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Health-related quality of life results from the phase III CheckMate 067 study.

Identifieur interne : 000B09 ( PubMed/Checkpoint ); précédent : 000B08; suivant : 000B10

Health-related quality of life results from the phase III CheckMate 067 study.

Auteurs : Dirk Schadendorf [Allemagne] ; James Larkin [Royaume-Uni] ; Jedd Wolchok [États-Unis] ; F Stephen Hodi [États-Unis] ; Vanna Chiarion-Sileni [Italie] ; Rene Gonzalez [États-Unis] ; Piotr Rutkowski [Pologne] ; Jean-Jacques Grob [France] ; C Lance Cowey [États-Unis] ; Christopher Lao [États-Unis] ; John Wagstaff [Royaume-Uni] ; Margaret K. Callahan [États-Unis] ; Michael A. Postow [États-Unis] ; Michael Smylie [Canada] ; Pier Francesco Ferrucci [Italie] ; Reinhard Dummer [Suisse] ; Andrew Hill [Australie] ; Fiona Taylor [États-Unis] ; Javier Sabater [États-Unis] ; Dana Walker [États-Unis] ; Srividya Kotapati [États-Unis] ; Amy Abernethy [États-Unis] ; Georgina V. Long [Australie]

Source :

RBID : pubmed:28651159

Descripteurs français

English descriptors

Abstract

Nivolumab, a monoclonal antibody of immune checkpoint programmed death 1 on T cells (PD-1), combined with ipilimumab, an immune checkpoint cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor, as combination therapy on the one hand and nivolumab as monotherapy on the other, have both demonstrated improved efficacy compared with ipilimumab alone in the CheckMate 067 study. However, the combination resulted in a higher frequency of grade 3/4 adverse events (AEs), which could result in diminished health-related quality of life (HRQoL). Here we report analyses of HRQoL for patients with advanced melanoma in clinical trial CheckMate 067.

DOI: 10.1016/j.ejca.2017.05.031
PubMed: 28651159


Affiliations:


