title: Fludarabine plus mitoxantrone with and without rituximab versus CHOP with and without rituximab as front-line treatment for patients with follicular lymphoma.
abstract: OBJECTIVE
  Promising new therapeutic options for follicular lymphoma (FL) include fludarabine plus mitoxantrone (FM) and the mouse/human anti-CD20 antibody, rituximab. We performed a randomized comparative trial of FM with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) front-line chemotherapy with and without sequential rituximab.
  
  
  METHODS
  All previously untreated CD20(+) FL patients presenting in 15 Italian cooperative institutions from October 1999 were randomly allocated to FM or CHOP. Following clinical or molecular restaging, patients in complete remission (CR) with bcl-2/IgH negativity (CR(-)) received no further treatment; those in CR with bcl-2/IgH positivity (CR(+)) received rituximab, as did those in partial remission (PR) with bcl-2/IgH negativity (PR(-)) or positivity (PR(+)); nonresponders (NR subgroup) were off study.
  
  
  RESULTS
  After chemotherapy, the FM arm achieved higher rates of CR (68% [49 of 72 patients] v 42% [29 of 68 patients]; P =.003) and CR(-) (39% [28 of 72 patients] v 13 of 68 patients [19%]; P =.001). Rituximab elicited CR(-) in 55 of 95 treated patients (58%). The final CR(-) rate was higher in the FM arm (71% [51 of 72 patients] v 51% [35 of 68 patients]; P =.01). However, with a median follow-up of 19 months (range, 9 to 37 months), no statistically significant difference was found among the various study arms in terms of both progression-free (PFS) and overall survival (OS).
  
  
  CONCLUSIONS
  These results indicate that FM is superior to CHOP for front-line treatment of FL and that rituximab is an effective sequential treatment option. However, they also confirm that this superiority is unlikely to translate into either better PFS or OS.
authors.affiliation: Institute of Hematology and Medical Oncology L. e A. Seràgnoli, University of Bologna, Italy. plzinzo@med.unibo.it
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Zinzani
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pulsoni
authors.forename: Alessio
authors.initials: A
authors.lastname: Perrotti
authors.forename: Simona
authors.initials: S
authors.lastname: Soverini
authors.forename: Francesco
authors.initials: F
authors.lastname: Zaja
authors.forename: Amalia
authors.initials: A
authors.lastname: De Renzo
authors.forename: Sergio
authors.initials: S
authors.lastname: Storti
authors.forename: Vito Michele
authors.initials: VM
authors.lastname: Lauta
authors.forename: Luciano
authors.initials: L
authors.lastname: Guardigni
authors.forename: Patrizia
authors.initials: P
authors.lastname: Gentilini
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tucci
authors.forename: Anna Lia
authors.initials: AL
authors.lastname: Molinari
authors.forename: Marco
authors.initials: M
authors.lastname: Gobbi
authors.forename: Brunangelo
authors.initials: B
authors.lastname: Falini
authors.forename: Pier Paolo
authors.initials: PP
authors.lastname: Fattori
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ciccone
authors.forename: Lapo
authors.initials: L
authors.lastname: Alinari
authors.forename: Maurizio
authors.initials: M
authors.lastname: Martelli
authors.forename: Stefano
authors.initials: S
authors.lastname: Pileri
authors.forename: Sante
authors.initials: S
authors.lastname: Tura
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D000069283:Rituximab; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone