A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma
Identifieur interne : 002487 ( Main/Exploration ); précédent : 002486; suivant : 002488A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma
Auteurs : Alba A. Brandes ; Antoine F. Carpentier ; Santosh Kesari ; Juan M. Sepulveda-Sanchez ; Helen R. Wheeler ; Olivier Chinot ; Lawrence Cher ; Joachim P. Steinbach ; David Capper ; Pol Specenier ; Jordi Rodon ; Ann Cleverly ; Claire Smith ; Ivelina Gueorguieva ; Colin Miles ; Susan C. Guba ; Durisala Desaiah ; Michael M. Lahn ; Wolfgang WickSource :
- Neuro-Oncology [ 1522-8517 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Antinéoplasiques alcoylants (effets indésirables), Antinéoplasiques alcoylants (usage thérapeutique), Association de médicaments (), Association de médicaments (effets indésirables), Estimation de Kaplan-Meier, Femelle, Glioblastome (traitement médicamenteux), Humains, Lomustine (effets indésirables), Lomustine (pharmacocinétique), Lomustine (usage thérapeutique), Mâle, Pyrazoles (effets indésirables), Pyrazoles (pharmacocinétique), Pyrazoles (usage thérapeutique), Quinoléines (effets indésirables), Quinoléines (pharmacocinétique), Quinoléines (usage thérapeutique), Résultat thérapeutique, Survie sans rechute, Tumeurs du cerveau (traitement médicamenteux).
- MESH :
- effets indésirables : Antinéoplasiques alcoylants, Association de médicaments, Lomustine, Pyrazoles, Quinoléines.
- pharmacocinétique : Lomustine, Pyrazoles, Quinoléines.
- traitement médicamenteux : Glioblastome, Tumeurs du cerveau.
- usage thérapeutique : Antinéoplasiques alcoylants, Lomustine, Pyrazoles, Quinoléines.
- Adulte d'âge moyen, Association de médicaments, Estimation de Kaplan-Meier, Femelle, Humains, Mâle, Résultat thérapeutique, Survie sans rechute.
English descriptors
- KwdEn :
- Antineoplastic Agents, Alkylating (adverse effects), Antineoplastic Agents, Alkylating (therapeutic use), Brain Neoplasms (drug therapy), Disease-Free Survival, Drug Therapy, Combination (adverse effects), Drug Therapy, Combination (methods), Female, Glioblastoma (drug therapy), Humans, Kaplan-Meier Estimate, Lomustine (adverse effects), Lomustine (pharmacokinetics), Lomustine (therapeutic use), Male, Middle Aged, Pyrazoles (adverse effects), Pyrazoles (pharmacokinetics), Pyrazoles (therapeutic use), Quinolines (adverse effects), Quinolines (pharmacokinetics), Quinolines (therapeutic use), Treatment Outcome.
- MESH :
- chemical , adverse effects : Antineoplastic Agents, Alkylating, Lomustine, Pyrazoles, Quinolines.
- chemical , pharmacokinetics : Lomustine, Pyrazoles, Quinolines.
- chemical , therapeutic use : Antineoplastic Agents, Alkylating, Lomustine, Pyrazoles, Quinolines.
- adverse effects : Drug Therapy, Combination.
- drug therapy : Brain Neoplasms, Glioblastoma.
- methods : Drug Therapy, Combination.
- Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Treatment Outcome.
Abstract
The combination of galunisertib, a transforming growth factor (TGF)-β receptor (R)1 kinase inhibitor, and lomustine was found to have antitumor activity in murine models of glioblastoma.
Galunisertib (300 mg/day) was given orally 14 days on/14 days off (intermittent dosing). Lomustine was given as approved. Patients were randomized in a 2:1:1 ratio to galunisertib + lomustine, galunisertib monotherapy, or placebo + lomustine. The primary objective was overall survival (OS); secondary objectives were safety, pharmacokinetics (PKs), and antitumor activity.
