Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma : Combination therapy improves time to progression
Identifieur interne : 009384 ( Main/Exploration ); précédent : 009383; suivant : 009385Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma : Combination therapy improves time to progression
Auteurs : Robert Z. Orlowski [États-Unis, Israël, Pays-Bas, Espagne, République tchèque, Australie, Pologne, Canada, Russie, France] ; Arnon Nagler ; Pieter Sonneveld ; Joan Blade ; Roman Hajek ; Andrew Spencer ; Jesus San Miguel ; Tadeusz Robak ; Anna Dmoszynska ; Noemi Horvath ; Ivan Spicka ; Heather J. Sutherland ; Alexander N. Suvorov ; Sen H. Zhuang ; Trilok Parekh ; LIANG XIU ; ZHILONG YUAN ; Wayne Rackoff ; Jean-Luc HarousseauSource :
- Journal of clinical oncology [ 0732-183X ] ; 2007.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Purpose This phase III international study compared the efficacy and safety of a combination of pegylated liposomal doxorubicin (PLD) plus bortezomib with bortezomib monotherapy in patients with relapsed or refractory multiple myeloma. Patients and Methods Six hundred forty-six patients were randomly assigned to receive either intravenous bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 of an every 21-days cycle, or the same bortezomib regimen with PLD 30 mg/m2 on day 4. Results Median time to progression was increased from 6.5 months for bortezomib to 9.3 months with the PLD + bortezomib combination (P = .000004; hazard ratio, 1.82 [monotherapy v combination therapy]; 95% Cl, 1.41 to 2.35). The 15-month survival rate for PLD + bortezomib was 76% compared with 65% for bortezomib alone (P = .03). The complete plus partial response rate was 41% for bortezomib and 44% for PLD + bortezomib, a difference that was not statistically significant. Median duration of response was increased from 7.0 to 10.2 months (P = .0008) with PLD + bortezomib. Grade 3/4 adverse events were more frequent in the combination group (80% v 64%), with safety profiles consistent with the known toxicities of the two agents. An increased incidence in the combination group was seen of grade 3/4 neutropenia, thrombocytopenia, asthenia, fatigue, diarrhea, and hand-foot syndrome. Conclusion PLD with bortezomib is superior to bortezomib monotherapy for the treatment of patients with relapsed or refractory multiple myeloma. The combination therapy is associated with a higher incidence of grade 3/4 myelosuppression, constitutional symptoms, and Gl and dermatologic toxicities.
Affiliations:
- Australie, Canada, Espagne, France, Israël, Pays-Bas, Pologne, Russie, République tchèque, États-Unis
- Bohême centrale, Caroline du Nord, Catalogne, Hollande-Méridionale, Moravie, Pays de la Loire, Victoria (État)
- Barcelone, Brno, Chapel Hill (Caroline du Nord), Melbourne, Nantes, Prague, Rotterdam
- Université de Caroline du Nord à Chapel Hill
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Le document en format XML
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<series><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term>
<term>Bortezomib</term>
<term>Cancerology</term>
<term>Combined treatment</term>
<term>Comparative study</term>
<term>Doxorubicin</term>
<term>Liposome</term>
<term>Myeloma</term>
<term>Pegylated form</term>
<term>Phase III trial</term>
<term>Randomization</term>
<term>Relapse</term>
<term>Treatment resistance</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term>
<term>Randomisation</term>
<term>Forme pégylée</term>
<term>Doxorubicine</term>
<term>Liposome</term>
<term>Etude comparative</term>
<term>Traitement associé</term>
<term>Récidive</term>
<term>Résistance traitement</term>
<term>Bortézomib</term>
<term>Cancérologie</term>
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<front><div type="abstract" xml:lang="en">Purpose This phase III international study compared the efficacy and safety of a combination of pegylated liposomal doxorubicin (PLD) plus bortezomib with bortezomib monotherapy in patients with relapsed or refractory multiple myeloma. Patients and Methods Six hundred forty-six patients were randomly assigned to receive either intravenous bortezomib 1.3 mg/m<sup>2</sup>
on days 1, 4, 8, and 11 of an every 21-days cycle, or the same bortezomib regimen with PLD 30 mg/m<sup>2</sup>
