Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL.
Identifieur interne : 000C29 ( PubMed/Corpus ); précédent : 000C28; suivant : 000C30Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL.
Auteurs : Paul M. Barr ; Jennifer R. Brown ; Peter Hillmen ; Susan O'Brien ; Jacqueline C. Barrientos ; Nishitha M. Reddy ; Steven Coutre ; Stephen P. Mulligan ; Ulrich Jaeger ; Richard R. Furman ; Florence Cymbalista ; Marco Montillo ; Claire Dearden ; Tadeusz Robak ; Carol Moreno ; John M. Pagel ; Jan A. Burger ; Samuel Suzuki ; Juthamas Sukbuntherng ; George Cole ; Danelle F. James ; John C. ByrdSource :
- Blood [ 1528-0020 ] ; 2017.
English descriptors
- KwdEn :
- Antineoplastic Agents (administration & dosage), Antineoplastic Agents (therapeutic use), Disease-Free Survival, Dose-Response Relationship, Drug, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy), Leukemia, Lymphocytic, Chronic, B-Cell (genetics), Male, Mutation, Patient Compliance, Protein Kinase Inhibitors (administration & dosage), Protein Kinase Inhibitors (therapeutic use), Protein-Tyrosine Kinases (antagonists & inhibitors), Pyrazoles (administration & dosage), Pyrazoles (therapeutic use), Pyrimidines (administration & dosage), Pyrimidines (therapeutic use), Tumor Suppressor Protein p53 (genetics).
- MESH :
- chemical , administration & dosage : Antineoplastic Agents, Protein Kinase Inhibitors, Pyrazoles, Pyrimidines.
- chemical , antagonists & inhibitors : Protein-Tyrosine Kinases.
- chemical , genetics : Tumor Suppressor Protein p53.
- chemical , therapeutic use : Antineoplastic Agents, Protein Kinase Inhibitors, Pyrazoles, Pyrimidines.
- drug therapy : Leukemia, Lymphocytic, Chronic, B-Cell.
- genetics : Leukemia, Lymphocytic, Chronic, B-Cell.
- Disease-Free Survival, Dose-Response Relationship, Drug, Female, Humans, Male, Mutation, Patient Compliance.
Abstract
Ibrutinib, an oral inhibitor of Bruton's tyrosine kinase (BTK), at a once-daily dose of 420 mg achieved BTK active-site occupancy in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) that was maintained at 24 hours. It is unknown if intermittent interruption of ibrutinib therapy contributes to altered clinical outcomes. We therefore evaluated the effect of ibrutinib dose adherence on patient outcomes in the phase 3 RESONATE trial. The overall mean dose intensity (DI) was 95% with median treatment duration of ∼9 months. Pharmacokinetic assessment of ibrutinib exposure at 420-mg dose suggested similar exposure regardless of patient weight or age. As assessed by independent review committee, patients with higher DI experienced longer median progression-free survival (PFS) compared with those with lower DI regardless of del17p and/or TP53 status. Of 79 patients requiring a drug hold, treatment was restarted at the original dose in 73 (92%) patients. Mean duration of a missed-dose event was 18.7 days (range, 8-56). Patients missing ≥8 consecutive days of ibrutinib had a shorter median PFS vs those missing <8 days (10.9 months vs not reached). These results support sustained adherence to once-daily ibrutinib dosing at 420 mg as clinically feasible to achieve optimal outcomes in patients with previously treated CLL. The trial was registered at www.clinicaltrials.gov as #NCT01578707.
