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Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study
O. Sezer, M. Beksac, R. Hajek, G. Sucak, S. Cagirgan, W. Linkesch, O. Meltem Akay, Z. Gülbas, H. Nahi, T. Plesner, JA. Snowden, A. Timurağaoğlu, T. Dechow, A. Lang, T. Tuğlular, J. Drach, G. Armbrecht, A. Potamianou, C. Couturier, RA. Olie, C....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
28382618
DOI
10.1111/bjh.14637
Knihovny.cz E-zdroje
- MeSH
- antitumorózní látky aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- biologické markery krev MeSH
- bortezomib aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- chemoterapie konsolidační metody MeSH
- dospělí MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom komplikace farmakoterapie patofyziologie MeSH
- následné studie MeSH
- osteolýza farmakoterapie etiologie patofyziologie MeSH
- rozvrh dávkování léků MeSH
- senioři MeSH
- transplantace kmenových buněk MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
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/m(2) 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.
3 Medical Dept Klinikum Rechts der Isar Technical University Munich Munich Germany
Department of Haematology Akdeniz University Antalya Turkey
Department of Haematology and Oncology LandesKrankenhaus Feldkirch Austria
Department of Haematology Eskisehir Osmangazi University Eskisehir Turkey
Department of Haematology Faculty of Medicine Gazi University Ankara Turkey
Department of Haematology Izmir Medical Park Private Hospital Izmir Turkey
Department of Haematology Karolinska University Hospital Stockholm Sweden
Department of Haematology Medical University Clinic Medical University of Graz Graz Austria
Department of Internal Medicine Marmara University Istanbul Turkey
Department of Medicine Ankara University Ankara Turkey
Janssen Cilag AG Zug Switzerland
Janssen Cilag Issy les Moulineaux France
Janssen Cilag Pharmaceutical SACI Athens Greece
Janssen Research and Development Division of Janssen Pharmaceutica NV Beerse Belgium
Citace poskytuje Crossref.org
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