HIGH-DOSE CYTARABINE AND MITOXANTRONE ±RITUXIMAB FOR COLLECTION OF PERIPHERAL BLOOD STEM CELLS IN HIGH-GRADE NON-HODGKINS´ LYMPHOMA. SINGLE CENTER EXPERIENCE WITH FILGRASTIM BIOSIMILARS

ABSSUB-5432

Background: For the patients with aggressive non-Hodgkins´ lymphomas (NHL) chemotherapy – high-dose of cytarabine with mitoxantrone ±rituximab (R±HAM) is used for the standard collection of peripheral blood stem cells at our Department as a part of Sequential Protocol chemotherapy (2xPACEBO, IVAM, PACEBO, HAM ±rituximab).

Aims: We describe here the experience with the efficacy and safety together with the comparison of two filgrastim (G-CSF) biosimilars.

Methods: R±HAM was given as follows: rituximab 375 mg/m² on day 1; cytarabine 2g/m² in 4 doses on day 1 and 2; mitoxantrone 10 mg/m² in 2 doses on day 2 and 3. In patients with age over 60 the dose of cytarabine and mitoxantrone was reduced to 0.5 g/m² and 7 mg/m², respectively. Three different types of G-CSF at the same dosage (10μg/kg of body weight) were used to stimulate peripheral blood stem cells: Neupogen (39 patients), Zarzio (28 patients) and Tevagrastim (11 patients). Retrospective analysis was performed in cohort of 78 patients with NHL in the period January 2009 - September 2013. Median of age was 53 (22-64) years.

Efficacy of the type of G-CSF in terms of the leucopheresis number (collection days) and number of CD34+ cells per kg collected was the first goal of our study. The incidence of infections and other side-effects were recorded in addition. Kruskal-Wallis and Fisher exact tests were used for comparison.

Results: There were no differences among the groups of patients with respect to the gender, age, marrow involvement and previous treatment. There were no statistically significant differences in number of collection procedures among the groups (p=0.084); on average 1.69 procedures for Neupogen, 1.53 procedures for Zarzio and 1.81 procedures for Tevagrastim. Also there were no statistically significant differences in number of CD34+ cells per kg collected (p=0.497); on average 8.29x10⁶ CD34+ cells per kg for Neupogen 8.51x10⁶ CD34+ cells per kg for Zarzio and 6.66x10⁶ CD34+ cells per kg for Tevagrastim. Patients hospitalized and central venous line inserted for the whole period of the priming (42 patients) have a significant higher risk of septicaemia (p=0.002). Patients who proceed to the transplantation engrafted in all cases.

Summary/Conclusion: R±HAM is well tolerated and highly efficient priming chemotherapy (average number of CD34+ cells collected was 7,82x10⁶ per kg, 78 patients). Different types of G-CSF show no statistically significant differences in the stimulation efficacy. Prolonged hospitalization and central venous catheterization is associated with higher risk of septic complications. More patients should be analysed in order to further increase the validity of results.

Acknowledgements: Supported by the grants MSM-6198959205 and IGA UP LF-2013-004.

Keywords: None

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