Naslov
Allogeneic transplantation for adult acute lymphoblastic leukemia: Intention to treat analysis of the EORTC ALL-4 phase III trial

Autori
B. Labar1, S. Suciu2, P. Muus3, R. Willemze4, J.-P. Marie5, G. Fillet6, Z. Berneman7, B. Jaksic8, W. Feremans9, D. Bron10, H. Sinnige11, M. Mistrik12, G. Vreugdenhil13, R. De Bock14, D. Nemet1, C. Gilotay2, T. De Witte3, S. Amadori15 1 University Hospital Center Rebro, Zagreb, Croatia 2 EORTC Data Center, Brussels, Belgium 3 St. Radboud University Hospital, Nijmegen, The Netherlands 4 Leiden University Hospital, Leiden, The Netherlands 5 Hotel-Dieu de Paris, Paris, France 6 CHU Sart-Tilman, Liege, Belgium 7 Universitair Ziekenhuis Antwerpen, Antwerpen, Belgium 8 Clinical Hospital Merkur, Zagreb, Croatia 9 Hopital Universitaire Erasme, Brussels, Belgium 10 Institut Jules Bordet, Brussels, Belgium 11 Groot Ziekengasthuis, Den Bosch, Netherlands 12 University Hospital, Bratislava, Slovakia (Slovak Republic) 13 St. Josef Ziekenhuis, Veldhoven, The Netherlands 14 Algemeen Ziekenhuis Middelheim, Antwerpen, Belgium 15 Ospedale San Eugenio, Rome, Italy

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Biology of Blood and Marrow Transplantation (Vol. 12, No. 2, Supplement 1) Pages 6-7(February 2006) / - , 2006, 6-7

Skup
ASBMT meeting

Mjesto i datum
Honolulu (HI), Sjedinjene Američke Države, 02.2006

Vrsta sudjelovanja
Predavanje

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
EORTC

Sažetak
Results of the EORTC ALL-3 reveal that the policy to perform allo-SCT in a case when a sibling donor is available does not result in a significantly better outcome than to offer auto-SCT or continuous maintenance. We also analysed the outcome of allografted patients in EORTC ALL-4. In this trial patients were randomized to receive either dexamethasone (10 mg/m2/day) or 6-methyl-prednisolone (60 mg/m2/day) on days 1-8 and 15-22 with standard induction chemotherapy (cyclophosphamide, daunorubicin, vincristine and MTX i.t.). After induction all patients had to receive a HAM consolidation course (HD-AraC 3 g/m2 every 12 hours, days 1-4 ; mitoxantrone 10 mg/m2, days 5-7 and MTX i.t.). Patients in CR received two courses of MA consolidation (MTX 1.5 g/m2 day 1 and L-asparaginase 104 IU/m2 day 2), and then underwent allo-SCT or patients without a donor were randomized either to receive autologous stem cells from peripheral blood or high maintenance therapy. The median follow-up was 4.9 years. Between 1998 and 2003, a total of 325 pts entered the study. The median age was 32 yrs range 15-72 yrs. In 248 (76%) patients CR1 was reached and 227 of them were HLA typed ; 100 had an identical sibling donor and 127 had no sibling donor. Allo-SCT was performed in 69 (69%) pts and auto-SCT or high maintenance therapy in 58 (46%). The 5-year DFS of pts with a donor vs pts without a donor was 41.8% vs. 35.5%, P = .40, hazard ratio 0.86, 95% CI 0.61-1.22). The relapse incidence was significantly lower (37.3% vs. 58.8% P = .004) and treatment related mortality (TRM) was significantly higher (20.9% vs. 5.7%, P = .0005) in the donor group compared to the no donor group. Five-year survival in pts with and without the donor was 43.0% and 36.9% respectively. For pts ≤ 50 years of age 199 of them were HLA-typed ; 91 had a donor and 108 had no sibling donor. The 5-yr DFS rate in the donor vs no donor group was 42.2% vs. 36.2%, P = .36, hazard ratio 0.84 95% CI 0.58-1.22). Relapse rate was significantly lower and TRM was significantly higher in the donor versus no donor group. Five-year survival for patients with and without a donor was 43.9% and 37.4% respectively (P = .58), hazard ratio 0.90 (95% CI 0.61-1.32). In conclusion, in the EORTC ALL-4 trial, the intention to treat analysis shows that DFS and survival rate for allografted pts younger than 50 years of age were not significantly different compared to those receiving auto-SCT or high maintenance. High TRM (∼ 20%) remains the main problem of allografting.

Izvorni jezik
Engleski

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