Following the death of 5 women with breast cancer treated with docetaxel, the National Medicines Safety Agency (ANSM) has launched a pharmacovigilance investigation.
48 patients with operable breast cancer treated with docetaxel died as a result of their treatment, according to the ANSM press release.
“187 cases of colitis or septic shock have been reported. Of these, 48 led to a fatal outcome. The majority of these deceased patients suffered from a breast cancer“, concluded the ANSM.” In relation to some 400,000 people treated, deaths are rare (around 1 / 10,000) for a drug that has reduced mortality in many cancers “, emphasizes the agency.
Continue the investigation
To establish all the risks caused by docetaxel, the pharmacovigilance survey will be extended to all the adverse effects. Just as a survey will also be set up for specialties based on paclitaxel, an alternative to docetaxel in the treatment of breast cancer early.
“In the meantime, the recommendation of not using docetaxel in localized operable breast cancers is maintained,” says the Agency. “Regarding the use of docetaxel in other indications and in view of the short time to onset of these adverse effects, close, systematic and above all early monitoring (clinical and biological) of patients is required. A systematic prescription of growth factors is also recommended ”.
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