKey="Colombat, Philippe" sort="Colombat, Philippe" uniqKey="Colombat P" first="Philippe" last="Colombat">Philippe Colombat</name><affiliation wicri:level="3"><nlm:aff id="aff12">Bretonneau University Hospital, Tours, France;</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Bretonneau University Hospital, Tours</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Tours</settlement></placeName></affiliation></author><author><name sortKey="Bron, Dominique" sort="Bron, Dominique" uniqKey="Bron D" first="Dominique" last="Bron">Dominique Bron</name><affiliation wicri:level="3"><nlm:aff id="aff13">Institut Jules Bordet, Bruxelles, Belgium;</nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Institut Jules Bordet, Bruxelles</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></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="aff14">Centre Hospitalier Lyon Sud, Pierre Bénite, Lyon, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre Hospitalier Lyon Sud, Pierre Bénite, 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">The Oncologist</title><idno type="ISSN">1083-7159</idno><idno type="eISSN">1549-490X</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background.</title><p>Patients with lymphoma who have experienced a first relapse or progression and have disease deemed sensitive to salvage chemotherapy nevertheless have a high likelihood of having a second relapse. To decrease the likelihood of a second relapse after high-dose therapy (HDT) and autologous stem cell transplantation (ASCT), interferon (IFN) α-2b was given in a prospective randomized international trial.</p></sec><sec><title>Methods.</title><p>In this trial, 221 patients with varying histologic diagnoses (8 small lymphocytic, 37 follicular, 9 mantle, 90 diffuse large B-cell, 20 peripheral T-cell, 3 high-grade B-cell non-Hodgkin lymphoma, and 54 Hodgkin lymphoma) were randomly assigned to receive no further treatment (arm A: 117 patients) or IFNα-2b, 3 MU three times weekly, for 18 months (arm B: 104 patients).</p></sec><sec><title>Results.</title><p>In arm B, 21 patients (20%) did not receive IFNα-2b because of early progression or absence of hematologic recovery, 29 patients (28%) completed the 18 months of treatment, and 54 patients (52%) interrupted treatment because of progression (23%) or toxicity (29%). Event-free survival and overall survival were not different between the two arms on an intent-to-treat analysis and also if analysis was restricted to patients who were alive and had not experienced disease progression three months after transplantation. The study was not sufficiently powered to evaluate effects in histologic subtypes.</p></sec><sec><title>Conclusion.</title><p>In this trial, post-autograft IFNα-2b did not improve outcomes in a heterogeneous group of patients with lymphoma.</p></sec></div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Espagne</li><li>France</li><li>Italie</li><li>Norvège</li><li>Portugal</li><li>Royaume-Uni</li><li>République tchèque</li></country><region><li>Angleterre</li><li>Auvergne-Rhône-Alpes</li><li>Bohême centrale</li><li>Catalogne</li><li>Centre-Val de Loire</li><li>Grand Manchester</li><li>Rhône-Alpes</li><li>Région Centre</li><li>Région de Bruxelles-Capitale</li><li>Victoria (État)</li><li>Île-de-France</li><li>Østlandet</li></region><settlement><li>Barcelone</li><li>Bruxelles</li><li>Lyon</li><li>Manchester</li><li>Melbourne</li><li>Oslo</li><li>Paris</li><li>Prague</li><li>Tours</li></settlement><orgName><li>Université de Manchester</li></orgName></list><tree><country name="Belgique"><noRegion><name sortKey="Bosly, Andre" sort="Bosly, Andre" uniqKey="Bosly A" first="André" last="Bosly">André Bosly</name></noRegion><name sortKey="Bron, Dominique" sort="Bron, Dominique" uniqKey="Bron D" first="Dominique" last="Bron">Dominique Bron</name></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Grigg, Andrew" sort="Grigg, Andrew" uniqKey="Grigg A" first="Andrew" last="Grigg">Andrew Grigg</name></region></country><country name="Norvège"><region name="Østlandet"><name sortKey="Holte, Harald" sort="Holte, Harald" uniqKey="Holte H" first="Harald" last="Holte">Harald Holte</name></region><name sortKey="Hagberg, Hans" sort="Hagberg, Hans" uniqKey="Hagberg H" first="Hans" last="Hagberg">Hans Hagberg</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="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><name sortKey="Colombat, Philippe" sort="Colombat, Philippe" uniqKey="Colombat P" first="Philippe" last="Colombat">Philippe Colombat</name><name sortKey="Sebban, Catherine" sort="Sebban, Catherine" uniqKey="Sebban C" first="Catherine" last="Sebban">Catherine Sebban</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Radford, John" sort="Radford, John" uniqKey="Radford J" first="John" last="Radford">John Radford</name></region></country><country name="Italie"><noRegion><name sortKey="Rossi, Andrea" sort="Rossi, Andrea" uniqKey="Rossi A" first="Andrea" last="Rossi">Andrea Rossi</name></noRegion></country><country name="Espagne"><region name="Catalogne"><name sortKey="Lopez Guillermo, Armando" sort="Lopez Guillermo, Armando" uniqKey="Lopez Guillermo A" first="Armando" last="Lopez-Guillermo">Armando Lopez-Guillermo</name></region></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Trneny, Marek" sort="Trneny, Marek" uniqKey="Trneny M" first="Marek" last="Trneny">Marek Trneny</name></region></country><country name="Portugal"><noRegion><name sortKey="Leal Da Costa, Fernando" sort="Leal Da Costa, Fernando" uniqKey="Leal Da Costa F" first="Fernando" last="Leal Da Costa">Fernando Leal Da Costa</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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