Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial
Identifieur interne : 003772 ( Main/Exploration ); précédent : 003771; suivant : 003773Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial
Auteurs : Eugene D. Kwon ; Charles G. Drake ; Howard I. Scher ; Karim Fizazi ; Alberto Bossi ; Alfons J M. Van Den Eertwegh ; Michael Krainer ; Nadine Houede ; Ricardo Santos ; Hakim Mahammedi ; Siobhan Ng ; Michele Maio ; Fabio A. Franke ; Santhanam Sundar ; Neeraj Agarwal ; Andries M. Bergman ; Tudor E. Ciuleanu ; Ernesto Korbenfeld ; Lisa Sengel V ; Steinbjorn Hansen ; Christopher Logothetis ; Tomasz M. Beer ; M Brent Mchenry ; Paul Gagnier ; David Liu ; Winald R. GerritsenSource :
- The Lancet. Oncology [ 1470-2045 ] ; 2014.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Anticorps monoclonaux (usage thérapeutique), Antinéoplasiques (usage thérapeutique), Association thérapeutique, Humains, Mâle, Méthode en double aveugle, Sujet âgé, Taxoïdes (usage thérapeutique), Tumeurs prostatiques résistantes à la castration (), Tumeurs prostatiques résistantes à la castration (mortalité), Évolution de la maladie.
- MESH :
- mortalité : Tumeurs prostatiques résistantes à la castration.
- usage thérapeutique : Anticorps monoclonaux, Antinéoplasiques, Taxoïdes.
- Adulte, Adulte d'âge moyen, Association thérapeutique, Humains, Mâle, Méthode en double aveugle, Sujet âgé, Tumeurs prostatiques résistantes à la castration, Évolution de la maladie.
English descriptors
- KwdEn :
- Adult, Aged, Antibodies, Monoclonal (therapeutic use), Antineoplastic Agents (therapeutic use), Combined Modality Therapy, Disease Progression, Double-Blind Method, Humans, Male, Middle Aged, Prostatic Neoplasms, Castration-Resistant (mortality), Prostatic Neoplasms, Castration-Resistant (therapy), Taxoids (therapeutic use).
- MESH :
- chemical , therapeutic use : Antibodies, Monoclonal, Antineoplastic Agents, Taxoids.
- mortality : Prostatic Neoplasms, Castration-Resistant.
- therapy : Prostatic Neoplasms, Castration-Resistant.
- Adult, Aged, Combined Modality Therapy, Disease Progression, Double-Blind Method, Humans, Male, Middle Aged.
Abstract
Ipilimumab is a fully human monoclonal antibody that binds cytotoxic T-lymphocyte antigen 4 to enhance antitumour immunity. Our aim was to assess the use of ipilimumab after radiotherapy in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel chemotherapy.
We did a multicentre, randomised, double-blind, phase 3 trial in which men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned in a 1:1 ratio to receive bone-directed radiotherapy (8 Gy in one fraction) followed by either ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses. Non-progressing patients could continue to receive ipilimumab at 10 mg/kg or placebo as maintenance therapy every 3 months until disease progression, unacceptable toxic effect, or death. Patients were randomly assigned to either treatment group via a minimisation algorithm, and stratified by Eastern Cooperative Oncology Group performance status, alkaline phosphatase concentration, haemoglobin concentration, and investigator site. Patients and investigators were masked to treatment allocation. The primary endpoint was overall survival, assessed in the intention-to-treat population. This trial is registered with
From May 26, 2009, to Feb 15, 2012, 799 patients were randomly assigned (399 to ipilimumab and 400 to placebo), all of whom were included in the intention-to-treat analysis. Median overall survival was 11·2 months (95% CI 9·5–12·7) with ipilimumab and 10·0 months (8·3–11·0) with placebo (hazard ratio [HR] 0·85, 0·72–1·00; p=0·053). However, the assessment of the proportional hazards assumption showed that it was violated (p=0·0031). A piecewise hazard model showed that the HR changed over time: the HR for 0–5 months was 1·46 (95% CI 1·10–1·95), for 5–12 months was 0·65 (0·50–0·85), and beyond 12 months was 0·60 (0·43–0·86). The most common grade 3–4 adverse events were immune-related, occurring in 101 (26%) patients in the ipilimumab group and 11 (3%) of patients in the placebo group. The most frequent grade 3–4 adverse events included diarrhoea (64 [16%] of 393 patients in the ipilimumab group
Although there was no significant difference between the ipilimumab group and the placebo group in terms of overall survival in the primary analysis, there were signs of activity with the drug that warrant further investigation.
