RT Journal Article A1 Bassi, Simona A1 Sammassimo, Simona A1 Gigli, Federica A1 Pruneri, Giancarlo A1 Bertazzoni, Paola A1 Quarna, Jessica A1 Cocorocchio, Emilia A1 Laszlo, Daniele A1 Negri, Mara A1 Lionetti, Maria A1 Vanazzi, Anna A1 Alietti, Alessandra A1 Agazzi, Alberto A1 Gardellini, Angelo A1 Andreola, Giovanna A1 Preda, Lorenzo A1 Pastano, Rocco A1 Martinelli, Giovanni T1 Rituximab Plus Chlorambucil Compared with Chlorambucil and Prednisone In Patients with Untreated Follicular Lymphoma JF Blood JO Blood YR 2010 DO 10.1182/blood.V116.21.3956.3956 VO 116 IS 21 SP 3956 OP 3956 SN 0006-4971 AB Abstract 3956Recently in large randomized studies, the addition of Rituximab to standard chemotherapy in the first-line treatment of follicular lymphoma (FL) demonstrated improvements in long-term outcome in FL.We compared the outcome of 111 naive FL patients (pts) treated at our institution from 1995 to 2009 with a single alkylating agent in combination or not with Rituximab: 58 pts received Chlorambucil plus Rituximab (R-Chl) and 53 pts Chlorambucil and prednisone (Chl+PDN). The 2 schedules included an induction phase, where Chlorambucil was given at 6mg/mq for 6 consecutive weeks in both groups and the Rituximab in 4 weekly administrations. The maintenance phase was longer in the Chl+PDN group: Chlorambucil was administered 6mg/mq daily 14 days each month for a total of 12-months of treatment versus 14 days with monthly-Rituximab for 4 consecutive months in the R-Chl group.The demographic and prognostic factors are reported in Table 1.R-Chlorambucil (58 pts)Chlorambucil+prednisone (53 pts)Sex (n° M)2819Median age (range)56 yrs (29–79)53 yrs (28–93)Ann Arbor Stage III–IV44 (76%)30 (57%)Grading 1–2462336652 evaluble pts36 evaluable ptsFLIPI 0–1312521411>210355 evaluable pts39 evaluable ptsAt the end of treatment the ORR was 98% in the R-Chl pts and 77% in the Chl+PDN group, with a percentage of complete response of 79% and 55% respectively. No significant incidence of adverse events were reported and only one HBsAg positive patient in R-Chl group discontinued the therapy. One case of myelodysplastic syndrome was described in a Chl+PDN relapsed patient. With a median follow up of 34 months, the OS and the EFS in R-Chl pts is 95% and 76% respectively. Otherwise, with a median observation time of 82 months in the Chl+PDN group 73% are alive and only 28% of pts maintained the response. The median time to subsequent therapy (TTST) is 21 and 15 months respectively in the 2 groups.The addition of Rituximab to alkylating in first-line treatment in previously untreated FL pts improves significantly the EFS and prolongs the time to next antilymphoma therapy compared with alkylating alone. Because of its low toxicity profile, our combination with Rituximab and Chlorambucil could be considered a first-line therapy, especially in FL patients not eligible for aggressive chemotherapy regimens.No relevant conflicts of interest to declare. RD 11/15/2025 UL https://doi.org/10.1182/blood.V116.21.3956.3956