Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma.
Identifieur interne : 000165 ( PubMed/Corpus ); précédent : 000164; suivant : 000166Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma.
Auteurs : Teresa M. Petrella ; Caroline Robert ; Erika Richtig ; Wilson H. Miller ; Giuseppe V. Masucci ; Euan Walpole ; Celeste Lebbe ; Neil Steven ; Mark R. Middleton ; Darcy Hille ; Wei Zhou ; Nageatte Ibrahim ; Jonathan CebonSource :
- European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2017.
Abstract
Report results of patient-reported health-related quality of life (HRQoL) and symptoms from phase III KEYNOTE-006 study of pembrolizumab versus ipilimumab in patients with ipilimumab-naive advanced melanoma.
DOI: 10.1016/j.ejca.2017.08.032
PubMed: 28987768
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Electronic address: caroline.robert@gustaveroussy.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Richtig, Erika" sort="Richtig, Erika" uniqKey="Richtig E" first="Erika" last="Richtig">Erika Richtig</name><affiliation><nlm:affiliation>Medical University of Graz, Auenbruggerpl. 2, 8036 Graz, Graz, Austria. Electronic address: erika.richtig@medunigraz.at.</nlm:affiliation></affiliation></author><author><name sortKey="Miller, Wilson H" sort="Miller, Wilson H" uniqKey="Miller W" first="Wilson H" last="Miller">Wilson H. Miller</name><affiliation><nlm:affiliation>Segal Cancer Centre, Jewish General Hospital, Rossy Cancer Network, and McGill University, 3755 Ch de la Côte-Sainte-Catherine, Montreal, QC, H3T 1E2, Canada. Electronic address: wilsonmiller@gmail.com.</nlm:affiliation></affiliation></author><author><name sortKey="Masucci, Giuseppe V" sort="Masucci, Giuseppe V" uniqKey="Masucci G" first="Giuseppe V" last="Masucci">Giuseppe V. Masucci</name><affiliation><nlm:affiliation>Karolinska Institute, Solnavägen 1, 171 77 Solna, Stockholm, Sweden. Electronic address: giuseppe.masucci@ki.se.</nlm:affiliation></affiliation></author><author><name sortKey="Walpole, Euan" sort="Walpole, Euan" uniqKey="Walpole E" first="Euan" last="Walpole">Euan Walpole</name><affiliation><nlm:affiliation>Princess Alexandra Hospital and The University of Queensland, 199 Ipswich Rd, Woolloongabba, Brisbane, QLD 4102, Australia. Electronic address: euan.walpole@health.qld.gov.au.</nlm:affiliation></affiliation></author><author><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Celeste" last="Lebbe">Celeste Lebbe</name><affiliation><nlm:affiliation>APHP, Dermatology and CIC, Université Paris Diderot, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75010 Paris, France. Electronic address: celeste.lebbe@aphp.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Steven, Neil" sort="Steven, Neil" uniqKey="Steven N" first="Neil" last="Steven">Neil Steven</name><affiliation><nlm:affiliation>Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham B15 2TH, UK. Electronic address: N.M.Steven@bham.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Middleton, Mark R" sort="Middleton, Mark R" uniqKey="Middleton M" first="Mark R" last="Middleton">Mark R. Middleton</name><affiliation><nlm:affiliation>The Churchill Hospital and The University of Oxford, Old Rd, Headington, Oxford OX3 7LE, UK. Electronic address: mark.middleton@oncology.ox.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Hille, Darcy" sort="Hille, Darcy" uniqKey="Hille D" first="Darcy" last="Hille">Darcy Hille</name><affiliation><nlm:affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: darcy_hille@merck.com.</nlm:affiliation></affiliation></author><author><name sortKey="Zhou, Wei" sort="Zhou, Wei" uniqKey="Zhou W" first="Wei" last="Zhou">Wei Zhou</name><affiliation><nlm:affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: wei.zhou2@merck.com.</nlm:affiliation></affiliation></author><author><name sortKey="Ibrahim, Nageatte" sort="Ibrahim, Nageatte" uniqKey="Ibrahim N" first="Nageatte" last="Ibrahim">Nageatte Ibrahim</name><affiliation><nlm:affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: nageatte.ibrahim@merck.com.