What is Docetaxel Winthrop?
Docetaxel Winthrop is a concentrate and solvent for the preparation of a solution for infusion (drip into a vein). It contains the active ingredient docetaxel.
The medicine is similar to TAXOTERE, already authorized in the European Union. The company that makes TAXOTERE has agreed that its scientific data will be used for Docetaxel Winthrop.
What is Docetaxel Winthrop used for?
Docetaxel Winthrop is an anticancer medicine. It is indicated for the treatment of:
- breast cancer. It can also be used on its own after other treatments have failed. It can be used in combination with other anticancer drugs (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not received previous therapy for their disease or after failure of other treatments, based on the type of breast cancer to be treated and at the stage of progression;
- non-small cell lung cancer. It can be used on its own after other treatments have failed. It can also be used in combination with cisplatin (another anticancer medicine) in patients who have not received previous treatment for this condition;
- prostate cancer, when the tumor does not respond to hormonal treatment. It is used in combination with prednisone or prednisolone (anti-inflammatory drugs);
- gastric adenocarcinoma (a type of stomach cancer) in patients who have not previously received treatment for cancer. It is used in combination with cisplatin and 5-fluorouracil (other anticancer drugs);
- head and neck cancer in patients with advanced carcinoma. It is used in combination with cisplatin and 5-fluorouracil.
For a detailed description, see the summary of product characteristics, included with the EPAR.
The medicine can only be obtained with a prescription.
How is Docetaxel Winthrop used?
The use of Docetaxel Winthrop should be restricted to specialized chemotherapy departments and its administration should be carried out under the supervision of a doctor authorized to administer anticancer chemotherapy. Docetaxel Winthrop should only be used when the neutrophil count (a type of white blood cell) is at least 1, 500 cells / mm3. For prostate cancer, treatment with dexamethasone (an anti-inflammatory drug) is required one day before starting therapy; for other types of cancer, the day before and two days after treatment.
Docetaxel Winthrop is given as a one-hour infusion every three weeks. The dose, duration of treatment and its use in combination with other drugs depends on the type of carcinoma to be treated. For more information, see the summary of product characteristics.
How does Docetaxel Winthrop work?
The active substance in Docetaxel Winthrop, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the cells' ability to destroy the internal "skeleton", which allows them to divide and multiply. In the presence of the skeleton the cells cannot divide and therefore die. Docetaxel also compromises non-tumor cells (for example, blood cells) causing side effects.
How has Docetaxel Winthrop been studied?
Docetaxel Winthrop has been studied in total in about 3, 000 breast cancer patients, about 1 900 lung cancer patients, about 1, 000 prostate cancer patients, 445 stomach cancer patients and 897 cancer patients head and neck. In most of these studies, Docetaxel Winthrop was used in combination with other anticancer treatments and was compared with combinations of different treatments or with the same treatment without Docetaxel Winthrop. The main efficacy parameters were response rates (percentage of patients whose cancer responded to treatment), time to progression and increased survival time.
What benefit has Docetaxel Winthrop shown during the studies?
The combination of Docetaxel Winthrop with other anticancer treatments has resulted in a significant increase in response rates, disease progression or survival in all five types of cancer treated (breast cancer, non-small cell lung cancer, carcinoma prostate, gastric adenocarcinoma and tumor of the head and neck). In the treatment of breast cancer used as monotherapy, Docetaxel Winthrop was at least as effective, and sometimes more effective, than the comparator medicines; moreover it was more adequate than the best supportive therapy in the treatment of lung cancer.
What is the risk associated with Docetaxel Winthrop?
The most common side effects in patients receiving Docetaxel Winthrop (seen in more than 1 patient in 10) are neutropenia (reduction in the number of white blood cells), anemia (decrease in the number of red blood cells), thrombocytopenia (low number of platelets ), febrile neutropenia, peripheral sensory neuropathy (damage to the nervous system that causes numbness, irritation and pain in the hands and feet), peripheral motor nemopathy (damage to the nerves that causes difficulties in coordinating movements), dysgeusia (alteration of taste sensitivity), dyspnoea (difficulty in breathing), stomatitis (inflammation of the mucous membranes covering the mouth), diarrhea, nausea, vomiting, alopecia (hair loss), skin reactions, nail changes, myalgia (muscle pain), anorexia (loss of appetite) ), infections, fluid retention, asthenia (weakness), pain and hypersensitivity (allergic reactions). These side effects may increase if Docetaxel Winthrop is given in combination with other anticancer drugs. For the full list of all side effects reported with Docetaxel Winthrop, see the Package Leaflet.
Docetaxel Winthrop should not be used in people who may be hypersensitive (allergic) to docetaxel or any of the other ingredients. Docetaxel Winthrop should not be used in patients whose neutrophil count is less than 1 500 cells / mm3, in the event of pregnancy or lactation, or in patients with severe liver disorders.
Why has Docetaxel Winthrop been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Docetaxel Winthrop outweigh the risks in the treatment of: breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of the head and neck. The Committee recommended the release of the marketing authorization for Docetaxel Winthrop.
More information on Docetaxel Winthrop
On 20 April 2007, the European Commission issued a marketing authorization for Aventis Pharma SA for Docetaxel Winthrop, valid throughout the European Union.
For the full evaluation (EPAR) of Docetaxel Winthrop click here.
Last update of this summary: 11-2007
