Purpose. Although rituximab (R) is commonly used for patients with advanced follicular lymphoma (FL) requiring treatment, the optimal associated chemotherapy regimen is yet to be clarified. Patients and Methods. We conducted an open label, multicenter, randomized trial on adult patients with previously untreated stage II-IV FL to compare the efficacy of 8 doses of R associated with 8 cycles of CVP, or 6 cycles of CHOP or 6 cycles of FM. The principal end point of the study was Time to Treatment Failure (TTF). Results. There were 534 patients enrolled in the study. The overall response rate was 88%, 93%, and 91% for R-CVP, R-CHOP, and R-FM, respectively (P=0.247). After a median follow-up of 34 months, the 3-year TTF was 46%, 62% and 59% for the respective treatment groups (R-CHOP vs R-CVP, P=0.003; R-FM vs R-CVP, P=0.006; R-FM vs RCHOP, P=0.763). The 3-year progression free survival (PFS) was 52%, 68% and 63% (overall P=0.011) and the 3-year overall survival was 95% for the whole series. R-FM resulted in higher rates of grade III-IV neutropenia (64%) compared to R-CVP (28%) and R-CHOP (50%) (P < 0.001). Overall, 23 second malignancies were registered during follow-up: 4 in R-CVP, 5 in R-CHOP and 14 in R-FM. Conclusions. In the present 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 RFM.
R-CVP vs R-CHOP vs R-FM for the initial treatment of patients with advanced stage Follicular Lymphoma. Results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi (FIL)
ARCAINI, LUCA;
2013-01-01
Abstract
Purpose. Although rituximab (R) is commonly used for patients with advanced follicular lymphoma (FL) requiring treatment, the optimal associated chemotherapy regimen is yet to be clarified. Patients and Methods. We conducted an open label, multicenter, randomized trial on adult patients with previously untreated stage II-IV FL to compare the efficacy of 8 doses of R associated with 8 cycles of CVP, or 6 cycles of CHOP or 6 cycles of FM. The principal end point of the study was Time to Treatment Failure (TTF). Results. There were 534 patients enrolled in the study. The overall response rate was 88%, 93%, and 91% for R-CVP, R-CHOP, and R-FM, respectively (P=0.247). After a median follow-up of 34 months, the 3-year TTF was 46%, 62% and 59% for the respective treatment groups (R-CHOP vs R-CVP, P=0.003; R-FM vs R-CVP, P=0.006; R-FM vs RCHOP, P=0.763). The 3-year progression free survival (PFS) was 52%, 68% and 63% (overall P=0.011) and the 3-year overall survival was 95% for the whole series. R-FM resulted in higher rates of grade III-IV neutropenia (64%) compared to R-CVP (28%) and R-CHOP (50%) (P < 0.001). Overall, 23 second malignancies were registered during follow-up: 4 in R-CVP, 5 in R-CHOP and 14 in R-FM. Conclusions. In the present 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 RFM.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
