[Randomized clinical case-control trial for the comparison of docetaxel plus thiotepa versus docetaxel plus capecitabine in patients with metastatic breast cancer].

Objective: To evaluate the efficacy and safety of docetaxel plus thiotepa(TXT/TSPA) and docetaxel plus capecitabine(TXT/CAPE) in patients with metastatic breast cancer.
Methods: The patients were randomized to give intravenous TXT 35 mg/m2 on days 1 and 8 plus intravenous TSPA 60-65 mg/m(2) on day 1 every 3 weeks, or intravenous TXT 35 mg/m(2) on days 1 and 8 plus oral CAPE 1 000 mg/m(2) twice daily on days 1 to 14 every 3 weeks, at least 2 cycles applied.
Results: TXT/TSPA group (22 patients) and TXT/CAPE group (24 patients) had consistent baseline. Docetaxel thiotepa group (21 cases) and docetaxel combined with capecitabine group (22 cases) were evaluated for their clinical responses, which showed that 2 of the 21 (9.52%) from TXT/TSPA group and 6 of the 22 (27.27%) from TXT/CAPE group had achieved partial remission; 11 of the 21 (52.38%) from TXT/TSPA group versus 7 of the 22 (31.82%) from TXT/CAPE group for stable diseases; 8 of the 21 (38.10%) from TXT/TSPA group versus and 9 of the 22 (40.91%) from TXT/CAPE group for progressive diseases, respectively. The disease control rate was 61.90% (13/21) and 59.09% (13/22) for TXT/TSPA and TXT/CAPE groups, the median progression-free survival(PFS) was 7.9 months [95% confidence interval(CI) 0.77 to 15.03] from TXT/TSPA group versus 8.3 months (95% CI 4.01 to 11.79) from TXT/CAPE group. One year survival rate was 88.20% for TXT/TSPA versus 81.00% for TXT/CAPE group, respectively. P values all exceeded 0.05, and the two groups showed no difference. No chemotherapy-related deaths occurred. Myelosuppression was the major side effect. The adverse events of grades 3 to 4 respectively occurred in TXT/TSPA and TXT/CAPE groups:leucocytopenia was 45.45% vs. 26.09%; neutropenia 45.45% vs. 21.74%; thrombocytopenia 9.09% vs. 0%; hand-foot syndrome 0% vs. 13.04%. P values all exceeded 0.05, and the two groups showed no difference.
Conclusion: Combination of docetaxel and thiotepa in the treatment of metastatic breast cancer has some curative effect and adverse reactions can be tolerated. It can be used as an economical and effective rescue plan.