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

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

Research output: Contribution to journalArticlepeer-review

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. Conclusion 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.

Original languageEnglish
Pages (from-to)1506-1513
Number of pages8
JournalJournal of Clinical Oncology
Volume31
Issue number12
DOIs
Publication statusPublished - 20 Apr 2013

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this