[Randomized controlled trial of two kinds of home-produced docetaxel in China for advanced breast cancer].

BACKGROUND & OBJECTIVE: Two kinds of home-produced docetaxel in China, injection Yiyoutasai and injection Aisu, have the same structure. Data from preclinical study had shown that injection Yiyoutasai has the same pharmacokinetics and toxicity as injection Aisu. This study was to evaluate the efficacy and toxicity of injection Yiyoutasai in treating advanced breast cancer. METHODS: Eligible breast cancer patients were enrolled and randomly assigned to study group and control group, and received injection of 75 mg/m(2) Yiyoutasai or Aisu, respectively. The injections were repeated every 3 weeks. All patients received at least 2 cycles. The efficacy of Yiyoutasai and Aisu were evaluated after treatment. RESULTS: A total of 67 patients were enrolled: 33 in study group, and 34 in control group. Of the 31 evaluable cases in study group, 1 achieved complete remission (CR), 9 achieved partial remission (PR), 11 had stable disease (SD), and 10 had progressive disease (PD); the total response rate was 22.22%. There were 1 CR, 5 PR, 19 SD, and 9 PD in control group; the total response rate was 15.15%. There was no significant difference between the 2 groups (P=0.662). The median follow-up was 16.5 months (8-28 months). In study group, the median progression-free survival time was 6.2 months (2-12 months), the 1-year survival rate was 68.51%, and the 2-year survival rate was 40.12%; in control group, the median progression-free survival time was 7.1 months (2.3-11 months), the 1-year survival rate was 65.23%, and the 2-year survival rate was 39.71%. There was no significant difference between the 2 groups (P=0.102, 0.098, 0.089, respectively). Common adverse events were myelosuppression, transient transaminase elevation, and alopecia. One patient in study group suffered from severe allergic reaction after infusion, 1 in control group suffered from whole body edema. CONCLUSION: Yiyoutasai and Aisu have similar efficacy on and toxicity to advanced breast cancer patients.

[A randomized control clinical trial of Euruikang (docetaxel) in treatment of advanced non-small cell lung cancer (NSCLC)].

BACKGROUND & OBJECTIVE: Docetaxel is one of the major drugs for advanced non-small cell lung cancer (NSCLC) treatment in clinical use. It is reported that the response rate of docetaxel alone is about 20% and its major toxicity is myelosuppression. The study was to evaluate the efficacy and tolerability of docetaxel (made in Beijing) in the treatment of advanced NSCLC. METHODS: 77 patients were randomized into two groups. In the study group, patients were received docetaxel (made in Beijing) 75 mg/m(2) in one hour plus cisplatin 70 mg/m(2); while in the control group, docetaxel (made in Jiangsu) 75 mg/m(2) plus cisplatin 70 mg/m(2) were administrated. Treatment in the two groups was repeated every 3 weeks. All patients had to receive at least two cycles of chemotherapy. RESULTS: The objective responses in the study and control group were 28.95% and 27.03% respectively, with no statistical difference (P>0.5). Common toxicities of docetaxel (made in Beijing) were grade II-III myelosuppression, grade I-II transaminase elevation, alopecia and hypodynamia. CONCLUSION: Docetaxel (made in Beijing) is an effective chemotherapy drug in advanced NSCLC treatment, which has the similar efficacy and toxicity to docetaxel (made in Jiangsu).