Abstract

lidomide orally, daily at dose of 5mg daily for 56 days followed by individual titration up in 5mg increments every 28 days to reach a maximum dose of 25mg daily based on patient tolerance. All pts received full supportive care, including transfusions of blood and blood products, antibiotics, and anti-emetics when appropriate. Use of filgrastim (G-CSF) and erythropoietin to treat for neutropenia and anemia, respectively, was permitted while on study. Allopurinol 300 mg daily was prescribed from day 1 to 14 as tumor lysis syndrome prophylaxis. Results: Out of 60 total pts, 17 (28%) were identified as long-term responders (TTF greater than or equal to 24 months) and were included in this analysis. Of the 17 long-term responder pts, median age was 72 years. Eight pts (47%) were female. Four had (24%) Rai stage 3 or 4 disease. Medians: hemoglobin 12.6 g/dL, platelet 154 K/uL, WBC 55.6 K/uL, absolute lymphocyte count 40.5 K/uL. Beta-2 microglobulin was 4.2 mg/L. Eleven pts (65%) expressed ZAP-70, and 12/16 (75%) had unmutated IGHV. Fluorescence in-situ hybridization (FISH) was as follows: 13q del (6 pts), trisomy 12 (5 pts), 11q del (4 pts) and no abnormalities (2 pts). The median dose of lenalidomide was 5 mg oral daily dose. Documented best responses to therapy were: CR (2 pts), CRi (1 pt), NPR (2pts), PR (12 pts). The median TTF was 26 months. To date, all these long-term responders are alive, 15 patients are continuing on therapy and 2 pts have discontinued treatment (1 pt who had achieved NPR was taken off secondary to the diagnosis of non-melanomatous skin cancer and 1 pt who had achieved PR taken off study secondary to venous thrombo-embolism). Conclusion: Lenalidomide induces lasting responses in pts with CLL. With continuation of therapy, these responses can be maintained for more than 2 years in 28% of the pts. Further studies are warranted on this sub-group of pts with emphasis on pt-related clinical and biological characteristics of these long-term responders.

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