Comparison of Efficacy and safety of Tinapeg® vs. Neulastim® to prevent chemotherapy-induced neutropenia in breast cancer patients: randomized, parallel, equivalence, multicentric and Phase III clinical trial study

Abstract Background This study investigated the efficacy and safety of Pegylated recombinant human granulocyte colony-stimulating factor (PEG‐rhGCSF) manufactured by Arya Tina gene company in the preventing chemotherapy-induced neutropenia in breast cancer patients. Methods This study was designed as a parallel, randomized, double- blind, multicenter, and Phase III clinical trial. In this way, patients diagnosed with breast cancer who entered the study were randomly assigned into two groups. Fifty-one patients were randomly assigned to the Neulastim®, and 51 patients were assigned to the Tinapeg®. Each patient received a chemotherapy regimen containing doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 on day 1, and 24 hours after (the second day), a single 6 mg dose of pegfilgrastim was administered subcutaneously. The primary endpoint was a rate of neutropenia during chemotherapy. The secondary endpoints were the incidence of febrile neutropenia, fever without neutropenia and its severity, occurrence of blood disorders, and rates of adverse events. Results Based on the results, at the end of the fourth cycle, the mean neutrophil counts in Tinapeg® and Neulastim® therapy groups increased by 26 and 34%, respectively, which was not statistically significant. Also, in the fourth cycle, the mean number of neutrophils in the Tinapeg® and Neulastim® therapy groups were 5315 and 5159; There was no significant difference between the two groups regarding the incidence of adverse events and unwanted reactions. Conclusions It was concluded that Tinapeg® and Neulastim® showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy. Clinical trial registrations: IRCT2017061234487N1; Iranian Registry of Clinical Trials (IRCT) https://www.irct.ir/trial/26341