Background and objectives: In the EORTC ALL-3 trial, the efficacy of allogeneic transplantation was compared with that of autologous marrow transplantation and maintenance chemotherapy in patients <or= 50 years who reached CR.
Design and methods: Among 340 patients who entered the study, 279 were <or=50 years old. Out of these, 220 reached CR, 184 patients started consolidation and were HLA typed; 68 had a donor and 116 had no sibling donor. The median follow-up was 9.5 years; 93 patients relapsed, 26 died in CR, and overall 116 patients died. Allogeneic transplantation was performed in 47 (68%) patients with a donor while autologous transplantation or maintenance chemotherapy was given to 84 (72%) patients without a sibling donor.
Results: The 6-year disease-free survival rate was similar in the groups with and without donor [38.2% (SE=5.9%) vs. 36.8% (SE=4.6%), hazard ratio 1.01, 95% CI 0.67-1.53]. Comparing the donor group with the no donor group, the former had a lower relapse incidence (38.2% vs. 56.3%, p=0.001), but a higher cumulative incidence of death in CR (23.5% vs. 6.9%, p=0.0004). The 6-year survival rates were similar [41.2% (SE=6.0%) vs. 38.8% (SE=4.6%)].
Interpretation and conclusions: This trial did not show that allogeneic transplantation, when a sibling donor is available, produces a better outcome than the policy of offering autotransplantation or chemotherapy in the absence of a donor.