Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma
Identifieur interne : 007E33 ( Main/Exploration ); précédent : 007E32; suivant : 007E34Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma
Auteurs : Edward A. Stadtmauer [États-Unis] ; Donna M. Weber [États-Unis] ; Ruben Niesvizky [États-Unis] ; Andrew Belch [Canada] ; Miles H. Prince [Australie] ; Jesús F. San Miguel [Espagne] ; Thierry Facon [France] ; Marta Olesnyckyj [États-Unis] ; Zhinuan Yu [États-Unis] ; Jerome B. Zeldis [États-Unis] ; Robert D. Knight [États-Unis] ; Meletios A. Dimopoulos [Grèce]Source :
- European Journal of Haematology [ 0902-4441 ] ; 2009-06.
English descriptors
- KwdEn :
- Abramson cancer center, Adverse events, Authors journal compilation, Baseline, Baseline characteristics, Blackwell munksgaard lenalidomide, Blackwell munksgaard stadtmauer, Bortezomib, Celgene, Celgene corporation, Cell transplantation, Combination therapy, Complete response, Dexamethasone, Dexamethasone treatment, Disease progression, Disease response, Dose reduction, European group, Further analysis, Grant support, Hazard ratio, Independent committee, International uniform response criteria, Last evaluation, Lecture fees, Lenalidomide, Lenalidomide treatment, Median, Median duration, More therapies, Multiple myeloma, Multivariate analysis, Munksgaard, Myeloma, National cancer institute, Novel agents, Overall survival, Peripheral neuropathy, Preliminary analysis, Progression, Relapse, Response rates, Separate line, Stadtmauer, Subset analysis, Thalidomide, Thalidomide treatment, Therapies lenalidomide, Therapy, Thrombotic events, Toxicity.
- Teeft :
- Abramson cancer center, Adverse events, Authors journal compilation, Baseline, Baseline characteristics, Blackwell munksgaard lenalidomide, Blackwell munksgaard stadtmauer, Bortezomib, Celgene, Celgene corporation, Cell transplantation, Combination therapy, Complete response, Dexamethasone, Dexamethasone treatment, Disease progression, Disease response, Dose reduction, European group, Further analysis, Grant support, Hazard ratio, Independent committee, International uniform response criteria, Last evaluation, Lecture fees, Lenalidomide, Lenalidomide treatment, Median, Median duration, More therapies, Multiple myeloma, Multivariate analysis, Munksgaard, Myeloma, National cancer institute, Novel agents, Overall survival, Peripheral neuropathy, Preliminary analysis, Progression, Relapse, Response rates, Separate line, Stadtmauer, Subset analysis, Thalidomide, Thalidomide treatment, Therapies lenalidomide, Therapy, Thrombotic events, Toxicity.
Abstract
This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β2‐microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end‐point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; P = 0.026) and progression‐free survival (14.1 vs. 9.5 months, P = 0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, P = 0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, P = 0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, P = 0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second‐line MM therapy and the data suggest that the greatest benefit occurs with earlier use.
