The efficacy of front-line chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (fcr) in patients with chronic lymphocytic leukemia in real clinical practice.
Kataeva E., Klinushkina E., Golenkov A., Chuksina Yu., Mitina T., Zakharov S., Trifonova E., Chernykh Yu.,Visotskaya L., Belousov K., Vardanyan R., Kharasova Z., Boginskaya E.
SBUZ MO MONIKI im. M. F. Vladimirsky
Brief summary
The aim of the study was to investigate the clinical efficacy of front-line FCR program treatment in CLL patients within a clinical model integrated into real practice.
Design and Methods. The study included 108 previously untreated patients with CD20-positive chronic lymphocytic leukemia. The stage of the disease was assessed according to the Rai classification, the functional state was determined on the ECOG scale, and the comorbidity was assessed on the SIRS - G scale. The 17p13/TP53 deletion was calculated using the FISH method, and the IGHV-status observed through PCR. The FCR program consisting of 6 standard courses was being conducted over a longer period of time, which extended the induction period and reduced treatment density. Minimal residual disease (MRD) was assessed according to the international standardized protocol (Rawstron, 2007) by 4-color flow cytometry. Some patients were receiving maintenance treatment with Rituximab for 2 years, compared to the group of patients without maintenance therapy. The main control points of the analysis were PFS and OS. The OS was evaluated according to the intent-to-treat principle.
Results. The clinical efficacy of the treatment was evaluated according to the iWCLL 2008. The overall response rate was 92.6%, complete remission(CR) was detected in 53.9%. 52.8% patients had undetectable MRD (UMRD) in the peripheral blood and 39.3% patients had UMRD in the bone marrow. The Me follow-up was of 51 months (range 8-150). The Me of PFS from the beginning of FCR induction was 42 months. PFS was significantly longer in patients who achieved CR (p=0,0001), with comorbidity in patients below 5 points (p=0,02), and with achievement of UMRD (p=0,002). Reduced treatment density and maintenance therapy with Rituximab did not affect the duration of PFS. OS from the beginning of FCR-induction was 120 months in 60% of patients.
Conclusion. The study showed that the decrease in the density of the FCR program induction in real clinical practice in patients with CLL was accompanied by high efficacy and did not lead to a significant decrease in the PFS compared to patients who received the standard program.
Key words
chronic lymphocytic leukemia, chemoimmunotherapy, FCR, immunophenotyping, minimal residual disease, real practice
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