EFFICACY AND SAFETY OF RITUXIMAB AND HIGH-DOSE DEXAMETHASONE (R-DEX) IN THE TREATMENT OF RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA

Background:

Refractory chronic lymphocytic leukemia  (CLL) has an extremely unfavourable prognosis with overall survival frequently shorter than 12 months. High-dose  methylprednisolone (HDMP) in combination with monoclonal anti-CD20 antibody rituximab is active in treatment of relapsed/refractory CLL but infectious toxicity is serious. Recently published pilot data suggest that high-dose dexamethasone might be equally effective but less toxic than HDMP.

Aims:

To assess efficacy and safety of high-dose dexamethasone combined with rituximab (R-dex) in relapsed/refractory CLL.

Methods:

We retrospectively evaluated medical records from patients (pts) with relapsed/refractory CLL treated with R-dex at 4th Department of Internal Medicine – Hematology, Charles University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic, between September 2008 and October 2012. A total of 52 pts were included (38 males [73 %], median age, 66 years [range, 37-86], Rai III/IV stage in 61%). The median number of therapies prior to R-dex was 2 (range, 1-6). The schedule of R-dex was as follows: rituximab, 500 mg/m² i.v. day 1 (375 mg/m² in 1st cycle), dexamethasone 40 mg orally on days 1-4 and 10-13, cycles repeated every 3 weeks for the maximum of 8 cycles. All pts received antimicrobial prophylaxis with sulfamethoxazole/trimethoprim and aciclovir. The median number of R-dex cycles was 5 (range, 1-8).

Results: The overall response (ORR)/complete remissions (CR) were achieved in 70/4%. With regard to side effects, serious infections  (grade III/IV according to Common Terminology Criteria for Adverse Events) occurred in 29% of the patients; 19% pts developed steroid diabetes requiring temporary use of short-acting insulin. At the median follow-up of 12.7 months, median progression-free survival was 7.6 months and median overall survival 22.6 months.

Summary / Conclusion:

Our data show that R-Dex is an active and feasible treatment for patients with relapsed/refractory CLL; however, major infections remain relatively frequent despite combined antimicrobial prophylaxis. In addition, significant and long-term disease control can be expected in a minority of patients only. Updated results will be presented.

Email address: simkovicm@gmail.com

Keywords: B-CLL, dexamethasone, Refractory, Rituximab

Abstrakta v časopise Haematologica 2013, Suppl1

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