The objective of the study was to assess the efficacy and safety of the Bendamustine (B) and Rituximab (R) combination therapy in pre-treated patients with relapsed/refractory chronic lymphocytic leukaemia (CLL).
Patients and Methods
13 patients with CLL were examined, out of which 9 were men and 4 women. The average age of the enrolled patients was 62 years (52-77). 5 CLL patients had RAI stage II, 1-III and 7 patients had stage IV. FISH test detected del (17p) in 4 patients (30.8%), del (11q) in 3 patients (13.1%) the immunophenotype test of peripheral blood lymphocytes identified 5 patients (38.5%) with CD38+positive (cut off over 20%).
The patients received prior therapy with COP, CHOP, RFC, FC, RCHOP, FluCam, Alemtuzumab and R courses. The treatment lasted for 23.7 months (12-36). 10.4 (7-20) treatment courses were made on average. Median of Chemotherapy lines in each patient was 4 (2-5). All the patients were resistant to the previous treatment and relapsed. The patients received R through intravenous infusions at a dose of 500 mg/m2 on day 1 of the therapy course and B through intravenous infusions at a dose of 100 mg/m2 on days 2 and 3 of the therapy course, and the course was repeated every 28 days. 4.6 (3-9) therapy courses were administered.
Results
All the patients (100%) responded to the administered therapy by achieving partial remission. Progression-free survival within 6 months is 67%. Median of the examination was 12.3 months (4-33) and 9 patients (69%) are alive. 3 patients (21%) had hematologic toxicity of levels 3 and 4. At the same time 2 patients (14%) had neutropenia, and 1 patient (7%) had thrombocytopenia respectively. 3 patients (23%) had non-haematological toxicity of level III in the form of infections (pneumonia) and 3 patients (27%) had gastroenterological toxicity.
Conclusion
thus, the BR combination has a high anticancer activity in heavily pre-treated patients with relapsed/refractory CLL. It should be noted that the examined patients had pejorative prognostic characters such as del (17p) and del 11(q), and high CD 38+ expression (82.4%). At the same time the toxicity profile was low.
Good anticancer effect and moderate toxicity indicate strict selectivity of the BR program.
Disclosures:
No relevant conflicts of interest to declare.
In this study we have assessed FOXP3 and its isoforms expression by CD4+ T cells from peripheral blood of 37 patients with various forms of multiple myeloma (MM) and 15 healthy volunteers. Newly diagnosed MM was in 17 patients; resistant/relapsed MM was registered in 13 patients and 7 patients had remission after chemotherapy. Significant role of FOXP3 expression by CD4+ T lymphocytes in pathogenesis of MM was shown. Thus, increase of FOXP3-expressing cells percent among CD4+ T cells is registered in patients with newly diagnosed MM and in resistant/relapsed patients. The main contribution to this percent increment is made by FOXP3D2 isoform expressing cells. In addition to the percent increment the number of CD4+FOXP3+ T cells is also risen in patients with newly diagnosed MM. The level of FOXP3 expression by CD4+ T cells also reflects the effectiveness of antitumor therapy, considering normalization of CD4+FOXP3+ T cells number and percent in patients with disease remission. We also discuss the possible relationship between FOXP3 mRNA post-transcriptional modification, namely alternative splicing, with stable expression of FOXP3 in T-regs cells.
The level of an expression of T-regs cells can will be applied as criterion of efficiency of antitumor therapy.
Disclosures
No relevant conflicts of interest to declare.
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