Url:
- https://api.istex.fr/document/FE44613D0B7B6665D5A5B0133E48AD8E3572089E/fulltext/pdf
- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2704925
DOI: 10.1111/j.1600-0609.2009.01257.x
Affiliations:
- Australie, Canada, Espagne, France, Grèce, États-Unis
- Attique (région), Hauts-de-France, New Jersey, Nord-Pas-de-Calais, Pennsylvanie, Texas, Victoria (État), État de New York
- Athènes, Lille, Melbourne
- Université de Melbourne
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Stadtmauer</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA</wicri:regionArea><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Weber, Donna M" sort="Weber, Donna M" uniqKey="Weber D" first="Donna M." last="Weber">Donna M. Weber</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>M. D. Anderson Cancer Center, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Niesvizky, Ruben" sort="Niesvizky, Ruben" uniqKey="Niesvizky R" first="Ruben" last="Niesvizky">Ruben Niesvizky</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Weill Cornell Medical College, New York, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Cross Cancer Institute, Edmonton, Alberta</wicri:regionArea><wicri:noRegion>Alberta</wicri:noRegion></affiliation></author><author><name sortKey="Prince, Miles H" sort="Prince, Miles H" uniqKey="Prince M" first="Miles H." last="Prince">Miles H. Prince</name><affiliation wicri:level="4"><country xml:lang="fr">Australie</country><wicri:regionArea>Peter MacCallum Cancer Institute Division of Haematology/Medical Oncology and University of Melbourne, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region><settlement type="city">Melbourne</settlement></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="San Miguel, Jesus F" sort="San Miguel, Jesus F" uniqKey="San Miguel J" first="Jesús F." last="San Miguel">Jesús F. San Miguel</name><affiliation wicri:level="1"><country xml:lang="fr">Espagne</country><wicri:regionArea>Servicio de Hematología, Hospital Universitario de Salamanca, CIC, IBMCC (USAL‐CSIC), Salamanca</wicri:regionArea><wicri:noRegion>Salamanca</wicri:noRegion></affiliation></author><author><name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Claude Huriez, Lille</wicri:regionArea><placeName><region type="region">Hauts-de-France</region><region type="old region">Nord-Pas-de-Calais</region><settlement type="city">Lille</settlement></placeName></affiliation></author><author><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Yu, Zhinuan" sort="Yu, Zhinuan" uniqKey="Yu Z" first="Zhinuan" last="Yu">Zhinuan Yu</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B." last="Zeldis">Jerome B. Zeldis</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Knight, Robert D" sort="Knight, Robert D" uniqKey="Knight R" first="Robert D." last="Knight">Robert D. Knight</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Celgene Corporation, Summit, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Dimopoulos, Meletios A" sort="Dimopoulos, Meletios A" uniqKey="Dimopoulos M" first="Meletios A." last="Dimopoulos">Meletios A. Dimopoulos</name><affiliation wicri:level="3"><country xml:lang="fr">Grèce</country><wicri:regionArea>University of Athens School of Medicine, Athens</wicri:regionArea><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">European Journal of Haematology</title><title level="j" type="alt">EUROPEAN JOURNAL OF HAEMATOLOGY</title><idno type="ISSN">0902-4441</idno><idno type="eISSN">1600-0609</idno><imprint><biblScope unit="vol">82</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="426">426</biblScope><biblScope unit="page" to="432">432</biblScope><biblScope unit="page-count">7</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2009-06">2009-06</date></imprint><idno type="ISSN">0902-4441</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0902-4441</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abramson cancer center</term><term>Adverse events</term><term>Authors journal compilation</term><term>Baseline</term><term>Baseline characteristics</term><term>Blackwell munksgaard lenalidomide</term><term>Blackwell munksgaard stadtmauer</term><term>Bortezomib</term><term>Celgene</term><term>Celgene corporation</term><term>Cell transplantation</term><term>Combination therapy</term><term>Complete response</term><term>Dexamethasone</term><term>Dexamethasone treatment</term><term>Disease progression</term><term>Disease response</term><term>Dose reduction</term><term>European group</term><term>Further analysis</term><term>Grant support</term><term>Hazard ratio</term><term>Independent committee</term><term>International uniform response criteria</term><term>Last evaluation</term><term>Lecture fees</term><term>Lenalidomide</term><term>Lenalidomide treatment</term><term>Median</term><term>Median duration</term><term>More therapies</term><term>Multiple