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
| 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 |
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| المؤلفون: | Bottomley, A., Coens, C., Mierzynska, J., Blank, C. U., Mandalà, M., Long, G. V., Atkinson, V. G., Dalle, S., Haydon, A. M., Meshcheryakov, A., Khattak, A., Carlino, M. S., Sandhu, S., Puig, S., Ascierto, P. A., Larkin, J., Lorigan, P. C., Rutkowski, P., Schadendorf, D., Koornstra, R., Hernandez-Aya, L., Di Giacomo, A. M., van den Eertwegh, A. J. M., Grob, J. -J., Gutzmer, R., Jamal, R., van Akkooi, A. C. J., Krepler, C., Ibrahim, N., Marreaud, S., Kicinski, M., Suciu, S., Robert, C., Eggermont, A. M. M., EORTC Melanoma Group, Lesimple, T., Maio, M., Linette, G., Mortier, L., Svane, I. M., Schachter, J., Brown, M., Hersey, P., Barrow, C., Kudchadkar, R., Dutriaux, C., Song, X., Quaglino, P., Queirolo, P., Meier, F., Stroyakovskiy, D., Guillot, B., Romero, P. L. O., Bastholt, L., Garbe, C., Grange, F., Mohr, P., Algazi, A., Bechter, O., Hernberg, M., Loquai, C., Meiss, F., Chiarion Sileni, V., Bar-Sela, G., Fitzharris, B., Saiag, P., Arnault, J. -P., Simon, J. -C., Stephens, R., Baurain, J. -F., Lebbe, C., Combemale, P., Dummer, R., Hauschild, A., Parente, P., Yamazaki, N., Milhem, M., Leccia, M. -T., Geoffrois, L., Kretschmer, L., Dunwoodie, E., Walker, J., Lotem, M., Hendler, D., Mackiewicz, A., Sekulovic, L., Dzienis, M., Hospers, G. A. P., Siano, M., Hassel, J., Corrie, P., Passos, M. -J., Levin, M., Hoeller, C., Machet, L., Hallmeyer, S., Waterston, A., Descamps, V., Kiecker, F., Aarts, M., Schmidt, H., Raimundo, A., Nyakas, M., Lacour, J. -P., Berking, C., Ferrucci, P. F., Jameson, M., Kim, K., Yokota, K., Kerger, J., Aubin, F., Groenewegen, G., Kapiteijn, H., Boehncke, W. -H., Utikal, J., Casasola, R., Marshall, E., Ferraresi, V., Richtig, E., Matkovic, S., Inozume, T., Crook, T., Mcneil, C., Kiyohara, Y., Avril, M. -F., Hein, R., Terheyden, P., Nathan, P., Aoi, J., Skytta, T., Jouary, T., Takenouchi, T., Straume, O., Martins, C., Mukhametshina, G. |
| المساهمون: | Boehncke, Wolf-Henning, Internal medicine, CCA - Cancer Treatment and quality of life, 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, University of Queensland [Brisbane], 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, 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), Hannover Medical School [Hannover] (MHH), Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal (UdeM), 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., Guided Treatment in Optimal Selected Cancer Patients (GUTS) |
| المصدر: | Lancet. Oncology, Vol. 22, No 5 (2021) pp. 655-664 EORTC Melanoma Group 2021, ' 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 ', The Lancet Oncology, vol. 22, no. 5, pp. 655-664 . https://doi.org/10.1016/S1470-2045Test(21)00081-4 Lancet Oncology, 22, 5, pp. 655-664 The Lancet Oncology, 22(5), 655-664. Lancet Publishing Group Lancet Oncology, 22, 655-664 Lancet Oncology Lancet Oncology, 2021, 22 (5), pp.655-664. ⟨10.1016/S1470-2045(21)00081-4⟩ The Lancet Oncology, 22(5), 655-664. ELSEVIER SCIENCE INC |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Male, Skin Neoplasms, Medizin, Skin Neoplasms / drug therapy, Pembrolizumab, law.invention, Cancer development and immune defence Radboud Institute for Health Sciences [Radboudumc 2], MESH: Aged, 80 and over, 0302 clinical medicine, Melanoma / pathology, Randomized controlled trial, law, Monoclonal, 80 and over, Clinical endpoint, MESH: Double-Blind Method, 030212 general & internal medicine, Humanized, Melanoma, MESH: Aged, ddc:616, Aged, 80 and over, education.field_of_study, MESH: Middle Aged, Antibodies, Monoclonal, Humanized, Neoplasm Staging, Quality of Life, Double-Blind Method, Adult, Aged, Middle aged, Humans [MeSH], Hazard ratio, MESH: Neoplasm Staging, Middle Aged, Oncology, 030220 oncology & carcinogenesis, Female, Humans, medicine.medical_specialty, Melanoma / psychology, Skin Neoplasms / psychology, MESH: Melanoma, Antibodies, Monoclonal, Humanized / therapeutic use, Population, [SDV.CAN]Life Sciences [q-bio]/Cancer, Placebo, Antibodies, Melanoma / mortality, 03 medical and health sciences, Internal medicine, medicine, Adjuvant therapy, education, Skin Neoplasms / pathology, MESH: Humans, Melanoma / drug therapy, business.industry, MESH: Skin Neoplasms, MESH: Quality of Life, MESH: Adult, Skin Neoplasms / mortality, MESH: Male, Clinical trial, MESH: Antibodies, Monoclonal, Humanized, business, MESH: Female |
| الوصف: | 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]; pMethods: 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 scores were similar between groups (77·55 [SD 18·20] in the pembrolizumab group and 76·54 [17·81] in the placebo group) and remained stable over time. The difference in average GHQ score between the two groups over the 2 years was -2·2 points (95% CI -4·3 to -0·2). The difference in average score during treatment was -1·1 points (95% CI -3·2 to 0·9) and the difference in average score after treatment was -2·2 points (-4·8 to 0·4). These differences are within the 5-point clinical relevance threshold for the QLQ-C30 and are therefore clinically non-significant.Interpretation: Pembrolizumab does not result in a clinically significant decrease in HRQOL compared with placebo when given as adjuvant therapy for patients with resected, high-risk stage III melanoma. These results support the use of adjuvant pembrolizumab in this setting. placebo when given as adjuvant therapy for patients with resected, high-risk stage III melanoma. These results support the use of adjuvant pembrolizumab in this setting. placebo when given as adjuvant therapy for patients with resected, high-risk stage III melanoma. These results support the use of adjuvant pembrolizumab in this setting. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1470-2045 1474-5488 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::80dc0ff7069bff303dade337b8effb2dTest https://archive-ouverte.unige.ch/unige:159804Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....80dc0ff7069bff303dade337b8effb2d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14702045 14745488 |
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