Evaluation of efficacy and side effects of FILGRASTIM versus PD-Grastim in prevention of neutropenia in patients with neuroblastoma under treatment with OPEC chemotherapy protocol - A Comparative Study|
Abolghasemi, H; Hatami, S; Ajami, H; Ehsani, MA; Sotoudeh, K; Ordouee, M; Salamati, P & Shahgholi, E
Background: The purpose of this study was to compare the efficacy and side effects of Filgrastim (Granulocyte, Colony Stimulating Factor [G-CSF] made by Roche, Swiss) and PD-grastim (An G-CSF Analogous made by Pooyesh Daru, IRAN) on chemotherapy related neutropenia in neuroblastoma patients.
Methods: This randomized clinical trial was performed on children with Neuroblastoma. The inclusion criteria were: histopathologic proven neuroblastamo, age<16 years, Stage 3 or 4, without fever and infection, Absolute neutrophil count more than 1000/μl and platelet more than 100,000/μl and OPEC chemotherapy protocol which consists of (Oncovin, Platinium, Etoposide and Cyclophosphamide). This protocol was used every 28 days for 12 courses, in each course after chemotherapy 10Âµg/kg G-CSF (Filgrastim or PD-grastim) was used for 4 days. Patients were assigned randomly as odd and even numbers. Odd number patients received PD-grastim in odd courses & Filgrastim in even courses and vice versa in even number patients. Cell blood counts was taken in the beginning and in the 6, 9, 13 days of the treatment, then two times weekly until neutrophil count reached 1000 μl/dl.
Findings: Eight Neuroblastoma (6 males and 2 females) with mean Age 2.5 years were studied. Two cases were new and others were in the middle of their chemotherapy courses. Forty four cycles (Chemotherapy plus G-CSF) were studied which in 22 cycles Filgrastim and in 22 cycles PD-grastim were used. Neutropenia was found in 34 cycles. The mean time of neutropenia in Filgrastim group was 6.4±4.68 days and in PD-grastim group was 6.5±5.09 days. Among the 2 groups there was no significant difference in the incidence, intensity, and duration of neutropenia. All patients were discharged after 9 days without any complications or side effect.
Conclusion: This study shows that there are no significant differences in the efficacy and side effects of Filgrastim versus PD-grastim in prevention of neutropenia after OPEC protocol chemotherapy treatment in stage 3 & 4 neuroblastoma patients.
Neuroblastoma , Granulocyte Colony Stimulating Factor , G-CSF , Filgrastim , PDgrastim