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Blood, Vol. 92 No. 7 (October 1), 1998:
pp. 2288-2293
Early Treatment of Acute Graft-Versus-Host Disease With High- or
Low-Dose 6-Methylprednisolone: A Multicenter Randomized Trial From the
Italian Group for Bone Marrow Transplantation
M.T. Van Lint,
C. Uderzo,
A. Locasciulli,
I. Majolino,
R. Scimé,
F. Locatelli,
G. Giorgiani,
W. Arcese,
A.P. Iori,
M. Falda,
F. Locatelli,
A. Bosi,
R. Miniero,
P. Alessandrino,
G. Dini,
B. Rotoli, and
A. Bacigalupo for the Italian Group of Bone Marrow
Transplantation (GITMO)
From the Divisione Ematologial, Ospedale San Martino, Genova; Clinica
Pediatrica, Milano; Divisione Ematologia Ospedale Cervello, Palermo;
Clinica Pediatrica, Pavia; Cattedra di Ematologia Universita' La
Sapienza, Roma; Divisione Ematologia Ospedale le Molinette, Torino;
Cattedra Ematologia Ospedale Careggi, Firenze; Oncologia Pediatrica Osp
Regina Margherita, Torino; Cattedra Ematologia Policlinico San Matteo,
Pavia; Medicina IV, Ospedale Gaslini, Genova; and Cattedra Ematologia,
Universita' Federico II, Napoli, Italy.
Ninety-five patients undergoing an allogeneic bone marrow transplant
(BMT) and developing acute graft-versus-host disease (aGvHD) were
randomized to receive low-dose intravenous 6-methylprednisolone (6MPred; 2 mg/kg /d; n = 47) or high-dose 6MPred (10 mg/kg/d; n = 48) for 5 days, with subsequent tapering doses. On day 5 patients not
responding or progressing on low-dose 6MPred could be switched to
high-dose 6MPred. All patients, aged 1 to 55 years, were recipients of
unmanipulated BMT from HLA identical sibling donors. Patients were
stratified at randomization for age (</ 20 years), disease (acute
leukemia, chronic myeloid leukemia [CML], nonneoplastic disease),
disease status (early/advanced), and GvHD prophylaxis (cyclosporin/cyclosporin + methotrexate). Primary endpoints were response to treatment and evolution of aGvHD to grade III-IV. Secondary
endpoints were cytomegalovirus (CMV) infections, transplant-related mortality (TRM), and relapse. The median interval between BMT and
treatment was 12 days (6 to 43). Results in the two groups (2 v
10 mg/kg) were as follows: response of aGvHD 68% versus 71% (P
= .9), evolution to aGvHD grade III-IV 17% versus 20% (P
= .6), CMV infections 55% versus 60% (P = .7), 3-year
actuarial TRM 28% versus 32% (P = .7), relapse 17% versus
7% (P = .1). The actuarial survival at 3 years was 63%
versus 62% (P = .9) with a median follow up of 580 and 778 days. On day 5 of therapy, 26 patients assigned to low-dose (2 mg/kg)
6MPred were switched to a higher dose of 6MPred because of no response
or progression. Their actuarial TRM was 46%, which is significantly
higher than TRM of patients who responded on 2 mg/kg and continued with
tapering doses (TRM = 16%, P = .007). In conclusion, early
treatment of acute GvHD with 6MPred 10 mg/kg/d does not improve the
response rate as compared with 2 mg/kg/d, nor does it prevent evolution to aGvHD grade III-IV. CMV infections, TRM, and survival were also
comparable. A group of patients at high risk of TRM can be identified
after 5 days of treatment with 6MPred 2 mg/kg and could be eligible for
alternative forms of therapy.
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