Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Sezer, O; Beksac, M; Hajek, R; Sucak, G; Cagirgan, S; Linkesch, W; Meltem Akay, O; Gülbas, Z; Nahi, H; Plesner, T; Snowden, JA; Timurağaoğlu, A; Dechow, T; Lang, A; Tuğlular, T; Drach, J; Armbrecht, G; Potamianou, A; Couturier, C; Olie, RA; Feys, C; Allietta, N; Terpos, E.
Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study.
Br J Haematol. 2017; 178(1):61-71
Doi: 10.1111/bjh.14637
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- Co-Autor*innen der Med Uni Graz
- Linkesch Werner
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- Abstract:
- This phase II study explored the effects of bortezomib consolidation versus observation on myeloma-related bone disease in patients who had a partial response or better after frontline high-dose therapy and autologous stem cell transplantation. Patients were randomized to receive four 35-day cycles of bortezomib 1·6 mg/m2 intravenously on days 1, 8, 15 and 22, or an equivalent observation period, and followed up for disease status/survival. The modified intent-to-treat population included 104 patients (51 bortezomib, 53 observation). There were no meaningful differences in the primary endpoint of change from baseline to end of treatment in bone mineral density (BMD). End-of-treatment rates (bortezomib versus observation) of complete response/stringent complete response were 22% vs. 11% (P = 0·19), very good partial response or better of 80% vs. 68% (P = 0·17), and progressive disease of 8% vs. 23% (P = 0·06); median progression-free survival was 44·9 months vs. 21·8 months (P = 0·22). Adverse events observed ≥15% more frequently with bortezomib versus observation were diarrhoea (37% vs. 0), peripheral sensory neuropathy (20% vs. 4%), nausea (18% vs. 0) and vomiting (16% vs. 0). Compared with observation, bortezomib appeared to have little impact on bone metabolism/health, but was associated with trends for improved myeloma response and survival. © 2017 John Wiley & Sons Ltd.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Antineoplastic Agents - administration & dosage
- Antineoplastic Agents - adverse effects
- Antineoplastic Agents - therapeutic use
- Biomarkers - blood
- Bortezomib - administration & dosage
- Bortezomib - adverse effects
- Bortezomib - therapeutic use
- Consolidation Chemotherapy - methods
- Drug Administration Schedule -
- Female -
- Follow-Up Studies -
- Humans -
- Kaplan-Meier Estimate -
- Male -
- Middle Aged -
- Multiple Myeloma - complications
- Multiple Myeloma - drug therapy
- Multiple Myeloma - physiopathology
- Osteolysis - drug therapy
- Osteolysis - etiology
- Osteolysis - physiopathology
- Stem Cell Transplantation -
- Treatment Outcome -
- Find related publications in this database (Keywords)
- bortezomib
- multiple myeloma
- consolidation
- bone
- bone mineral density