Dose Intensive Rituximab and High-Dose Methylprednisolone in Elderly or Unfit Patients with Relapsed Chronic Lymphocytic Leukemia

Regina Pileckyte, Vilma Valceckiene, Mindaugas Stoskus, Reda Matuzeviciene, Jurgita Sejoniene, Tadas Zvirblis, Laimonas Griskevicius, Regina Pileckyte, Vilma Valceckiene, Mindaugas Stoskus, Reda Matuzeviciene, Jurgita Sejoniene, Tadas Zvirblis, Laimonas Griskevicius

Abstract

Background and Objectives: BTK and BCL2 inhibitors have changed the treatment paradigms of high-risk and elderly patients with chronic lymphocytic leukemia (CLL), but their long-term efficacy and toxicity are still unknown and the costs are considerable. Our previous data showed that Rituximab (Rtx) and high-dose methylprednisolone (HDMP) can be an effective and safe treatment option for relapsed high-risk CLL patients. Materials and Methods: We explored the efficacy and safety of a higher Rtx dose in combination with a shorter (3-day) schedule of HDMP in relapsed elderly or unfit CLL patients. Results: Twenty-five patients were included in the phase-two, single-arm trial. The median progression free survival (PFS) was 11 months (range 10-12). Median OS was 68 (range 47-89) months. Adverse events (AE) were mainly grade I-II° (77%) and no deaths occurred during the treatment period. Conclusions: 3-day HDMP and Rtx was associated with clinically meaningful improvement in most patients. The median PFS in 3-day and 5-day HDMP studies was similar and the toxicity of the 3-day HDMP schedule proved to be lower. The HDMP and Rtx combination can still be applied in some relapsed high-risk and elderly or unfit CLL patients if new targeted therapies are contraindicated or unavailable. (ClinicalTrials.gov identifier: NCT01576588).

Keywords: chronic lymphocytic leukemia; elderly; high-dose methylprednisolone; rituximab.

Conflict of interest statement

R.P., L.G.: research support from Roche Lietuva was achieved (study drug Rituximab was provided by Roche Lietuva) V.V., M.S., J.S., R.M., A.J., T.Z. have no conflicts-of-interest to disclose.

Figures

Figure 1
Figure 1
(A)—Hemoglobin (Hb); (B)—absolute lymphocyte count (ALC); (C)—platelet (Plt); (D)—absolute neutrophil count (ANC) at screening and cessation of treatment.
Figure 2
Figure 2
Progression-free survival (PFS).
Figure 3
Figure 3
Overall survival (OS).
Figure 4
Figure 4
Overall survival from first salvage according to given treatment.

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