Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial.
Identifieur interne : 001E67 ( PubMed/Corpus ); précédent : 001E66; suivant : 001E68Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial.
Auteurs : Jeffrey H. Lipton ; Charles Chuah ; Agnès Guerci-Bresler ; Gianantonio Rosti ; David Simpson ; Sarit Assouline ; Gabriel Etienne ; Franck E. Nicolini ; Philipp Le Coutre ; Richard E. Clark ; Leif Stenke ; David Andorsky ; Vivian Oehler ; Stephanie Lustgarten ; Victor M. Rivera ; Timothy Clackson ; Frank G. Haluska ; Michele Baccarani ; Jorge E. Cortes ; François Guilhot ; Andreas Hochhaus ; Timothy Hughes ; Hagop M. Kantarjian ; Neil P. Shah ; Moshe Talpaz ; Michael W. DeiningerSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2016.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (adverse effects), Disease-Free Survival, Drug-Related Side Effects and Adverse Reactions (classification), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Fusion Proteins, bcr-abl (genetics), Humans, Imatinib Mesylate (administration & dosage), Imatinib Mesylate (adverse effects), Imidazoles (administration & dosage), Imidazoles (adverse effects), Kaplan-Meier Estimate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy), Leukemia, Myelogenous, Chronic, BCR-ABL Positive (genetics), Leukemia, Myelogenous, Chronic, BCR-ABL Positive (pathology), Male, Middle Aged, Philadelphia Chromosome (drug effects), Pyridazines (administration & dosage), Pyridazines (adverse effects), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Imatinib Mesylate, Imidazoles, Pyridazines.
- chemical , adverse effects : Imatinib Mesylate, Imidazoles, Pyridazines.
- chemical , genetics : Fusion Proteins, bcr-abl.
- administration & dosage : Antineoplastic Combined Chemotherapy Protocols.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- classification : Drug-Related Side Effects and Adverse Reactions.
- drug effects : Philadelphia Chromosome.
- drug therapy : Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
- genetics : Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
- pathology : Drug-Related Side Effects and Adverse Reactions, Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
- Adolescent, Adult, Aged, Aged, 80 and over, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Treatment Outcome.
Abstract
Ponatinib has shown potent activity against chronic myeloid leukaemia that is resistant to available treatment, although it is associated with arterial occlusion. We investigated whether this activity and safety profile would result in superior outcomes compared with imatinib in previously untreated patients with chronic myeloid leukaemia.
DOI: 10.1016/S1470-2045(16)00080-2
PubMed: 27083332
Links to Exploration step
pubmed:27083332Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial.</title><author><name sortKey="Lipton, Jeffrey H" sort="Lipton, Jeffrey H" uniqKey="Lipton J" first="Jeffrey H" last="Lipton">Jeffrey H. Lipton</name><affiliation><nlm:affiliation>Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada. Electronic address: Jeff.Lipton@uhn.ca.</nlm:affiliation></affiliation></author><author><name sortKey="Chuah, Charles" sort="Chuah, Charles" uniqKey="Chuah C" first="Charles" last="Chuah">Charles Chuah</name><affiliation><nlm:affiliation>Duke-NUS Medical School, Singapore General Hospital, Singapore.</nlm:affiliation></affiliation></author><author><name sortKey="Guerci Bresler, Agnes" sort="Guerci Bresler, Agnes" uniqKey="Guerci Bresler A" first="Agnès" last="Guerci-Bresler">Agnès Guerci-Bresler</name><affiliation><nlm:affiliation>Brabois Hospital, Vandoeuvre-lès-Nancy, France.</nlm:affiliation></affiliation></author><author><name sortKey="Rosti, Gianantonio" sort="Rosti, Gianantonio" uniqKey="Rosti G" first="Gianantonio" last="Rosti">Gianantonio Rosti</name><affiliation><nlm:affiliation>Institute of Hematology, University of Bologna, Bologna, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Simpson, David" sort="Simpson, David" uniqKey="Simpson D" first="David" last="Simpson">David Simpson</name><affiliation><nlm:affiliation>North Shore Hospital, Westlake, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Assouline, Sarit" sort="Assouline, Sarit" uniqKey="Assouline S" first="Sarit" last="Assouline">Sarit Assouline</name><affiliation><nlm:affiliation>Department of Oncology, Jewish General Hospital, McGill University, Montréal, QC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Etienne, Gabriel" sort="Etienne, Gabriel" uniqKey="Etienne G" first="Gabriel" last="Etienne">Gabriel Etienne</name><affiliation><nlm:affiliation>Département d'Hématologie, Institut Bergonié, Bordeaux, France.