Abstract
18512 Background: Flare reaction (flr) is a new side effect unique to CLL pts treated with immunomodulating agents both thalidomide (T) and L. It is characterized by tender swelling of disease involved lymph nodes (LN), spleen, rash, low-grade fever and/or increase in absolute lymphocyte counts (ALC). Underlying biologic process remains unknown though it is postulated to be mediated through activation of immune effector cells and/or change in serum concentration of pro-inflammatory cytokines. In a phase II clinical trial of L in rel/ref CLL pts we noted a high incidence of flr. Here we report treatment schema for flr and a new preventive approach employed in this study. Methods: A total of 35 pts are enrolled. No prophylaxis given to initial cohort (A). Pts were treated at onset of symptoms with (1) ibuprofen (Ib) 600 mg po q6 hours (2) oxycodone (oxy) 5–10 mg po prn q 6 hours. In subsequent cohort (B) we are investigating prophylactic use of P 20 mg PO QD starting day −1 × 5 days followed by 10 mg QD × 5 days. Results: All pts had rel or ref disease. Median age 63 (range 48–76) year. In cohort A (n = 29) overall incidence of flr was 79% (n = 23). Of these the severity was graded as I, II and III in 48%, 24%, and 7% respectively. There was no grade IV flr. Symptoms initiated within hours of intake of the 1st dose of L lasting for a median of 14 days (cycle 1 only). Pts were adequately managed with symptom resolution using Ib/oxy. Recurrence in cycle 2 was noted in 1 pt. Pain in LN was the most common complaint. Increase ALC noted in 2 pts. Serum cytokine analysis (n = 5) pre and post 7-days of L treatment showed significant increase in TNF-α, IL-10 and MIG. In cohort B (n = 6) 2 pts had flr (grade I) lasting ≤ 10 days. Conclusions: Prophylactic use of P results in decrease incidence, severity and duration of flr. There was no correlation with clinical response. Elevation of ALC can be part of the flr, pts response should be interpreted cautiously for disease progression. Our findings suggest that use of P may be an effective prophylactic maneuver for prevention of L induced flr. Updated results of cohort B will be presented at this meeting. [Table: see text]
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