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A randomized study of cyclosporine and methotrexate with or without methylprednisolone for the prevention of graft‐versus‐host disease: Improved long‐term survival with triple prophylaxis
Author(s) -
Ruutu Tapani,
Nihtinen Anne,
Niittyvuopio Riitta,
Juvonen Eeva,
Volin Liisa
Publication year - 2018
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.31100
Subject(s) - medicine , methotrexate , methylprednisolone , incidence (geometry) , cumulative incidence , surgery , gastroenterology , graft versus host disease , transplantation , randomized controlled trial , physics , optics
BACKGROUND In a previously published study, the authors randomized 108 adult patients with a malignant hematologic disorder undergoing allogeneic bone marrow transplantation from a human leukocyte antigen‐identical sibling to receive methylprednisolone (53 patients; MP+) or not to receive methylprednisolone (55 patients; MP‐) as a part of graft‐versus‐host disease (GVHD) prophylaxis. All patients received cyclosporine and methotrexate. The cumulative incidence of acute GVHD was found to be significantly lower among the patients given MP. METHODS In the current study, the authors performed a long‐term follow‐up to discover possible late effects of the intensified GVHD prophylaxis. RESULTS The median follow‐up for surviving patients was 24.5 years. In the MP+ group, the overall survival and recurrence‐free survival were higher ( P = .021 and P = .028, respectively) and the nonrecurrence mortality was lower ( P = .003) than in the MP‐ group. There was a trend toward a lower cumulative incidence and a significantly lower prevalence ( P = .031) of chronic GVHD in the MP+ group. There was no difference noted with regard to the rate of disease recurrence or in the incidence of secondary malignancies. Eleven patients in the MP‐ group but none in the MP+ group died >15 years after transplantation. At the end of follow‐up, the overall survival rates in the MP+ and MP‐ groups were 55% and 20%, respectively, and the recurrence‐free survival rates were 49% and 15%, respectively. CONCLUSIONS Long‐term survival was found to be higher among the patients given MP in addition to cyclosporine and methotrexate. There was marked late nonrecurrence mortality observed in the group not given MP. No adverse late effects caused by the addition of corticosteroid were observed. Cancer 2018;124:727‐33 . © 2017 American Cancer Society .