Bristol-Myers Squibb.
Url:
DOI: 10.1016/S1470-2045(14)70189-5
PubMed: 24831977
PubMed Central: 4418935
Affiliations:
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Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial</title>
<author><name sortKey="Kwon, Eugene D" sort="Kwon, Eugene D" uniqKey="Kwon E" first="Eugene D" last="Kwon">Eugene D. Kwon</name>
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<author><name sortKey="Drake, Charles G" sort="Drake, Charles G" uniqKey="Drake C" first="Charles G" last="Drake">Charles G. Drake</name>
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<author><name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I" last="Scher">Howard I. Scher</name>
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<author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
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<author><name sortKey="Bossi, Alberto" sort="Bossi, Alberto" uniqKey="Bossi A" first="Alberto" last="Bossi">Alberto Bossi</name>
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<author><name sortKey="Van Den Eertwegh, Alfons J M" sort="Van Den Eertwegh, Alfons J M" uniqKey="Van Den Eertwegh A" first="Alfons J M" last="Van Den Eertwegh">Alfons J M. Van Den Eertwegh</name>
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<author><name sortKey="Krainer, Michael" sort="Krainer, Michael" uniqKey="Krainer M" first="Michael" last="Krainer">Michael Krainer</name>
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<author><name sortKey="Houede, Nadine" sort="Houede, Nadine" uniqKey="Houede N" first="Nadine" last="Houede">Nadine Houede</name>
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<author><name sortKey="Santos, Ricardo" sort="Santos, Ricardo" uniqKey="Santos R" first="Ricardo" last="Santos">Ricardo Santos</name>
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<author><name sortKey="Mahammedi, Hakim" sort="Mahammedi, Hakim" uniqKey="Mahammedi H" first="Hakim" last="Mahammedi">Hakim Mahammedi</name>
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<author><name sortKey="Ng, Siobhan" sort="Ng, Siobhan" uniqKey="Ng S" first="Siobhan" last="Ng">Siobhan Ng</name>
</author>
<author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name>
</author>
<author><name sortKey="Franke, Fabio A" sort="Franke, Fabio A" uniqKey="Franke F" first="Fabio A" last="Franke">Fabio A. Franke</name>
</author>
<author><name sortKey="Sundar, Santhanam" sort="Sundar, Santhanam" uniqKey="Sundar S" first="Santhanam" last="Sundar">Santhanam Sundar</name>
</author>
<author><name sortKey="Agarwal, Neeraj" sort="Agarwal, Neeraj" uniqKey="Agarwal N" first="Neeraj" last="Agarwal">Neeraj Agarwal</name>
</author>
<author><name sortKey="Bergman, Andries M" sort="Bergman, Andries M" uniqKey="Bergman A" first="Andries M" last="Bergman">Andries M. Bergman</name>
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<author><name sortKey="Ciuleanu, Tudor E" sort="Ciuleanu, Tudor E" uniqKey="Ciuleanu T" first="Tudor E" last="Ciuleanu">Tudor E. Ciuleanu</name>
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<author><name sortKey="Korbenfeld, Ernesto" sort="Korbenfeld, Ernesto" uniqKey="Korbenfeld E" first="Ernesto" last="Korbenfeld">Ernesto Korbenfeld</name>
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<author><name sortKey="Sengel V, Lisa" sort="Sengel V, Lisa" uniqKey="Sengel V L" first="Lisa" last="Sengel V">Lisa Sengel V</name>
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<author><name sortKey="Hansen, Steinbjorn" sort="Hansen, Steinbjorn" uniqKey="Hansen S" first="Steinbjorn" last="Hansen">Steinbjorn Hansen</name>
</author>
<author><name sortKey="Logothetis, Christopher" sort="Logothetis, Christopher" uniqKey="Logothetis C" first="Christopher" last="Logothetis">Christopher Logothetis</name>
</author>
<author><name sortKey="Beer, Tomasz M" sort="Beer, Tomasz M" uniqKey="Beer T" first="Tomasz M" last="Beer">Tomasz M. Beer</name>
</author>
<author><name sortKey="Mchenry, M Brent" sort="Mchenry, M Brent" uniqKey="Mchenry M" first="M Brent" last="Mchenry">M Brent Mchenry</name>
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<author><name sortKey="Gagnier, Paul" sort="Gagnier, Paul" uniqKey="Gagnier P" first="Paul" last="Gagnier">Paul Gagnier</name>
</author>
<author><name sortKey="Liu, David" sort="Liu, David" uniqKey="Liu D" first="David" last="Liu">David Liu</name>
