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

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.

• Authors: C R Crawley, J M Foran, R K Gupta, A Z Rohatiner, K Summers, J Matthews, I N Micallef, J A Radford, S A Johnson, P W Johnson, J W Sweetenham, T A Lister
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 11 Issue 7 Pg. 861-5 (Jul 2000) ISSN: 0923-7534 [Print] England
• PMID: 10997815 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• DNA, Neoplasm
• Dexamethasone
• Mitoxantrone
• Vidarabine
• fludarabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• DNA, Neoplasm (analysis)
• Dexamethasone (administration & dosage)
• Female
• Humans
• Lymphoma, Follicular (drug therapy, genetics, pathology)
• Male
• Middle Aged
• Mitoxantrone (administration & dosage)
• Polymerase Chain Reaction
• Recurrence
• Treatment Outcome
• Vidarabine (administration & dosage, analogs & derivatives)