Pre-emptive treatment of acute GVHD: a randomized multicenter trial of rabbit anti-thymocyte globulin, given on day+7 after alternative donor transplants.
We have previously shown that hemopoietic stem cell transplant (HSCT) recipients can be stratified on day+7 as having low, intermediate or a high risk of transplant-related mortality (TRM). With the aim of reducing TRM and GVHD, intermediate and high-risk patients (n=170) were randomized to receive anti-thymocyte globulin (ATG, thymoglobuline) on day+7 (n=84) or no treatment (n=86) (controls). There was a reduction of TRM from 35% in controls to 29% in ATG patients (P=0.3), of acute GVHD III-IV from 15 to 5% (P=0.02) and of chronic GVHD from 26 to 11% (P=0.03); survival was comparable. The predictive value of the day+7 score on TRM was confirmed for controls (19 vs 42% for intermediate vs high risk, respectively, P=0.03), whereas ATG abrogated this predictive effect (29 vs 29%). ATG reduced GVHD (P=0.006) in high-risk patients, but not in patients with an intermediate risk. In conclusion, we confirm that TRM can be predicted on the basis of day+7 laboratory values, after alternative donor HSCT; in high-, but not intermediate-risk patients, the administration of ATG on day+7 reduces GVHD. These results may represent a platform for risk-adapted post transplant immune modulation.
Bacigalupo
A
A
Divisione Ematologia, Ospedale San Martino, Genova, Italy. andrea.bacigalupo@hsanmartino.it
Lamparelli
T
T
Milone
G
G
Sormani
M P
MP
Ciceri
F
F
Peccatori
J
J
Locasciulli
A
A
Majolino
I
I
Di Bartolomeo
P
P
Mazza
F
F
Sacchi
N
N
Pollicheni
S
S
Pinto
V
V
Van Lint
M T
MT
D000328:Adult; D000818:Animals; D000961:Antilymphocyte Serum / Q000627:therapeutic use*; D002423:Cause of Death; D006086:Graft vs Host Disease / Q000401:mortality* / Q000517:prevention & control; D018380:Hematopoietic Stem Cell Transplantation / Q000401:mortality*; D006801:Humans; D015999:Multivariate Analysis; D011817:Rabbits; D012008:Recurrence; D012306:Risk
D000961:Antilymphocyte Serum