One hundred fifty-eight patients were randomized: galunisertib + lomustine (N = 79), galunisertib (N = 39), and placebo + lomustine (N = 40). Baseline characteristics were: male (64.6%), white (75.3%), median age 58 years, ECOG performance status (PS) 1 (63.3%), and primary glioblastoma (93.7%). The PKs of galunisertib were not altered with lomustine, and galunisertib had a median half-life of ∼8 hours. Median OS in months (95% credible interval [CrI]) for galunisertib + lomustine was 6.7 (range: 5.3–8.5), 8.0 (range: 5.7–11.7) for galunisertib alone, and 7.5 (range: 5.6–10.3) for placebo + lomustine. There was no difference in OS for patients treated with galunisertib + lomustine compared with placebo + lomustine [P (HR < 1) = 26%]. Median progression-free survival of ∼2 months was observed in all 3 arms. Among 8 patients with IDH1 mutation, 7 patients were treated with galunisertib (monotherapy or with lomustine); OS ranged from 4 to 17 months. Patients treated with galunisertib alone had fewer drug-related grade 3/4 adverse events (
Galunisertib + lomustine failed to demonstrate improved OS relative to placebo + lomustine. Efficacy outcomes were similar in all 3 arms.
NCT01582269, ClinicalTrials.gov.
Url:
DOI: 10.1093/neuonc/now009
PubMed: 26902851
PubMed Central: 4933481
Affiliations:
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Brandes</name></author><author><name sortKey="Carpentier, Antoine F" sort="Carpentier, Antoine F" uniqKey="Carpentier A" first="Antoine F." last="Carpentier">Antoine F. Carpentier</name></author><author><name sortKey="Kesari, Santosh" sort="Kesari, Santosh" uniqKey="Kesari S" first="Santosh" last="Kesari">Santosh Kesari</name></author><author><name sortKey="Sepulveda Sanchez, Juan M" sort="Sepulveda Sanchez, Juan M" uniqKey="Sepulveda Sanchez J" first="Juan M." last="Sepulveda-Sanchez">Juan M. Sepulveda-Sanchez</name></author><author><name sortKey="Wheeler, Helen R" sort="Wheeler, Helen R" uniqKey="Wheeler H" first="Helen R." last="Wheeler">Helen R. Wheeler</name></author><author><name sortKey="Chinot, Olivier" sort="Chinot, Olivier" uniqKey="Chinot O" first="Olivier" last="Chinot">Olivier Chinot</name></author><author><name sortKey="Cher, Lawrence" sort="Cher, Lawrence" uniqKey="Cher L" first="Lawrence" last="Cher">Lawrence Cher</name></author><author><name sortKey="Steinbach, Joachim P" sort="Steinbach, Joachim P" uniqKey="Steinbach J" first="Joachim P." last="Steinbach">Joachim P. Steinbach</name></author><author><name sortKey="Capper, David" sort="Capper, David" uniqKey="Capper D" first="David" last="Capper">David Capper</name></author><author><name sortKey="Specenier, Pol" sort="Specenier, Pol" uniqKey="Specenier P" first="Pol" last="Specenier">Pol Specenier</name></author><author><name sortKey="Rodon, Jordi" sort="Rodon, Jordi" uniqKey="Rodon J" first="Jordi" last="Rodon">Jordi Rodon</name></author><author><name sortKey="Cleverly, Ann" sort="Cleverly, Ann" uniqKey="Cleverly A" first="Ann" last="Cleverly">Ann Cleverly</name></author><author><name sortKey="Smith, Claire" sort="Smith, Claire" uniqKey="Smith C" first="Claire" last="Smith">Claire Smith</name></author><author><name sortKey="Gueorguieva, Ivelina" sort="Gueorguieva, Ivelina" uniqKey="Gueorguieva I" first="Ivelina" last="Gueorguieva">Ivelina Gueorguieva</name></author><author><name sortKey="Miles, Colin" sort="Miles, Colin" uniqKey="Miles C" first="Colin" last="Miles">Colin Miles</name></author><author><name sortKey="Guba, Susan C" sort="Guba, Susan C" uniqKey="Guba S" first="Susan C." last="Guba">Susan C. Guba</name></author><author><name sortKey="Desaiah, Durisala" sort="Desaiah, Durisala" uniqKey="Desaiah D" first="Durisala" last="Desaiah">Durisala Desaiah</name></author><author><name sortKey="Lahn, Michael M" sort="Lahn, Michael M" uniqKey="Lahn M" first="Michael M." last="Lahn">Michael M. Lahn</name></author><author><name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name></author></analytic><series><title level="j">Neuro-Oncology</title><idno