Journal of Clinical Oncology, Vol 12, 575-579, Copyright © 1994 by American Society of Clinical Oncology
Phase I study of the combination of fludarabine, mitoxantrone, and dexamethasone in low-grade lymphoma
P McLaughlin, FB Hagemeister, F Swan Jr, F Cabanillas, O Pate, JE Romaguera, MA Rodriguez, JR Redman and M Keating
Department of Hematology, University of Texas M.D. Anderson Cancer Center, Houston 77030.
PURPOSE: Fludarabine is an active agent for patients with low-grade
lymphoma (LGL) but has mainly been used as a single agent. This trial was
designed to define the maximum-tolerated dose (MTD) of a combination of
fludarabine, mitoxantrone, and dexamethasone (FND), to identify the
toxicities of these agents in combination, and to make preliminary
observations about the efficacy of this combination. PATIENTS AND METHODS:
Twenty-one patients with recurrent LGL or follicular large-cell lymphoma
were treated, in cohorts of three, at stepwise escalating doses. Patients
were required to have adequate marrow function and normal renal, hepatic,
and cardiac function. RESULTS: The MTD of the combination was found to be
as follows: fludarabine, 25 mg/m2/d (days 1 to 3); mitoxantrone, 10 mg/m2
(day 1); and dexamethasone, 20 mg/d (days 1 to 5). Each course was
administered monthly, and up to eight courses were given. Dose-limiting
toxicities were neutropenia and infections. Thrombocytopenia was modest.
Nonhematologic toxicity was very modest. Responses were seen at every dose
level. The overall response rate was 71%, with a 43% complete remission
(CR) rate. The median duration of CR was 18 months (with follow-up duration
from 13 to 28+ months). CONCLUSION: FND was well tolerated in this
population. While our primary aim was to define the MTD, our preliminary
observations on the efficacy of the regimen were favorable. The overall
response rate was high, there was a high fraction of CRs, and our early
impression is that these responses are durable.
 CiteULike  Complore  Connotea  Del.icio.us  Digg  Facebook  Reddit  Technorati  Twitter What's this?
This article has been cited by other articles:
|
|
|
|
 
S. Montoto, C. Moreno, E. Domingo-Domenech, C. Estany, A. Oriol, A. Altes, J. Besalduch, C. Pedro, S. Gardella, L. Escoda, et al.
High clinical and molecular response rates with fludarabine, cyclophosphamide and mitoxantrone in previously untreated patients with advanced stage follicular lymphoma
Haematologica,
February 1, 2008;
93(2):
207 - 214.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. Leonard, M. Coleman, L. Kostakoglu, A. Chadburn, E. Cesarman, R. R. Furman, M. W. Schuster, R. Niesvizky, D. Muss, J. Fiore, et al.
Abbreviated Chemotherapy With Fludarabine Followed by Tositumomab and Iodine I 131 Tositumomab for Untreated Follicular Lymphoma
J. Clin. Oncol.,
August 20, 2005;
23(24):
5696 - 5704.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M.S. Czuczman, A. Koryzna, A. Mohr, C. Stewart, K. Donohue, L. Blumenson, Z.P. Bernstein, P. McCarthy, A. Alam, F. Hernandez-Ilizaliturri, et al.
Rituximab in Combination With Fludarabine Chemotherapy in Low-Grade or Follicular Lymphoma
J. Clin. Oncol.,
February 1, 2005;
23(4):
694 - 704.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. L. Zinzani, A. Pulsoni, A. Perrotti, S. Soverini, F. Zaja, A. De Renzo, S. Storti, V. M. Lauta, L. Guardigni, P. Gentilini, et al.
Fludarabine Plus Mitoxantrone With and Without Rituximab Versus CHOP With and Without Rituximab As Front-Line Treatment for Patients With Follicular Lymphoma
J. Clin. Oncol.,
July 1, 2004;
22(13):
2654 - 2661.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Alliot
Fludarabine Versus Cyclophosphamide, Vincristine, and Prednisone in Recurrent Low-Grade Lymphomas
J. Clin. Oncol.,
July 1, 2003;
21(13):
2626 - 2626.
[Full Text]
[PDF]
|
|
|
|
|
|
|
W. S. Velasquez, D. Lew, T. M. Grogan, C. H. Spiridonidis, S. P. Balcerzak, S. R. Dakhil, T. P. Miller, K. S. Lanier, R. A. Chapman, and R. I. Fisher
Combination of Fludarabine and Mitoxantrone in Untreated Stages III and IV Low-Grade Lymphoma: S9501
J. Clin. Oncol.,
May 15, 2003;
21(10):
1996 - 2003.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. M. Tsimberidou, P. McLaughlin, A. Younes, M. A. Rodriguez, F. B. Hagemeister, A. Sarris, J. Romaguera, M. Hess, T. L. Smith, Y. Yang, et al.
Fludarabine, mitoxantrone, dexamethasone (FND) compared with an alternating triple therapy (ATT) regimen in patients with stage IV indolent lymphoma
Blood,
December 15, 2002;
100(13):
4351 - 4357.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. L. Zinzani, M. Magagnoli, L. Moretti, A. De Renzo, R. Battista, A. Zaccaria, L. Guardigni, P. Mazza, R. Marra, F. Ronconi, et al.
Randomized Trial of Fludarabine Versus Fludarabine and Idarubicin as Frontline Treatment in Patients With Indolent or Mantle-Cell Lymphoma
J. Clin. Oncol.,
February 14, 2000;
18(4):
773 - 773.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. M. Foran, A. Z.S. Rohatiner, B. Coiffier, T. Barbui, S. A. Johnson, W. Hiddemann, J. A. Radford, A. J. Norton, S. M. Tollerfield, M. P. Wilson, et al.
Multicenter Phase II Study of Fludarabine Phosphate for Patients With Newly Diagnosed Lymphoplasmacytoid Lymphoma, Waldenstrom's Macroglobulinemia, and Mantle-Cell Lymphoma
J. Clin. Oncol.,
February 1, 1999;
17(2):
546 - 546.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. Fidias, B. A. Chabner, and M. L. Grossbard
Purine Analogs for the Treatment of Low-Grade Lymphoproliferative Disorders
Oncologist,
June 1, 1996;
1(3):
125 - 139.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. M. Kolesar, A. K. Morris, and J. G. Kuhn
Review : Purine nucleoside analogues: Fludarabine, pentostatin, and cladribine: Part 1: Fludarabine
Journal of Oncology Pharmacy Practice,
January 1, 1996;
2(3):
160 - 181.
[Abstract]
[PDF]
|
|
|
|
