Clinical study on safety and efficacy of JiSaiXin (recombinant human granulocyte colony stimulating factor injection manufactured in China) for Chinese undergoing chemotherapy.

Lin Wang,Xin-En Huang

doi:10.7314/apjcp.2015.16.1.299

Abstract

To assess safety and efficacy of JiSaiXin (Recombinant Human Granulocyte Colony Stimulating Factor Injection manufactured in China, G-CSF) 150ug per day for three days and whether this regimen could reduce the incidence of febrile neutropenia caused by chemotherapy. From July 2014 to December 2014 patients treated by chemotherapy in our hospital were randomly divided into two groups: Group A with prophylactic use of G-CSF (JiSaiXin) 24 hours after chemotherapy for consecutive 3 days; and Group B with G-CSF (JiSaiXin) after neutropenia. Routine blood tests were performed 7 days and 14 days after chemotherapy. A total of 100 patients fulfilled study criteria, and the incidence of severe neutropenia (grade III/IV) and the incidence of febrile neutropenia in Group A were lower than those in Group B. Nine patients were found severe neutropenia (grade III/IV) in Group B, but one in Group A, three febrile neutropenia in Group B, but 0 in Group A. This study suggested that prophylactic use of G-CSF (JiSaiXin) 150ug per day 24 hours after chemotherapy for consecutive 3 days is safe and could be effective for preventing febrile neutropenia in patients with chemotherapy.

Highlights

Neutropenia is one of the most common adverse reaction, and one of the dose-limiting toxicities of chemotherapy, Subsequent febrile neutropenia (FN) is related to life-threatening infections, which would result in 7- 11% mortality rate (Caggiano et al, 2005; Kuderer et al, 2006; Lal et al, 2008), Granulocyte colony stimulating factor (G-CSF) could reduce the incidence of neutropenia, FN and infection, the risk of infection-related deaths and a variety of early death risk, and the incidence of chemotherapy reductions and delays (Kuderer et al, 2007), G-CSF is usually recommended to be administered until neutrophil recovery after the chemotherapyinduced nadir during chemotherapy
To assess safety and efficacy of JiSaiXin (Recombinant Human Granulocyte Colony Stimulating Factor Injection manufactured in China, G-CSF) 150ug per day for three days and whether this regimen could reduce the incidence of febrile neutropenia caused by chemotherapy
This study suggested that prophylactic use of G-CSF (JiSaiXin) 150ug per day 24 hours after chemotherapy for consecutive 3 days is safe and could be effective for preventing febrile neutropenia in patients with chemotherapy

Summary

Introduction

Neutropenia is one of the most common adverse reaction, and one of the dose-limiting toxicities of chemotherapy, Subsequent febrile neutropenia (FN) is related to life-threatening infections, which would result in 7- 11% mortality rate (Caggiano et al, 2005; Kuderer et al, 2006; Lal et al, 2008), Granulocyte colony stimulating factor (G-CSF) could reduce the incidence of neutropenia, FN and infection, the risk of infection-related deaths and a variety of early death risk, and the incidence of chemotherapy reductions and delays (Kuderer et al, 2007), G-CSF is usually recommended to be administered until neutrophil recovery after the chemotherapyinduced nadir during chemotherapy. Retrospective study showed that prophylactic use of G-CSF was associated with a one-third to two-thirds reduction in the risk of hospitalization for FN (Weycker et al, 2007). Two more recent studies on comparative effectiveness of G-CSF prophylaxis reported similar findings (Tan et al, 2010; Weycker et al, 2011). G-CSF is widely used in China to reduce chemotherapy induced neutropenia. With products manufactured in Main Land China. JiSaiXin is producted by Huabei Jintan pharmaceutical Co. each 150ug.Safety and efficacy of prophylactic use of JiSaiXin is not clear and no standardized use is established. We designed a comparative study: one group received G-CSF prophylaxis use 24 hours afer chemotherapy for consecutive 3 days, another group received G-CSF only after neutropenia

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