Phase II trial of fludarabine monophosphate as first-line treatment in patients with advanced follicular lymphoma: a multicenter study by the Groupe d'Etude des Lymphomes de l'Adulte.

Abstract

PURPOSE:

Fludarabine monophosphate (FAMP) is a major drug in the treatment of chronic lymphocytic leukemia and showed efficacy in selected groups of patients with low-grade lymphomas, most of them pretreated. The aim of this trial was to assess the efficacy and the toxicity of FAMP in untreated patients with follicular lymphoma.

PATIENTS AND METHODS:

Fifty-four untreated patients with advanced follicular lymphoma were treated with intravenous (i.v.) fludarabine at a dose of 25 mg/m2/d during 5 days every 4 weeks, to a maximum of nine cycles.

RESULTS:

The toxicity of the drug was mild, mainly granulocytic. Granulocytopenia > or = 3 (World Health Organization [WHO]) was observed during 48 of 328 cycles (14.6%) and in 22 of 53 (41%) patients assessable for toxicity. Fludarabine had to be stopped prematurely because of toxicity in nine patients: marrow toxicity in five, peripheral neuropathy in two, and interstitial pneumonitis and hepatitis in one patient each. Among 49 patients assessable for response, the overall response rate was 65% and the complete response (CR) rate 37%. The median progression-free survival interval for all patients was 13.6 months.

CONCLUSION:

These results confirm that fludarabine is active when used as first-line treatment in patients with follicular lymphoma and has a low toxicity rate. It may be used as single treatment in elderly patients. Associations of fludarabine with other drugs active against follicular lymphoma need to be determined.

• Authors: P Solal-Céligny, P Brice, N Brousse, H Caspard, Y Bastion, C Haïoun, A Bosly, H Tilly, D Bordessoule, C Sebban, J L Harousseau, P Morel, B Dupas, F Plassart, N Vasile, N Fort, M Leporrier
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 14 Issue 2 Pg. 514-9 (Feb 1996) ISSN: 0732-183X [Print] United States
• PMID: 8636765 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antimetabolites, Antineoplastic
• Vidarabine Phosphate
• fludarabine phosphate

Topics

• Adult
• Aged
• Agranulocytosis (chemically induced)
• Antimetabolites, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Disease-Free Survival
• Female
• Humans
• Lymphoma, Follicular (drug therapy, mortality)
• Male
• Middle Aged
• Treatment Outcome
• Vidarabine Phosphate (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)