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

C. R. Crawley, James M Foran, R. K. Gupta, A. Z S Rohatiner, K. Summers, J. Matthews, Ivana Micallef, J. A. Radford, S. A. Johnson, P. W. Johnson, J. W. Sweetenham, T. A. Lister

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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.

Original languageEnglish (US)
Pages (from-to)861-865
Number of pages5
JournalAnnals of Oncology
Volume11
Issue number7
DOIs
StatePublished - 2000
Externally publishedYes

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Mitoxantrone
Follicular Lymphoma
Dexamethasone
fludarabine
Patient Admission
Granulocyte Colony-Stimulating Factor
Real-Time Polymerase Chain Reaction
Stem Cells
Bone Marrow
Recurrence
Polymerase Chain Reaction
Therapeutics

Keywords

  • Fludarabine
  • Follicular lymphoma
  • Real time PCR

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A phase II study to evaluate the combination of fludarabine, mitoxantrone and dexamethasone (FMD) in patients with follicular lymphoma. / Crawley, C. R.; Foran, James M; Gupta, R. K.; Rohatiner, A. Z S; Summers, K.; Matthews, J.; Micallef, Ivana; Radford, J. A.; Johnson, S. A.; Johnson, P. W.; Sweetenham, J. W.; Lister, T. A.

In: Annals of Oncology, Vol. 11, No. 7, 2000, p. 861-865.

Research output: Contribution to journalArticle

Crawley, CR, Foran, JM, Gupta, RK, Rohatiner, AZS, Summers, K, Matthews, J, Micallef, I, Radford, JA, Johnson, SA, Johnson, PW, Sweetenham, JW & Lister, TA 2000, 'A phase II study to evaluate the combination of fludarabine, mitoxantrone and dexamethasone (FMD) in patients with follicular lymphoma', Annals of Oncology, vol. 11, no. 7, pp. 861-865. https://doi.org/10.1023/A:1008381105849
Crawley, C. R. ; Foran, James M ; Gupta, R. K. ; Rohatiner, A. Z S ; Summers, K. ; Matthews, J. ; Micallef, Ivana ; Radford, J. A. ; Johnson, S. A. ; Johnson, P. W. ; Sweetenham, J. W. ; Lister, T. A. / A phase II study to evaluate the combination of fludarabine, mitoxantrone and dexamethasone (FMD) in patients with follicular lymphoma. In: Annals of Oncology. 2000 ; Vol. 11, No. 7. pp. 861-865.
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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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T1 - A phase II study to evaluate the combination of fludarabine, mitoxantrone and dexamethasone (FMD) in patients with follicular lymphoma

AU - Crawley, C. R.

AU - Foran, James M

AU - Gupta, R. K.

AU - Rohatiner, A. Z S

AU - Summers, K.

AU - Matthews, J.

AU - Micallef, Ivana

AU - Radford, J. A.

AU - Johnson, S. A.

AU - Johnson, P. W.

AU - Sweetenham, J. W.

AU - Lister, T. A.

PY - 2000

Y1 - 2000

N2 - 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.

AB - 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.

KW - Fludarabine

KW - Follicular lymphoma

KW - Real time PCR

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