A randomized controlled trial of pentoxifylline for the prevention of regimen-related toxicities in patients undergoing allogeneic marrow transplantation.
This study evaluated the effect of pentoxifylline (PTX) on the incidence of regimen-related toxicity in patients receiving allogeneic marrow transplants from related donors. All patients received a regimen of methotrexate and cyclosporine as prophylaxis against acute graft-versus-host disease (GVHD). Patients were randomized to receive PTX or a placebo for 70 days and the outcome was examined in a blinded fashion. Forty-four patients were evaluate in each study arm. PTX had no significant effect on engraftment, the incidence of GVHD, venocclusive disease of the liver, infection, the need for oxygen, posttransplant survival, or the duration of hospitalization. Patients receiving PTX were significantly more likely to develop major elevations of serum creatinine levels. PTX was poorly tolerated and induced significantly more vomiting than the placebo. PTX as administered in this randomized study was associated with significant toxicity and offered no benefit in reducing transplant-related morbidity or mortality.
Fred Hutchinson Cancer Research Center, Seattle, WA 98104-2092.
R A
RA
Clift
J A
JA
Bianco
F R
FR
Appelbaum
C D
CD
Buckner
J W
JW
Singer
L
L
Bakke
W I
WI
Bensinger
R A
RA
Bowden
G B
GB
McDonald
M
M
Schubert
D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D002648:Child; D016572:Cyclosporine / Q000009:adverse effects* / Q000627:therapeutic use; D003586:Cytomegalovirus Infections / Q000175:diagnosis; D004311:Double-Blind Method; D005334:Fever; D006086:Graft vs Host Disease / Q000517:prevention & control*; D006801:Humans; D008727:Methotrexate / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D010431:Pentoxifylline / Q000627:therapeutic use*; D010919:Placebos; D011336:Probability; D012008:Recurrence; D016019:Survival Analysis; D014184:Transplantation, Homologous; D014916:Whole-Body Irradiation / Q000009:adverse effects
D010919:Placebos; D016572:Cyclosporine; D010431:Pentoxifylline; D008727:Methotrexate