Taxotere

Taxotere and Cancer Growth

Taxotere is indicated to treat various types of cancer, including breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, gastric adenocarcinoma (stomach cancer), and head and neck cancer. Its earliest FDA-approval was for the treatment of NSCLC in 1999. Prostate and breast cancer approvals followed in 2004, with stomach, head and neck cancers obtaining approval for treatment with Taxotere in 2006.

Cancer is the name given to a collection of related diseases where the body’s cells begin to divide without stopping and spread into surrounding tissues, according to the National Institutes of Health (NIH). This phenomenon can occur most anywhere in the human body as it is made up of trillions of cells.

In a noncancerous framework, the body’s cells grow and divide to form new cells as they become needed. The old or damaged cells then die off so the new cells can take their place. With cancer, this process breaks down, as old or damaged cells remain alive when they should otherwise die, and new cells continue to form when they’re not needed. As these extra cells begin to divide they can form growths called tumors.

Cancerous tumors are called malignant, meaning they can spread into, or invade, nearby tissues. Some cancer cells can also break off and travel through the blood or the lymphatic system (a part of the circulatory system and a vital part of the immune system that protects against disease) forming new tumors distant from the original one.

In patients with breast cancer, Taxotere is indicated to treat those cases which are locally advanced or metastatic after failure of prior chemotherapy. Taxotere is also used as an adjuvant (a substance that aids another or modifies the effect of other agents) treatment in patients with operable node-positive breast cancer (meaning it has been found in the lymph nodes in the armpit area) in combination with doxorubicin and cyclophosphamide.

How Does Taxotere Work?

Like other types of chemotherapy drugs, Taxotere works by stopping cells from dividing and multiplying. Normal, healthy cells stop dividing when they are around similar cells. Cancer cells are damaged and no longer have the ability to stop dividing. This is how cancer continues to spread. Chemotherapy drugs like Taxotere attack the cancer cells’ DNA or RNA so the tumor can no longer copy itself and spread.

Along with another chemo drug called Paclitaxel, Taxotere belongs to a specific class of drug called a taxane. Taxanes are made from plant alkaloids. Specifically, Taxotere is made from the bark of the Pacific Yew tree. It works by inhibiting microtubules within cancer cells. Microtubules are necessary for cell division and replication. When the cell can no longer divide or replicate, it dies.

Permanent Hair Loss Linked to Taxotere

While chemotherapy is known to cause hair loss, most cases resolve in three to six months after the treatment is finished, and the patient’s hair completely regrows. Hair loss following chemotherapy is one of the most distressing side effects of treatment. Studies show it has a direct impact on quality of life. Permanent hair loss can be devastating.

Some studies now show that Taxotere can cause permanent, irreversible alopecia. All body hair is affected, including eyebrows, eyelashes and pubic hair.

Side Effects of Taxotere

In addition to the risk of permanent hair loss, this drug has a number of other side effects associated with its use. Many of these are reversible, though in some cases these complications can result in death.

Toxic death occurred in about 2 percent (19 out of 965) of metastatic breast cancer patients using Taxotere, according to Warnings and Precautions section of the medication insert. The deaths occurred at a dose of 100 mg/m2. Death occurred in 11.5 percent (7 out of 61) of patients with other tumor types with abnormal liver function.

FDA Black Box Warning on Taxotere

Taxotere includes a black box warning (or boxed warning), the FDA’s most serious type of warning, for several conditions that can result in serious injury or death for patients given the chemotherapy drug.

Dosage and Administration of Taxotere

There is no oral pill form of Taxotere. The drug is instead, given intravenously. One day before therapy starts, patients take corticosteroid pills to reduce fluid retention and allergic reactions to the drug. This continues for three days. Depending on a patient’s height, weight, type of cancer and general health, the doctor will determine the dose and schedule of chemotherapy.

Doctors will first try to reduce the dose, but if the symptoms worsen or continue at lower doses, the treatment should be discontinued.

Overdose

In case of a possible overdose, patients need to be monitored and given granulocyte-colony stimulating factor (G-CSF). G-CSF is a protein that causes the bone marrow to produce stem cells and white blood cells and release them into the blood stream. These cells will help prevent infection and fever.

According to the medication insert, two overdoses were reported in patients. Both patients experienced asthma, skin reactions and tingling or prickling of the skin; but they both recovered following appropriate treatment.

Taxotere Drug Interactions and Contraindications

When Taxotere is used along with cytochrome P450 3A4 (CYP3A4) inducers, inhibitors or substrates it may alter the metabolism of the drug’s active ingredient docetaxel (a CYP3A4 substrate). Cytochrome P450 3A4 is an important enzyme in the body, mainly occurring in the liver and the intestine. It metabolizes approximately 50 percent of all marketed drugs in the body, according to the National Institutes of Health (NIH).

In pregnant women, Taxotere can cause harm to the fetus, as shown in animal studies. The drug label advises that women taking Taxotere should avoid becoming pregnant. It is not known if Taxotere is excreted into a nursing mother’s milk, but there is a potential for serious adverse reactions to nursing infants if exposure occurs.

When Taxotere is administered to children, the alcohol content of docetaxel should be considered with dosing. In general, dosing for an elderly patient should be cautious, reflecting the greater frequency of decreased liver, kidney and cardiac function, and the presence of other diseases and/or drug treatments, in this specific population.

Patients with impaired liver function exhibiting unusually high bilirubin levels should not be given Taxotere. Bilirubin is a brownish-yellow substance found in bile that is produced when old red blood cells are broken down in the liver. High levels of the substance can lead to jaundice, which often results in the yellowing of the skin and eyes. The alcohol content of Taxotere should be taken into account when administering the drug to patients with liver impairment.