</nlm:affiliation></affiliation></author><author><name sortKey="Nicolini, Franck E" sort="Nicolini, Franck E" uniqKey="Nicolini F" first="Franck E" last="Nicolini">Franck E. Nicolini</name><affiliation><nlm:affiliation>Haematology Department, Centre Hospitalier Lyon Sud, Pierre Bénite, France.</nlm:affiliation></affiliation></author><author><name sortKey="Le Coutre, Philipp" sort="Le Coutre, Philipp" uniqKey="Le Coutre P" first="Philipp" last="Le Coutre">Philipp Le Coutre</name><affiliation><nlm:affiliation>Department of Hematology, Oncology and Tumor Immunology, Charité-Universitätsmedizin Berlin, Berlin, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Clark, Richard E" sort="Clark, Richard E" uniqKey="Clark R" first="Richard E" last="Clark">Richard E. Clark</name><affiliation><nlm:affiliation>Department of Haematology, Royal Liverpool University Hospital, Liverpool, Merseyside, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Stenke, Leif" sort="Stenke, Leif" uniqKey="Stenke L" first="Leif" last="Stenke">Leif Stenke</name><affiliation><nlm:affiliation>Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Andorsky, David" sort="Andorsky, David" uniqKey="Andorsky D" first="David" last="Andorsky">David Andorsky</name><affiliation><nlm:affiliation>Rocky Mountain Cancer Centers, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Oehler, Vivian" sort="Oehler, Vivian" uniqKey="Oehler V" first="Vivian" last="Oehler">Vivian Oehler</name><affiliation><nlm:affiliation>Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lustgarten, Stephanie" sort="Lustgarten, Stephanie" uniqKey="Lustgarten S" first="Stephanie" last="Lustgarten">Stephanie Lustgarten</name><affiliation><nlm:affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Rivera, Victor M" sort="Rivera, Victor M" uniqKey="Rivera V" first="Victor M" last="Rivera">Victor M. Rivera</name><affiliation><nlm:affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Clackson, Timothy" sort="Clackson, Timothy" uniqKey="Clackson T" first="Timothy" last="Clackson">Timothy Clackson</name><affiliation><nlm:affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Haluska, Frank G" sort="Haluska, Frank G" uniqKey="Haluska F" first="Frank G" last="Haluska">Frank G. Haluska</name><affiliation><nlm:affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Baccarani, Michele" sort="Baccarani, Michele" uniqKey="Baccarani M" first="Michele" last="Baccarani">Michele Baccarani</name><affiliation><nlm:affiliation>Department of Hematology and Oncology, University of Bologna, Bologna, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E" last="Cortes">Jorge E. Cortes</name><affiliation><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name><affiliation><nlm:affiliation>INSERM Clinical Investigation Center 1402, Centre Hospitalier et Universitaire de Poitiers, Poitiers, France.</nlm:affiliation></affiliation></author><author><name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name><affiliation><nlm:affiliation>Abteilung für Hämatologie und Onkologie, Universitätsklinikum Jena, Jena, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name><affiliation><nlm:affiliation>Haematology Division, Royal Adelaide Hospital, University of Adelaide and South Australian Health and Medical Research Institute, Adelaide, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M" last="Kantarjian">Hagop M. Kantarjian</name><affiliation><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Shah, Neil P" sort="Shah, Neil P" uniqKey="Shah N" first="Neil P" last="Shah">Neil P. Shah</name><affiliation><nlm:affiliation>Department of Medicine (Hematology/Oncology), University of California, San Francisco, San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Talpaz, Moshe" sort="Talpaz, Moshe" uniqKey="Talpaz M" first="Moshe" last="Talpaz">Moshe Talpaz</name><affiliation><nlm:affiliation>Division of Hematology/Oncology, Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Deininger, Michael W" sort="Deininger, Michael W" uniqKey="Deininger M" first="Michael W" last="Deininger">Michael W. Deininger</name><affiliation><nlm:affiliation>Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27083332</idno><idno type="pmid">27083332</idno><idno type="doi">10.1016/S1470-2045(16)00080-2</idno><idno type="wicri:Area/PubMed/Corpus">001E67</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001E67</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial.