Continuous High-Dose Idarubicin and Busulfan As Conditioning Regimen for Chinese Patients with Acute Myeloid Leukemia Undergoing Autologous Stem Cell Transplantation

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4539-4539
Author(s):  
Hong Ming ◽  
Sixuan Qian ◽  
Liu Peng ◽  
Wu Hanxin ◽  
Qiu Hongxia ◽  
...  

Abstract Abstract 4539 Objective: To investigate the efficacy and toxicity of continuous high-dose idarubicin and busulfan as conditioning regimen for Chinese patients with acute myeloid leukemia (AML) undergoing autologous stem cell transplantation (ASCT). Methods: A total of 27 patients with AML were enrolled in our prospective study, including 25 of first complete remission and 2 of second complete remission. Twelve patients were male, and 15 were female, with ages ranging from 14 to 56 (median, 31) years. All the patients were given induction and consolidation treatments and underwent ASCT receiving a continuous infusion of high-dose idarubicin (20 mg/m2 qd, days -13 to -11) and busulfan (oral busulfan 1 mg/kg q6h or intravenous busulfan 0.8 mg/kg q6h, d-5∼-2) as conditioning regimen. Results: All the patients acquired hematopoietic reconstitution. The median number of days to neutrophil (©ƒ0.5×109/l) and platelet (©ƒ20×109/l) recovery was 10 and 12, respectively. After a median follow-up of 23 months from diagnosis, the median overall survival (OS) and the median disease-free survival (DFS) were 19(7∼87) and 15(6∼85) months, respectively. A total of 18 patients (73.4%) are alive (17 in continuous complete remission) and 10 (37.4%) relapsed after transplant. Those who underwent standard dose of idarubicin (12 mg/m2 qd, days1–3) and cytarabine (100∼200 mg/m2 qd, days1–7) as induction treatment showed lower relapse rate and better OS and DFS as compared to other induction regimens without significant difference. Patients with favorable karyotypes and molecular biological types acquired better OS and DFS as compared to those with intermediate karyotypes and molecular biological types, but there was no significant difference. Myelosuppression and infections due to neutropenia was the most frequent adverse effects, severe nonhematologic toxicity was not observed in all patients. The patients in our study acquired similar OS and DFS compared to those with intermediate karyotypes and molecular biological types who underwent allogeneic transplantation (HLA identical sibling donor) in first complete remission, and the side effects were minor. Conclusion: Continuous high-dose idarubicin and busulfan as conditioning regimen for Chinese patients with AML undergoing ASCT was effect and well tolerable. Disclosures: No relevant conflicts of interest to declare.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 961-961 ◽  
Author(s):  
Regis Peffault de Latour ◽  
Myriam Labopin ◽  
Jan Cornelissen ◽  
Lars Vindelov ◽  
Didier Blaise ◽  
...  

Abstract Abstract 961 Background: Current data indicates that allogeneic hematopoietic stem cell transplantation (HSCT) provides identical long-term survival for patients (pts) with acute myeloid leukemia (AML) receiving grafts from matched 8/8 unrelated donor (MUD) or matched sibling donor (MSD) after reduced intensity conditioning (RIC) regimen. Given those results, one may question the requirement for an “older” MSD when a healthy younger MUD is available. This study assessed the impact of older age of MSD on outcomes post-HSCT for pts older than 50 years with AML in first complete remission (CR1) transplanted after a RIC regimen. Patients and methods: From January 2000 to December 2010, this retrospective multi-center study included 1102 pts with AML in CR1 who received PBSC after a RIC regimen, either from MSD (n=854) or from 8/8 HLA MUD (n=248). Conditioning regimen was fludarabine-based in 95% of the pts and Graft versus Host Disease (GvHD) prophylaxis consisted of cyclosporine plus MMF in 42% of cases. To address the role of donor age in our population, 3 groups of pts were defined: pts who were transplanted from a MUD (“MUD group”), pts who received their graft from a sibling aged less than 60 years old (“MSD<60 group”) and pts who were transplanted from a sibling aged of 60 years old or more (“MSD360 group”). Results: Patient characteristics were similar between the 3 groups for gender, disease distribution (FAB classification) and cytogenetic risks (MRC classification). Recipients were younger in the MSD<60 group (57 years versus 60 and 61 years for MUD and MSD360, respectively, p<0.001). Donors were younger for MUD (median age 35 years versus 53 years and 64 years for MSD<60 and MSD360 respectively, p<0.001). In the MUD group, pts were transplanted more recently (2009 versus 2006 and 2007 for MSD<60 and MSD360 respectively, p<0.001), with a longer time interval between diagnosis and HSCT (184 days versus 154 days and 151 days for MSD<60 and MSD360 respectively, p<0.001) and the conditioning regimen included more ATG (p< 0.0001). The median follow-up was 24 months (range, 2–122) for MUD, 42 months (range, 1.5–140) for MSD<60 and 33 months (range, 1–129) for MSD360. During evolution, the cumulative incidence (CI) of acute GvHD was 28% in MUD versus 20% and 17% in MSD<60 and MSD360, respectively (p=0.006) while the CI of chronic GvHD at 2 years was about 50% in each group (p=0.93). CI of treatment related mortality (TRM) and relapse as well as leukemia free survival (LFS) and overall survival (OS) were not different at 2 years between the 3 groups (Table 1). In multivariate analysis, TRM was decreased in pts who received ATG in the conditioning regimen (HR: 0.62; 95%CI 0.41–0.95; p=0.03). A longer interval between AML diagnosis and CR1 (>median) was the only factor associated with relapse (Hazard ratio - HR: 1.35; 95%CI 1.05–1.74; p=0.02). Two independent factors were associated with worse LFS: a longer delay between AML diagnosis and CR1 (HR: 1.34; 95%CI 1.09–1.64; p=0.01) and CMV donor seropositivity (HR: 1.28; 95%CI 1.02–1.6; p=0.04). For pts alive after 2 years post HSCT (n=454), a significant higher rate of TRM was found in pts transplanted from MUD compared with the 2 other groups (Landmark analysis, Table 2). Conclusion: These data suggest equivalence of outcome using MUD, MSD<60 or MSD360 in pts older than 50 years with AML in CR1 transplanted after a RIC regimen. Until prospective studies are completed, this study supports the recommendation to consider HLA-identical donors for HSCT even after 60 years of age (if eligible for donation) prior to younger 8/8 MUD for pts with AML older than 50 years in CR1 after a RIC regimen. Disclosures: No relevant conflicts of interest to declare.


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