DOI: 10.1182/blood-2016-12-737346
PubMed: 28373262
Links to Exploration step
pubmed:28373262Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL.</title><author><name sortKey="Barr, Paul M" sort="Barr, Paul M" uniqKey="Barr P" first="Paul M" last="Barr">Paul M. Barr</name><affiliation><nlm:affiliation>Wilmot Cancer Institute, University of Rochester, Rochester, NY.</nlm:affiliation></affiliation></author><author><name sortKey="Brown, Jennifer R" sort="Brown, Jennifer R" uniqKey="Brown J" first="Jennifer R" last="Brown">Jennifer R. Brown</name><affiliation><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Hillmen, Peter" sort="Hillmen, Peter" uniqKey="Hillmen P" first="Peter" last="Hillmen">Peter Hillmen</name><affiliation><nlm:affiliation>The Leeds Teaching Hospitals, St. James Institute of Oncology, Leeds, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="O Brien, Susan" sort="O Brien, Susan" uniqKey="O Brien S" first="Susan" last="O'Brien">Susan O'Brien</name><affiliation><nlm:affiliation>Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX.</nlm:affiliation></affiliation></author><author><name sortKey="Barrientos, Jacqueline C" sort="Barrientos, Jacqueline C" uniqKey="Barrientos J" first="Jacqueline C" last="Barrientos">Jacqueline C. Barrientos</name><affiliation><nlm:affiliation>Hofstra Northwell School of Medicine, Hempstead, NY.</nlm:affiliation></affiliation></author><author><name sortKey="Reddy, Nishitha M" sort="Reddy, Nishitha M" uniqKey="Reddy N" first="Nishitha M" last="Reddy">Nishitha M. Reddy</name><affiliation><nlm:affiliation>Vanderbilt-Ingram Cancer Center, Nashville, TN.</nlm:affiliation></affiliation></author><author><name sortKey="Coutre, Steven" sort="Coutre, Steven" uniqKey="Coutre S" first="Steven" last="Coutre">Steven Coutre</name><affiliation><nlm:affiliation>Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Mulligan, Stephen P" sort="Mulligan, Stephen P" uniqKey="Mulligan S" first="Stephen P" last="Mulligan">Stephen P. Mulligan</name><affiliation><nlm:affiliation>Royal North Shore Hospital, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Jaeger, Ulrich" sort="Jaeger, Ulrich" uniqKey="Jaeger U" first="Ulrich" last="Jaeger">Ulrich Jaeger</name><affiliation><nlm:affiliation>Division of Hematology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Furman, Richard R" sort="Furman, Richard R" uniqKey="Furman R" first="Richard R" last="Furman">Richard R. Furman</name><affiliation><nlm:affiliation>Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY.</nlm:affiliation></affiliation></author><author><name sortKey="Cymbalista, Florence" sort="Cymbalista, Florence" uniqKey="Cymbalista F" first="Florence" last="Cymbalista">Florence Cymbalista</name><affiliation><nlm:affiliation>Hôpital Avicenne, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Montillo, Marco" sort="Montillo, Marco" uniqKey="Montillo M" first="Marco" last="Montillo">Marco Montillo</name><affiliation><nlm:affiliation>Niguarda Ca' Granda Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Dearden, Claire" sort="Dearden, Claire" uniqKey="Dearden C" first="Claire" last="Dearden">Claire Dearden</name><affiliation><nlm:affiliation>Royal Marsden Hospital, London, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation><nlm:affiliation>Department of Hematology, Medical University of Lodz, Lodz, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Moreno, Carol" sort="Moreno, Carol" uniqKey="Moreno C" first="Carol" last="Moreno">Carol Moreno</name><affiliation><nlm:affiliation>Hospital de la Santa Creu Sant Pau, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Pagel, John M" sort="Pagel, John M" uniqKey="Pagel J" first="John M" last="Pagel">John M. Pagel</name><affiliation><nlm:affiliation>Swedish Cancer Institute, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Burger, Jan A" sort="Burger, Jan A" uniqKey="Burger J" first="Jan A" last="Burger">Jan A. Burger</name><affiliation><nlm:affiliation>Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX.</nlm:affiliation></affiliation></author><author><name sortKey="Suzuki, Samuel" sort="Suzuki, Samuel" uniqKey="Suzuki S" first="Samuel" last="Suzuki">Samuel Suzuki</name><affiliation><nlm:affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Sukbuntherng, Juthamas" sort="Sukbuntherng, Juthamas" uniqKey="Sukbuntherng J" first="Juthamas" last="Sukbuntherng">Juthamas Sukbuntherng</name><affiliation><nlm:affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Cole, George" sort="Cole, George" uniqKey="Cole G" first="George" last="Cole">George Cole</name><affiliation><nlm:affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</nlm:affiliation></affiliation></author><author><name sortKey="James, Danelle F" sort="James, Danelle F" uniqKey="James D" first="Danelle F" last="James">Danelle F. James</name><affiliation><nlm:affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Byrd, John C" sort="Byrd, John C" uniqKey="Byrd J" first="John C" last="Byrd">John C. Byrd</name><affiliation><nlm:affiliation>The Ohio State University Medical Center, The Ohio State University, Columbus, OH.