myeloma</term><term>Multivariate analysis</term><term>Munksgaard</term><term>Myeloma</term><term>National cancer institute</term><term>Novel agents</term><term>Overall survival</term><term>Peripheral neuropathy</term><term>Preliminary analysis</term><term>Progression</term><term>Relapse</term><term>Response rates</term><term>Separate line</term><term>Stadtmauer</term><term>Subset analysis</term><term>Thalidomide</term><term>Thalidomide treatment</term><term>Therapies lenalidomide</term><term>Therapy</term><term>Thrombotic events</term><term>Toxicity</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Abramson cancer center</term><term>Adverse events</term><term>Authors journal compilation</term><term>Baseline</term><term>Baseline characteristics</term><term>Blackwell munksgaard lenalidomide</term><term>Blackwell munksgaard stadtmauer</term><term>Bortezomib</term><term>Celgene</term><term>Celgene corporation</term><term>Cell transplantation</term><term>Combination therapy</term><term>Complete response</term><term>Dexamethasone</term><term>Dexamethasone treatment</term><term>Disease progression</term><term>Disease response</term><term>Dose reduction</term><term>European group</term><term>Further analysis</term><term>Grant support</term><term>Hazard ratio</term><term>Independent committee</term><term>International uniform response criteria</term><term>Last evaluation</term><term>Lecture fees</term><term>Lenalidomide</term><term>Lenalidomide treatment</term><term>Median</term><term>Median duration</term><term>More therapies</term><term>Multiple myeloma</term><term>Multivariate analysis</term><term>Munksgaard</term><term>Myeloma</term><term>National cancer institute</term><term>Novel agents</term><term>Overall survival</term><term>Peripheral neuropathy</term><term>Preliminary analysis</term><term>Progression</term><term>Relapse</term><term>Response rates</term><term>Separate line</term><term>Stadtmauer</term><term>Subset analysis</term><term>Thalidomide</term><term>Thalidomide treatment</term><term>Therapies lenalidomide</term><term>Therapy</term><term>Thrombotic events</term><term>Toxicity</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β2‐microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end‐point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; P = 0.026) and progression‐free survival (14.1 vs. 9.5 months, P = 0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, P = 0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, P = 0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, P = 0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second‐line MM therapy and the data suggest that the greatest benefit occurs with earlier use.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Grèce</li><li>États-Unis</li></country><region><li>Attique (région)</li><li>Hauts-de-France</li><li>New Jersey</li><li>Nord-Pas-de-Calais</li><li>Pennsylvanie</li><li>Texas</li><li>Victoria (État)</li><li>État de New York</li></region><settlement><li>Athènes</li><li>Lille</li><li>Melbourne</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Stadtmauer, Edward A" sort="Stadtmauer, Edward A" uniqKey="Stadtmauer E" first="Edward A." last="Stadtmauer">Edward A. Stadtmauer</name></region><name sortKey="Knight, Robert D" sort="Knight, Robert D" uniqKey="Knight R" first="Robert D." last="Knight">Robert D. Knight</name><name sortKey="Niesvizky, Ruben" sort="Niesvizky, Ruben" uniqKey="Niesvizky R" first="Ruben" last="Niesvizky">Ruben Niesvizky</name><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name><name sortKey="Weber, Donna M" sort="Weber, Donna M" uniqKey="Weber D" first="Donna M." last="Weber">Donna M. Weber</name><name sortKey="Yu, Zhinuan" sort="Yu, Zhinuan" uniqKey="Yu Z" first="Zhinuan" last="Yu">Zhinuan Yu</name><name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B." last="Zeldis">Jerome B. Zeldis</name></country><country name="Canada"><noRegion><name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name></noRegion></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Prince, Miles H" sort="Prince, Miles H" uniqKey="Prince M" first="Miles H." last="Prince">Miles H. Prince</name></region></country><country name="Espagne"><noRegion><name sortKey="San Miguel, Jesus F" sort="San Miguel, Jesus F" uniqKey="San Miguel J" first="Jesús F." last="San Miguel">Jesús F. San Miguel</name></noRegion></country><country name="France"><region name="Hauts-de-France"><name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name></region></country><country name="Grèce"><region name="Attique (région)"><name sortKey="Dimopoulos, Meletios A" sort="Dimopoulos, Meletios A" uniqKey="Dimopoulos M" first="Meletios A." last="Dimopoulos">Meletios A. Dimopoulos</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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