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

Identifieur interne : 000640 ( PubMed/Corpus ); précédent : 000639; suivant : 000641

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

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

Source :

RBID : pubmed:28651159

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

Links to Exploration step

pubmed:28651159

Le document en format XML

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<nlm:affiliation>Duke University Medical Center, Durham, NC, USA.</nlm: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>Hospital de la Timone, Marseille, France.</nlm:affiliation>
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<name sortKey="Postow, Michael A" sort="Postow, Michael A" uniqKey="Postow M" first="Michael A" last="Postow">Michael A. Postow</name>
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<nlm:affiliation>Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.</nlm:affiliation>
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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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<nlm:affiliation>Tasman Oncology Research, Brisbane, QLD, Australia.</nlm:affiliation>
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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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<nlm:affiliation>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
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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>Bristol-Myers Squibb, Princeton, NJ, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Abernethy, Amy" sort="Abernethy, Amy" uniqKey="Abernethy A" first="Amy" last="Abernethy">Amy Abernethy</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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<nlm:affiliation>Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia. Electronic address: georgina.long@sydney.edu.au.</nlm:affiliation>
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<term>Antibodies, Monoclonal (therapeutic use)</term>
<term>Antineoplastic Agents (therapeutic use)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Female</term>
<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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<Month>06</Month>
<Day>26</Day>
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<Month>09</Month>
<Day>07</Day>
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<Day>16</Day>
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<Year>2017</Year>
<Month>Sep</Month>
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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>
<Pagination>
<MedlinePgn>80-91</MedlinePgn>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2017.05.031</ELocationID>
<Abstract>
<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>
<AffiliationInfo>
<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>
<AffiliationInfo>
<Affiliation>Royal Marsden Hospital, London, UK.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Wolchok</LastName>
<ForeName>Jedd</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Memorial Sloan Kettering Cancer Center, New York, NY, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Hodi</LastName>
<ForeName>F Stephen</ForeName>
<Initials>FS</Initials>
<AffiliationInfo>
<Affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Chiarion-Sileni</LastName>
<ForeName>Vanna</ForeName>
<Initials>V</Initials>
<AffiliationInfo>
<Affiliation>Istituto Oncologico Veneto, Veneto, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Gonzalez</LastName>
<ForeName>Rene</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>University of Colorado, Denver, CO, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Rutkowski</LastName>
<ForeName>Piotr</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Grob</LastName>
<ForeName>Jean-Jacques</ForeName>
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<AffiliationInfo>
<Affiliation>Hospital de la Timone, Marseille, France.</Affiliation>
</AffiliationInfo>
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<LastName>Cowey</LastName>
<ForeName>C Lance</ForeName>
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<Affiliation>Texas Oncology-Baylor Cancer Center, Dallas, TX, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Lao</LastName>
<ForeName>Christopher</ForeName>
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<Affiliation>University of Michigan, Ann Arbor, MI, USA.</Affiliation>
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<LastName>Wagstaff</LastName>
<ForeName>John</ForeName>
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