title: Phase III study of ACVBP versus ACVBP plus rituximab for patients with localized low-risk diffuse large B-cell lymphoma (LNH03-1B).
abstract: BACKGROUND
  The superiority of a chemotherapy with doxorubicin, cyclophosphamide, vindesine, bleomycin and prednisone (ACVBP) in comparison with cyclophosphamide, doxorubicin, vincristin and prednisone plus radiotherapy for young patients with localized diffuse large B-cell lymphoma (DLBCL) was previously demonstrated. We report the results of a trial which evaluates the role of rituximab combined with ACVBP (R-ACVBP) in these patients.
  
  
  METHODS
  Untreated patients younger than 66 years with stage I or II DLBCL and no adverse prognostic factors of the age-adjusted International Prognostic Index were randomly assigned to receive three cycles of ACVBP plus sequential consolidation with or without the addition of four infusions of rituximab.
  
  
  RESULTS
  A total of 223 patients were randomly allocated to the study, 110 in the R-ACVBP group and 113 in the ACVBP group. After a median follow-up of 43 months, our 3-year estimate of event-free survival was 93% in the R-ACVBP group and 82% in the ACVBP group (P = 0.0487). Three-year estimate of progression-free survival was increased in the R-ACVBP group (95% versus 83%, P = 0.0205). Overall survival did not differ between the two groups with a 3-year estimates of 98% and 97%, respectively (P = 0.686).
  
  
  CONCLUSIONS
  In young patients with low-risk localized DLBCL, rituximab combined with three cycles of ACVBP plus consolidation is significantly superior to ACVBP plus consolidation alone.
authors.affiliation: Department of Oncology, University Hospital, Lausanne, Switzerland. nicolas.ketterer@hirslanden.ch
authors.forename: N
authors.initials: N
authors.lastname: Ketterer
authors.forename: B
authors.initials: B
authors.lastname: Coiffier
authors.forename: C
authors.initials: C
authors.lastname: Thieblemont
authors.forename: C
authors.initials: C
authors.lastname: Fermé
authors.forename: J
authors.initials: J
authors.lastname: Brière
authors.forename: O
authors.initials: O
authors.lastname: Casasnovas
authors.forename: S
authors.initials: S
authors.lastname: Bologna
authors.forename: B
authors.initials: B
authors.lastname: Christian
authors.forename: T
authors.initials: T
authors.lastname: Connerotte
authors.forename: C
authors.initials: C
authors.lastname: Récher
authors.forename: D
authors.initials: D
authors.lastname: Bordessoule
authors.forename: C
authors.initials: C
authors.lastname: Fruchart
authors.forename: R
authors.initials: R
authors.lastname: Delarue
authors.forename: C
authors.initials: C
authors.lastname: Bonnet
authors.forename: F
authors.initials: F
authors.lastname: Morschhauser
authors.forename: B
authors.initials: B
authors.lastname: Anglaret
authors.forename: C
authors.initials: C
authors.lastname: Soussain
authors.forename: B
authors.initials: B
authors.lastname: Fabiani
authors.forename: H
authors.initials: H
authors.lastname: Tilly
authors.forename: C
authors.initials: C
authors.lastname: Haioun
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D000069283:Rituximab; D016896:Treatment Outcome; D014751:Vindesine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D001761:Bleomycin; D000069283:Rituximab; D004317:Doxorubicin; D003520:Cyclophosphamide; D014751:Vindesine; D011241:Prednisone