Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation.
This is an update of a randomized study on antithymocyte globulin (ATG; Thymoglobulin) before transplantation in patients undergoing unmanipulated marrow transplantation from unrelated donors. The median follow-up for surviving patients is 5.7 years. At last follow-up, chronic graft-versus-host disease (GVHD) was scored in 60% of non-ATG and in 37% of ATG patients (P=.05), and extensive chronic GVHD was present in 41% and 15%, respectively (P=.01). Chronic lung dysfunction was diagnosed in 51% versus 19% of patients (P=.005). Forced vital capacity decreased significantly with time in non-ATG patients (P=.005), but not in patients who received ATG (P=.30). The proportion of patients with Karnofsky scores of >or=90% at 4 years was 57% versus 89% in non-ATG versus ATG patients (P=.03). The actuarial 6-year survival for all patients randomized was 31% versus 44% (non-ATG versus ATG; P=.80). The cumulative incidence of transplant-related mortality was 51% versus 41% (P=.70) and of relapse was 32% versus 40% (P=.90). For patients who survived 1 year, transplant-related mortality was 25% versus 3% (P=.03), and actuarial survival was 58% versus 85% (P=.09). In conclusion, the addition of ATG to cyclosporine/methotrexate provides significant protection against extensive chronic GVHD and chronic lung dysfunction, reduces late transplant mortality, and improves quality of life in patients undergoing unrelated donor transplantation.
Bacigalupo
Andrea
A
Divisione di Ematologia, Ospedale San Martino, Genova.
Lamparelli
Teresa
T
Barisione
Giovanni
G
Bruzzi
Paolo
P
Guidi
Stefano
S
Alessandrino
Paolo Emilio
PE
di Bartolomeo
Paolo
P
Oneto
Rosi
R
Bruno
Barbara
B
Sacchi
Nicoletta
N
van Lint
Maria Teresa
MT
Bosi
Alberto
A
D000293:Adolescent; D000328:Adult; D000961:Antilymphocyte Serum / Q000627:therapeutic use*; D016026:Bone Marrow Transplantation / Q000009:adverse effects / Q000401:mortality; D002423:Cause of Death; D002908:Chronic Disease; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006086:Graft vs Host Disease / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015994:Incidence; D017567:Karnofsky Performance Status; D007938:Leukemia / Q000401:mortality / Q000601:surgery; D015993:Life Tables; D008171:Lung Diseases / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000517:prevention & control*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D009436:Neural Tube Defects / Q000401:mortality / Q000601:surgery; D011292:Premedication; D011446:Prospective Studies; D012008:Recurrence; D016019:Survival Analysis; D013601:T-Lymphocytes / Q000276:immunology*; D014184:Transplantation, Homologous / Q000009:adverse effects / Q000401:mortality; D016896:Treatment Outcome; D014797:Vital Capacity
D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D008727:Methotrexate