title: 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: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Groupe d'Etude des Lymphomes de l'Adulte, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Solal-Céligny
authors.forename: P
authors.initials: P
authors.lastname: Brice
authors.forename: N
authors.initials: N
authors.lastname: Brousse
authors.forename: H
authors.initials: H
authors.lastname: Caspard
authors.forename: Y
authors.initials: Y
authors.lastname: Bastion
authors.forename: C
authors.initials: C
authors.lastname: Haïoun
authors.forename: A
authors.initials: A
authors.lastname: Bosly
authors.forename: H
authors.initials: H
authors.lastname: Tilly
authors.forename: D
authors.initials: D
authors.lastname: Bordessoule
authors.forename: C
authors.initials: C
authors.lastname: Sebban
authors.forename: J L
authors.initials: JL
authors.lastname: Harousseau
authors.forename: P
authors.initials: P
authors.lastname: Morel
authors.forename: B
authors.initials: B
authors.lastname: Dupas
authors.forename: F
authors.initials: F
authors.lastname: Plassart
authors.forename: N
authors.initials: N
authors.lastname: Vasile
authors.forename: N
authors.initials: N
authors.lastname: Fort
authors.forename: M
authors.initials: M
authors.lastname: Leporrier
mesh_terms: D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D001084:Vidarabine Phosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000964:Antimetabolites, Antineoplastic; D001084:Vidarabine Phosphate; C042382:fludarabine phosphate