Docetaxel Concentrate and Solvent for Solution for Infusion is an antineoplastic agent. It promotes formation of stable tubulin microtubules and inhibits their decomposition, which leads to a marked decrease in the concentration of free tubulin. Docetaxel binding to microtubules does not affect the number of protofilaments.

Mechanism of Action

Docetaxel is an antineoplastic drug whose mechanism of action is based on the fact that the drug promotes the accumulation of tubulin in cell microtubules and prevents their breakdown, leading to a significant reduction in free tubulin levels. Docetaxel binding to microtubules does not change the number of protofilaments. In in vitro studies, docetaxel has been shown to disrupt the microtubule network, which plays an important role in implementing the cell’s vital functions both during mitosis and in interphase.

Pharmacodynamic effects

Clonogenic in vitro assays have demonstrated the cytotoxicity of Docetaxel against various murine and human tumor cell lines, as well as against human tumor cells alone. Docetaxel achieves significant concentrations in the intercellular fluid and provides high cell longevity. In addition, Docetaxel shows activity against some cell lines in which there is expression of p-glycoprotein encoded by the gene of drug multidrug resistance. In in vivo studies it turned out that Docetaxel action is independent of the mode of administration and manifests itself in experiments with a wide range of antitumor activity against common tumors – both experimental mouse tumors and inoculated human tumors.

Breast cancer

Docetaxel in combination with doxorubicin and cyclophosphamide is intended for adjuvant therapy of patients with:

• operable breast cancer with lymph node involvement;
• operable breast cancer without lymph node involvement.

Patients with operable breast cancer without lymph node involvement should be limited to adjuvant therapy, if patients are subject to chemotherapy in accordance with the accepted international criteria for the primary therapy of early stages of breast cancer.

Docetaxel in combination with doxorubicin is intended to treat patients with locally or metastatic breast cancer who have not previously received cytotoxic therapy for this disease. Docetaxel as monotherapy is intended to treat patients with locally or metastatic breast cancer after ineffective cytotoxic therapy that included anthracycline or alkyluvannia. Docetaxel in combination with trastuzumab is intended to treat patients with metastatic breast cancer with increased expression of HER-2 by tumor cells if they have not previously received chemotherapy for metastases.