</title><author><name sortKey="Lipton, Jeffrey H" sort="Lipton, Jeffrey H" uniqKey="Lipton J" first="Jeffrey H" last="Lipton">Jeffrey H. Lipton</name><affiliation><nlm:affiliation>Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada. Electronic address: Jeff.Lipton@uhn.ca.</nlm:affiliation></affiliation></author><author><name sortKey="Chuah, Charles" sort="Chuah, Charles" uniqKey="Chuah C" first="Charles" last="Chuah">Charles Chuah</name><affiliation><nlm:affiliation>Duke-NUS Medical School, Singapore General Hospital, Singapore.</nlm:affiliation></affiliation></author><author><name sortKey="Guerci Bresler, Agnes" sort="Guerci Bresler, Agnes" uniqKey="Guerci Bresler A" first="Agnès" last="Guerci-Bresler">Agnès Guerci-Bresler</name><affiliation><nlm:affiliation>Brabois Hospital, Vandoeuvre-lès-Nancy, France.</nlm:affiliation></affiliation></author><author><name sortKey="Rosti, Gianantonio" sort="Rosti, Gianantonio" uniqKey="Rosti G" first="Gianantonio" last="Rosti">Gianantonio Rosti</name><affiliation><nlm:affiliation>Institute of Hematology, University of Bologna, Bologna, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Simpson, David" sort="Simpson, David" uniqKey="Simpson D" first="David" last="Simpson">David Simpson</name><affiliation><nlm:affiliation>North Shore Hospital, Westlake, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Assouline, Sarit" sort="Assouline, Sarit" uniqKey="Assouline S" first="Sarit" last="Assouline">Sarit Assouline</name><affiliation><nlm:affiliation>Department of Oncology, Jewish General Hospital, McGill University, Montréal, QC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Etienne, Gabriel" sort="Etienne, Gabriel" uniqKey="Etienne G" first="Gabriel" last="Etienne">Gabriel Etienne</name><affiliation><nlm:affiliation>Département d'Hématologie, Institut Bergonié, Bordeaux, France.</nlm:affiliation></affiliation></author><author><name sortKey="Nicolini, Franck E" sort="Nicolini, Franck E" uniqKey="Nicolini F" first="Franck E" last="Nicolini">Franck E. Nicolini</name><affiliation><nlm:affiliation>Haematology Department, Centre Hospitalier Lyon Sud, Pierre Bénite, France.</nlm:affiliation></affiliation></author><author><name sortKey="Le Coutre, Philipp" sort="Le Coutre, Philipp" uniqKey="Le Coutre P" first="Philipp" last="Le Coutre">Philipp Le Coutre</name><affiliation><nlm:affiliation>Department of Hematology, Oncology and Tumor Immunology, Charité-Universitätsmedizin Berlin, Berlin, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Clark, Richard E" sort="Clark, Richard E" uniqKey="Clark R" first="Richard E" last="Clark">Richard E. Clark</name><affiliation><nlm:affiliation>Department of Haematology, Royal Liverpool University Hospital, Liverpool, Merseyside, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Stenke, Leif" sort="Stenke, Leif" uniqKey="Stenke L" first="Leif" last="Stenke">Leif Stenke</name><affiliation><nlm:affiliation>Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Andorsky, David" sort="Andorsky, David" uniqKey="Andorsky D" first="David" last="Andorsky">David Andorsky</name><affiliation><nlm:affiliation>Rocky Mountain Cancer Centers, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Oehler, Vivian" sort="Oehler, Vivian" uniqKey="Oehler V" first="Vivian" last="Oehler">Vivian Oehler</name><affiliation><nlm:affiliation>Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lustgarten, Stephanie" sort="Lustgarten, Stephanie" uniqKey="Lustgarten S" first="Stephanie" last="Lustgarten">Stephanie Lustgarten</name><affiliation><nlm:affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Rivera, Victor M" sort="Rivera, Victor M" uniqKey="Rivera V" first="Victor M" last="Rivera">Victor M. Rivera</name><affiliation><nlm:affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Clackson, Timothy" sort="Clackson, Timothy" uniqKey="Clackson T" first="Timothy" last="Clackson">Timothy Clackson</name><affiliation><nlm:affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Haluska, Frank G" sort="Haluska, Frank G" uniqKey="Haluska F" first="Frank G" last="Haluska">Frank G. Haluska</name><affiliation><nlm:affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Baccarani, Michele" sort="Baccarani, Michele" uniqKey="Baccarani M" first="Michele" last="Baccarani">Michele Baccarani</name><affiliation><nlm:affiliation>Department of Hematology and Oncology, University of Bologna, Bologna, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Cortes, Jorge E" sort="Cortes, Jorge E" uniqKey="Cortes J" first="Jorge E" last="Cortes">Jorge E. Cortes</name><affiliation><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Guilhot, Francois" sort="Guilhot, Francois" uniqKey="Guilhot F" first="François" last="Guilhot">François Guilhot</name><affiliation><nlm:affiliation>INSERM Clinical Investigation Center 1402, Centre Hospitalier et Universitaire de Poitiers, Poitiers, France.