Active Substance: docetaxel
Common Name: docetaxel
ATC Code: L01CD02
Marketing Authorisation Holder: Aventis Pharma S.A.
Active Substance: docetaxel
Authorisation Date: 2007-04-20
Therapeutic Area: Carcinoma, Non-Small-Cell Lung Prostatic Neoplasms Head and Neck Neoplasms Stomach Neoplasms Adenocarcinoma Breast Neoplasms
Pharmacotherapeutic Group: Antineoplastic agents
Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
- operable node-positive breast cancer;
- operable node-negative breast cancer.
For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.
Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.
Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
Non-small-cell lung cancer
Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.
Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Docetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.
Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Head and neck cancer
Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
What is Docetaxel Winthrop?
Docetaxel Winthrop is a medicine that contains the active substance docetaxel. It is available in two forms:
- as two vials (one containing a concentrated solution and the other containing a solvent), whose contents are mixed together before being made up into a solution for infusion (drip into a vein);
- a single vial containing a concentrate that is ready to make up into a solution for infusion.
What is Docetaxel Winthrop used for?
Docetaxel Winthrop is used to treat the following types of cancer:
- breast cancer. Docetaxel Winthrop can be used on its own after other treatments have failed. It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
- non-small-cell lung cancer. Docetaxel Winthrop can be used on its own after other treatments have failed. It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;
- prostate cancer, when the cancer does not respond to hormonal treatment. Docetaxel Winthrop is used with prednisone or prednisolone (anti-inflammatory medicines);
- gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Docetaxel Winthrop is used with cisplatin and 5-fluorouracil (other anticancer medicines);
- head and neck cancer in patients whose cancer is locally advanced (has started to spread to other parts of the body). Docetaxel Winthrop is used with cisplatin and 5-fluorouracil.
For full details, see the summary of product characteristics (also part of the EPAR).
The medicine can only be obtained with a prescription.
How is Docetaxel Winthrop used?
Docetaxel Winthrop should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Docetaxel Winthrop is given as a one-hour infusion (drip into a vein) every three weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Docetaxel Winthrop is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3). Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Winthrop infusion. 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 ability of cells to destroy the internal ‘skeleton’ that allows them to divide and multiply. With the skeleton still in place, the cells cannot divide and they eventually die. Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
How has Docetaxel Winthrop been studied?
Docetaxel Winthrop has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-cell-lung-cancer patients, 1,006 prostate-cancer patients, 457 gastric-adenocarcinoma patients and 897 head- and neck-cancer patients. In most of these studies, Docetaxel Winthrop was combined with other anticancer treatments and compared either with combinations of different treatments or with the same treatments but without Docetaxel Winthrop. The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived.
What benefit has Docetaxel Winthrop shown during the studies?
Adding Docetaxel Winthrop to other anticancer treatments produced increases in the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived, in all five types of cancer. When used on its own, Docetaxel Winthrop was at least as effective as and sometimes more effective than the comparator medicines in breast cancer, and more effective than best supportive care (any medicines or techniques to help patients, but not other anticancer medicines) in lung cancer.
What is the risk associated with Docetaxel Winthrop?
The most common side effects with Docetaxel Winthrop (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils), anaemia (low red-blood-cell counts), thrombocytopenia (low blood platelet counts), febrile neutropenia (neutropenia with fever), peripheral sensory neuropathy (nerve damage in the hands and feet), peripheral motor neuropathy (damage to the nerves causing difficulty coordinating movements), dysgeusia (taste disturbances), dyspnoea (difficulty breathing), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss), skin reactions, nail disorders, myalgia (muscle pain), loss of appetite, infections, fluid retention, asthenia (weakness), pain and hypersensitivity (allergic reactions). These side effects may be more severe when Docetaxel Winthrop is used with other anticancer medicines. 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 must not be used in patients who have a neutrophil count of less than 1,500 cells/mm3 or who have severe problems with their liver.
Why has Docetaxel Winthrop been approved?
The CHMP decided that Docetaxel Winthrop’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about Docetaxel Winthrop
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Winthrop on 20 April 2007. This authorisation was based on the authorisation granted to Taxotere in 1995 (‘informed consent’).
For more information about treatment with Docetaxel Winthrop, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
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