title: Watchful waiting in low-tumor burden follicular lymphoma in the rituximab era: results of an F2-study database.
abstract: OBJECTIVE
  Patients with follicular lymphoma (FL) registered in the F2-study and initially managed without treatment were analyzed to describe the presentation and outcome of a watch and wait (W&W) strategy in the rituximab era, to identify parameters for initiating treatment, and to evaluate whether initial W&W could have deleterious effects on treatment efficacy after progression or relapse.
  
  
  METHODS
  Between 2003 and 2005, 120 patients selected from the 1,093 treatment-naive patients with FL in the F2-study cohort were initially managed expectantly (W&W), and 107 patients were assessed. Most of these patients (80%) had disseminated disease with a low tumor burden according to Groupe d'Etudes des Lymphomes Folliculaires criteria.
  
  
  RESULTS
  After a median follow-up of 64 months, treatment was initiated in 54 patients (50%), with a median delay of 55 months for the entire cohort. In a univariate analysis, involvement of more than four nodal areas (hazard ratio [HR], 2.26) and serum albumin less than 3.5 g/dL (HR, 3.51) were predictive of a shorter time to lymphoma treatment initiation. In a multivariate analysis, only involvement of more than four nodal areas remained significant (HR, 2.32). The 4-year freedom from treatment failure (FFTF) rate of W&W patients (79%; 95% CI, 69% to 85%) was not inferior to that of a subgroup of 242 patients from the F2-study cohort with good prognosis characteristics who were initially treated with a rituximab-based regimen (69%; 95% CI, 61% to 76%; P = .103).
  
  
  CONCLUSIONS
  In the rituximab era, patients with FL in a selected prognostically favorable group can still be managed with W&W. W&W does not seem to have detrimental effects on FFTF and overall survival rates after treatment.
authors.affiliation: Institut de Cancérologie de l'Ouest, Bld Jacques Monod, 44805 Saint-Herblain Cedex, France. philippe.solal-celigny@ico.unicancer.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Solal-Céligny
authors.forename: Monica
authors.initials: M
authors.lastname: Bellei
authors.forename: Luigi
authors.initials: L
authors.lastname: Marcheselli
authors.forename: Emanuela Anna
authors.initials: EA
authors.lastname: Pesce
authors.forename: Stefano
authors.initials: S
authors.lastname: Pileri
authors.forename: Peter
authors.initials: P
authors.lastname: McLaughlin
authors.forename: Stefano
authors.initials: S
authors.lastname: Luminari
authors.forename: Barbara
authors.initials: B
authors.lastname: Pro
authors.forename: Silvia
authors.initials: S
authors.lastname: Montoto
authors.forename: Andrés J M
authors.initials: AJ
authors.lastname: Ferreri
authors.forename: Eric
authors.initials: E
authors.lastname: Deconinck
authors.forename: Noël
authors.initials: N
authors.lastname: Milpied
authors.forename: Leo I
authors.initials: LI
authors.lastname: Gordon
authors.forename: Massimo
authors.initials: M
authors.lastname: Federico
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000175:diagnosis* / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D000069283:Rituximab; D016896:Treatment Outcome; D047368:Tumor Burden; D057832:Watchful Waiting
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab