Abstract
High-dose methylprednisolone (HDMP) in combination with rituximab is active in the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) but serious infections are frequent. Recently published data suggest that high-dose dexamethasone might be equally effective to HDMP despite lower cumulative dose.
To assess efficacy and safety of high-dose dexamethasone combined with rituximab (R-dex) in relapsed/refractory CLL.
A total of 60 pts (pts) with relapsed/refractory CLL treated at a single tertiary center between September 2008 and October 2012 were included in this retrospective analysis. Basic characteristics are summarized in Table 1. The schedule of R-dex consisted of rituximab 500 mg/m2 i.v. day 1 (375 mg/m2 in cycle 1) and dexamethasone 40 mg orally on days 1-4 and 10-13. Treatment was repeated every 3 weeks for a maximum of 8 cycles. All pts received antimicrobial prophylaxis with sulfamethoxazole/trimethoprim and aciclovir.
Basic characteristics.
| Total number of patients | 60 |
|---|---|
| Age (median, range) | 69 (54-83) |
| Males | 73% |
| Rai stage III/IV | 65% |
| Bulky lymphadenopathy (≥ 5cm) | 58% |
| Previous treatment lines (median, range) | 2 (1-7) |
| Unmutated IgVH | 82% |
| Del 11q | 42% |
| Del 17p | 19% |
| Fludarabine-refractory | 50% |
| Bulky fludarabine-refractory | 33% |
| Total number of patients | 60 |
|---|---|
| Age (median, range) | 69 (54-83) |
| Males | 73% |
| Rai stage III/IV | 65% |
| Bulky lymphadenopathy (≥ 5cm) | 58% |
| Previous treatment lines (median, range) | 2 (1-7) |
| Unmutated IgVH | 82% |
| Del 11q | 42% |
| Del 17p | 19% |
| Fludarabine-refractory | 50% |
| Bulky fludarabine-refractory | 33% |
Median number of administered R-dex cycles was 6 (range, 1-8). The overall response (ORR)/complete remissions (CR) were achieved in 75/3%. At the median follow-up of 9 months, median progression-free survival was 8 months and median overall survival 24 months. Significant predictors of short PFS in univariate analysis were bulky lymphadenopathy (p=0.023) and refractoriness to fludarabine (p=0.02). Interestingly, activity of R-dex in bulky fludarabine-refractory CLL was similar to ofatumumab (ORR 62 %, median PFS, 4 months, median OS, 12 months) (Wierda et al., 2010). R-dex was successfully used as a debulking regimen before allogeneic stem cell transplantation in 8 patients. Serious (CTCAE grade III/IV) infections occurred in 29% of patients; 19% pts developed steroid diabetes requiring temporary short-acting insulin.
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, durable responses are infrequent. Therefore, further optimization of this therapeutic approach is warranted. Updated results will be presented.
No relevant conflicts of interest to declare.
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