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Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial

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العنوان: Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial
المؤلفون: Bottomley, Andrew, Coens, Corneel, Mierzynska, Justyna, Blank, Christian, U., Mandalà, Mario, Long, Georgina, Atkinson, Victoria, Dalle, Stéphane, Haydon, Andrew, Meshcheryakov, Andrey, Khattak, Adnan, Carlino, Matteo, Sandhu, Shahneen, Puig, Susana, Ascierto, Paolo, Larkin, James, Lorigan, Paul, Rutkowski, Piotr, Schadendorf, Dirk, Koornstra, Rutger, Hernandez-Aya, Leonel, Di Giacomo, Anna Maria, van den Eertwegh, Alfonsus, Grob, Jean-Jacques, Gutzmer, Ralf, Jamal, Rahima, van Akkooi, Alexander, Krepler, Clemens, Ibrahim, Nageatte, Marreaud, Sandrine, Kicinski, Michal, Suciu, Stefan, Robert, Caroline, Eggermont, Alexander, Lesimple, Thierry, Maio, Michele, Linette, Gerald, Mortier, Laurent, Svane, Inge Marie, Schachter, Jacob, Brown, Michael, Hersey, Peter, Barrow, Catherine, Kudchadkar, Ragini, Dutriaux, Caroline, Song, Xinni, Quaglino, Pietro, Queirolo, Paola, Meier, Friedegund, Stroyakovskiy, Daniil, Guillot, Bernard, Romero, Pablo Luis Ortiz, Bastholt, Lars, Garbe, Claus, Grange, Florent, Mohr, Peter, Algazi, Alain, Bechter, Oliver, Hernberg, Micaela, Loquai, Carmen, Meiss, Frank, Chiarion Sileni, Vanna, Bar-Sela, Gil, Fitzharris, Bernard, Saiag, Philippe, Arnault, Jean-Philippe, Simon, Jan-Christoph, Stephens, Rosalie, Baurain, Jean-Francois, Lebbe, Célèste, Combemale, Patrick, Dummer, Reinhard, Hauschild, Axel, Parente, Phillip, Yamazaki, Naoya, Milhem, Mohammed, Leccia, Marie-Thérèse, Geoffrois, Lionel, Kretschmer, Lutz, Dunwoodie, Elaine, Walker, John, Lotem, Michal, Hendler, Daniel, Mackiewicz, Andrzej, Sekulovic, Lidija, Dzienis, Marcin, Hospers, Geke A.P., Siano, Marco, Hassel, Jessica, Corrie, Philippa, Passos, Maria-Jose, Levin, Max, Hoeller, Christoph, Machet, Laurent, Hallmeyer, Sigrun, Waterston, Ashita, Descamps, Vincent, Kiecker, Felix, Aarts, Maureen, Schmidt, Henrik, Raimundo, Ana, Nyakas, Marta, Lacour, Jean-Philippe, Berking, Carola, Ferrucci, Pier Francesco, Jameson, Michael, Kim, Kevin, Yokota, Kenji, Kerger, Joseph, Aubin, François, Groenewegen, Gerard, Kapiteijn, Helena, Boehncke, Wolf-Henning, Utikal, Jochen, Casasola, Richard, Marshall, Ernest, Ferraresi, Virginia, Richtig, Erika, Matkovic, Suzana, Inozume, Takashi, Crook, Timothy, Mcneil, Catriona, Kiyohara, Yoshio, Avril, Marie-Francoise, Hein, Rüdiger, Terheyden, Patrick, Nathan, Paul, Aoi, Jun, Skytta, Tanja, Jouary, Thomas, Takenouchi, Tatsuya, Straume, Oddbjorn, Martins, César, Mukhametshina, Guzel
المساهمون: European Organisation for Research and Treatment of Cancer Bruxelles (EORTC), European Cancer Organisation Bruxelles (ECCO), Ospedale "Santa Maria della Misericordia" = University Hospital "Santa Maria della Misericordia", The University of Sydney, Princess Alexandra Hospital, Brisbane, The University of Queensland (UQ All campuses : Brisbane, Dutton Park Gatton, Herston, St Lucia and other locations ), Centre Léon Bérard Lyon, Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard Lyon -Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Edith Cowan University (ECU), Universitat de Barcelona (UB), The Christie NHS Foundation Trust Manchester, Royaume-Uni, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology (MCMCC), Radboud University Medical Center Nijmegen, Washington University School of Medicine in St. Louis, Washington University in Saint Louis (WUSTL), University Hospital of Siena, Amsterdam UMC - Amsterdam University Medical Center, Hôpital de la Timone CHU - APHM (TIMONE), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes (IPC), Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Medizinische Hochschule Hannover = Hannover Medical School (MHH), Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal (UdeM), Merck Sharp and Dohme (Merck & Co. Inc), AP-HP. Université Paris Saclay, Institut Gustave Roussy (IGR), University Medical Center Utrecht, Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Université de Montpellier (UM), Merck Sharp & Dohme.
