Yazarlar : 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

Yayın : Blood.

Yayın Yılı : 2011

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/21951682

Konu : Myelom

Literatür İçeriği :  

Abstract

We assessed efficacy, safety and renal impairment (RI) reversal in untreated multiple myeloma patients treated with bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide (VMPT-VT) maintenance versus bortezomib-melphalan-prednisone (VMP). Exclusion criteria included serum creatinine≥2.5mg/dL. In the VMPT-VT/VMP arms, severe RI [estimated glomerular filtration rate (eGFR)≤30mL/min], moderate (eGFR=31-50mL/min) and normal renal function (eGFR>50mL/min), were respectively 6%/7.9%, 24.1%/24.9% and 69.8%/67.2%. Statistically significant improvements in overall response rates (ORRs) and progression-free survival (PFS) were observed in VMPT-VT versus VMP arms across renal cohorts, except in severe RI patients. In the VMPT group, severe RI reduced 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, higher rates of severe hematologic adverse events (AEs) were associated with RI (eGFR<50mL/min), however therapy discontinuation rates were unaffected. VMPT-VT was superior to VMP for cases with normal renal function and moderate RI, while VMPT-VT failed to outperform VMP in patients with severe RI, although the relatively low number of cases due to protocol inclusion criteria preclude drawing definitive conclusions. The VMPT-VT had no advantage in terms of RI reversal over VMP. This study was registered at www.clinicaltrials.gov as #NCT01063179.

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