Phase III Trial: Comparing TINAGRAST® (AryaTinaGene) to Neupogen (Amgen) in the Prevention of Neutropenic Complications in Breast Cancer Patient in 5 Azar hospital of Gorgan

In the early 1940s, the chemotherapy used as a treatment strategy in cancer therapy however the life of normal cells and tissues in different organs, especially cells with rapid cell division damaged by the side effects of chemotherapy. From a theoretical perspective, all chemotherapy regimens can be induced bone marrow and immunosuppressant. This suppression can reduce platelets, red and white blood cells.The GCSF drug also with Filgrastim generic name is known to be an effective treatment to avoid reducing neutrophils. Thus, the present study was done to evaluate the efficiency of TINAGRAST (Filgrastim) (provided by AryaTinaGene Company) to treat neutropenia. The results were compared to Neupogen inventor brands of Filgristim in the market. Moreover the clinical trial is discussed in parallel. The patients with Breast cancer were randomly divided into two groups. At the beginning of the study and after randomly specification of patients, 20 cases by Neupogen and 20 cases by TINAGRAST were assigned. Each patient daily received 5 micrograms of TINAGRAST per kilogram of body weight after each cycle of chemotherapy (the period of each chemotherapycycle is 3 weeks). The distribution of 26 patients ages with breast cancer were from 45.2 ± 10 and 66.8 ± 9.8, respectively. The drug did not show side effect in any cases. Except bone pain, the second and fourth courses of treatment, the group treated with the higher frequency Neupogen had bone pain. The difference between treatments periods was statistically significant. The distribution of hematologic indices in the two treatment groups and four courses of treatment showed that the average indices of the different treatment groups are not statistically significant. Conclussion: TINGRAST not only showed that the same efficacy to boost neutrophil produce from bone marrow, but also TINGRAST shoed less bone pain. Taken all together TINAGRAST have at least the same efficacy of Neupogen it is suggested to use to protection of Neutropenia.