Results show that the use of a Taxotere® injection concentrate-based regimen after surgery reduces the risk of relapse by 28 percent and decreases in the risk of death by 30 percent. The New England Journal of Medicine is the first to publish the phase III study results.
The Breast Cancer International Research Group (BCIRG) held the trial with 1,491 women from around the world in 112 sites in 20 countries between June 1997 and June 1999. The women were treated after surgery with Taxotere, doxorubicin and cyclophosphamide (TAC) or with a standard adjuvant regiment consisting of 5-fluorouracil, doxorubicin (FAC) and cyclophosphamide. In both treatment groups more than 90 percent of the women received all six cycles of the treatment.
These results were found in women with operable, node-positive breast cancer 55 months after their follow-ups. The outcome was looked at regardless of the women’s nodal, hormone-receptor, menopausal and HER-2/neu status. The risk of relapse was lowered in both the hormone receptor positive and hormone receptor negative patients regardless of the amount of positive lymph nodes present.
At the 55 month follow-up, no unexpected side effects were identified, and results were consistent with observations made at 33 months. It was noted that the TAC arm had a lower white blood cell count than the FAC arm, though infection in both groups remained similar.
The other side effects occurring in 5 percent or more of the patients in the TAC arm were neutropenia, nausea, stomatitis and asthenia, whereas the FAC arm experienced neutropenia, nausea, vomiting and asthenia. In the Taxotere arm, 87 percent (9 out of 10) of the women treated were alive after five years while only 81 percent (8 out of 10) in the arm not using Taxotere survived. This treatment can benefit more women who have early stage breast cancer.
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Taxotere when used along with doxorubicin and cyclophosphamide has FDA and EMEA approval and is the only FDA-approved drug in the taxane class with a disease-free survival benefit in both hormone receptor positive and negative disease. This drug is indicated for patients with locally advanced or metastatic breast cancer after the failure of prior chemotherapy.
Taxotere has important safety information that each patient should be aware of. This treatment may cause serious, physically limiting and potentially life-threatening side effects such as infection, low blood cell counts, allergic reaction and retention of excess fluid. Patients with low white blood cell counts, abnormal liver function or a history of allergic reactions to Taxotere or ingredients found in Taxotere should not receive treatment. Prior to receiving Taxotere treatment patients should take dexamethasone, which can help in lowering the risk of fluid retention and allergic reaction. Taxotere should only be given by a qualified physician who is experienced with anticancer treatments.
Common side effects seen in patients were nausea, vomiting, hair loss, rash, infusion site reactions, odd sensations (numbness, tingling or burning), weakness in the hands and feet, nail changes, muscle and bone pain or excessive tearing. It is noted that those over 65 may experience these side effects more frequently. Taxotere should not be used by pregnant women or those trying to become pregnant.
Doctors should be informed of any allergies or medicine that the patient is taking; this includes nonprescription drugs, vitamins and dietary or herbal supplements. They should be contacted if the patient experiences warm sensations, tightness in the chest, itching or hives, shortness of breath, and any of the other listed side effects.
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