engleski

Allogeneic Stem Cell Transplantation in Adult Acute Lymphoblastic Leukemia (ALL) Patients 50 Years Old in First Complete Remission (CR): A Donor vs No Donor Comparison in the EORTC ALL-3 Study.

Background. Allogeneic stem cell transplantation (allo-SCT) has been included in the treatment of adult patients (pts) with ALL in first CR for more than 20 years. Despite the general application, its role compared to standard maintenance or autologous stem cell transplantation (auto-SCT) remains unclear. Material and methods. In the ALL-3 trial, CR pts received an intensive consolidation course. Subsequently, all pts 50 years with a family donor were assigned to undergo allo-SCT, whereas pts without a donor were planned to be randomized for auto-SCT or continuous standard maintenance therapy. Results. Between 11.1986 and 11.1996 a total of 340 pts entered the study. The median age was 33 yrs (range 14-79), M/F 208/131, ALL/NHL 296/44, mediastinal mass 48%, WBC < 30 x 109/l 66%, CNS involvement 6%, Ph+ 9%. Among 279 pts 50 yrs, 220 reached CR. 184 pts received consolidation and were HLA typed ; 68 had a donor and 116 had no sibling donor. The median follow-up was 9.5 years ; 93 pts relapsed, 26 died in CR1. Overall 116 pts have died. Allo-SCT was performed in 46 (67.6%) with a donor and auto-SCT or continuous maintenance therapy in 78 (67.2%) without a sibling donor. The 10-year disease-free survival (DFS) rate of pts with a donor was similar to that of pts without a donor (33.9% vs 33.8%, p=0.80 ; hazard ratio=0.95, 95% CI 0.66-1.38). The relapse incidence was significantly lower in pts with donor (38.2% vs. 59.3% p=0.01), and treatment-related mortality (TRM) was higher in the group of pts with donor (27.8% vs. 6.9% (p=0.0004). The 10-year survival rate in pts with and without a donor was 36.7% and 34.9%, respectively (p=0.89), hazard ratio=0.98 (95% CI 0.67-1.43). Initial WBC was the most important prognostic factor (p=0.0025) for DFS: pts with a WBC < 30 x 109/l had 10-year DFS rate of 39.7% vs 25.6% for those with a WBC 30 x 109/l. Within the WBC subgroups the availability of a donor or not resulted in a similar outcome. Age (35 yrs vs 36-50 yrs) was not of prognostic importance (p=0.34). Younger pts tended to have a higher relapse rate than older pts (53.6% vs 46.1%), but a lower TRM (9.6% vs 25.7%). Age and donor availability were 2 independent prognostic factors for the risk of death in CR. Conclusions. Analysis by intention to treat of the EORTC ALL-3 study reveals that the policy to perform an allo-SCT in case a sibling donor is available does not result in a significantly better outcome than to offer auto-SCT or continuous maintenance. The lower relapse incidence in pts with a donor was compensated by a higher TRM, and this happened independently of the initial WBC and patient's age

Allogeneic transplantation\ Donor\ ALL

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