</nlm:affiliation></affiliation></author><author><name sortKey="Cebon, Jonathan" sort="Cebon, Jonathan" uniqKey="Cebon J" first="Jonathan" last="Cebon">Jonathan Cebon</name><affiliation><nlm:affiliation>Olivia Newton-John Cancer Research Institute, Austin Health, School of Cancer Medicine, La Trobe University, 145 Studley Road, Heidelberg VIC 3084, Melbourne, Australia. Electronic address: jonathan.cebon@onjcri.org.au.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28987768</idno><idno type="pmid">28987768</idno><idno type="doi">10.1016/j.ejca.2017.08.032</idno><idno type="wicri:Area/PubMed/Corpus">000165</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000165</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma.</title><author><name sortKey="Petrella, Teresa M" sort="Petrella, Teresa M" uniqKey="Petrella T" first="Teresa M" last="Petrella">Teresa M. Petrella</name><affiliation><nlm:affiliation>Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Ave, T2-041, Toronto, ON, M4N 3M5, Canada. Electronic address: teresa.petrella@sunnybrook.ca.</nlm:affiliation></affiliation></author><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation><nlm:affiliation>Gustave Roussy and Université Paris-Sud, 114 Rue Edouard Vaillant, 94800 Villejuif, France. Electronic address: caroline.robert@gustaveroussy.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Richtig, Erika" sort="Richtig, Erika" uniqKey="Richtig E" first="Erika" last="Richtig">Erika Richtig</name><affiliation><nlm:affiliation>Medical University of Graz, Auenbruggerpl. 2, 8036 Graz, Graz, Austria. Electronic address: erika.richtig@medunigraz.at.</nlm:affiliation></affiliation></author><author><name sortKey="Miller, Wilson H" sort="Miller, Wilson H" uniqKey="Miller W" first="Wilson H" last="Miller">Wilson H. Miller</name><affiliation><nlm:affiliation>Segal Cancer Centre, Jewish General Hospital, Rossy Cancer Network, and McGill University, 3755 Ch de la Côte-Sainte-Catherine, Montreal, QC, H3T 1E2, Canada. Electronic address: wilsonmiller@gmail.com.</nlm:affiliation></affiliation></author><author><name sortKey="Masucci, Giuseppe V" sort="Masucci, Giuseppe V" uniqKey="Masucci G" first="Giuseppe V" last="Masucci">Giuseppe V. Masucci</name><affiliation><nlm:affiliation>Karolinska Institute, Solnavägen 1, 171 77 Solna, Stockholm, Sweden. Electronic address: giuseppe.masucci@ki.se.</nlm:affiliation></affiliation></author><author><name sortKey="Walpole, Euan" sort="Walpole, Euan" uniqKey="Walpole E" first="Euan" last="Walpole">Euan Walpole</name><affiliation><nlm:affiliation>Princess Alexandra Hospital and The University of Queensland, 199 Ipswich Rd, Woolloongabba, Brisbane, QLD 4102, Australia. Electronic address: euan.walpole@health.qld.gov.au.</nlm:affiliation></affiliation></author><author><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Celeste" last="Lebbe">Celeste Lebbe</name><affiliation><nlm:affiliation>APHP, Dermatology and CIC, Université Paris Diderot, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75010 Paris, France. Electronic address: celeste.lebbe@aphp.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Steven, Neil" sort="Steven, Neil" uniqKey="Steven N" first="Neil" last="Steven">Neil Steven</name><affiliation><nlm:affiliation>Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham B15 2TH, UK. Electronic address: N.M.Steven@bham.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Middleton, Mark R" sort="Middleton, Mark R" uniqKey="Middleton M" first="Mark R" last="Middleton">Mark R. Middleton</name><affiliation><nlm:affiliation>The Churchill Hospital and The University of Oxford, Old Rd, Headington, Oxford OX3 7LE, UK. Electronic address: mark.middleton@oncology.ox.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Hille, Darcy" sort="Hille, Darcy" uniqKey="Hille D" first="Darcy" last="Hille">Darcy Hille</name><affiliation><nlm:affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: darcy_hille@merck.com.</nlm:affiliation></affiliation></author><author><name sortKey="Zhou, Wei" sort="Zhou, Wei" uniqKey="Zhou W" first="Wei" last="Zhou">Wei Zhou</name><affiliation><nlm:affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: wei.zhou2@merck.com.