Safety and efficacy of bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance (VMPT-VT) versus bortezomib-melphalan-prednisone (VMP) in untreated multiple myeloma patients with renal impairment
| Autor: | Morabito, F, Gentile, M, Mazzone, C, Rossi, D, Di Raimondo, F, Bringhen, S, Ria, R, Offidani, M, Patriarca, F, Nozzoli, C, Petrucci, Mt, Benevolo, G, Vincelli, I, Guglielmelli, T, Grasso, M, Marasca, R, Baldini, L, Montefusco, V, Musto, P, Cascavilla, N, Majolino, I, Musolino, Caterina, Cavo, M, Boccadoro, M, Palumbo, A, Musolino, C. |
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| Přispěvatelé: | Morabito F., Gentile M., Mazzone C., Rossi D., Di Raimondo F., Bringhen S., Ria R., Offidani M., Patriarca F., Nozzoli C., Petrucci M.T., Benevolo G., Vincelli I., Guglielmelli T., Grasso M., Marasca R., Baldini L., Montefusco V., Musto P., Cascavilla N., Majolino I., Musolino C., Cavo M., Boccadoro M., Palumbo A. |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Melphalan
Male CHRONIC KIDNEY-DISEASE DOXORUBICIN-DEXAMETHASONE BDD PRESENTING FEATURES FAILURE ARF PHASE-II REGIMENS REVERSIBILITY PATHOGENESIS REVERSAL SURVIVAL Biochemistry Bortezomib chemistry.chemical_compound MULTIPLE MYELOMA Prednisone Multiple myeloma Antineoplastic Combined Chemotherapy Protocols Multiple Myeloma thalidomide bortezomib-melphalan-prednisone Kidney treatment Hematology Induction Chemotherapy Boronic Acids Neoadjuvant Therapy Thalidomide medicine.anatomical_structure Treatment Outcome Pyrazines Female Kidney Diseases medicine.drug Glomerular Filtration Rate renal impairment medicine.medical_specialty Immunology Urology Renal function MPT-VT Maintenance Chemotherapy medicine Humans Adverse effect Aged Creatinine business.industry Cell Biology medicine.disease Survival Analysis Surgery melphalan chemistry VMP prednisone bortezomib-melphalan-prednisone-thalidomide business |
| Popis: | We assessed efficacy, safety, and reversal of renal impairment (RI) in untreated patients with multiple myeloma given bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide (VMPT-VT) maintenance or bortezomib-melphalan-prednisone (VMP). Exclusion criteria included serum creatinine ≥ 2.5 mg/dL. In the VMPT-VT/VMP arms, severe RI (estimated glomerular filtration rate [eGFR] ≤ 30 mL/min), moderate RI (eGFR 31-50 mL/min), and normal renal function (eGFR > 50 mL/min), were 6%/7.9%, 24.1%/24.9%, and 69.8%/67.2%, respectively. Statistically significant improvements in overall response rates and progression-free survival were observed in VMPT-VT versus VMP arms across renal cohorts, except in severe RI patients. In the VMPT group, severe RI reduced overall survival (OS). RI was reversed in 16/63 (25.4%) patients receiving VMPT-VT versus 31/77 (40.3%) receiving VMP. Multivariate analysis showed male sex (P = .022) and moderate RI (P = .003) significantly predicted RI recovery. VMP patients achieving renal response showed longer OS. In both arms, greater rates of severe hematologic adverse events were associated with RI (eGFR < 50 mL/min), however, therapy discontinuation rates were unaffected. VMPT-VT was superior to VMP for cases with normal renal function and moderate RI, whereas VMPT-VT failed to outperform VMP in patients with severe RI, although the relatively low number of cases analyzed preclude drawing definitive conclusions. VMPT-VT had no advantage in terms of RI reversal over VMP. This study is registered at http://www.clinicaltrials.gov as NCT01063179. |
| Databáze: | OpenAIRE |
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