Use of Biosimilar G-CSF Is Effective After Autologous Bone Marrow Transplantation

Abstract

5321 OBJECTIVES: Granulocyte colony-stimulating factors (G-CSFs) are widely used to accelerate haematopoietic recovery after bone marrow transplantation (BMT). Regulatory approval of biosimilar G-CSFs in Europe has been on the basis of comparable efficacy, safety and quality as the originator product. However, data are not presently available for all G-CSF clinical settings. This is the first reported use of a biosimilar G-CSF for neutrophil recovery after BMT. METHODS: A total of 23 consecutive patients (12 male, 11 female; mean ± SD age 47 ± 13 years) with haematological malignancy (multiple myeloma, n=12; Hodgkin’s lymphoma, n=6; non-Hodgkin’s lymphoma, n=4; acute myeloid leukaemia, n=1) were recruited at a single-centre. Nineteen patients were receiving their first BMT while it was the second autograft for 4 patients. Mobilisation chemotherapy consisted of high-dose (HD) VEP (n=14), ESHAP (n=4), HD Ara-C (n=3), HD cyclophosphamide (n=2) or ICE (n=1). Patients received biosimilar G-CSF (EP-2006, Sandoz Biopharmaceuticals) after myeloablative chemotherapy (primarily BEAM or melphalan 140/200 mg/m2 +/− bortozemib) with or without radiotherapy followed by autologous BMT. G-CSF therapy was started when absolute neutrophil count (ANC) was <0.5 × 109/l and was continued until ANC reached >1.5 × 109/l for 3 consecutive days. Response was evaluated after BMT using International Uniform Response Criteria. RESULTS: Mean ± SD number of CD34+ cells collected before transplantation was 10.1 ± 4.0 x106/kg/body weight. After BMT, one patient had a stringent complete response (CR), 7 patients had a CR, one patient a near CR, one patient a very good partial response (PR), 12 patients a PR, and one patient had progressive disease (overall response 96%). Mean recovery to ANC >0.5 × 109/l was 13.0 ± 4.0 days. Mean duration until platelet recovery >20 000/ml was 16.1 ± 4.4 days (not achieved in 5 patients at last available assessment). Mean duration of treatment with biosimilar G-CSF was 14.4 ± 5.1 days (range 6−23). Patients required antibiotics on a median of 4 days (range 1−6). Five patients (22%) experienced neutropenic events (neutropenic fever, n=4 and neutropenic enterocolitis and sepsis, n=1). Mean number of days in hospital was 28 ± 6. CONCLUSION: Biosimilar G-CSF appears to be effective in reducing the duration of neutropenia in patients undergoing myeloablative therapy followed by autologous BMT. The use of biosimilar G-CSFs may result in cost savings in cancer supportive care budgets. Disclosures: Dmoszynska: Mundipharma: Advisory Board; Roche: Honoraria.

Filgrastim versus TBO‐filgrastim to reduce the duration of neutropenia after autologous hematopoietic stem cell transplantation: TBO, or not TBO, that is the question

“…Biosimilar use following autologous stem cell transplantation is based largely upon extrapolation from non‐transplantation studies . Limited engraftment data following autologous stem cell transplantation which has emerged from European studies treated with a variety of biosimliar agents, report engraftment times between 11 and 15 d . However, differences in the types of hematological malignancies treated, conditioning regimens used, growth factor dose and schedules and institution‐specific clinical practices are major limitations for comparing results from these small studies.…”

Biosimilar granulocyte–colony‐stimulating factor for healthy donor stem cell mobilization: need we be afraid?

“…Collectively, these studies have shown that there are no significant differences between biosimilar versus originator G‐CSF in the median number of CD34+ cells mobilized (frequency in peripheral blood or dose of apheresed CD34+ cells by body weight) or in the number of G‐CSF injections and leukapheresis procedures required to harvest the target CD34+ cell dose . Furthermore, the side effect profiles of biosimilar versus originator G‐CSF were comparable, with a similar incidence and severity of common AEs such as bone or muscle pain and headache and no severe or unexpected AEs.…”