</nlm:affiliation></affiliation></author><author><name sortKey="Ibrahim, Nageatte" sort="Ibrahim, Nageatte" uniqKey="Ibrahim N" first="Nageatte" last="Ibrahim">Nageatte Ibrahim</name><affiliation><nlm:affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: nageatte.ibrahim@merck.com.</nlm:affiliation></affiliation></author><author><name sortKey="Cebon, Jonathan" sort="Cebon, Jonathan" uniqKey="Cebon J" first="Jonathan" last="Cebon">Jonathan Cebon</name><affiliation><nlm:affiliation>Olivia Newton-John Cancer Research Institute, Austin Health, School of Cancer Medicine, La Trobe University, 145 Studley Road, Heidelberg VIC 3084, Melbourne, Australia. Electronic address: jonathan.cebon@onjcri.org.au.</nlm:affiliation></affiliation></author></analytic><series><title level="j">European journal of cancer (Oxford, England : 1990)</title><idno type="eISSN">1879-0852</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Report results of patient-reported health-related quality of life (HRQoL) and symptoms from phase III KEYNOTE-006 study of pembrolizumab versus ipilimumab in patients with ipilimumab-naive advanced melanoma.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28987768</PMID><DateCreated><Year>2017</Year><Month>10</Month><Day>08</Day></DateCreated><DateRevised><Year>2017</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-0852</ISSN><JournalIssue CitedMedium="Internet"><Volume>86</Volume><PubDate><Year>2017</Year><Month>Nov</Month></PubDate></JournalIssue><Title>European journal of cancer (Oxford, England : 1990)</Title><ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation></Journal><ArticleTitle>Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma.</ArticleTitle><Pagination><MedlinePgn>115-124</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0959-8049(17)31257-1</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2017.08.032</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Report results of patient-reported health-related quality of life (HRQoL) and symptoms from phase III KEYNOTE-006 study of pembrolizumab versus ipilimumab in patients with ipilimumab-naive advanced melanoma.</AbstractText><AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Patients received pembrolizumab 10 mg/kg every 2 (Q2W) or every 3 weeks (Q3W) for up to 2 years, or four cycles of ipilimumab 3 mg/kg Q3W. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was administered at baseline and throughout the study. Patient-reported outcome (PRO) analyses were pre-specified exploratory endpoints; the primary PRO assessment was the score change from baseline to week 12 in EORTC QLQ-C30 global health status (GHS)/HRQoL score between the arms using constrained longitudinal data analysis.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The PRO analysis population included 776 patients: pembrolizumab Q2W (n = 270); pembrolizumab Q3W (n = 266); ipilimumab (n = 240). Baseline GHS was similar across arms. QLQ-C30 compliance rates at week 12 were 87% (n = 214), 97% (n = 226), and 96% (n = 178), for the pembrolizumab Q2W, pembrolizumab Q3W, and ipilimumab arms, respectively. From baseline to week 12, GHS/HRQoL scores were better maintained with pembrolizumab than with ipilimumab (decrease of -1.9 and -2.5 for pembrolizumab versus -10.0 for ipilimumab; p < 0.001 for each pembrolizumab arm versus ipilimumab). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31% for pembrolizumab Q2W; 29% for Q3W and 44% for ipilimumab), with similar trends observed for individual functioning and symptoms scales.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">HRQoL was better maintained with pembrolizumab than with ipilimumab in patients with ipilimumab-naive advanced melanoma. CLINICALTRIALS.</AbstractText><AbstractText Label="GOV IDENTIFIER" NlmCategory="UNASSIGNED">NCT01866319.</AbstractText><CopyrightInformation>Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Petrella</LastName><ForeName>Teresa M</ForeName><Initials>TM</Initials><AffiliationInfo><Affiliation>Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Ave, T2-041, Toronto, ON, M4N 3M5, Canada. Electronic address: teresa.petrella@sunnybrook.