Comparing the Efficacy and Side Effects of PDLASTA® (Peg-Filgrastim) with PDGRASTIM® (Filgrastim) in Breast Cancer Patients; A Non-inferiority Randomized Clinical Trial

Abstract Background: The objective of this study was to compare the efficacy and side effects of to evaluate the efficacy and safety of a single dose (Peg-Filgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial.Methods: In this randomized clinical trial, 80 patients recruited and allocated randomly in two equal arms. In one group, a single subcutaneous dose of 6 mg of PDL was injected the day after receiving a chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of 300 micrograms per day for six consecutive days in each course of treatment. Side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight courses of chemotherapy.Results: 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. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs.Conclusion: Regarding our results, PDL is completely non- inferior in efficacy and also less toxic compared to PDG. Prescribing in single-dose and lower expenses of PDL introduces it as a cost-effective drug in the treatment of chemotherapy-induced neutropenia. Trial registration number, date of registration: IRCT20190504043465N1, May 2019https://www.irct.ir/search/result?query=IRCT20190504043465N1