type="ISSN">1522-8517</idno><idno type="eISSN">1523-5866</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic Agents, Alkylating (adverse effects)</term><term>Antineoplastic Agents, Alkylating (therapeutic use)</term><term>Brain Neoplasms (drug therapy)</term><term>Disease-Free Survival</term><term>Drug Therapy, Combination (adverse effects)</term><term>Drug Therapy, Combination (methods)</term><term>Female</term><term>Glioblastoma (drug therapy)</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Lomustine (adverse effects)</term><term>Lomustine (pharmacokinetics)</term><term>Lomustine (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Pyrazoles (adverse effects)</term><term>Pyrazoles (pharmacokinetics)</term><term>Pyrazoles (therapeutic use)</term><term>Quinolines (adverse effects)</term><term>Quinolines (pharmacokinetics)</term><term>Quinolines (therapeutic use)</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Antinéoplasiques alcoylants (effets indésirables)</term><term>Antinéoplasiques alcoylants (usage thérapeutique)</term><term>Association de médicaments ()</term><term>Association de médicaments (effets indésirables)</term><term>Estimation de Kaplan-Meier</term><term>Femelle</term><term>Glioblastome (traitement médicamenteux)</term><term>Humains</term><term>Lomustine (effets indésirables)</term><term>Lomustine (pharmacocinétique)</term><term>Lomustine (usage thérapeutique)</term><term>Mâle</term><term>Pyrazoles (effets indésirables)</term><term>Pyrazoles (pharmacocinétique)</term><term>Pyrazoles (usage thérapeutique)</term><term>Quinoléines (effets indésirables)</term><term>Quinoléines (pharmacocinétique)</term><term>Quinoléines (usage thérapeutique)</term><term>Résultat thérapeutique</term><term>Survie sans rechute</term><term>Tumeurs du cerveau (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Agents, Alkylating</term><term>Lomustine</term><term>Pyrazoles</term><term>Quinolines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Lomustine</term><term>Pyrazoles</term><term>Quinolines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents, Alkylating</term><term>Lomustine</term><term>Pyrazoles</term><term>Quinolines</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Drug Therapy, Combination</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Brain Neoplasms</term><term>Glioblastoma</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antinéoplasiques alcoylants</term><term>Association de médicaments</term><term>Lomustine</term><term>Pyrazoles</term><term>Quinoléines</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Drug Therapy, Combination</term></keywords><keywords scheme="MESH" qualifier="pharmacocinétique" xml:lang="fr"><term>Lomustine</term><term>Pyrazoles</term><term>Quinoléines</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Glioblastome</term><term>Tumeurs du cerveau</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antinéoplasiques alcoylants</term><term>Lomustine</term><term>Pyrazoles</term><term>Quinoléines</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Association de médicaments</term><term>Estimation de Kaplan-Meier</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Résultat thérapeutique</term><term>Survie sans rechute</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>The combination of galunisertib, a transforming growth factor (TGF)-β receptor (R)1 kinase inhibitor, and lomustine was found to have antitumor activity in murine models of glioblastoma.</p></sec><sec><title>Methods</title><p>Galunisertib (300 mg/day) was given orally 14 days on/14 days off (intermittent dosing). Lomustine was given as approved. Patients were randomized in a 2:1:1 ratio to galunisertib + lomustine, galunisertib monotherapy, or placebo + lomustine. The primary objective was overall survival (OS); secondary objectives were safety, pharmacokinetics (PKs), and antitumor activity.