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robert</LastName><ForeName>Caroline</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Gustave Roussy and Université Paris-Sud, 114 Rue Edouard Vaillant, 94800 Villejuif, France. Electronic address: caroline.robert@gustaveroussy.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Richtig</LastName><ForeName>Erika</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Medical University of Graz, Auenbruggerpl. 2, 8036 Graz, Graz, Austria. Electronic address: erika.richtig@medunigraz.at.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Miller</LastName><ForeName>Wilson H</ForeName><Initials>WH</Initials><Suffix>Jr</Suffix><AffiliationInfo><Affiliation>Segal Cancer Centre, Jewish General Hospital, Rossy Cancer Network, and McGill University, 3755 Ch de la Côte-Sainte-Catherine, Montreal, QC, H3T 1E2, Canada. Electronic address: wilsonmiller@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Masucci</LastName><ForeName>Giuseppe V</ForeName><Initials>GV</Initials><AffiliationInfo><Affiliation>Karolinska Institute, Solnavägen 1, 171 77 Solna, Stockholm, Sweden. Electronic address: giuseppe.masucci@ki.se.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Walpole</LastName><ForeName>Euan</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Princess Alexandra Hospital and The University of Queensland, 199 Ipswich Rd, Woolloongabba, Brisbane, QLD 4102, Australia. Electronic address: euan.walpole@health.qld.gov.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lebbe</LastName><ForeName>Celeste</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>APHP, Dermatology and CIC, Université Paris Diderot, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75010 Paris, France. Electronic address: celeste.lebbe@aphp.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Steven</LastName><ForeName>Neil</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham B15 2TH, UK. Electronic address: N.M.Steven@bham.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Middleton</LastName><ForeName>Mark R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>The Churchill Hospital and The University of Oxford, Old Rd, Headington, Oxford OX3 7LE, UK. Electronic address: mark.middleton@oncology.ox.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hille</LastName><ForeName>Darcy</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: darcy_hille@merck.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhou</LastName><ForeName>Wei</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: wei.zhou2@merck.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ibrahim</LastName><ForeName>Nageatte</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: nageatte.ibrahim@merck.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cebon</LastName><ForeName>Jonathan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Olivia Newton-John Cancer Research Institute, Austin Health, School of Cancer Medicine, La Trobe University, 145 Studley Road, Heidelberg VIC 3084, Melbourne, Australia. Electronic address: jonathan.cebon@onjcri.org.au.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>10</Month><Day>04</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Eur J Cancer</MedlineTA><NlmUniqueID>9005373</NlmUniqueID><ISSNLinking>0959-8049</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Advanced melanoma</Keyword><Keyword MajorTopicYN="N">EORTC QLQ-C30</Keyword><Keyword MajorTopicYN="N">Health-related quality of life</Keyword><Keyword MajorTopicYN="N">KEYNOTE-006</Keyword><Keyword MajorTopicYN="N">Patient-reported outcomes</Keyword><Keyword MajorTopicYN="N">Pembrolizumab</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>05</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2017</Year><Month>07</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>08</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>10</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>10</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>10</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28987768</ArticleId><ArticleId IdType="pii">S0959-8049(17)31257-1</ArticleId><ArticleId IdType="doi">10.1016/j.ejca.2017.08.032</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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