</nlm:affiliation></affiliation></author><author><name sortKey="Hochhaus, Andreas" sort="Hochhaus, Andreas" uniqKey="Hochhaus A" first="Andreas" last="Hochhaus">Andreas Hochhaus</name><affiliation><nlm:affiliation>Abteilung für Hämatologie und Onkologie, Universitätsklinikum Jena, Jena, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Hughes, Timothy" sort="Hughes, Timothy" uniqKey="Hughes T" first="Timothy" last="Hughes">Timothy Hughes</name><affiliation><nlm:affiliation>Haematology Division, Royal Adelaide Hospital, University of Adelaide and South Australian Health and Medical Research Institute, Adelaide, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Kantarjian, Hagop M" sort="Kantarjian, Hagop M" uniqKey="Kantarjian H" first="Hagop M" last="Kantarjian">Hagop M. Kantarjian</name><affiliation><nlm:affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Shah, Neil P" sort="Shah, Neil P" uniqKey="Shah N" first="Neil P" last="Shah">Neil P. Shah</name><affiliation><nlm:affiliation>Department of Medicine (Hematology/Oncology), University of California, San Francisco, San Francisco, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Talpaz, Moshe" sort="Talpaz, Moshe" uniqKey="Talpaz M" first="Moshe" last="Talpaz">Moshe Talpaz</name><affiliation><nlm:affiliation>Division of Hematology/Oncology, Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Deininger, Michael W" sort="Deininger, Michael W" uniqKey="Deininger M" first="Michael W" last="Deininger">Michael W. Deininger</name><affiliation><nlm:affiliation>Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antineoplastic Combined Chemotherapy Protocols (administration & dosage)</term><term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term><term>Disease-Free Survival</term><term>Drug-Related Side Effects and Adverse Reactions (classification)</term><term>Drug-Related Side Effects and Adverse Reactions (pathology)</term><term>Female</term><term>Fusion Proteins, bcr-abl (genetics)</term><term>Humans</term><term>Imatinib Mesylate (administration & dosage)</term><term>Imatinib Mesylate (adverse effects)</term><term>Imidazoles (administration & dosage)</term><term>Imidazoles (adverse effects)</term><term>Kaplan-Meier Estimate</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (genetics)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (pathology)</term><term>Male</term><term>Middle Aged</term><term>Philadelphia Chromosome (drug effects)</term><term>Pyridazines (administration & dosage)</term><term>Pyridazines (adverse effects)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Imatinib Mesylate</term><term>Imidazoles</term><term>Pyridazines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Imatinib Mesylate</term><term>Imidazoles</term><term>Pyridazines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Fusion Proteins, bcr-abl</term></keywords><keywords scheme="MESH" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="classification" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Philadelphia Chromosome</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><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></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Ponatinib has shown potent activity against chronic myeloid leukaemia that is resistant to available treatment, although it is associated with arterial occlusion. We investigated whether this activity and safety profile would result in superior outcomes compared with imatinib in previously untreated patients with chronic myeloid leukaemia.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27083332</PMID><DateCreated><Year>2016</Year><Month>06</Month><Day>15</Day></DateCreated><DateCompleted><Year>2017</Year><Month>06</Month><Day>13</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>30</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>17</Volume><Issue>5</Issue><PubDate><Year>2016</Year><Month>May</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial.