Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia (EORTC and GIMEMA Leukemia Cooperative Groups)
N = 623
- Population
- Adults with acute myelogenous leukemia in complete remission after induction and one intensive consolidation course (donor availability determined allogeneic assignment; the rest were randomised).
- Design
- After induction with daunorubicin and cytarabine and one course of intensive consolidation chemotherapy (intermediate-dose cytarabine plus amsacrine), patients in complete remission with an HLA-identical sibling were assigned to allogeneic transplantation; the others were randomly assigned to autologous transplantation (unpurged marrow) or a second course of intensive chemotherapy (high-dose cytarabine plus daunorubicin). 623 patients had a complete remission; 168 were assigned to allogeneic transplantation and 254 were randomised between the other two groups. 343 completed the assigned treatment (144 allogeneic, 95 autologous, 104 chemotherapy). Comparisons were made on an intention-to-treat basis, as stated in the abstract.
- Arms
- Second intensive chemotherapy course (control): High-dose cytarabine plus daunorubicin
- Autologous marrow transplantation (experimental): Autologous bone marrow transplantation (unpurged marrow)
- Allogeneic marrow transplantation (experimental, n = 168): Allogeneic bone marrow transplantation from an HLA-identical sibling (genetic assignment, not randomised)
- People
- Zittoun RA, EORTC and GIMEMA Leukemia Cooperative Groups
Δ 48-month DFS+25 points
Show the numbers
| Endpoint | Analysis | Autologous marrow transplantation / Allogeneic marrow transplantation | Second intensive chemotherapy course | Effect |
|---|---|---|---|---|
| DFSPatients in complete remission after induction (623 reached remission) | primaryZittoun 1995 | 55% at 4 y | 30% at 4 y | Projected 4-year DFS as published; the abstract gives no confidence intervals or P values. It reports the relapse rate as highest with intensive chemotherapy and lowest with allogeneic transplantation, mortality as highest after allogeneic transplantation and lowest after intensive chemotherapy, and overall survival after complete remission as similar in the three groups (no figures given). |
| Endpoint | Analysis | Autologous marrow transplantation / Allogeneic marrow transplantation | Second intensive chemotherapy course | Effect |
|---|---|---|---|---|
| DFSPatients in complete remission after induction (623 reached remission) | primaryZittoun 1995 | 55% at 4 y | 30% at 4 y | Projected 4-year DFS as published; the abstract gives no confidence intervals or P values. It reports the relapse rate as highest with intensive chemotherapy and lowest with allogeneic transplantation, mortality as highest after allogeneic transplantation and lowest after intensive chemotherapy, and overall survival after complete remission as similar in the three groups (no figures given). |
Appears in
Sources
Zittoun RA, Mandelli F, Willemze R, de Witte T, Labar B, Resegotti L, et al. Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia. European Organization for Research and Treatment of Cancer (EORTC) and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Leukemia Cooperative Groups. N Engl J Med. 1995;332(4):217-23.