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

Richardson, Paul G.;Schlag, Rudolf;Khuageva, Nuriet;Dimopoulos, Meletios;San Miguel, Jesús F.;et.al.
(2011) British Journal of Haematology — Vol. 153, n° 2, p. 212-221 (2011)

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Authors
  • Richardson, Paul G.
    Author
  • Schlag, Rudolf
    Author
  • Khuageva, Nuriet
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  • Dimopoulos, Meletios
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  • Vekemans, Marie-ChristianeUCLouvain
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  • San Miguel, Jesús F.
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Abstract
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 <sup>®</sup> 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&lt;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.
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Richardson, P. G., Schlag, R., Khuageva, N., Dimopoulos, M., Shpilberg, O., Kropff, M., Vekemans, M.-C., Petrucci, M. T., Rossiev, V., Hou, J., Robak, T., Mateos, M.-V., Anderson, K., Esseltine, D.-L., Cakana, A., Liu, K., Deraedt, W., van de Velde, H., & San Miguel, J. F. (2011). 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. British Journal of Haematology, 153(2), 212-221. https://doi.org/10.1111/j.1365-2141.2011.08569.x (Original work published 2011)