TY - JOUR
T1 - Melphalan and purine analog-containing preparative regimens
T2 - Reduced-intensity conditioning for patients with hematologic malignancies undergoing allogeneic progenitor cell transplantation
AU - Giralt, Sergio
AU - Thall, Peter F.
AU - Khouri, Issa
AU - Wang, Xuemei
AU - Braunschweig, Ira
AU - Ippolitti, Cindy
AU - Claxton, David
AU - Donato, Michele
AU - Bruton, Jill
AU - Cohen, Agueda
AU - Davis, Marilyn
AU - Andersson, Borje S.
AU - Anderlini, Paolo
AU - Gajewski, James
AU - Kornblau, Steven
AU - Andreeff, Michael
AU - Przepiorka, Donna
AU - Ueno, Naoto T.
AU - Molldrem, Jeff
AU - Champlin, Richard
PY - 2001/2/1
Y1 - 2001/2/1
N2 - A reduced-intensity preparative regimen consisting of melphalan and a purine analog was evaluated for allogeneic transplantation in 86 patients who had a variety of hematologic malignancies and were considered poor Candidates for conventional myeloablative therapies because of age or comorbidity. Seventy-eight patients received fludarabine 25 mg/m2 daily for 5 days in combination with melphalan 180 mg/m2 (n = 66) or 140 mg/m2 (n = 12). Eight patients received cladribine 12 mg/m2 continuous infusion for 5 days with melphalan 180 mg/m2. The median age was 52 years (range, 22-70 years). Disease status at transplantation was either first remission or first chronic phase in 7 patients, untreated first relapse or subsequent remission in 16 patients, and refractory leukemia or transformed chronic myelogenous leukemia in 63 patients. Non-relapse mortality rates on day 100 were 37.4% for the fludarabine/melphalan combination and 87.5% for the cladribine/melphalan combination. The median percentage of donor cells at 1 month in 75 patients was 100% (range, 0%-100%). The probability of grade 2-4 and 3-4 acute graft-versus-host disease was 0.49 (95% Cl, 0.38-0.60) and 0.29 (95% Cl, 0.18-0.41), respectively. Disease-free survival at 1 year was 57% for patients in first remission or chronic phase and 49% for patients with untreated first relapse or in a second or later remission. On multivariate analysis the strongest predictor for disease-free survival was a good or intermediate risk category. In summary, fludarabine/melphalan combinations are feasible in older patients with associated comorbidities, and long-term disease control cart be achieved with reduced-intensity conditioning in this population.
AB - A reduced-intensity preparative regimen consisting of melphalan and a purine analog was evaluated for allogeneic transplantation in 86 patients who had a variety of hematologic malignancies and were considered poor Candidates for conventional myeloablative therapies because of age or comorbidity. Seventy-eight patients received fludarabine 25 mg/m2 daily for 5 days in combination with melphalan 180 mg/m2 (n = 66) or 140 mg/m2 (n = 12). Eight patients received cladribine 12 mg/m2 continuous infusion for 5 days with melphalan 180 mg/m2. The median age was 52 years (range, 22-70 years). Disease status at transplantation was either first remission or first chronic phase in 7 patients, untreated first relapse or subsequent remission in 16 patients, and refractory leukemia or transformed chronic myelogenous leukemia in 63 patients. Non-relapse mortality rates on day 100 were 37.4% for the fludarabine/melphalan combination and 87.5% for the cladribine/melphalan combination. The median percentage of donor cells at 1 month in 75 patients was 100% (range, 0%-100%). The probability of grade 2-4 and 3-4 acute graft-versus-host disease was 0.49 (95% Cl, 0.38-0.60) and 0.29 (95% Cl, 0.18-0.41), respectively. Disease-free survival at 1 year was 57% for patients in first remission or chronic phase and 49% for patients with untreated first relapse or in a second or later remission. On multivariate analysis the strongest predictor for disease-free survival was a good or intermediate risk category. In summary, fludarabine/melphalan combinations are feasible in older patients with associated comorbidities, and long-term disease control cart be achieved with reduced-intensity conditioning in this population.
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U2 - 10.1182/blood.V97.3.631
DO - 10.1182/blood.V97.3.631
M3 - Article
C2 - 11157478
AN - SCOPUS:0035254219
SN - 0006-4971
VL - 97
SP - 631
EP - 637
JO - Blood
JF - Blood
IS - 3
ER -