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28373262</idno><idno type="pmid">28373262</idno><idno type="doi">10.1182/blood-2016-12-737346</idno><idno type="wicri:Area/PubMed/Corpus">000C29</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000C29</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL.</title><author><name sortKey="Barr, Paul M" sort="Barr, Paul M" uniqKey="Barr P" first="Paul M" last="Barr">Paul M. Barr</name><affiliation><nlm:affiliation>Wilmot Cancer Institute, University of Rochester, Rochester, NY.</nlm:affiliation></affiliation></author><author><name sortKey="Brown, Jennifer R" sort="Brown, Jennifer R" uniqKey="Brown J" first="Jennifer R" last="Brown">Jennifer R. Brown</name><affiliation><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Hillmen, Peter" sort="Hillmen, Peter" uniqKey="Hillmen P" first="Peter" last="Hillmen">Peter Hillmen</name><affiliation><nlm:affiliation>The Leeds Teaching Hospitals, St. James Institute of Oncology, Leeds, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="O Brien, Susan" sort="O Brien, Susan" uniqKey="O Brien S" first="Susan" last="O'Brien">Susan O'Brien</name><affiliation><nlm:affiliation>Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX.</nlm:affiliation></affiliation></author><author><name sortKey="Barrientos, Jacqueline C" sort="Barrientos, Jacqueline C" uniqKey="Barrientos J" first="Jacqueline C" last="Barrientos">Jacqueline C. Barrientos</name><affiliation><nlm:affiliation>Hofstra Northwell School of Medicine, Hempstead, NY.</nlm:affiliation></affiliation></author><author><name sortKey="Reddy, Nishitha M" sort="Reddy, Nishitha M" uniqKey="Reddy N" first="Nishitha M" last="Reddy">Nishitha M. Reddy</name><affiliation><nlm:affiliation>Vanderbilt-Ingram Cancer Center, Nashville, TN.</nlm:affiliation></affiliation></author><author><name sortKey="Coutre, Steven" sort="Coutre, Steven" uniqKey="Coutre S" first="Steven" last="Coutre">Steven Coutre</name><affiliation><nlm:affiliation>Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Mulligan, Stephen P" sort="Mulligan, Stephen P" uniqKey="Mulligan S" first="Stephen P" last="Mulligan">Stephen P. Mulligan</name><affiliation><nlm:affiliation>Royal North Shore Hospital, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Jaeger, Ulrich" sort="Jaeger, Ulrich" uniqKey="Jaeger U" first="Ulrich" last="Jaeger">Ulrich Jaeger</name><affiliation><nlm:affiliation>Division of Hematology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Furman, Richard R" sort="Furman, Richard R" uniqKey="Furman R" first="Richard R" last="Furman">Richard R. Furman</name><affiliation><nlm:affiliation>Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY.</nlm:affiliation></affiliation></author><author><name sortKey="Cymbalista, Florence" sort="Cymbalista, Florence" uniqKey="Cymbalista F" first="Florence" last="Cymbalista">Florence Cymbalista</name><affiliation><nlm:affiliation>Hôpital Avicenne, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Montillo, Marco" sort="Montillo, Marco" uniqKey="Montillo M" first="Marco" last="Montillo">Marco Montillo</name><affiliation><nlm:affiliation>Niguarda Ca' Granda Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Dearden, Claire" sort="Dearden, Claire" uniqKey="Dearden C" first="Claire" last="Dearden">Claire Dearden</name><affiliation><nlm:affiliation>Royal Marsden Hospital, London, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation><nlm:affiliation>Department of Hematology, Medical University of Lodz, Lodz, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Moreno, Carol" sort="Moreno, Carol" uniqKey="Moreno C" first="Carol" last="Moreno">Carol Moreno</name><affiliation><nlm:affiliation>Hospital de la Santa Creu Sant Pau, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Pagel, John M" sort="Pagel, John M" uniqKey="Pagel J" first="John M" last="Pagel">John M. Pagel</name><affiliation><nlm:affiliation>Swedish Cancer Institute, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Burger, Jan A" sort="Burger, Jan A" uniqKey="Burger J" first="Jan A" last="Burger">Jan A. Burger</name><affiliation><nlm:affiliation>Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX.