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Phase I-II trial of pentoxifylline for the prevention of transplant-
related toxicities following bone marrow transplantation [published erratum
appears in Blood 1992 Jun 15;79(12):3397] [see comments]
JA Bianco, FR Appelbaum, J Nemunaitis, J Almgren, F Andrews, P Kettner, A Shields and JW Singer
Marrow Transplant Program, Department of Veterans Affairs Medical Center,
Seattle, WA.
Disease relapse and transplant related toxicities have limited the
application of bone marrow transplantation (BMT) in the treatment for
hematologic malignancies. Because elevated levels of tumor necrosis factor
alpha (TNF-alpha) have been correlated with the development of transplant
related complications, we conducted a phase I-II trial of pentoxifylline
(PTX), a xanthine derivative capable of down-regulating TNF-alpha
production, in patients with hematologic malignancies undergoing BMT.
Thirty consecutive adult patients (median age, 34) were entered and
received either an allogeneic (n = 26) or autologous (n = 4) BMT. Patients
were enrolled at increasing dose levels (1,200, 1,600, and 2,000 mg/d) from
day -10 through day +100 posttransplant. PTX was well tolerated with no
significant adverse side effects noted at any of the dose levels
administered. The actuarial day 100 survival for these 30 patients was 90%
(95% confidence interval 79% to 100%). When compared with a good risk
control group, PTX recipients experienced less mucositis (3.7 +/- 1.1 v
18.7 +/- 1.1 days, P = .004), less hepatic venocclusive disease (10% v 65%,
P = .001), a lower incidence of renal insufficiency (3% v 65%, P = .0003),
required less days of total parenteral nutrition (TPN) (24.0 +/- 1.3 v 35.0
+/- 2.4, P = .001) and were discharged from the hospital earlier than
controls (day 26.0 +/- 1.8 v 37.0 +/- 3.8, P = .01). In addition the
incidence of graft-versus-host disease (GVHD) greater than or equal to
grade II was also reduced among the PTX recipients (35% v 68%, P = .03).
PTX at doses in excess of 1,200 mg/d further reduced the severity of
mucositis, and TPN requirements resulting in earlier hospital discharge
than patients receiving 1,200 mg/d of PTX. In this study oral
administration of PTX in doses up to 2,000 mg/d was well tolerated and
associated with a reduction in morbidity and mortality in patients
undergoing BMT. Prospective randomized trials are currently in progress to
test these preliminary observations.
Volume 78,
Issue 5,
pp. 1205-1211,
09/01/1991
Copyright © 1991 by The American Society of Hematology
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