R-CVP versus R-CHOP versus R-FM for the initial treatment of patients withadvanced-stage follicular lymphoma: results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi.

Vito Franco, Sara Galimberti, Alessandra Dondi, Angelo Michele Carella, Francesco Di Raimondo, Stefano Sacchi, Alessandra Tucci, Francesco Angrilli, Gianluca Gaidano, Francesco Di Raimondo, Francesco Di Raimondo, Luigi Marcheselli, Matteo Dell'Olio, Stefano Luminari, Caterina Stelitano, Francesco Merli, Luigi Rigacci, Luca Arcaini, Umberto Vitolo, Alessandro PulsoniMaura Brugiatelli, Massimo Federico

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    176 Citations (Scopus)

    Abstract

    PURPOSE: 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.PATIENTS AND 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.
    Original languageEnglish
    Pages (from-to)1506-1513
    Number of pages8
    JournalJournal of Clinical Oncology
    Volume31
    Publication statusPublished - 2013

    All Science Journal Classification (ASJC) codes

    • Oncology
    • Cancer Research

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