Comparing the efficacy and side effects of PDlasta® (Peg-Filgrastim) with PDgrastim® (Filgrastim) in breast cancer patients; a non-inferiority Rrandomized Clinical Trial abstract
Introduction: G-CSF is the main cytokine in the control of neutrophil production, which is used clinically for the treatment of
chemotherapy induced neutropenia. It may be prescribed in single dose (Peg-Filgrastim) or repeated six daily injections (Filgrastim) during
chemotherapy courses. The objective of this study was to compare the efficacy and side effects of to evaluate the efficacy and safety of
Peg-Filgrastim product of Pooyesh Darou Biopharmaceuticals Company with
Filgrastim in
breast cancer patients in a non-inferiority clinical trial.Methods: In this randomized clinical trial, 80 patients recruited and allocated randomly in two arms of study, equally. In first group, a single subcutaneous dose of 6 mg of
Peg-Filgrastim was injected the day after receiving
chemotherapy regimen in each cycle. The second arm received subcutaneous injection of 300 micrograms per day for six consecutive days in each course of treatment. Hematologic parameters were measured at first day and 7th and 15th days of each cycle of chemotherapy. All probable side effects were recorded during the eight courses of treatment in two groups of study. Side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during 8 courses of chemotherapy.Result: hematologic parameters showed no significant difference in each course of treatment between two groups of study. The comparison of the WBC (p=0.527), Hgb (p=0.075), Platelet (p=0.819), Neutrophil (p=0.575), Lymphocyte (p=705) and ANC (p=0.675) changes during eight courses of treatment identified no statistically significant difference between two study groups, too. Side effects including headache, injection site reaction and muscle pain had lower frequency in patients receiving
Peg-Filgrastim drug.Conclusion: Regarding to our results.
Peg-Filgrastim is completely non- inferior in efficacy and also less toxic compared to Filgrastim. Prescribing in single dose and lower expenses of Peg-Filgrastim, introduces it as a cost-effective drug in treatment of
chemotherapy induced neutropenia.