| Autor: |
Bensinger, W I, Becker, P S, Gooley, T A, Chauncey, T R, Maloney, D G, Gopal, A K, Green, D J, Press, O W, Lill, M, Ifthikharuddin, J J, Vescio, R, Holmberg, L A, Phillips, G L |
| Zdroj: |
Bone Marrow Transplantation; January 2016, Vol. 51 Issue: 1 p67-71, 5p |
| Abstrakt: |
We aimed to examine whether doses of melphalan higher than 200 mg/m2improve response rates when used as conditioning before autologous transplant (ASCT) in multiple myeloma (MM) patients. Patients with MM, n=131, were randomized to 200 mg/m2(mel200) vs 280 mg/m2(mel280) using amifostine pretreatment. The primary end point was the proportion of patients achieving near complete response (⩾nCR). No treatment-related deaths occurred in this study. Responses following ASCT were for mel200 vs mel280, respectively, ⩾nCR 22 vs 39%, P=0.03, ⩾PR 57 vs 74%, P=0.04. The hazard of mortality was not statistically significantly different between groups (mel200 vs mel280; hazard ratio (HR)=1.15 (95% confidence interval (CI), 0.62–2.13, P=0.66)) nor was the rate of progression/mortality (HR=0.81 (0.52–1.27, P=0.36)). The estimated PFS at 1 and 3 years were 83 and 46%, respectively, for mel200 and 78 and 54%, respectively, for mel280. Amifostine and mel280 were well tolerated, with no grade 4 regimen-related toxicities and only one grade 3 mucositis (none with mel200) and three grade 3 gastrointestinal (GI) toxicities (two in mel200). Hospitalization rates were more frequent in the mel280 group (59 vs 43%, P=0.08). Mel280 resulted in a higher major response rate (CR+nCR) and should be evaluated in larger studies. |
| Databáze: |
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