دورية أكاديمية
Health-related quality of life and quality-adjusted progression free survival for carfilzomib and dexamethasone maintenance following salvage autologous stem-cell transplantation in patients with multiple myeloma:a randomized phase 2 trial by the Nordic Myeloma Study Group
| العنوان: | Health-related quality of life and quality-adjusted progression free survival for carfilzomib and dexamethasone maintenance following salvage autologous stem-cell transplantation in patients with multiple myeloma:a randomized phase 2 trial by the Nordic Myeloma Study Group |
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| المؤلفون: | Nielsen, Lene Kongsgaard, Schjesvold, Fredrik, Möller, Sören, Guldbrandsen, Nina, Hansson, Markus, Remes, Kari, Peceliunas, Valdas, Abildgaard, Niels, Gregersen, Henrik, King, Madeleine T. |
| المصدر: | Nielsen , L K , Schjesvold , F , Möller , S , Guldbrandsen , N , Hansson , M , Remes , K , Peceliunas , V , Abildgaard , N , Gregersen , H & King , M T 2024 , ' Health-related quality of life and quality-adjusted progression free survival for carfilzomib and dexamethasone maintenance following salvage autologous stem-cell transplantation in patients with multiple myeloma : a randomized phase 2 trial by the Nordic Myeloma Study Group ' , Journal of Patient-Reported Outcomes , vol. 8 , no. 1 , 15 . https://doi.org/10.1186/s41687-024-00691-2Test |
| سنة النشر: | 2024 |
| المجموعة: | Aarhus University: Research |
| مصطلحات موضوعية: | Carfilzomib, Health-related quality of life, Multiple myeloma, Randomized clinical trial |
| الوصف: | Background: Decisions regarding maintenance therapy in patients with multiple myeloma should be based on both treatment efficacy and health-related quality of life (HRQL) consequences. In the CARFI trial, patients with first relapse of multiple myeloma underwent salvage autologous stem cell transplantation (salvage ASCT) before randomization to carfilzomib-dexamethasone maintenance therapy (Kd) or observation. The primary clinical endpoint was time to progression, which was extended by 8 months by Kd. The aim of this paper is to present the all HRQL endpoints of the CARFI trial including the HRQL effect of Kd maintenance therapy relative to observation. The primary HRQL endpoint was assessed by EORTC QLQ-C30 Summary score (QLQ-C30-sum) at 8 months follow-up. A key secondary HRQL endpoint was quality-adjusted progression-free-survival (QAPFS). Methods: HRQL was assessed with EORTC QLQ-C30, EORTC QLQ-MY20 and FACT/GOG-Ntx at randomization and every second month during follow-up. HRQL data were analyzed with linear mixed effect models until 8 months follow-up. QAPFS per individual was calculated by multiplying progression-free survival (PFS) by two quality-adjustment metrics, the QLQ-C30-sum and EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The QAPFS per treatment group was estimated with the Kaplan-Meier method. P < 0.05 was used for statistical significance, and a between-group minimal important difference of 10 points was interpreted as clinically relevant for the QLQ-C30-sum. Results: 168 patients were randomized. HRQL questionnaire compliance was 93%. For the QLQ-C30-sum, the difference of 4.62 points (95% confidence interval (CI) -8.9: -0.4, p = 0.032) was not clinically relevant. PFS was 19.3 months for the Kd maintenance group and 16.8 months for the observation group; difference = 2.5 months (95% CI 0.5; 4.5). QAPFS based on the QLQ-C30-sum for the Kd maintenance group was 18.0 months (95% CI 16.4; 19.6) and for the observation group 15.0 months (95% CI 13.5; 16.5); difference = ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://pure.au.dk/portal/en/publications/fa10abbd-6201-49dd-8242-e75162794745Test |
| DOI: | 10.1186/s41687-024-00691-2 |
| الإتاحة: | https://doi.org/10.1186/s41687-024-00691-2Test https://pure.au.dk/portal/en/publications/fa10abbd-6201-49dd-8242-e75162794745Test http://www.scopus.com/inward/record.url?scp=85184449271&partnerID=8YFLogxKTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.BCA5F638 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s41687-024-00691-2 |
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