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Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: A Meta-Analysis of Phase III Randomized, Controlled Trials

Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 200...

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Main Authors: Sonneveld, Pieter (Author) , Goldschmidt, Hartmut (Author) , Rosiñol, Laura (Author) , Bladé, Joan (Author) , Lahuerta, Juan José (Author) , Cavo, Michele (Author) , Tacchetti, Paola (Author) , Zamagni, Elena (Author) , Attal, Michel (Author) , Lokhorst, Henk M. (Author) , Desai, Avinash (Author) , Cakana, Andrew (Author) , Liu, Kevin (Author) , Velde, Helgi van de (Author) , Esseltine, Dixie-Lee (Author) , Moreau, Philippe (Author)
Format: Article (Journal)
Language:English
Published: 2013
In: Journal of clinical oncology
Year: 2013, Volume: 31, Issue: 26, Pages: 3279-3287
ISSN:1527-7755
DOI:10.1200/JCO.2012.48.4626
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2012.48.4626
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/pdf/10.1200/JCO.2012.48.4626
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Author Notes:Pieter Sonneveld, Hartmut Goldschmidt, Laura Rosiñol, Joan Bladé, Juan José Lahuerta, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M. Lokhorst, Avinash Desai, Andrew Cakana, Kevin Liu, Helgi van de Velde, Dixie-Lee Esseltine, and Philippe Moreau
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Summary:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-dexamethasone v vincristine-doxorubicin-dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-dexamethasone v thalidomide-dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-dexamethasone v thalidomide-dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-based induction, n = 785) were included. Post-transplantation CR+nCR rate was significantly higher following bortezomib-based versus nonbortezomib-based induction (38% v 24%; odds ratio, 2.05; P < .001); the benefit remained similar (pooled odds ratio, 1.96) when GIMEMA MM-BO2005 data were included. Median PFS was 35.9 months versus 28.6 months with bortezomib-based versus nonbortezomib-based induction, respectively (hazard ratio, 0.75; P < .001); 3-year overall survival (OS) rates were 79.7% and 74.7%, respectively (hazard ratio for OS, 0.81; P = .0402). Median duration of induction treatment was 11 weeks in both treatment groups. Rates of peripheral neuropathy during induction were 34% versus 17% (grade ≥ 3, 6% v 1%). Overall, 3% and 4% of patients died during bortezomib-based and nonbortezomib-based induction, respectively. Conclusion Bortezomib-based induction results in significant improvements in response and PFS/OS compared with nonbortezomib-based induction and is generally well tolerated, with a higher rate of peripheral neuropathy but no apparent increase in risk of death during induction.
Item Description:Published online ahead of print on July 29, 2013
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Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.2012.48.4626

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