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<author><name sortKey="Gerritsen, Winald R" sort="Gerritsen, Winald R" uniqKey="Gerritsen W" first="Winald R" last="Gerritsen">Winald R. Gerritsen</name>
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<series><title level="j">The Lancet. Oncology</title>
<idno type="ISSN">1470-2045</idno>
<idno type="eISSN">1474-5488</idno>
<imprint><date when="2014">2014</date>
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<term>Aged</term>
<term>Antibodies, Monoclonal (therapeutic use)</term>
<term>Antineoplastic Agents (therapeutic use)</term>
<term>Combined Modality Therapy</term>
<term>Disease Progression</term>
<term>Double-Blind Method</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prostatic Neoplasms, Castration-Resistant (mortality)</term>
<term>Prostatic Neoplasms, Castration-Resistant (therapy)</term>
<term>Taxoids (therapeutic use)</term>
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<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Anticorps monoclonaux (usage thérapeutique)</term>
<term>Antinéoplasiques (usage thérapeutique)</term>
<term>Association thérapeutique</term>
<term>Humains</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Sujet âgé</term>
<term>Taxoïdes (usage thérapeutique)</term>
<term>Tumeurs prostatiques résistantes à la castration ()</term>
<term>Tumeurs prostatiques résistantes à la castration (mortalité)</term>
<term>Évolution de la maladie</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Antineoplastic Agents</term>
<term>Taxoids</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Prostatic Neoplasms, Castration-Resistant</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Tumeurs prostatiques résistantes à la castration</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Prostatic Neoplasms, Castration-Resistant</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux</term>
<term>Antinéoplasiques</term>
<term>Taxoïdes</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Combined Modality Therapy</term>
<term>Disease Progression</term>
<term>Double-Blind Method</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Association thérapeutique</term>
<term>Humains</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Sujet âgé</term>
<term>Tumeurs prostatiques résistantes à la castration</term>
<term>Évolution de la maladie</term>
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<front><div type="abstract" xml:lang="en"><title>Summary</title>
<sec id="S1"><title>Background</title>
<p id="P2">Ipilimumab is a fully human monoclonal antibody that binds cytotoxic T-lymphocyte antigen 4 to enhance antitumour immunity. Our aim was to assess the use of ipilimumab after radiotherapy in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel chemotherapy.</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P3">We did a multicentre, randomised, double-blind, phase 3 trial in which men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned in a 1:1 ratio to receive bone-directed radiotherapy (8 Gy in one fraction) followed by either ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses. Non-progressing patients could continue to receive ipilimumab at 10 mg/kg or placebo as maintenance therapy every 3 months until disease progression, unacceptable toxic effect, or death. Patients were randomly assigned to either treatment group via a minimisation algorithm, and stratified by Eastern Cooperative Oncology Group performance status, alkaline phosphatase concentration, haemoglobin concentration, and investigator site. Patients and investigators were masked to treatment allocation. The primary endpoint was overall survival, assessed in the intention-to-treat population. This trial is registered with <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link>
, number NCT00861614.</p>
</sec>
<sec id="S3"><title>Findings</title>
<p id="P4">From May 26, 2009, to Feb 15, 2012, 799 patients were randomly assigned (399 to ipilimumab and 400 to placebo), all of whom were included in the intention-to-treat analysis. Median overall survival was 11·2 months (95% CI 9·5–12·7) with ipilimumab and 10·0 months (8·3–11·0) with placebo (hazard ratio [HR] 0·85, 0·72–1·00; p=0·053). However, the assessment of the proportional hazards assumption showed that it was violated (p=0·0031). A piecewise hazard model showed that the HR changed over time: the HR for 0–5 months was 1·46 (95% CI 1·10–1·95), for 5–12 months was 0·65 (0·50–0·85), and beyond 12 months was 0·60 (0·43–0·86). The most common grade 3–4 adverse events were immune-related, occurring in 101 (26%) patients in the ipilimumab group and 11 (3%) of patients in the placebo group. The most frequent grade 3–4 adverse events included diarrhoea (64 [16%] of 393 patients in the ipilimumab group <italic>vs</italic>
