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Persistent overall survival benefit and no increased risk of second malignancies with bortezomib-melphalan-prednisone versus melphalan-prednisone in patients with previously untreated multiple myeloma.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2013 Feb 01; Vol. 31 (4), pp. 448-55. Date of Electronic Publication: 2012 Dec 10. - Publication Year :
- 2013
-
Abstract
- Purpose: This final analysis of the phase III VISTA trial (Velcade As Initial Standard Therapy in Multiple Myeloma: Assessment With Melphalan and Prednisone) was conducted to determine whether the overall survival (OS) benefit with bortezomib-melphalan-prednisone (VMP) versus melphalan-prednisone (MP) in patients with myeloma who were ineligible for transplantation was maintained after 5 years of follow-up and to explore the risk of second primary malignancies.<br />Patients and Methods: In all, 682 patients received up to nine 6-week cycles of VMP or MP and were then observed every 12 weeks or less. Data on second primary malignancies were collected by individual patient inquiries at all sites from 655 patients.<br />Results: After median follow-up of 60.1 months (range, 0 to 74 months), there was a 31% reduced risk of death with VMP versus MP (hazard ratio [HR], 0.695; P < .001; median OS 56.4 v 43.1 months). OS benefit with VMP was seen across prespecified patient subgroups (age ≥ 75 years, stage III myeloma, creatinine clearance < 60 mL/min). Sixty-three percent of VMP patients and 73% of MP patients had received subsequent therapy. Time to next therapy (median, 30.7 v 20.5 months; HR, 0.557; P < .001) was longer with VMP than with MP. Among patients who received subsequent therapies, survival from start of subsequent therapy was similar following VMP (median, 28.1 months) or MP (median, 26.8 months; HR, 0.914). Following VMP/MP, incidence proportions of hematologic malignancies (1%/1%) and solid tumors (5%/3%) and exposure-adjusted incidence rates (0.017/0.013 per patient-year) were similar and were consistent with background rates.<br />Conclusion: VMP resulted in a significant reduction in risk of death versus MP that was maintained after 5 years' follow-up and despite substantial use of novel-agent-based salvage therapies. There is no emerging safety signal for second primary malignancies following VMP.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Biomarkers, Tumor blood
Boronic Acids administration & dosage
Boronic Acids adverse effects
Bortezomib
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Incidence
Kaplan-Meier Estimate
Male
Melphalan administration & dosage
Melphalan adverse effects
Middle Aged
Multiple Myeloma pathology
Multivariate Analysis
Neoplasm Staging
Neoplasms, Second Primary chemically induced
Odds Ratio
Prednisone administration & dosage
Prednisone adverse effects
Proportional Hazards Models
Pyrazines administration & dosage
Pyrazines adverse effects
Risk
Spain epidemiology
Treatment Outcome
beta 2-Microglobulin blood
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Multiple Myeloma drug therapy
Multiple Myeloma mortality
Neoplasms, Second Primary epidemiology
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 31
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 23233713
- Full Text :
- https://doi.org/10.1200/JCO.2012.41.6180