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.

R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lmphoma: results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi / Federico, Massimo; Luminari, Stefano; Dondi, Alessandra; Tucci, Alessandra; Vitolo, Umberto; Rigacci, Luigi; Di Raimondo, Francesco; Carella, Angelo Michele; Pulsoni, Alessandro; Merli, Francesco; Arcaini, Luca; Angrilli, Francesco; Stelitano, Caterina; Gaidano, Gianluca; Dell'Olio, Matteo; Marcheselli, Luigi; Franco, Vito; Galimberti, Sara; Sacchi, Stefano; Brugiatelli, Maura. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - STAMPA. - 31:12(2013), pp. 1506-1513. [10.1200/JCO.2012.45.0866]

R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lmphoma: results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi

FEDERICO, Massimo;LUMINARI, Stefano;DONDI, Alessandra;MARCHESELLI, Luigi;SACCHI, Stefano;
2013

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.
2013
31
12
1506
1513
R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lmphoma: results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi / Federico, Massimo; Luminari, Stefano; Dondi, Alessandra; Tucci, Alessandra; Vitolo, Umberto; Rigacci, Luigi; Di Raimondo, Francesco; Carella, Angelo Michele; Pulsoni, Alessandro; Merli, Francesco; Arcaini, Luca; Angrilli, Francesco; Stelitano, Caterina; Gaidano, Gianluca; Dell'Olio, Matteo; Marcheselli, Luigi; Franco, Vito; Galimberti, Sara; Sacchi, Stefano; Brugiatelli, Maura. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - STAMPA. - 31:12(2013), pp. 1506-1513. [10.1200/JCO.2012.45.0866]
Federico, Massimo; Luminari, Stefano; Dondi, Alessandra; Tucci, Alessandra; Vitolo, Umberto; Rigacci, Luigi; Di Raimondo, Francesco; Carella, Angelo M...espandi
File in questo prodotto:
File Dimensione Formato  
JCO-2013-Federico-1506-13.pdf

Accesso riservato

Tipologia: Versione pubblicata dall'editore
Dimensione 174.06 kB
Formato Adobe PDF
174.06 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/934890
Citazioni
  • ???jsp.display-item.citation.pmc??? 74
  • Scopus 213
  • ???jsp.display-item.citation.isi??? 201
social impact