seven [2%] of 396 in the placebo group), fatigue (40 [11%] <italic>vs</italic>
35 [9%]), anaemia (40 [10%] <italic>vs</italic>
43 [11%]), and colitis (18 [5%] <italic>vs</italic>
0). Four (1%) deaths occurred because of toxic effects of the study drug, all in the ipilimumab group.</p>
</sec>
<sec id="S4"><title>Interpretation</title>
<p id="P5">Although there was no significant difference between the ipilimumab group and the placebo group in terms of overall survival in the primary analysis, there were signs of activity with the drug that warrant further investigation.</p>
</sec>
<sec id="S5"><title>Funding</title>
<p id="P6">Bristol-Myers Squibb.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list></list>
<tree><noCountry><name sortKey="Agarwal, Neeraj" sort="Agarwal, Neeraj" uniqKey="Agarwal N" first="Neeraj" last="Agarwal">Neeraj Agarwal</name>
<name sortKey="Beer, Tomasz M" sort="Beer, Tomasz M" uniqKey="Beer T" first="Tomasz M" last="Beer">Tomasz M. Beer</name>
<name sortKey="Bergman, Andries M" sort="Bergman, Andries M" uniqKey="Bergman A" first="Andries M" last="Bergman">Andries M. Bergman</name>
<name sortKey="Bossi, Alberto" sort="Bossi, Alberto" uniqKey="Bossi A" first="Alberto" last="Bossi">Alberto Bossi</name>
<name sortKey="Ciuleanu, Tudor E" sort="Ciuleanu, Tudor E" uniqKey="Ciuleanu T" first="Tudor E" last="Ciuleanu">Tudor E. Ciuleanu</name>
<name sortKey="Drake, Charles G" sort="Drake, Charles G" uniqKey="Drake C" first="Charles G" last="Drake">Charles G. Drake</name>
<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
<name sortKey="Franke, Fabio A" sort="Franke, Fabio A" uniqKey="Franke F" first="Fabio A" last="Franke">Fabio A. Franke</name>
<name sortKey="Gagnier, Paul" sort="Gagnier, Paul" uniqKey="Gagnier P" first="Paul" last="Gagnier">Paul Gagnier</name>
<name sortKey="Gerritsen, Winald R" sort="Gerritsen, Winald R" uniqKey="Gerritsen W" first="Winald R" last="Gerritsen">Winald R. Gerritsen</name>
<name sortKey="Hansen, Steinbjorn" sort="Hansen, Steinbjorn" uniqKey="Hansen S" first="Steinbjorn" last="Hansen">Steinbjorn Hansen</name>
<name sortKey="Houede, Nadine" sort="Houede, Nadine" uniqKey="Houede N" first="Nadine" last="Houede">Nadine Houede</name>
<name sortKey="Korbenfeld, Ernesto" sort="Korbenfeld, Ernesto" uniqKey="Korbenfeld E" first="Ernesto" last="Korbenfeld">Ernesto Korbenfeld</name>
<name sortKey="Krainer, Michael" sort="Krainer, Michael" uniqKey="Krainer M" first="Michael" last="Krainer">Michael Krainer</name>
<name sortKey="Kwon, Eugene D" sort="Kwon, Eugene D" uniqKey="Kwon E" first="Eugene D" last="Kwon">Eugene D. Kwon</name>
<name sortKey="Liu, David" sort="Liu, David" uniqKey="Liu D" first="David" last="Liu">David Liu</name>
<name sortKey="Logothetis, Christopher" sort="Logothetis, Christopher" uniqKey="Logothetis C" first="Christopher" last="Logothetis">Christopher Logothetis</name>
<name sortKey="Mahammedi, Hakim" sort="Mahammedi, Hakim" uniqKey="Mahammedi H" first="Hakim" last="Mahammedi">Hakim Mahammedi</name>
<name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name>
<name sortKey="Mchenry, M Brent" sort="Mchenry, M Brent" uniqKey="Mchenry M" first="M Brent" last="Mchenry">M Brent Mchenry</name>
<name sortKey="Ng, Siobhan" sort="Ng, Siobhan" uniqKey="Ng S" first="Siobhan" last="Ng">Siobhan Ng</name>
<name sortKey="Santos, Ricardo" sort="Santos, Ricardo" uniqKey="Santos R" first="Ricardo" last="Santos">Ricardo Santos</name>
<name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I" last="Scher">Howard I. Scher</name>
<name sortKey="Sengel V, Lisa" sort="Sengel V, Lisa" uniqKey="Sengel V L" first="Lisa" last="Sengel V">Lisa Sengel V</name>
<name sortKey="Sundar, Santhanam" sort="Sundar, Santhanam" uniqKey="Sundar S" first="Santhanam" last="Sundar">Santhanam Sundar</name>
<name sortKey="Van Den Eertwegh, Alfons J M" sort="Van Den Eertwegh, Alfons J M" uniqKey="Van Den Eertwegh A" first="Alfons J M" last="Van Den Eertwegh">Alfons J M. Van Den Eertwegh</name>
</noCountry>
</tree>
</affiliations>
</record>
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