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A phase II study to evaluate the combination of fludarabine, mitoxantrone and dexamethasone (FMD) in patients with follicular lymphoma

A phase II study to evaluate the combination of fludarabine, mitoxantrone and dexamethasone (FMD) in patients with follicular lymphoma
A phase II study to evaluate the combination of fludarabine, mitoxantrone and dexamethasone (FMD) in patients with follicular lymphoma
BACKGROUND: 'Molecular response' is being investigated as a therapeutic goal in follicular lymphoma (FL). High response rates in FL with the fludarabine combination 'FMD' have been associated with 'molecular remission'. A phase II study of FMD in FL was therefore conducted. PATIENTS AND METHODS: Fifty-four patients, ten of whom were newly diagnosed received FMD. Forty-four percent of the previously treated patients had 'chemoresistant' disease. Treatment comprised: fludarabine 25 mg/m2 days 1-3, mitoxantrone 10 mg/m2 day 1, and dexamethasone 20 mg days 1-5. Blood/bone marrow was collected for quantitation of t(14;18) by 'real-time' PCR. RESULTS: The overall response rate was 37 of 54 (69%), complete responses being seen in 11 patients (20%), with no difference between newly diagnosed and the previously treated patients. However, the response rate in 'chemosensitive' relapse was 84% compared to 44% in patients in whom the last prior regimen had failed. Molecular responses were seen in 17 of 25 and PCR negativity in 8 of 25, although molecular and clinical responses did not always correlate. Toxicity was moderate, 19 patients required admission. However, in 6 of 12 patients, subsequent G-CSF mobilised stem cell harvests failed. CONCLUSIONS: FMD was well tolerated but with a lower than expected response rate. Molecular responses were seen in the majority of responding patients however, 'molecular remission' was rare.
1569-8041
861-865
Crawley, C.R.
5425cd35-b464-47d6-a7ea-cf22736d5d61
Foran, J.M.
4b469095-77d2-4c02-92ec-3d3751d4cbf0
Gupta, R. K.
de1cf9ad-f52f-450b-b03b-d8bf1f44b91a
Rohatiner, A.Z.
6555b742-d414-4fcb-908f-f43b6de8b71a
Summers, K.
05646b22-8f86-44ef-ba11-c89d94278dd9
Matthews, J.
4c708491-7509-44d6-9375-2b7313a36f3e
Micallef, I.N.
f37b18a5-a105-48c0-a644-59bc1e308370
Radford, J.A.
77dd6342-413d-47e4-8c72-1b7829efba99
Johnson, S.A.
b3b18ab7-3e5a-416b-8306-bf27df6d6ff6
Johnson, Peter W.M.
3f6068ce-171e-4c2c-aca9-dc9b6a37413f
Sweetenham, J.W.
4ea41ea4-f6aa-43c2-bb4c-804832d980e5
Lister, T. A.
0de6a9a4-2fe0-41b0-8226-a10d28d31f4c
Crawley, C.R.
5425cd35-b464-47d6-a7ea-cf22736d5d61
Foran, J.M.
4b469095-77d2-4c02-92ec-3d3751d4cbf0
Gupta, R. K.
de1cf9ad-f52f-450b-b03b-d8bf1f44b91a
Rohatiner, A.Z.
6555b742-d414-4fcb-908f-f43b6de8b71a
Summers, K.
05646b22-8f86-44ef-ba11-c89d94278dd9
Matthews, J.
4c708491-7509-44d6-9375-2b7313a36f3e
Micallef, I.N.
f37b18a5-a105-48c0-a644-59bc1e308370
Radford, J.A.
77dd6342-413d-47e4-8c72-1b7829efba99
Johnson, S.A.
b3b18ab7-3e5a-416b-8306-bf27df6d6ff6
Johnson, Peter W.M.
3f6068ce-171e-4c2c-aca9-dc9b6a37413f
Sweetenham, J.W.
4ea41ea4-f6aa-43c2-bb4c-804832d980e5
Lister, T. A.
0de6a9a4-2fe0-41b0-8226-a10d28d31f4c

Crawley, C.R., Foran, J.M., Gupta, R. K., Rohatiner, A.Z., Summers, K., Matthews, J., Micallef, I.N., Radford, J.A., Johnson, S.A., Johnson, Peter W.M., Sweetenham, J.W. and Lister, T. A. (2000) A phase II study to evaluate the combination of fludarabine, mitoxantrone and dexamethasone (FMD) in patients with follicular lymphoma. Annals of Oncology, 11 (7), 861-865.

Record type: Article

Abstract

BACKGROUND: 'Molecular response' is being investigated as a therapeutic goal in follicular lymphoma (FL). High response rates in FL with the fludarabine combination 'FMD' have been associated with 'molecular remission'. A phase II study of FMD in FL was therefore conducted. PATIENTS AND METHODS: Fifty-four patients, ten of whom were newly diagnosed received FMD. Forty-four percent of the previously treated patients had 'chemoresistant' disease. Treatment comprised: fludarabine 25 mg/m2 days 1-3, mitoxantrone 10 mg/m2 day 1, and dexamethasone 20 mg days 1-5. Blood/bone marrow was collected for quantitation of t(14;18) by 'real-time' PCR. RESULTS: The overall response rate was 37 of 54 (69%), complete responses being seen in 11 patients (20%), with no difference between newly diagnosed and the previously treated patients. However, the response rate in 'chemosensitive' relapse was 84% compared to 44% in patients in whom the last prior regimen had failed. Molecular responses were seen in 17 of 25 and PCR negativity in 8 of 25, although molecular and clinical responses did not always correlate. Toxicity was moderate, 19 patients required admission. However, in 6 of 12 patients, subsequent G-CSF mobilised stem cell harvests failed. CONCLUSIONS: FMD was well tolerated but with a lower than expected response rate. Molecular responses were seen in the majority of responding patients however, 'molecular remission' was rare.

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Published date: July 2000

Identifiers

Local EPrints ID: 157839
URI: http://eprints.soton.ac.uk/id/eprint/157839
ISSN: 1569-8041
PURE UUID: ab43fb8d-9603-4024-9cb7-328c0a947da9
ORCID for Peter W.M. Johnson: ORCID iD orcid.org/0000-0003-2306-4974

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Date deposited: 16 Jun 2010 14:02
Last modified: 10 Dec 2019 01:51

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Contributors

Author: C.R. Crawley
Author: J.M. Foran
Author: R. K. Gupta
Author: A.Z. Rohatiner
Author: K. Summers
Author: J. Matthews
Author: I.N. Micallef
Author: J.A. Radford
Author: S.A. Johnson
Author: J.W. Sweetenham
Author: T. A. Lister

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