</nlm:affiliation></affiliation></author><author><name sortKey="Suzuki, Samuel" sort="Suzuki, Samuel" uniqKey="Suzuki S" first="Samuel" last="Suzuki">Samuel Suzuki</name><affiliation><nlm:affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Sukbuntherng, Juthamas" sort="Sukbuntherng, Juthamas" uniqKey="Sukbuntherng J" first="Juthamas" last="Sukbuntherng">Juthamas Sukbuntherng</name><affiliation><nlm:affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Cole, George" sort="Cole, George" uniqKey="Cole G" first="George" last="Cole">George Cole</name><affiliation><nlm:affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</nlm:affiliation></affiliation></author><author><name sortKey="James, Danelle F" sort="James, Danelle F" uniqKey="James D" first="Danelle F" last="James">Danelle F. James</name><affiliation><nlm:affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</nlm:affiliation></affiliation></author><author><name sortKey="Byrd, John C" sort="Byrd, John C" uniqKey="Byrd J" first="John C" last="Byrd">John C. Byrd</name><affiliation><nlm:affiliation>The Ohio State University Medical Center, The Ohio State University, Columbus, OH.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Blood</title><idno type="eISSN">1528-0020</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic Agents (administration & dosage)</term><term>Antineoplastic Agents (therapeutic use)</term><term>Disease-Free Survival</term><term>Dose-Response Relationship, Drug</term><term>Female</term><term>Humans</term><term>Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy)</term><term>Leukemia, Lymphocytic, Chronic, B-Cell (genetics)</term><term>Male</term><term>Mutation</term><term>Patient Compliance</term><term>Protein Kinase Inhibitors (administration & dosage)</term><term>Protein Kinase Inhibitors (therapeutic use)</term><term>Protein-Tyrosine Kinases (antagonists & inhibitors)</term><term>Pyrazoles (administration & dosage)</term><term>Pyrazoles (therapeutic use)</term><term>Pyrimidines (administration & dosage)</term><term>Pyrimidines (therapeutic use)</term><term>Tumor Suppressor Protein p53 (genetics)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Agents</term><term>Protein Kinase Inhibitors</term><term>Pyrazoles</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Protein-Tyrosine Kinases</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Tumor Suppressor Protein p53</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents</term><term>Protein Kinase Inhibitors</term><term>Pyrazoles</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Lymphocytic, Chronic, B-Cell</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Leukemia, Lymphocytic, Chronic, B-Cell</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disease-Free Survival</term><term>Dose-Response Relationship, Drug</term><term>Female</term><term>Humans</term><term>Male</term><term>Mutation</term><term>Patient Compliance</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Ibrutinib, an oral inhibitor of Bruton's tyrosine kinase (BTK), at a once-daily dose of 420 mg achieved BTK active-site occupancy in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) that was maintained at 24 hours. It is unknown if intermittent interruption of ibrutinib therapy contributes to altered clinical outcomes. We therefore evaluated the effect of ibrutinib dose adherence on patient outcomes in the phase 3 RESONATE trial. The overall mean dose intensity (DI) was 95% with median treatment duration of ∼9 months. Pharmacokinetic assessment of ibrutinib exposure at 420-mg dose suggested similar exposure regardless of patient weight or age. As assessed by independent review committee, patients with higher DI experienced longer median progression-free survival (PFS) compared with those with lower DI regardless of del17p and/or TP53 status. Of 79 patients requiring a drug hold, treatment was restarted at the original dose in 73 (92%) patients. Mean duration of a missed-dose event was 18.7 days (range, 8-56). Patients missing ≥8 consecutive days of ibrutinib had a shorter median PFS vs those missing <8 days (10.9 months vs not reached). These results support sustained adherence to once-daily ibrutinib dosing at 420 mg as clinically feasible to achieve optimal outcomes in patients with previously treated CLL. The trial was registered at www.clinicaltrials.gov as #NCT01578707.