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Characterization of haematological parameters with bortezomib-melphalan-prednisone versus melphalan-prednisone in newly diagnosed myeloma, with evaluation of long-term outcomes and risk of thromboembolic events with use of erythropoiesis-stimulating agents: Analysis of the VISTA trial

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Richardson, Paul G. Schlag, Rudolf Khuageva, Nuriet Dimopoulos, Meletios Shpilberg, Ofer Vekemans, Marie-Christiane [UCL] San Miguel, Jesús F.

Although haematological toxicities, such as anaemia, are common in multiple myeloma (MM), no clear consensus exists on the use and impact of erythropoiesis-stimulating agents (ESA) on outcomes in MM. This analysis characterizes haematological toxicities and associated interventions in the phase III VISTA (Velcade ® as Initial Standard Therapy in Multiple Myeloma: Assessment with Melphalan and Prednisone) study of bortezomib plus melphalan/prednisone (VMP, n=344) versus MP (n=338) in previously untreated MM patients ineligible for high-dose therapy, and evaluates the impact of ESA use or red-blood-cell (RBC) transfusions on outcomes and thromboembolic risk. Incidence of haematological toxicities was similar with VMP and MP; similar rates of interventions and associated complications (e.g. bleeding, febrile neutropenia) were observed. Two hundred thirty three patients received ESA; 204 had RBC transfusions. Frequency of thromboembolic events was low and not affected by ESA use. Median time-to progression (TTP) was similar between ESA/non-ESA [hazard ratio: 1·03 (95% confidence interval 0·76-1·39); P=0·8478] in both arms (VMP: 19·9/not reached; MP: 15·0/17·5months). Three-year overall survival (OS) rates were similar between ESA/non-ESA in each arm. Patients receiving RBC transfusions had significantly shorter OS (P<0·0001) versus non-RBC-transfusion patients. In conclusion, bortezomib did not add to melphalan haematological toxicity. Concomitant ESA use with VMP/MP in previously untreated MM patients did not adversely affect TTP or OS, or increase thromboembolic risk. However, RBC transfusion was associated with significantly shorter survival. © 2011 Blackwell Publishing Ltd.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès restreint
Publication date 2011
Language Anglais
Journal information "British Journal of Haematology" - Vol. 153, no. 2, p. 212-221 (2011)
Peer reviewed yes
Publisher Wiley-Blackwell Publishing Ltd. ((United Kingdom) Oxford)
issn 0007-1048
e-issn 1365-2141
Publication status Publié
Affiliation UCL - (SLuc) Service d'hématologie
Links
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Bibliographic reference Richardson, Paul G. ; Schlag, Rudolf ; Khuageva, Nuriet ; Dimopoulos, Meletios ; Shpilberg, Ofer ; et. al. Characterization of haematological parameters with bortezomib-melphalan-prednisone versus melphalan-prednisone in newly diagnosed myeloma, with evaluation of long-term outcomes and risk of thromboembolic events with use of erythropoiesis-stimulating agents: Analysis of the VISTA trial. In: British Journal of Haematology, Vol. 153, no. 2, p. 212-221 (2011)
Permanent URL http://hdl.handle.net/2078.1/163953