Taxotere (Docetaxel)
Docetaxel, more popularly known as Taxotere, is a relatively new drug that has been tested and marketed for other forms of cancer besides mesothelioma.
After being discontinued from the Alimta trial at the San Antonio Cancer Therapy and Research Center (CTRC), however, one of our clients returned home to his oncologist who prescribed Taxotere to treat his mesothelioma. We could find no statistics regarding Taxotere’s efficacy against mesothelioma, and the results of the treatment in our client’s case are, as of yet, unclear; however, we offer you available information on the drug in its own right as a possible line of defense against this terrible disease. Naturally, we are neither doctors nor drug research specialists, and would urge you to conduct your won research and consult with your doctors.
The following is based on research we were able to find on the internet. We are posting this information so that it may help patients explore their options and ask follow up questions with their own doctors. We have no independent opinions on the merits or efficacy of the drug or its treatment regimen.
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Docetaxel, branded as Taxotere, is the bridge to a newer generation of pharmaceuticals designed to attack cancer. Standard chemotherapies attack the structures of cancer cells; however, in addition to hammering the tumor, they often kill off healthy cells. This effect is commonly called "toxicity." Docetaxel, unlike the newer medications, Iressa and Tarceva, is still considered chemotherapy, but like the other two drugs, it is less toxic to the cancer patient than other chemotherapies.
Developed and manufactured by Aventis Pharmaceuticals, AG, Taxotere (docetaxel) is an antineoplastic agent belonging to the taxoid family, according to labeling information provided by the Food and Drug Administration (FDA). The reports available through the FDA go on to report that Taxotere is related to Taxol and is derived from the needles of yew plants. In pure form, it is a white powder that is practically insoluble in water. As an injection concentrate suitable for treatment, it is a yellow to brownish-yellow viscous solution.
According to the data from CenterWatch online, in order for cells, including cancer cells, to replicate, they must undergo a process called mitosis, or cell division. Mitosis can only happen when microtubules in cells disassemble. Docetaxel chemically latches onto free tubulin, aids in transforming them into stable microtubules and prevents them from coming apart, thereby stopping cell division and the construction of more tumor.
In several clinical trials reported by both the FDA and Aventis, Taxotere (docetaxel) was measured in efficacy against other perennial treatment regimens such as vinorelbine, ifosfamide and doxorubicin, beating out all three in terms of survival percentage of the patient group for given periods of time (usually one and two years) as well as median survival time by relatively wide margins. The recommended dosage of Taxotere based on trials is 75mg/ m², and the time required for dosage application is shorter than with other chemotherapies.
Thus far, docetaxel has been tested for its efficacy and safety in both breast cancer and non-small cell lung cancer (NSCLC) as a second-line defense. Tested in efficacy against breast cancer versus the tried treatments – doxorubicin or a combination of mytomycin and vinblastine – in patients who had previously undergone alkylating- or anthracycline-containing regimens, respectively, docetaxel purportedly increased both median survival rates and times to progression of the disease.
When tested in efficacy against NSCLC, all patients tested had a prior history of platinum-based chemotherapy. The drug was tested against vinorelbine or ifosfamide. Docetaxel purportedly increased survival time and time to progression marginally.
According to an Aventis press release at the time of the drug’s approval, median survival for NSCLC patients treated with Taxotere was 7.5 months, an increase in three months over the alternative. In another study, patients treated with Taxotere had a 30 percent one-year survival rate, while patients treated with vinorelbine and ifosfamide had a 20 percent one-year survival rate.
Additionally, the results of a Phase III study at the University of Texas, M.D. Anderson Cancer Center in Houston, Texas, were released on October 24, 2001. The study compared the efficacy of a combination of Taxotere and Cisplatin versus a combination of vinorelbine and Cisplatin in patients with NSCLC. The two-year survival rate for the patients taking the Taxotere regimen was at 21 percent, as compared to the 14 percent two-year survival rate for patients on the vinorelbine regimen. One-year survival in the patients treated with Taxotere came in at 46 percent, and patients who received vinorelbine had a one-year survival rate of 41 percent. A third group was treated with Taxotere and Carboplatin. Survival rates for that group were not immediately available.
The drug was submitted to the FDA and was approved for treatment of NSCLC on December 23, 1999. It was approved for treatment of breast cancer in May 1996.
Currently, Taxotere is recommended for locally advanced or metastatic breast cancer after failure of prior chemotherapy and for locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.
As of March 2002, Aventis was reporting that Taxotere’s efficacy was being maximized by combining it with anthracycline-based chemotherapy. The pharmaceutical company goes on to say that survival has increased by several months in treating patients and the percentage of patients delaying progression has jumped.
Side effects of the drug include the following:
- Neutropenia – a decrease in neutrophilic leukocytes, which are cells found in the bloodstream. The loss of them can produce infections, sometimes fatal.
- Thrombocytopenia – low platelet count.
- Myelosuppression – low blood cell counts.
- Hypersensitivity – patients developing this or having a history should not use this treatment.
- Fatigue.
- Nausea.
- Hair loss.
- Anyone with prior or ongoing liver impairment should not take Taxotere.
- Taxotere can also be harmful or fatal to a fetus or embryo.
Aventis notes that "All patients should be premedicated with an oral corticosteroid prior to the initiation of the infusion of Taxotere." Aventis also states that there is no known antidote for Taxotere overdosage. The recommended dosage of Taxotere for NSCLC is 75mg/m².
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Note: The above list of side effects is by no means comprehensive or complete. Patients must consult with their doctors before taking this medication. For more complete information regarding Taxotere, its benefits and its side effects, please visit www.taxotere.com or www.aventispharma-us.com.
-Sources consulted for this story include CenterWatch.com Clinical Trials Listing Service, the National Library of Medicine’s Medline Plus Health Information Website, the Food and Drug Administration and press releases from Yahoo!’s Business Wire, as well as information provided by Aventis Pharmaceuticals, AG, and the American Society of Clinical Oncology.
** POSTED APRIL 23, 2002 **