Chemoimmunotherapy with fludarabine (F), cyclophosphamide (C), and rituximab (R) improves complete response (CR), remission duration and survival as initial therapy of chronic lymphocytic leukemia (CLL).

6565 Background: Fludarabine Monophosphate (F) is the most active chemotherapy agent in CLL. Combination of F with C produced superior results to F in a German randomized trial (Blood: 102, 243a, 2003). In CLL, CR pts. have a superior survival to partial responders (PR). Addition of R to FC is reported to result in a high rate of complete clinical, flow cytomety, and molecular remissions. (Proc ASCO: 22, 2289a, 2003) Methods: We conducted multivariate analyses to evaluate the effect of FCR on CR rate, remission duration (RD), and overall survival (OS) in 552 pts. who received fludarabine based regimens as initial Rx for progressive or advanced CLL. 193 pts. were treated with F ± Prednisone (P), 135 with FC or F + mitoxantrone (M), and 224 with FCR. NCI-WG criteria for initiating Rx and evaluating response were used. RESULTS The results for CR, remission duration, and survival as shown in the table below: [Figure: see text] After covariate adjustment for clinically significant pretreatment variables. Response to Rx and protocol were evaluated for statistical significance. Response and FCR were associated with all three outcome parameters. CONCLUSIONS This analysis suggests that FCR has significantly improved the prognosis for CLL when used as initial therapy. No significant financial relationships to disclose.