Comparative Study Of Anti-tumor Effect And Safety Of Domestic And Imported Paclitaxel Injection

OBJECTIE:To compare anti-tumor effect and safety of domestic and imported paclitaxel injection.METHODS:1. Comparison of anti-tumor effect and safety of domestic and imported paclitaxel injection in tumor bearing miceThe model of mice solid S180 sarcoma was established and then the mice were divided into 7 groups: model group, imported paclitaxel d1,5,910mg/kg group (paclitaxel given on days 1, 5 and 9), imported paclitaxel d130mg/kg group (paclitaxel given on days 1), domestic paclitaxel group A d1,5,910mg/kg group, domestic paclitaxel group A d130mg/kg group, domestic paclitaxel group B d1,5,910mg/kg group, domestic paclitaxel group B d130mg/kg group.Index detection: Life quality, body weight, tumor growth curve, weight of tumor, inhibitory rate(IR) were observed. Contents of white blood cell (WBC), red blood cell (RC), platelet (PLT), hemoglobin (HG) in blood were detected. ALT, AST in serum and MDA, SOD, GSH-PX in liver tissue were detected by biochemical analysis. Tumor and liver tissue was dyed by HE stain and pathological changes were observed by light microscope, the protein expressions of VEGF in tumor tissue were determined by immunohistochemistry. The survival-extending rate of each group were observed. 2. Clinical analysis of advanced breast cancer treated with paclitaxelClinic data of thirty-one patients with advanced breast cancer from June 2004 to December 2007 were reviewed by using HIS and digital image medical record management system. Among them, twenty patients treated with domestic paclitaxel regimen, eleven patients treated with imported paclitaxel regimen. The effect, adverse reaction and cost of a treatment course were evaluated after 2 cycles.RESULTS:1. The effect of domestic and imported paclitaxel injection to tumor bearing mice Both domestic and imported paclitaxel can improve life qualities of tumor bearing mice and had obvious effects on tumor inhibition. The pathological section shows that both domestic and imported paclitaxel can make tumor cell necrosis for large area. Immunohistochemistry shows that both domestic and imported paclitaxel can decreased the protein expressions of VEGF in tumor tissue. The live time of tumor bearing mice in all paclitaxel groups were extended in different level.Compared with modle group, the contents of RC, HG in blood markly decreased in all paclitaxel groups, there were no significant changes in WBC and PLT among those groups.Serum ALT, AST were not changed significantly. MDA in liver tissue increased ang SOD, GSH-PX in liver tissue declined in different level. Some degeneration of liver cell were discovered in all paclitaxel groups. The indexes changes were larger in the way of d130mg/kg administration. Other adverse reaction, such as muscle and arthralgia pain and heart toxicity were not observed for the restriction of experiment condition.2. Clinical analysis of advanced breast cancer treated with paclitaxelThe overall response rates was 64.5%, with 65.0% in domestic group and 63.6% in imported group respectively. The frequent side effects included myelosuppression, gastroenteric reactions, alopecia, muscle and arthralgia pain, allergic response. The incidence of III grade leucopenia in domestic and imported group were 20.0% and 18.2% respectively. There was one III grade muscle and arthralgia pain case in domestic group. Other side effects between two groups were similar. The average cost of paclitaxel of a treatment course in domestic and imported group were $1918 and $10220 respectively.CONCLUSIONS:1. Domestic paclitaxel show good anti-tumor effect in inhibitory rate, anti-angiogenesis, survival-extending rate, and so on. There is no significant difference with imported paclitaxel.2. Paclitaxel can induce some hepatic injury and hematological toxicity. There are no significant difference between domestic and imported paclitaxel in adverse reaction under the same dosage regimen.3. Low dose, short intermission, multiple dosing might lighten hepatic injury.4. The anti-tumor effect and adverse reaction between domestic and imported paclitaxel are similar. The cost of domestic paclitaxel of a treatment course is much lower than imported paclitaxel, so it is worth to be recommended.