title: Effect of single-agent rituximab given at the standard schedule or as prolonged treatment in patients with mantle cell lymphoma: a study of the Swiss Group for Clinical Cancer Research (SAKK).
abstract: OBJECTIVE
  To evaluate the effect of single-agent rituximab given at the standard or a prolonged schedule in patients with newly diagnosed, or refractory or relapsed mantle cell lymphoma (MCL).
  
  
  METHODS
  After induction treatment with the standard schedule (375 mg/m2 weekly x 4), patients who were responding or who had stable disease at week 12 from the start of treatment were randomly assigned to no further treatment (arm A) or prolonged rituximab administration (375 mg/m2) every 8 weeks for four times (arm B).
  
  
  RESULTS
  The trial enrolled 104 patients. After induction, clinical response was 27% with 2% complete responses. Among patients with detectable t(11;14)-positive cells in blood and bone marrow at baseline, four of 20, and one of 14, respectively, became polymerase chain-reaction-negative after induction. Anemia was the only adverse predictor of response in the multivariate analysis. After a median follow-up of 29 months, response rate and duration of response were not significantly different between the two schedules in 61 randomly assigned patients. Median event-free survival (EFS) was 6 months in arm A versus 12 months in arm B; the difference was not significant (P = .1). Prolonged treatment seemed to improve EFS in the subgroup of pretreated patients (5 months in arm A v 11 months in arm B; P = .04). Thirteen percent of patients in arm A and 9% in arm B presented with grade 3 to 4 hematologic toxicity.
  
  
  CONCLUSIONS
  Single-agent rituximab is active in MCL, but the addition of four single doses at 8-week intervals does not seem to significantly improve response rate, duration of response, or EFS after treatment with the standard schedule.
authors.affiliation: Oncology Institute of Southern Switzerland, Bellinzona, Switzerland. mghielmini@ticino.com
authors.forename: Michele
authors.initials: M
authors.lastname: Ghielmini
authors.forename: Shu-Fang Hsu
authors.initials: SF
authors.lastname: Schmitz
authors.forename: Sergio
authors.initials: S
authors.lastname: Cogliatti
authors.forename: Francesco
authors.initials: F
authors.lastname: Bertoni
authors.forename: Ursula
authors.initials: U
authors.lastname: Waltzer
authors.forename: Martin F
authors.initials: MF
authors.lastname: Fey
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Betticher
authors.forename: Hubert
authors.initials: H
authors.lastname: Schefer
authors.forename: Gabriella
authors.initials: G
authors.lastname: Pichert
authors.forename: Rolf
authors.initials: R
authors.lastname: Stahel
authors.forename: Nicolas
authors.initials: N
authors.lastname: Ketterer
authors.forename: Mario
authors.initials: M
authors.lastname: Bargetzi
authors.forename: Thomas
authors.initials: T
authors.lastname: Cerny
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D008297:Male; D008875:Middle Aged; D000069283:Rituximab
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab