What is TAXOTERE?
TAXOTERE is composed of a concentrate and a solvent to make up a solution for infusion (drip into a vein). The active substance is docetaxel.
What is TAXOTERE used for?
TAXOTERE is an anticancer medicine indicated for the treatment of:
- breast cancer. It can 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 TAXOTERE used?
The use of TAXOTERE must be limited to the departments specialized in chemotherapy and its administration must be carried out under the supervision of a doctor authorized to administer anticancer chemotherapy. TAXOTERE 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, one day before and two days after treatment.
TAXOTERE 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 TAXOTERE work?
The active substance in TAXOTERE, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the cells' ability to destroy the internal "skeleton" that 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.
What studies have been carried out on TAXOTERE?
TAXOTERE 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 348 head cancer patients and neck. In most of these studies, TAXOTERE was used in combination with other anticancer treatments and was compared to combinations of different treatments or with the same treatment without TAXOTERE. As with many cancer studies, the main parameters of effectiveness were response rates (percentage of patients whose cancer responded to treatment), time to progression and increased survival time.
What benefit has TAXOTERE shown during the studies?
The combination of TAXOTERE 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, prostate cancer, gastric adenocarcinoma and tumor of the head and neck). In the treatment of breast cancer used as monotherapy, TAXOTERE was 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 are the risks associated with TAXOTERE?
The most common side effects in patients receiving TAXOTERE (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 platelet count in the blood), febrile neutropenia, peripheral sensory neuropathy (nerve damage with numbness, tingling and pain in hands and feet), peripheral motor neuropathy (nerve damage with difficulty in coordinating movements), dysgeusia (alteration of gustatory perception), dyspnea (wheezing), stomatitis (inflammation of the mucous membrane of 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 TAXOTERE is given in combination with other anticancer drugs. For the full list of all side effects reported with TAXOTERE, see the Package Leaflet.
TAXOTERE should not be used in people who are hypersensitive (allergic) to docetaxel or any of the other substances. TAXOTERE should not be used in patients whose neutrophil count is less than 1 500 cells / mm3, in case of pregnancy or lactation, or in patients with severe liver disorders.
Why has TAXOTERE been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of TAXOTERE 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 CHMP therefore recommended granting marketing authorization for TAXOTERE.
TAXOTERE was originally authorized in "exceptional circumstances" because only limited information was available for scientific reasons at the time the authorization was granted. After the company has notified the requested additional information, the term "exceptional circumstances" is expired on 7 July 1998.
More information on TAXOTERE
On November 27, 1995, the European Commission issued a marketing authorization valid for TAXOTERE, valid throughout the European Union, to Aventis Pharma SA. The marketing authorization was renewed on 27 November 2005.
For the full version of the evaluation (EPAR) of TAXOTERE click here.
Last update of this summary: 11-2007.
