- 作者：John E Wagner ; John S Thompson ; Shelly L Carter ; Nancy A Kernan and for the members of the Unrelated Donor Marrow Transplantation Trial
- 刊名：The Lancet
- 出版年：2005
- 期刊代码：182_01406736
- 类别：med
- 出版时间：2005
- 卷：366
- 期：9487
- 页码：733-741
- 文件大小：186 K
Summary
BackgroundGraft-versus-host disease (GVHD) reduces the efficacy of unrelated donor bone marrow transplantation in patients with lymphohaemopoietic malignancy. A multi-centre, randomised trial was undertaken to determine the effects of ex-vivo T-cell depletion versus methotrexate and cyclosporine immunosuppression on 3-year disease-free survival.Methods
Between Mar 1, 1995, and Oct 31, 2000, 405 patients with lymphohaemopoietic malignancy, from 15 participating centres, were randomly assigned to undergo transplantation with either T-cell depleted marrow and cyclosporine A (TCD arm; n=201) or methotrexate and cyclosporine A after transplantation of T-replete marrow (M/C arm; n=204). The primary outcome was 3-year disease-free survival and was analysed by intention to treat.
Findings
Five patients died before transplantation. Seven in the TCD arm received T-replete grafts. Disease-free survival at 3 years was 27%(95%CI 21–33) and 34%(27–40) in recipients of TCD and M/C, respectively (p=0·16). TCD was associated with significantly more rapid neutrophil recovery (15 days vs 20 days, p<0·0001), less grade III–IV acute GVHD (18%vs 37%, p<0·0001), reduced grade III–IV toxicities (19%vs 29%, p=0·017), reduced duration of initial hospitalisation, but higher risk of chronic myelogenous leukaemia relapse (20%vs 7%, p=0·009) and cytomegalovirus infection (28%vs 17%, p=0·023) than was M/C.
Interpretation
Disease-free survival at 3 years did not differ between TCD and M/C groups. Relapse and opportunistic infection are important obstacles to successful unrelated donor bone marrow transplantation, irrespective of the method of GVHD prophylaxis used.