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28373262</PMID><DateCreated><Year>2017</Year><Month>04</Month><Day>04</Day></DateCreated><DateCompleted><Year>2017</Year><Month>09</Month><Day>08</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>08</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1528-0020</ISSN><JournalIssue CitedMedium="Internet"><Volume>129</Volume><Issue>19</Issue><PubDate><Year>2017</Year><Month>May</Month><Day>11</Day></PubDate></JournalIssue><Title>Blood</Title><ISOAbbreviation>Blood</ISOAbbreviation></Journal><ArticleTitle>Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL.</ArticleTitle><Pagination><MedlinePgn>2612-2615</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1182/blood-2016-12-737346</ELocationID><Abstract><AbstractText>Ibrutinib, an oral inhibitor of Bruton's tyrosine kinase (BTK), at a once-daily dose of 420 mg achieved BTK active-site occupancy in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) that was maintained at 24 hours. It is unknown if intermittent interruption of ibrutinib therapy contributes to altered clinical outcomes. We therefore evaluated the effect of ibrutinib dose adherence on patient outcomes in the phase 3 RESONATE trial. The overall mean dose intensity (DI) was 95% with median treatment duration of ∼9 months. Pharmacokinetic assessment of ibrutinib exposure at 420-mg dose suggested similar exposure regardless of patient weight or age. As assessed by independent review committee, patients with higher DI experienced longer median progression-free survival (PFS) compared with those with lower DI regardless of del17p and/or TP53 status. Of 79 patients requiring a drug hold, treatment was restarted at the original dose in 73 (92%) patients. Mean duration of a missed-dose event was 18.7 days (range, 8-56). Patients missing ≥8 consecutive days of ibrutinib had a shorter median PFS vs those missing <8 days (10.9 months vs not reached). These results support sustained adherence to once-daily ibrutinib dosing at 420 mg as clinically feasible to achieve optimal outcomes in patients with previously treated CLL. The trial was registered at www.clinicaltrials.gov as #NCT01578707.</AbstractText><CopyrightInformation>© 2017 by The American Society of Hematology.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Barr</LastName><ForeName>Paul M</ForeName><Initials>PM</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-9733-401X</Identifier><AffiliationInfo><Affiliation>Wilmot Cancer Institute, University of Rochester, Rochester, NY.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brown</LastName><ForeName>Jennifer R</ForeName><Initials>JR</Initials><AffiliationInfo><Affiliation>Dana-Farber Cancer Institute, Boston, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hillmen</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>The Leeds Teaching Hospitals, St. James Institute of Oncology, Leeds, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>O'Brien</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barrientos</LastName><ForeName>Jacqueline C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Hofstra Northwell School of Medicine, Hempstead, NY.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Reddy</LastName><ForeName>Nishitha M</ForeName><Initials>NM</Initials><AffiliationInfo><Affiliation>Vanderbilt-Ingram Cancer Center, Nashville, TN.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coutre</LastName><ForeName>Steven</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mulligan</LastName><ForeName>Stephen P</ForeName><Initials>SP</Initials><AffiliationInfo><Affiliation>Royal North Shore Hospital, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jaeger</LastName><ForeName>Ulrich</ForeName><Initials>U</Initials><AffiliationInfo><Affiliation>Division of Hematology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Furman</LastName><ForeName>Richard R</ForeName><Initials>RR</Initials><AffiliationInfo><Affiliation>Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cymbalista</LastName><ForeName>Florence</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Hôpital Avicenne, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Montillo</LastName><ForeName>Marco</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Niguarda Ca' Granda Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dearden</LastName><ForeName>Claire</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Royal Marsden Hospital, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robak</LastName><ForeName>Tadeusz</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Hematology, Medical University of Lodz, Lodz, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moreno</LastName><ForeName>Carol</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Hospital de la Santa Creu Sant Pau, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pagel</LastName><ForeName>John M</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Swedish