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pubmed:28651159

Le document en format XML

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<name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean-Jacques" last="Grob">Jean-Jacques Grob</name>
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<name sortKey="Lao, Christopher" sort="Lao, Christopher" uniqKey="Lao C" first="Christopher" last="Lao">Christopher Lao</name>
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<nlm:affiliation>University of Michigan, Ann Arbor, MI, USA.</nlm:affiliation>
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<name sortKey="Wagstaff, John" sort="Wagstaff, John" uniqKey="Wagstaff J" first="John" last="Wagstaff">John Wagstaff</name>
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<region type="state">État de New York</region>
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<name sortKey="Hill, Andrew" sort="Hill, Andrew" uniqKey="Hill A" first="Andrew" last="Hill">Andrew Hill</name>
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<name sortKey="Taylor, Fiona" sort="Taylor, Fiona" uniqKey="Taylor F" first="Fiona" last="Taylor">Fiona Taylor</name>
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<nlm:affiliation>Adelphi Values, Boston, MA, USA.</nlm:affiliation>
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<region type="state">Massachusetts</region>
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<name sortKey="Sabater, Javier" sort="Sabater, Javier" uniqKey="Sabater J" first="Javier" last="Sabater">Javier Sabater</name>
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<name sortKey="Walker, Dana" sort="Walker, Dana" uniqKey="Walker D" first="Dana" last="Walker">Dana Walker</name>
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<name sortKey="Kotapati, Srividya" sort="Kotapati, Srividya" uniqKey="Kotapati S" first="Srividya" last="Kotapati">Srividya Kotapati</name>
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<nlm:affiliation>Duke University Medical Center, Durham, NC, USA.</nlm:affiliation>
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<name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name>
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<title xml:lang="en">Health-related quality of life results from the phase III CheckMate 067 study.</title>
<author>
<name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Dermatology, University of Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Dermatology, University of Essen, Essen, Germany; German Cancer Consortium, Heidelberg</wicri:regionArea>
<placeName>
<region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
</placeName>
</affiliation>
</author>
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<name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name>
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<nlm:affiliation>Royal Marsden Hospital, London, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Royal Marsden Hospital, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
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<name sortKey="Wolchok, Jedd" sort="Wolchok, Jedd" uniqKey="Wolchok J" first="Jedd" last="Wolchok">Jedd Wolchok</name>
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<nlm:affiliation>Memorial Sloan Kettering Cancer Center, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Memorial Sloan Kettering Cancer Center, New York, NY</wicri:regionArea>
<placeName>
<region type="state">État de New York</region>
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<name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F Stephen" last="Hodi">F Stephen Hodi</name>
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<nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Dana-Farber Cancer Institute, Boston, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
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<name sortKey="Chiarion Sileni, Vanna" sort="Chiarion Sileni, Vanna" uniqKey="Chiarion Sileni V" first="Vanna" last="Chiarion-Sileni">Vanna Chiarion-Sileni</name>
<affiliation wicri:level="1">
<nlm:affiliation>Istituto Oncologico Veneto, Veneto, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Istituto Oncologico Veneto, Veneto</wicri:regionArea>
<wicri:noRegion>Veneto</wicri:noRegion>
</affiliation>
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<name sortKey="Gonzalez, Rene" sort="Gonzalez, Rene" uniqKey="Gonzalez R" first="Rene" last="Gonzalez">Rene Gonzalez</name>
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<nlm:affiliation>University of Colorado, Denver, CO, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Colorado, Denver, CO</wicri:regionArea>
<placeName>
<region type="state">Colorado</region>
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<name sortKey="Rutkowski, Piotr" sort="Rutkowski, Piotr" uniqKey="Rutkowski P" first="Piotr" last="Rutkowski">Piotr Rutkowski</name>
<affiliation wicri:level="1">
<nlm:affiliation>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.</nlm:affiliation>
<country xml:lang="fr">Pologne</country>
<wicri:regionArea>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw</wicri:regionArea>
<wicri:noRegion>Warsaw</wicri:noRegion>
</affiliation>
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<name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean-Jacques" last="Grob">Jean-Jacques Grob</name>
<affiliation wicri:level="3">
<nlm:affiliation>Hospital de la Timone, Marseille, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Hospital de la Timone, Marseille</wicri:regionArea>
<placeName>
<region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Marseille</settlement>
</placeName>
</affiliation>
</author>
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<name sortKey="Cowey, C Lance" sort="Cowey, C Lance" uniqKey="Cowey C" first="C Lance" last="Cowey">C Lance Cowey</name>
<affiliation wicri:level="2">
<nlm:affiliation>Texas Oncology-Baylor Cancer Center, Dallas, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Texas Oncology-Baylor Cancer Center, Dallas, TX</wicri:regionArea>
<placeName>
<region type="state">Texas</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Lao, Christopher" sort="Lao, Christopher" uniqKey="Lao C" first="Christopher" last="Lao">Christopher Lao</name>
<affiliation wicri:level="2">
<nlm:affiliation>University of Michigan, Ann Arbor, MI, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Michigan, Ann Arbor, MI</wicri:regionArea>
<placeName>
<region type="state">Michigan</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Wagstaff, John" sort="Wagstaff, John" uniqKey="Wagstaff J" first="John" last="Wagstaff">John Wagstaff</name>
<affiliation wicri:level="1">
<nlm:affiliation>The College of Medicine, Swansea University, Swansea, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>The College of Medicine, Swansea University, Swansea</wicri:regionArea>
<wicri:noRegion>Swansea</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Callahan, Margaret K" sort="Callahan, Margaret K" uniqKey="Callahan M" first="Margaret K" last="Callahan">Margaret K. Callahan</name>
<affiliation wicri:level="2">
<nlm:affiliation>Memorial Sloan Kettering Cancer Center, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Memorial Sloan Kettering Cancer Center, New York, NY</wicri:regionArea>
