title: R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lymphoma: results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi.
abstract: OBJECTIVE
  Although rituximab (R) is commonly used for patients with advanced follicular lymphoma (FL) requiring treatment, the optimal associated chemotherapy regimen has yet to be clarified.
  
  
  METHODS
  We conducted an open-label, multicenter, randomized trial among adult patients with previously untreated stages II to IV FL to compare efficacy of eight doses of R associated with eight cycles of cyclophosphamide, vincristine, and prednisone (CVP) or six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or six cycles of fludarabine and mitoxantrone (FM). The principal end point of the study was time to treatment failure (TTF).
  
  
  RESULTS
  There were 534 patients enrolled onto the study. Overall response rates were 88%, 93%, and 91% for R-CVP, R-CHOP, and R-FM, respectively (P=.247). After a median follow-up of 34 months, 3-year TTFs were 46%, 62%, and 59% for the respective treatment groups (R-CHOP v R-CVP, P=.003; R-FM v R-CVP, P=.006; R-FM v R-CHOP, P=.763). Three-year progression-free survival (PFS) rates were 52%, 68%, and 63% (overall P=.011), respectively, and 3-year overall survival was 95% for the whole series. R-FM resulted in higher rates of grade 3 to 4 neutropenia (64%) compared with R-CVP (28%) and R-CHOP (50%; P< .001). Overall, 23 second malignancies were registered during follow-up: four in R-CVP, five in R-CHOP, and 14 in R-FM.
  
  
  CONCLUSIONS
  In this study, R-CHOP and R-FM were superior to R-CVP in terms of 3-year TTF and PFS. In addition, R-CHOP had a better risk-benefit ratio compared with R-FM.
authors.affiliation: Dipartimento di Oncologia ed Ematologia, Centro Oncologico Modenese, Clinica e di Sanità Pubblica, Università di Modena e Reggio Emilia, Modena, Italy. federico@unimore.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Federico
authors.forename: Stefano
authors.initials: S
authors.lastname: Luminari
authors.forename: Alessandra
authors.initials: A
authors.lastname: Dondi
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tucci
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
authors.forename: Luigi
authors.initials: L
authors.lastname: Rigacci
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Raimondo
authors.forename: Angelo Michele
authors.initials: AM
authors.lastname: Carella
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pulsoni
authors.forename: Francesco
authors.initials: F
authors.lastname: Merli
authors.forename: Luca
authors.initials: L
authors.lastname: Arcaini
authors.forename: Francesco
authors.initials: F
authors.lastname: Angrilli
authors.forename: Caterina
authors.initials: C
authors.lastname: Stelitano
authors.forename: Gianluca
authors.initials: G
authors.lastname: Gaidano
authors.forename: Matteo
authors.initials: M
authors.lastname: Dell'olio
authors.forename: Luigi
authors.initials: L
authors.lastname: Marcheselli
authors.forename: Vito
authors.initials: V
authors.lastname: Franco
authors.forename: Sara
authors.initials: S
authors.lastname: Galimberti
authors.forename: Stefano
authors.initials: S
authors.lastname: Sacchi
authors.forename: Maura
authors.initials: M
authors.lastname: Brugiatelli
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D008942:Mitoxantrone; D014740:Vidarabine; C024352:fludarabine; D011241:Prednisone