Carfilzomib or bortezomib in combination with cyclophosphamide and dexamethasone followed by carfilzomib maintenance for patients with multiple myeloma after one prior therapy: results from a multi-centre, phase II, randomized, controlled trial (MUKfive)
| Autor: | Stephen F. Hawkins, James Croft, Faith E. Davies, Holger W. Auner, Catherine D. Williams, Debbie Sherratt, Mamta Garg, Ceri Bygrave, Jamie Cavenagh, Gareth J. Morgan, Ruth M. de Tute, Sarah Brown, Kwee Yong, Louise Flanagan, Neil Rabin, Karthik Ramasamy, Roger G. Owen, Martin Kaiser, Samantha Hinsley |
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| Přispěvatelé: | Myeloma UK |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
medicine.medical_specialty Proteasome Endopeptidase Complex Cyclophosphamide Immunology Article law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Humans 1102 Cardiorespiratory Medicine and Haematology Multiple myeloma Dexamethasone Bortezomib business.industry Hazard ratio Hematology Odds ratio medicine.disease Carfilzomib chemistry business Proteasome Inhibitors 030215 immunology medicine.drug |
| Zdroj: | Haematologica |
| Popis: | The proteasome inhibitors, carfilzomib and bortezomib, are widely used to treat myeloma but head-to-head comparisons have produced conflicting results. We compared the activity of these proteasome inhibitors in combination with cyclophosphamide and dexamethasone (KCd vs. VCd) in second-line treatment using fixed duration therapy and evaluated the efficacy of carfilzomib maintenance. MUKfive was a phase II controlled, parallel group trial that randomized patients (2:1) to KCd (n=201) or VCd (n=99); responding patients on carfilzomib were randomized to maintenance carfilzomib (n=69) or no further treatment (n=72). Primary endpoints were: (i) very good partial response (non-inferiority, odds ratio [OR] 0.8) at 24 weeks, and (ii) progression-free survival. More participants achieved a very good partial response or better with carfilzomib than with bortezomib (40.2% vs. 31.9%, OR=1.48, 90% confidence interval [CI]: 0.95, 2.31; non-inferior), with a trend for particular benefit in patients with adverse-risk disease. KCd was associated with higher overall response (partial response or better, 84.0% vs. 68.1%, OR=2.72, 90% CI: 1.62, 4.55, P=0.001). Neuropathy (grade ≥3 or ≥2 with pain) was more common with bortezomib (19.8% vs. 1.5%, P |
| Databáze: | OpenAIRE |
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