VMP (Bortezomib, Melphalan, and Prednisone) Is Active and Well Tolerated in Newly Diagnosed Patients With Multiple Myeloma With Moderately Impaired Renal Function, and Results in Reversal of Renal Impairment: Cohort Analysis of the Phase III VISTA Study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] Journal article | | Title | VMP (Bortezomib, Melphalan, and Prednisone) Is Active and Well Tolerated in Newly Diagnosed Patients With Multiple Myeloma With Moderately Impaired Renal Function, and Results in Reversal of Renal Impairment: Cohort Analysis of the Phase III VISTA Study. | | Author(s) | Dimopoulos MA, Richardson PG, Schlag R, Khuageva NK, Shpilberg O, Kastritis E, Kropff M, Petrucci MT, Delforge M, Alexeeva J, Schots R, Masszi T, Mateos MV, Deraedt W, Liu K, Cakana A, van de Velde H, San Miguel JF | | Institution | Department of Clinical Therapeutics, Alexandra Hospital, University of Athens, School of Medicine, Athens, Greece; Dana-Farber Cancer Institute, Boston, MA; Johnson & Johnson Pharmaceutical Research & Development LLC, Raritan, NJ; Praxisklinik Dr Schlag, Würzburg; University of Münster, Münster, Germany; SP Botkin Moscow City Clinical Hospital, Russian Federation, Rabin Medical Center, Petah-Tiqva, Israel; University La Sapienza, Rome, Italy; Myeloma Study Group Belgian Hematological Society, Brussels; Johnson & Johnson Pharmaceutical Research & Development, Beerse, Belgium; St Petersburg Clinical City Hospital, St Petersburg, Russia; St István and St László Hospital of Budapest, Budapest, Hungary; and the Hospital Universitario Salamanca, Centro de Investigación del Cáncer, Instituto de Biología Molecular y Celular del Cáncer (Universidad de Salamance, Consejo Superior de Investigaciones Cientificas), Salamanca, Spain. | | Source | J Clin Oncol 2009 Oct 26. | | Abstract | PURPOSE: To assess bortezomib plus melphalan and prednisone (VMP) and melphalan and prednisone (MP) in previously untreated patients with multiple myeloma (MM) with renal impairment enrolled on the phase III VISTA study, and to evaluate renal impairment reversibility.
PATIENTS AND METHODS: Patients received nine 6-week cycles of VMP (bortezomib 1.3 mg/m(2), melphalan 9 mg/m(2), prednisone 60 mg/m(2)) or MP. Patients with serum creatinine higher than 2 mg/dL were excluded.
RESULTS: In the VMP/MP arms, 6%/4%, 27%/30%, and 67%/66% of patients had baseline glomerular filtration rate (GFR) of </= 30, 31 to 50, and higher than 50 mL/min, respectively. Response rates were higher and time to progression (TTP) and overall survival (OS) longer with VMP versus MP across renal cohorts. Response rates with VMP and TTP in both arms did not appear significantly different between patients with GFR </= 50 or higher than 50 mL/min; OS appeared somewhat longer in patients with normal renal function in both arms. Renal impairment reversal (baseline GFR < 50 improving to > 60 mL/min) was seen in 49 (44%) of 111 patients receiving VMP versus 40 (34%) of 116 patients receiving MP. By multivariate analysis, younger age (< 75 years; P = .006) and less severe impairment (GFR >/= 30 mL/min; P = .027) were associated with higher reversal rates. In addition, treatment with VMP approached significance (P = .07). In both arms, rates of grade 4 and 5 adverse events (AEs) and serious AEs appeared higher in patients with renal impairment; with VMP, rates of discontinuations/bortezomib dose reductions due to AEs did not appear affected.
CONCLUSION: VMP is a feasible, active, and well-tolerated treatment option for previously untreated patients with MM with moderate renal impairment, resulting in 44% renal impairment reversal. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19858394 |
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