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New treatment option approved for head and neck
Source: (cancerfacts.com)
Wednesday, October 03, 2007
BRIDGEWATER, NJ – Oct. 3, 2007 – Based on a study showing a significantly lower risk of dying, the U.S. FDA has approved a new treatment regimen for initial treatment of advanced cancers of the head and neck.
Docetaxel marketed by pharmaceutical giant Sanofi-Aventis as Taxotere® has long been approved for breast, lung, gastric, and prostate cancers. The new FDA approval involves the addition of Taxotere to the current standard treatment of cisplatin and 5-fluorouracil for patients with locally advanced cancers of the mouth, throat, larynx, oropharynx and hypopharynx.
The FDA based its approval on the results of a large international clinical trial comparing the Taxotere-based regimen to the standard regimen, called TAX 324, which showed a 3-year survival advantage for the Taxotere group.
"The TAX 324 trial found that the addition of Taxotere to standard induction chemotherapy significantly improved patient survival, adding years to patients' lives," said lead investigator Dr. Marshall Posner, medical director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute in Boston. "The approval of Taxotere to be given in combination with other standard chemotherapy as the first step in a therapeutic sequence followed by chemoradiotherapy and surgery is a significant advancement in treatment for patients with locally advanced head and neck cancer."
Among 251 patients treated with Taxotere-based therapy the relative risk of death was reduced by 30 percent compared to the 243 patients receiving just cisplatin and 5-FU. Patients treated with the Taxotere combination regimen survived a median of 70.6 months compared to 30.1 months for patients receiving cisplatin and 5-fluorouracil. This represents a more than three year improvement in median overall survival for patients treated with the Taxotere regimen. The probability that patients in the Taxotere group would survive three years was 62 percent compared to 48 percent in the cisplatin 5-fluorouracil.
All patients in the trial had tumors of the head and neck that either could not be removed, were considered potentially operable but unlikely to be cured with surgery, or could not be removed in order to preserve organ function.
The regimen involved treatment every three weeks for three cycles with either Taxotere, cisplatin and 5-FU or cisplatin and 5-FU, the standard therapy. The study was designed primarily to evaluate overall survival. They also evaluated the amount of time the regimen halted the growth of the cancer (progression-free survival), how the tumors responded to the regimen (response rates), and how well patients tolerated the combination of drugs. They also evaluated the quality of life and clinical benefits.
Overall, 65 percent of the patients experienced serious or severe side effects on the Taxotere regimen compared to 62 percent of those on the standard cisplatin, 5-FU regimen. This indicates that the Taxotere does not add substantially to the toxicity of the treatment.
The most common side effects were fever associated with a loss of infection-fighting white cells (febrile neutropenia), which occurred in 12 percent of the Taxotere group compared to 7 percent of the standard therapy group. Also, 84 percent of the Taxotere group experienced loss of white blood cells (neutropenia) compared to 56 percent of those on the standard regimen. Uncommon side effects included dizziness, loss of hair, and diarrhea, all of which were experienced by less than 7 percent of the participants.
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