Cancer Institute, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Burger</LastName><ForeName>Jan A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Suzuki</LastName><ForeName>Samuel</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sukbuntherng</LastName><ForeName>Juthamas</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cole</LastName><ForeName>George</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>James</LastName><ForeName>Danelle F</ForeName><Initials>DF</Initials><AffiliationInfo><Affiliation>Pharmacyclics LLC, AbbVie, Sunnyvale, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Byrd</LastName><ForeName>John C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>The Ohio State University Medical Center, The Ohio State University, Columbus, OH.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>04</Month><Day>03</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Blood</MedlineTA><NlmUniqueID>7603509</NlmUniqueID><ISSNLinking>0006-4971</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C551803">PCI 32765</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D047428">Protein Kinase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011720">Pyrazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011743">Pyrimidines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D016159">Tumor Suppressor Protein p53</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber><NameOfSubstance UI="C082176">Agammaglobulinaemia tyrosine kinase</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber><NameOfSubstance UI="D011505">Protein-Tyrosine Kinases</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Blood. 2016 Jan 7;127(1):79-86</RefSource><PMID Version="1">26472752</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Leukemia. 2011 Jan;25(1):7-22</RefSource><PMID Version="1">21102425</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Hematology Am Soc Hematol Educ Program. 2009;:461-76</RefSource><PMID Version="1">20008232</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cancer Chemother Pharmacol. 2015 Jan;75(1):111-21</RefSource><PMID Version="1">25381051</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2000 Dec 14;343(24):1750-7</RefSource><PMID Version="1">11114313</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2013 Jan 1;31(1):88-94</RefSource><PMID Version="1">23045577</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2014 Mar 20;370(12):1101-10</RefSource><PMID Version="1">24401022</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Haematologica. 2016 Dec;101(12 ):1563-1572</RefSource><PMID Version="1">27756834</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2010 Oct 2;376(9747):1164-74</RefSource><PMID Version="1">20888994</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2014 Jul 17;371(3):213-23</RefSource><PMID Version="1">24881631</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Manag Care Pharm. 2007 Oct;13(8 Suppl A):13-7</RefSource><PMID Version="1">17970610</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2010 May 10;28(14):2381-8</RefSource><PMID Version="1">20385986</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2013;8(2):e56813</RefSource><PMID Version="1">23437249</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000970" MajorTopicYN="N">Antineoplastic Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015451" MajorTopicYN="N">Leukemia, Lymphocytic, Chronic, B-Cell</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009154" MajorTopicYN="N">Mutation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010349" MajorTopicYN="N">Patient Compliance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D047428" MajorTopicYN="N">Protein Kinase Inhibitors</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011505" MajorTopicYN="N">Protein-Tyrosine Kinases</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011720" MajorTopicYN="N">Pyrazoles</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011743" MajorTopicYN="N">Pyrimidines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016159" MajorTopicYN="N">Tumor Suppressor Protein p53</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>12</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>03</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>4</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>9</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>4</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28373262</ArticleId><ArticleId IdType="pii">blood-2016-12-737346</ArticleId><ArticleId IdType="doi">10.1182/blood-2016-12-737346</ArticleId><ArticleId 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