<placeName>
<region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Postow, Michael A" sort="Postow, Michael A" uniqKey="Postow M" first="Michael A" last="Postow">Michael A. Postow</name>
<affiliation wicri:level="2">
<nlm:affiliation>Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY</wicri:regionArea>
<placeName>
<region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Smylie, Michael" sort="Smylie, Michael" uniqKey="Smylie M" first="Michael" last="Smylie">Michael Smylie</name>
<affiliation wicri:level="1">
<nlm:affiliation>Cross Cancer Institute, Edmonton, Alberta, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Cross Cancer Institute, Edmonton, Alberta</wicri:regionArea>
<wicri:noRegion>Alberta</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Ferrucci, Pier Francesco" sort="Ferrucci, Pier Francesco" uniqKey="Ferrucci P" first="Pier Francesco" last="Ferrucci">Pier Francesco Ferrucci</name>
<affiliation wicri:level="3">
<nlm:affiliation>Istituto Europeo di Oncologia, Milan, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
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<name sortKey="Taylor, Fiona" sort="Taylor, Fiona" uniqKey="Taylor F" first="Fiona" last="Taylor">Fiona Taylor</name>
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<name sortKey="Sabater, Javier" sort="Sabater, Javier" uniqKey="Sabater J" first="Javier" last="Sabater">Javier Sabater</name>
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<name sortKey="Walker, Dana" sort="Walker, Dana" uniqKey="Walker D" first="Dana" last="Walker">Dana Walker</name>
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<name sortKey="Kotapati, Srividya" sort="Kotapati, Srividya" uniqKey="Kotapati S" first="Srividya" last="Kotapati">Srividya Kotapati</name>
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<nlm:affiliation>Duke University Medical Center, Durham, NC, USA.</nlm:affiliation>
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<name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V" last="Long">Georgina V. Long</name>
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<region type="état">Nouvelle-Galles du Sud</region>
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<title level="j">European journal of cancer (Oxford, England : 1990)</title>
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<term>Health Status</term>
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<div type="abstract" xml:lang="en">Nivolumab, a monoclonal antibody of immune checkpoint programmed death 1 on T cells (PD-1), combined with ipilimumab, an immune checkpoint cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor, as combination therapy on the one hand and nivolumab as monotherapy on the other, have both demonstrated improved efficacy compared with ipilimumab alone in the CheckMate 067 study. However, the combination resulted in a higher frequency of grade 3/4 adverse events (AEs), which could result in diminished health-related quality of life (HRQoL). Here we report analyses of HRQoL for patients with advanced melanoma in clinical trial CheckMate 067.</div>
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<Day>26</Day>
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<Month>09</Month>
<Day>07</Day>
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<Year>2017</Year>
<Month>11</Month>
<Day>16</Day>
</DateRevised>
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<Volume>82</Volume>
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<Year>2017</Year>
<Month>Sep</Month>
</PubDate>
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<Title>European journal of cancer (Oxford, England : 1990)</Title>
<ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation>
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<ArticleTitle>Health-related quality of life results from the phase III CheckMate 067 study.</ArticleTitle>
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<MedlinePgn>80-91</MedlinePgn>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Nivolumab, a monoclonal antibody of immune checkpoint programmed death 1 on T cells (PD-1), combined with ipilimumab, an immune checkpoint cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor, as combination therapy on the one hand and nivolumab as monotherapy on the other, have both demonstrated improved efficacy compared with ipilimumab alone in the CheckMate 067 study. However, the combination resulted in a higher frequency of grade 3/4 adverse events (AEs), which could result in diminished health-related quality of life (HRQoL). Here we report analyses of HRQoL for patients with advanced melanoma in clinical trial CheckMate 067.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">HRQoL was assessed at weeks 1 and 5 per 6-week cycle for the first 6 months, once every 6 weeks thereafter, and at two follow-up visits using the European Organization for Research and Treatment of Care Core Quality of Life Questionnaire and the EuroQoL Five Dimensions Questionnaire. In addition to the randomised population, patient subgroups, including BRAF mutation status, partial or complete response, treatment-related AEs of grade 3/4, and those who discontinued due to any reason and due to an AE, were investigated.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Nivolumab and ipilimumab combination and nivolumab alone both maintained HRQoL, and no clinically meaningful deterioration was observed over time compared with ipilimumab. In addition, similar results were observed across patient subgroups, and no clinically meaningful changes in HRQoL were observed during follow-up visits for patients who discontinued due to any cause.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">These results further support the clinical benefit of nivolumab monotherapy and nivolumab and ipilimumab combination therapy in patients with advanced melanoma. The finding that the difference in grade 3/4 AEs between the arms did not translate into clinically meaningful differences in the reported HRQoL may be relevant in the clinical setting.</AbstractText>
<AbstractText Label="STUDY NUMBER" NlmCategory="UNASSIGNED">NCT01844505.</AbstractText>
<CopyrightInformation>Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
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<LastName>Schadendorf</LastName>
<ForeName>Dirk</ForeName>
<Initials>D</Initials>
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<Affiliation>Department of Dermatology, University of Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Larkin</LastName>
<ForeName>James</ForeName>
<Initials>J</Initials>
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</AffiliationInfo>
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<LastName>Wolchok</LastName>
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</AffiliationInfo>
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</AffiliationInfo>
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<ForeName>Vanna</ForeName>
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</AffiliationInfo>
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</AffiliationInfo>
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