</ArticleTitle><Pagination><MedlinePgn>612-21</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(16)00080-2</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(16)00080-2</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Ponatinib has shown potent activity against chronic myeloid leukaemia that is resistant to available treatment, although it is associated with arterial occlusion. We investigated whether this activity and safety profile would result in superior outcomes compared with imatinib in previously untreated patients with chronic myeloid leukaemia.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia (EPIC) study was a randomised, open-label, phase 3 trial designed to assess the efficacy and safety of ponatinib, compared with imatinib, in newly diagnosed patients with chronic-phase chronic myeloid leukaemia. Patients from 106 centres in 21 countries were randomly assigned (1:1, with stratification by Sokal score at diagnosis) using an interactive voice and web response system to receive oral ponatinib (45 mg) or imatinib (400 mg) once daily until progression, unacceptable toxicity, or other criteria for withdrawal were met. Eligible patients were at least 18 years of age, within 6 months of diagnosis, and Philadelphia chromosome-positive by cytogenetic assessment, with Eastern Cooperative Oncology Group performance status of 0-2, and had not previously been treated with tyrosine kinase inhibitors. The primary endpoint was major molecular response at 12 months. Patients who remained on study and had molecular assessments at specified timepoints were studied at those timepoints. Safety analyses included all treated patients, as per study protocol. This trial is registered with ClinicalTrials.gov, number NCT01650805.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Aug 14, 2012, and Oct 9, 2013, 307 patients were randomly assigned to receive ponatinib (n=155) or imatinib (n=152). The trial was terminated early, on Oct 17, 2013, following concerns about vascular adverse events observed in patients given ponatinib in other trials. Trial termination limited assessment of the primary endpoint of major molecular response at 12 months, as only 13 patients in the imatinib group and ten patients in the ponatinib group could be assessed at this timepoint; the proportion of patients achieving a major molecular response at 12 months did not differ significantly between the two groups (eight [80%] of ten patients given ponatinib and five [38%] of 13 patients given imatinib; p=0·074). 11 (7%) of 154 patients given ponatinib and three (2%) of 152 patients given imatinib had arterial occlusive events (p=0·052); arterial occlusive events were designated serious in ten (6%) of 154 patients given ponatinib and in one (1%) of 152 patients given imatinib (p=0·010). The data monitoring committee criterion for risk assessment (significant difference in serious grade 3 or 4 ischaemic events between groups) was not met (five [3%] of 154 vs one [1%] of 152; p=0·21). Grade 3 or 4 adverse events observed in more than 5% of patients in the ponatinib group were increased lipase (22 [14%] of 154 vs three [2%] of 152 with imatinib), thrombocytopenia (19 [12%] of 154 vs ten [7%] of 152 with imatinib), rash (ten [6%] of 154 vs two [1%] of 152 with imatinib). In the imatinib group, grade 3 or 4 adverse events observed in more than 5% of patients were neutropenia (12 [8%] of 152 vs five [3%] of 154 with ponatinib) and thrombocytopenia (ten [7%] of 152 vs 19 [12%] of 154 with ponatinib). Serious adverse events that occurred in three or more patients given ponatinib were pancreatitis (n=5), atrial fibrillation (n=3), and thrombocytopenia (n=3). No serious adverse event occurred in three or more patients given imatinib.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">The efficacy of ponatinib treatment of newly diagnosed chronic-phase chronic myeloid leukaemia compared with imatinib could not be assessed due to trial termination, but preliminary data suggest there might be benefit, although with more arterial occlusive events than with imatinib at the doses studied. Because the EPIC trial was terminated early, efficacy of ponatinib in this setting remains to be established.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">ARIAD Pharmaceuticals.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lipton</LastName><ForeName>Jeffrey H</ForeName><Initials>JH</Initials><AffiliationInfo><Affiliation>Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada. Electronic address: Jeff.Lipton@uhn.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chuah</LastName><ForeName>Charles</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Duke-NUS Medical School, Singapore General Hospital, Singapore.