title: The use and effectiveness of rituximab maintenance in patients with follicular lymphoma diagnosed between 2004 and 2007 in the United States.
abstract: BACKGROUND
  The authors examined the "real-world" effectiveness of rituximab (R) maintenance therapy (R-maintenance) compared with observation after R-based induction therapy in patients with previously untreated follicular lymphoma (FL) in the United States.
  
  
  METHODS
  The National LymphoCare Study is a prospective, multicenter, observational study that enrolled > 2700 untreated patients with FL diagnosed from 2004 to 2007 at 265 sites in the United States. Among these, patients who achieved at least stable disease after R-based induction therapy were eligible for the current analysis. Patients who initiated R-maintenance within 215 days of completing induction therapy were categorized as the R-maintenance group, and those who did not initiate therapy during this period were categorized as the observation group. The objective of the current study was to determine the effect of R-maintenance on progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS).
  
  
  RESULTS
  A total of 1439 patients completed R-based induction therapy, 1186 of whom met all inclusion criteria (541 patients received R-maintenance and 645 patients were observed). Characteristics that were found to be predictive of receiving R-maintenance were histology grade (1/2), Ann Arbor stage of disease (III/IV), geographic region (region other than the West), and practice setting (community practice). With a median follow-up of 5.7 years, R-maintenance was associated with superior PFS (hazards ratio [HR], 0.68; 95% confidence interval [95% CI], 0.56-0.84 [P = .0003]) and TTNT (HR, 0.66; 95% CI, 0.52-0.84 [P = .0007]). No significant difference in OS was observed (HR, 0.81; 95% CI, 0.58-1.14 [P = .23]).
  
  
  CONCLUSIONS
  R-maintenance in patients with FL and at least stable disease after R-based induction therapy provided significantly longer PFS and TTNT in comparison with observation, but no significant difference in OS was observed with 5-years of follow-up. This comparative effectiveness study aligns with the results of randomized trials suggesting that similar outcomes occur with R-maintenance in FL with the treatment variations observed in clinical practice.
authors.affiliation: Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Loretta J
authors.initials: LJ
authors.lastname: Nastoupil
authors.forename: Rajni
authors.initials: R
authors.lastname: Sinha
authors.forename: Michelle
authors.initials: M
authors.lastname: Byrtek
authors.forename: Xiaolei
authors.initials: X
authors.lastname: Zhou
authors.forename: Michael D
authors.initials: MD
authors.lastname: Taylor
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Friedberg
authors.forename: Brian K
authors.initials: BK
authors.lastname: Link
authors.forename: James R
authors.initials: JR
authors.lastname: Cerhan
authors.forename: Keith
authors.initials: K
authors.lastname: Dawson
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Flowers
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology / Q000628:therapy; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D000069283:Rituximab; D016019:Survival Analysis; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab
keywords: follicular lymphoma; frontline therapy; non-Hodgkin lymphoma; outcomes; rituximab maintenance