المصدر: ISSN: 1470-2045.
بيانات النشر: HAL CCSD
Elsevier
سنة النشر: 2021
المجموعة: Université de Montpellier: HAL
مصطلحات موضوعية: MESH: Adult, MESH: Aged, MESH: Double-Blind Method, MESH: Female, MESH: Humans, MESH: Male, MESH: Melanoma, MESH: Middle Aged, MESH: Neoplasm Staging, MESH: Quality of Life, MESH: Skin Neoplasms, 80 and over, MESH: Antibodies, Monoclonal, Humanized, [SDV.CAN]Life Sciences [q-bio]/Cancer
الوصف: International audience ; Background: The European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 trial in patients with resected, high-risk stage III melanoma demonstrated improved recurrence-free survival with adjuvant pembrolizumab compared with placebo (hazard ratio 0·57 [98·4% CI 0·43-0·74]; p<0·0001). This study reports the results from the health-related quality-of-life (HRQOL) exploratory endpoint.Methods: This double-blind, randomised, controlled, phase 3 trial was done at 123 academic centres and community hospitals across 23 countries. Patients aged 18 years or older with previously untreated histologically confirmed stage IIIA, IIIB, or IIIC resected cutaneous melanoma, and an Eastern Cooperative Oncology Group performance status score of 1 or 0 were eligible. Patients were randomly assigned (1:1) using a central interactive voice-response system on the basis of a minimisation technique stratified for stage and geographic region to receive intravenously 200 mg pembrolizumab or placebo. Treatment was administered every 3 weeks for 1 year, or until disease recurrence, unacceptable toxicity, or death. The primary endpoint of the trial was recurrence-free survival (reported elsewhere). HRQOL was a prespecified exploratory endpoint, with global health/quality of life (GHQ) over 2 years measured by the EORTC QLQ-C30 as the primary analysis. Analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37, and long-term follow-up is ongoing.Findings: Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were assigned to pembrolizumab (n=514) or placebo (n=505). Median follow-up was 15·1 months (IQR 12·8-16·9) at the time of this analysis. HRQOL compliance was greater than 90% at baseline, greater than 70% during the first year, and greater than 60% thereafter for both groups. Because of low absolute compliance numbers at later follow-up, the analysis was truncated to week 84. Baseline GHQ ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/33857414; hal-03659672; https://hal.science/hal-03659672Test; PUBMED: 33857414; WOS: 000708645000001
DOI: 10.1016/S1470-2045(21)00081-4
الإتاحة: https://doi.org/10.1016/S1470-2045Test(21)00081-4
https://hal.science/hal-03659672Test
رقم الانضمام: edsbas.7EEC0EED
قاعدة البيانات: BASE
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Array ( [Name] => Abstract [Label] => Description [Group] => Ab [Data] => International audience ; Background: The European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 trial in patients with resected, high-risk stage III melanoma demonstrated improved recurrence-free survival with adjuvant pembrolizumab compared with placebo (hazard ratio 0&#183;57 [98&#183;4% CI 0&#183;43-0&#183;74]; p&lt;0&#183;0001). This study reports the results from the health-related quality-of-life (HRQOL) exploratory endpoint.Methods: This double-blind, randomised, controlled, phase 3 trial was done at 123 academic centres and community hospitals across 23 countries. Patients aged 18 years or older with previously untreated histologically confirmed stage IIIA, IIIB, or IIIC resected cutaneous melanoma, and an Eastern Cooperative Oncology Group performance status score of 1 or 0 were eligible. Patients were randomly assigned (1:1) using a central interactive voice-response system on the basis of a minimisation technique stratified for stage and geographic region to receive intravenously 200 mg pembrolizumab or placebo. Treatment was administered every 3 weeks for 1 year, or until disease recurrence, unacceptable toxicity, or death. The primary endpoint of the trial was recurrence-free survival (reported elsewhere). HRQOL was a prespecified exploratory endpoint, with global health/quality of life (GHQ) over 2 years measured by the EORTC QLQ-C30 as the primary analysis. Analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37, and long-term follow-up is ongoing.Findings: Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were assigned to pembrolizumab (n=514) or placebo (n=505). Median follow-up was 15&#183;1 months (IQR 12&#183;8-16&#183;9) at the time of this analysis. HRQOL compliance was greater than 90% at baseline, greater than 70% during the first year, and greater than 60% thereafter for both groups. Because of low absolute compliance numbers at later follow-up, the analysis was truncated to week 84. Baseline GHQ ... )
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Array ( [Name] => DOI [Label] => DOI [Group] => ID [Data] => 10.1016/S1470-2045(21)00081-4 )
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[NameFull] => Grange, Florent ) ) ) [55] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Mohr, Peter ) ) ) [56] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Algazi, Alain ) ) ) [57] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Bechter, Oliver ) ) ) [58] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hernberg, Micaela ) ) ) [59] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Loquai, Carmen ) ) ) [60] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Meiss, Frank ) ) ) [61] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Chiarion Sileni, Vanna ) ) ) [62] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Bar-Sela, Gil ) ) ) [63] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Fitzharris, Bernard ) ) ) [64] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Saiag, Philippe ) ) ) [65] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Arnault, Jean-Philippe ) ) ) [66] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Simon, Jan-Christoph ) ) ) [67] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Stephens, Rosalie ) ) ) [68] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Baurain, Jean-Francois ) ) ) [69] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Lebbe, Célèste ) ) ) [70] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Combemale, Patrick ) ) ) [71] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Dummer, Reinhard ) ) ) [72] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hauschild, Axel ) ) ) [73] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Parente, Phillip ) ) ) [74] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Yamazaki, Naoya ) ) ) [75] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Milhem, Mohammed ) ) ) [76] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Leccia, Marie-Thérèse ) ) ) [77] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Geoffrois, Lionel ) ) ) [78] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Kretschmer, Lutz ) ) ) [79] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Dunwoodie, Elaine ) ) ) [80] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Walker, John ) ) ) [81] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Lotem, Michal ) ) ) [82] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hendler, Daniel ) ) ) [83] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Mackiewicz, Andrzej ) ) ) [84] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Sekulovic, Lidija ) ) ) [85] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Dzienis, Marcin ) ) ) [86] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hospers, Geke A.P. ) ) ) [87] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Siano, Marco ) ) ) [88] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hassel, Jessica ) ) ) [89] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Corrie, Philippa ) ) ) [90] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Passos, Maria-Jose ) ) ) [91] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Levin, Max ) ) ) [92] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hoeller, Christoph ) ) ) [93] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Machet, Laurent ) ) ) [94] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hallmeyer, Sigrun ) ) ) [95] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Waterston, Ashita ) ) ) [96] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Descamps, Vincent ) ) ) [97] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Kiecker, Felix ) ) ) [98] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Aarts, Maureen ) ) ) [99] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Schmidt, Henrik ) ) ) [100] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Raimundo, Ana ) ) ) [101] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Nyakas, Marta ) ) ) [102] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Lacour, Jean-Philippe ) ) ) [103] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Berking, Carola ) ) ) [104] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Ferrucci, Pier Francesco ) ) ) [105] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Jameson, Michael ) ) ) [106] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Kim, Kevin ) ) ) [107] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Yokota, Kenji ) ) ) [108] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Kerger, Joseph ) ) ) [109] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Aubin, François ) ) ) [110] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Groenewegen, Gerard ) ) ) [111] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Kapiteijn, Helena ) ) ) [112] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Boehncke, Wolf-Henning ) ) ) [113] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Utikal, Jochen ) ) ) [114] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Casasola, Richard ) ) ) [115] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Marshall, Ernest ) ) ) [116] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Ferraresi, Virginia ) ) ) [117] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Richtig, Erika ) ) ) [118] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Matkovic, Suzana ) ) ) [119] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Inozume, Takashi ) ) ) [120] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Crook, Timothy ) ) ) [121] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Mcneil, Catriona ) ) ) [122] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Kiyohara, Yoshio ) ) ) [123] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Avril, Marie-Francoise ) ) ) [124] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Hein, Rüdiger ) ) ) [125] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => Terheyden, Patrick ) ) ) [126] => Array ( [PersonEntity] 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Inc) ) ) ) [161] => Array ( [PersonEntity] => Array ( [Name] => Array ( [NameFull] => AP-HP. 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IllustrationInfo