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guerci-Bresler</LastName><ForeName>Agnès</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Brabois Hospital, Vandoeuvre-lès-Nancy, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rosti</LastName><ForeName>Gianantonio</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Institute of Hematology, University of Bologna, Bologna, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Simpson</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>North Shore Hospital, Westlake, Auckland, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Assouline</LastName><ForeName>Sarit</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Oncology, Jewish General Hospital, McGill University, Montréal, QC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Etienne</LastName><ForeName>Gabriel</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Département d'Hématologie, Institut Bergonié, Bordeaux, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nicolini</LastName><ForeName>Franck E</ForeName><Initials>FE</Initials><AffiliationInfo><Affiliation>Haematology Department, Centre Hospitalier Lyon Sud, Pierre Bénite, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>le Coutre</LastName><ForeName>Philipp</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Hematology, Oncology and Tumor Immunology, Charité-Universitätsmedizin Berlin, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Clark</LastName><ForeName>Richard E</ForeName><Initials>RE</Initials><AffiliationInfo><Affiliation>Department of Haematology, Royal Liverpool University Hospital, Liverpool, Merseyside, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stenke</LastName><ForeName>Leif</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Oncology-Pathology, Karolinska Institute and University Hospital, Stockholm, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Andorsky</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Rocky Mountain Cancer Centers, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oehler</LastName><ForeName>Vivian</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lustgarten</LastName><ForeName>Stephanie</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rivera</LastName><ForeName>Victor M</ForeName><Initials>VM</Initials><AffiliationInfo><Affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Clackson</LastName><ForeName>Timothy</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Haluska</LastName><ForeName>Frank G</ForeName><Initials>FG</Initials><AffiliationInfo><Affiliation>ARIAD Pharmaceuticals, Inc, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Baccarani</LastName><ForeName>Michele</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Hematology and Oncology, University of Bologna, Bologna, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cortes</LastName><ForeName>Jorge E</ForeName><Initials>JE</Initials><AffiliationInfo><Affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guilhot</LastName><ForeName>François</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>INSERM Clinical Investigation Center 1402, Centre Hospitalier et Universitaire de Poitiers, Poitiers, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hochhaus</LastName><ForeName>Andreas</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Abteilung für Hämatologie und Onkologie, Universitätsklinikum Jena, Jena, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hughes</LastName><ForeName>Timothy</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Haematology Division, Royal Adelaide Hospital, University of Adelaide and South Australian Health and Medical Research Institute, Adelaide, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kantarjian</LastName><ForeName>Hagop M</ForeName><Initials>HM</Initials><AffiliationInfo><Affiliation>The University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shah</LastName><ForeName>Neil P</ForeName><Initials>NP</Initials><AffiliationInfo><Affiliation>Department of Medicine (Hematology/Oncology), University of California, San Francisco, San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Talpaz</LastName><ForeName>Moshe</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Division of Hematology/Oncology, Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Deininger</LastName><ForeName>Michael W</ForeName><Initials>MW</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>EPIC investigators</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01650805</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal 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