</p></sec><sec><title>Results</title><p>One hundred fifty-eight patients were randomized: galunisertib + lomustine (N = 79), galunisertib (N = 39), and placebo + lomustine (N = 40). Baseline characteristics were: male (64.6%), white (75.3%), median age 58 years, ECOG performance status (PS) 1 (63.3%), and primary glioblastoma (93.7%). The PKs of galunisertib were not altered with lomustine, and galunisertib had a median half-life of ∼8 hours. Median OS in months (95% credible interval [CrI]) for galunisertib + lomustine was 6.7 (range: 5.3–8.5), 8.0 (range: 5.7–11.7) for galunisertib alone, and 7.5 (range: 5.6–10.3) for placebo + lomustine. There was no difference in OS for patients treated with galunisertib + lomustine compared with placebo + lomustine [P (HR < 1) = 26%]. Median progression-free survival of ∼2 months was observed in all 3 arms. Among 8 patients with IDH1 mutation, 7 patients were treated with galunisertib (monotherapy or with lomustine); OS ranged from 4 to 17 months. Patients treated with galunisertib alone had fewer drug-related grade 3/4 adverse events (<italic>n</italic> = 34) compared with lomustine-treated patients (10% vs 26%). Baseline PS, post-discontinuation of bevacizumab, tumor size, and baseline levels of MDC/CCL22 were correlated with OS.</p></sec><sec><title>Conclusions</title><p>Galunisertib + lomustine failed to demonstrate improved OS relative to placebo + lomustine. Efficacy outcomes were similar in all 3 arms.</p></sec><sec><title>Clinical Trial Registration</title><p>NCT01582269, ClinicalTrials.gov.</p></sec></div></front></TEI><affiliations><list></list><tree><noCountry><name sortKey="Brandes, Alba A" sort="Brandes, Alba A" uniqKey="Brandes A" first="Alba A." last="Brandes">Alba A. Brandes</name><name sortKey="Capper, David" sort="Capper, David" uniqKey="Capper D" first="David" last="Capper">David Capper</name><name sortKey="Carpentier, Antoine F" sort="Carpentier, Antoine F" uniqKey="Carpentier A" first="Antoine F." last="Carpentier">Antoine F. Carpentier</name><name sortKey="Cher, Lawrence" sort="Cher, Lawrence" uniqKey="Cher L" first="Lawrence" last="Cher">Lawrence Cher</name><name sortKey="Chinot, Olivier" sort="Chinot, Olivier" uniqKey="Chinot O" first="Olivier" last="Chinot">Olivier Chinot</name><name sortKey="Cleverly, Ann" sort="Cleverly, Ann" uniqKey="Cleverly A" first="Ann" last="Cleverly">Ann Cleverly</name><name sortKey="Desaiah, Durisala" sort="Desaiah, Durisala" uniqKey="Desaiah D" first="Durisala" last="Desaiah">Durisala Desaiah</name><name sortKey="Guba, Susan C" sort="Guba, Susan C" uniqKey="Guba S" first="Susan C." last="Guba">Susan C. Guba</name><name sortKey="Gueorguieva, Ivelina" sort="Gueorguieva, Ivelina" uniqKey="Gueorguieva I" first="Ivelina" last="Gueorguieva">Ivelina Gueorguieva</name><name sortKey="Kesari, Santosh" sort="Kesari, Santosh" uniqKey="Kesari S" first="Santosh" last="Kesari">Santosh Kesari</name><name sortKey="Lahn, Michael M" sort="Lahn, Michael M" uniqKey="Lahn M" first="Michael M." last="Lahn">Michael M. Lahn</name><name sortKey="Miles, Colin" sort="Miles, Colin" uniqKey="Miles C" first="Colin" last="Miles">Colin Miles</name><name sortKey="Rodon, Jordi" sort="Rodon, Jordi" uniqKey="Rodon J" first="Jordi" last="Rodon">Jordi Rodon</name><name sortKey="Sepulveda Sanchez, Juan M" sort="Sepulveda Sanchez, Juan M" uniqKey="Sepulveda Sanchez J" first="Juan M." last="Sepulveda-Sanchez">Juan M. Sepulveda-Sanchez</name><name sortKey="Smith, Claire" sort="Smith, Claire" uniqKey="Smith C" first="Claire" last="Smith">Claire Smith</name><name sortKey="Specenier, Pol" sort="Specenier, Pol" uniqKey="Specenier P" first="Pol" last="Specenier">Pol Specenier</name><name sortKey="Steinbach, Joachim P" sort="Steinbach, Joachim P" uniqKey="Steinbach J" first="Joachim P." last="Steinbach">Joachim P. Steinbach</name><name sortKey="Wheeler, Helen R" sort="Wheeler, Helen R" uniqKey="Wheeler H" first="Helen R." last="Wheeler">Helen R. Wheeler</name><name sortKey="Wick, Wolfgang" sort="Wick, Wolfgang" uniqKey="Wick W" first="Wolfgang" last="Wick">Wolfgang Wick</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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