title: 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.
  
  
  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.affiliation: Department of Medical Oncology, St. Bartholomew's Hospital, London, UK.
authors.forename: C R
authors.initials: CR
authors.lastname: Crawley
authors.forename: J M
authors.initials: JM
authors.lastname: Foran
authors.forename: R K
authors.initials: RK
authors.lastname: Gupta
authors.forename: A Z
authors.initials: AZ
authors.lastname: Rohatiner
authors.forename: K
authors.initials: K
authors.lastname: Summers
authors.forename: J
authors.initials: J
authors.lastname: Matthews
authors.forename: I N
authors.initials: IN
authors.lastname: Micallef
authors.forename: J A
authors.initials: JA
authors.lastname: Radford
authors.forename: S A
authors.initials: SA
authors.lastname: Johnson
authors.forename: P W
authors.initials: PW
authors.lastname: Johnson
authors.forename: J W
authors.initials: JW
authors.lastname: Sweetenham
authors.forename: T A
authors.initials: TA
authors.lastname: Lister
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D004273:DNA, Neoplasm / Q000032:analysis; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D016133:Polymerase Chain Reaction; D012008:Recurrence; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D004273:DNA, Neoplasm; D003907:Dexamethasone; D008942:Mitoxantrone; D014740:Vidarabine; C024352:fludarabine