on day 4. Results Median time to progression was increased from 6.5 months for bortezomib to 9.3 months with the PLD + bortezomib combination (P = .000004; hazard ratio, 1.82 [monotherapy v combination therapy]; 95% Cl, 1.41 to 2.35). The 15-month survival rate for PLD + bortezomib was 76% compared with 65% for bortezomib alone (P = .03). The complete plus partial response rate was 41% for bortezomib and 44% for PLD + bortezomib, a difference that was not statistically significant. Median duration of response was increased from 7.0 to 10.2 months (P = .0008) with PLD + bortezomib. Grade 3/4 adverse events were more frequent in the combination group (80% v 64%), with safety profiles consistent with the known toxicities of the two agents. An increased incidence in the combination group was seen of grade 3/4 neutropenia, thrombocytopenia, asthenia, fatigue, diarrhea, and hand-foot syndrome. Conclusion PLD with bortezomib is superior to bortezomib monotherapy for the treatment of patients with relapsed or refractory multiple myeloma. The combination therapy is associated with a higher incidence of grade 3/4 myelosuppression, constitutional symptoms, and Gl and dermatologic toxicities.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Israël</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Russie</li>
<li>République tchèque</li>
<li>États-Unis</li>
</country>
<region><li>Bohême centrale</li>
<li>Caroline du Nord</li>
<li>Catalogne</li>
<li>Hollande-Méridionale</li>
<li>Moravie</li>
<li>Pays de la Loire</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Barcelone</li>
<li>Brno</li>
<li>Chapel Hill (Caroline du Nord)</li>
<li>Melbourne</li>
<li>Nantes</li>
<li>Prague</li>
<li>Rotterdam</li>
</settlement>
<orgName><li>Université de Caroline du Nord à Chapel Hill</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Blade, Joan" sort="Blade, Joan" uniqKey="Blade J" first="Joan" last="Blade">Joan Blade</name>
<name sortKey="Dmoszynska, Anna" sort="Dmoszynska, Anna" uniqKey="Dmoszynska A" first="Anna" last="Dmoszynska">Anna Dmoszynska</name>
<name sortKey="Hajek, Roman" sort="Hajek, Roman" uniqKey="Hajek R" first="Roman" last="Hajek">Roman Hajek</name>
<name sortKey="Harousseau, Jean Luc" sort="Harousseau, Jean Luc" uniqKey="Harousseau J" first="Jean-Luc" last="Harousseau">Jean-Luc Harousseau</name>
<name sortKey="Horvath, Noemi" sort="Horvath, Noemi" uniqKey="Horvath N" first="Noemi" last="Horvath">Noemi Horvath</name>
<name sortKey="Liang Xiu" sort="Liang Xiu" uniqKey="Liang Xiu" last="Liang Xiu">LIANG XIU</name>
<name sortKey="Nagler, Arnon" sort="Nagler, Arnon" uniqKey="Nagler A" first="Arnon" last="Nagler">Arnon Nagler</name>
<name sortKey="Parekh, Trilok" sort="Parekh, Trilok" uniqKey="Parekh T" first="Trilok" last="Parekh">Trilok Parekh</name>
<name sortKey="Rackoff, Wayne" sort="Rackoff, Wayne" uniqKey="Rackoff W" first="Wayne" last="Rackoff">Wayne Rackoff</name>
<name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name>
<name sortKey="San Miguel, Jesus" sort="San Miguel, Jesus" uniqKey="San Miguel J" first="Jesus" last="San Miguel">Jesus San Miguel</name>
<name sortKey="Sonneveld, Pieter" sort="Sonneveld, Pieter" uniqKey="Sonneveld P" first="Pieter" last="Sonneveld">Pieter Sonneveld</name>
<name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name>
<name sortKey="Spicka, Ivan" sort="Spicka, Ivan" uniqKey="Spicka I" first="Ivan" last="Spicka">Ivan Spicka</name>
<name sortKey="Sutherland, Heather J" sort="Sutherland, Heather J" uniqKey="Sutherland H" first="Heather J." last="Sutherland">Heather J. Sutherland</name>
<name sortKey="Suvorov, Alexander N" sort="Suvorov, Alexander N" uniqKey="Suvorov A" first="Alexander N." last="Suvorov">Alexander N. Suvorov</name>
<name sortKey="Zhilong Yuan" sort="Zhilong Yuan" uniqKey="Zhilong Yuan" last="Zhilong Yuan">ZHILONG YUAN</name>
<name sortKey="Zhuang, Sen H" sort="Zhuang, Sen H" uniqKey="Zhuang S" first="Sen H." last="Zhuang">Sen H. Zhuang</name>
</noCountry>
<country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</region>
<name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</country>
<country name="Israël"><noRegion><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</noRegion>
</country>
<country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</region>
</country>
<country name="Espagne"><region name="Catalogne"><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</region>
<name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</country>
<country name="République tchèque"><region name="Moravie"><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</region>
<name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</region>
<name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</noRegion>
<name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</country>
<country name="Canada"><noRegion><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</noRegion>
</country>
<country name="Russie"><noRegion><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</noRegion>
</country>
<country name="France"><region name="Pays de la Loire"><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name>
</region>
</country>
</tree>
</affiliations>
</record>
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